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epoetin alfa

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Description

Epoetin Alfa: A recombinant glycosylated form of erythropoietin which stimulates the differentiation and proliferation of erythroid precursors. It is used for the treatment of ANEMIA associated with CHRONIC RENAL FAILURE in dialysis and predialysis patients. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID92043599
MeSH IDM0028770

Synonyms (4)

Synonym
113427-24-0
epoetin alfa
rhepo
(4r,5s,6s,7r,9r,10r,11e,13e,16r)-10-[(2r,4r,5s,6s)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-6-[(2s,3r,4r,5s,6r)-5-[(2r,4r,5s,6s)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-7-(2-hydroxyethyl)-5-methox

Research Excerpts

Overview

Darbepoetin alfa (DA) is a long-acting ESA used to treat anemia in premature neonates and in children with chronic kidney disease or on cancer chemotherapy. It is an erythropoiesis-stimulating glycoprotein with up to 3 times longer half-life than recombinant human erythroietin (rHuEPO) in humans.

ExcerptReferenceRelevance
"Darbepoetin alfa (DA) is a long-acting ESA used to treat anemia in premature neonates and in children with chronic kidney disease or on cancer chemotherapy."( Darbepoetin Alfa for Late-onset Anemia in Neonates with Rhesus Hemolytic Disease.
Rv, S; S, R, 2023
)
1.95
"Darbepoetin alfa is a new erythropoietic protein with greater biologic activity and a longer dosing interval than those of r-HuEPO."( Darbepoetin alfa, a new therapy for the management of anemia of chronic kidney disease.
Hudson, JQ; Sameri, RM, 2002
)
1.35
"Darbepoetin alfa is a new erythropoietic agent with a 3-fold longer half-life and increased in vivo potency relative to r-HuEPO."( Dose conversion from recombinant human erythropoietin to darbepoetin alfa: recommendations from clinical studies.
Scott, SD, 2002
)
1.04
"Darbepoetin alfa is an erythropoiesis-stimulating glycoprotein with up to 3 times longer half-life than recombinant human erythropoietin (rHuEPO) in humans. "( [Treatment of renal anemia with darbepoetin alfa administered once every other week in predialysis patients with chronic kidney disease and previously treated with epoetin alfa].
Cacho, M; De Gracia, MC; García Hernández, MA; Molina, M; Navarro, MJ; Pérez Silva, F, 2004
)
1.16
"Epoetin alfa is an established treatment of anemia in patients with cancer who are receiving chemotherapy with or without radiation therapy. "( Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy.
Shasha, D; Williams, D, 2006
)
2.23
"Epoetin alfa appears to be a safe alternative to PAD in patients who are at risk for transfusion in the perioperative period following total knee arthroplasty."( Preoperative epoetin alfa vs autologous blood donation in primary total knee arthroplasty.
Deutsch, A; Marcus, RE; Spaulding, J, 2006
)
1.42
"Darbepoetin alfa also is an effective treatment for anemia in patients with cancer not receiving chemotherapy, at extended dosing intervals of at least 3 weeks."( Darbepoetin alfa: an effective treatment with flexible and simplified dosing for anemia in patients with cancer.
Natale, JJ; Stevenson, JG, 2007
)
1.38

Effects

Epoetin alfa has been used to treat the anemia that develops in the HDCT setting. It has been shown to accelerate erythropoiesis and reduce allogeneic blood transfusion in major elective, noncardiac, nonvascular surgery.

ExcerptReferenceRelevance
"Darbepoetin alfa has a longer half-life than epoetin alfa, enabling less frequent administration."( Novel approaches to anemia associated with cancer and chemotherapy.
Kolesar, JM, 2002
)
0.8
"Epoetin alfa has been the standard of therapy for patients with renal disease and cancer-related anemia for more than a decade."( Clinical and economic comparison of epoetin alfa and darbepoetin alfa.
Boggie, D; DeLattre, M; Morreale, A; Plowman, B; Schaefer, M, 2004
)
1.32
"Epoetin alfa has been well tolerated so far in the study."( A new dose-intense epoetin alfa regimen effective in anemic cancer patients receiving chemotherapy: an open-label, non randomized, pilot study.
Cassandro, R; Dicuonzo, G; Esposito, V; Groeger, AM; La Cesa, A; Malafarina, V; Montesarchio, V; Navajas, F; Santini, D; Tonini, G; Vincenzi, B; Virzi, V,
)
1.18
"Epoetin alfa has been used to treat the anemia that develops in the HDCT setting."( Epoetin alfa and high-dose chemotherapy.
Henry, DH, 1998
)
2.46
"Epoetin alfa has been widely used to treat the anemia that develops in the HDCT setting."( [The use of erythropoietin alpha in programs of high-dose chemotherapy].
Aglietta, M; Danova, M; Ferrari, S; Henry, D; Perillo, A; Pierelli, L; Scambia, G, 2000
)
1.03
"Epoetin alfa has been shown to accelerate erythropoiesis and reduce allogeneic blood transfusion in major elective, noncardiac, nonvascular surgery and in certain anemic patients with chronic renal failure, nonmyeloid malignancies and human immunodeficiency virus infection."( Erythropoietin, the biology of erythropoiesis and epoetin alfa. An overview.
Bieber, E, 2001
)
1.29
"Epoetin alfa has been shown to safely increase preoperative hemoglobin (Hb) levels in anemic patients undergoing elective noncardiac, nonvascular surgery and is more effective than preoperative autologous blood donation in reducing the need for perioperative blood transfusions in orthopedic surgery patients."( Clinical experience with epoetin alfa in the management of hemoglobin levels in orthopedic surgery and cancer. Implications for use in gynecologic surgery.
Stovall, TG, 2001
)
1.34
"Epoetin alfa has been shown to increase haemoglobin concentration, decrease transfusion requirements and increase quality of life."( Managing cancer-related anaemia with epoetin alfa.
Itri, LM, 2002
)
1.31
"Epoetin alfa has been in use for over a decade to increase hemoglobin in patients with cancer who develop chemotherapy-associated anemia. "( The use of epoetin alfa in chemotherapy patients: a consistent profile of efficacy and safety.
Itri, LM, 2002
)
2.15

Actions

ExcerptReferenceRelevance
"Epoetin alfa patients had lower transfusion requirements (28.2% versus 33.3%), improvement or preservation versus deterioration of quality of life, and a higher proportion of responders (patients achieving a > or = 2 g/dL increase in hemoglobin levels unrelated to transfusion) (68.0% versus 22.9% for placebo)."( Efficacy of epoetin alfa in a retrospective non-stratified subgroup analysis of a breast cancer cohort receiving non-platinum chemotherapy.
Bajetta, E; da Costa, RM; Guastalla, JP; Janmohamed, R; Matulonis, U; Reinhardt, U; Vercammen, E,
)
1.23

Treatment

Treatment with epoetin alfa has repeatedly been shown to improve the quality of life (QoL) of cancer patients with anaemia. The treatment is associated with an increase in the incidence of thrombotic events.

ExcerptReferenceRelevance
"The Epoetin alfa-treated group showed a statistically significant improvement in the Kidney Disease Questionnaire symptom of fatigue in comparison with placebo."( Dialysis patients treated with Epoetin alfa show improved anemia symptoms: A new analysis of the Canadian Erythropoietin Study Group trial.
Agodoa, I; Churchill, DN; Gandra, SR; Gantotti, S; Gitlin, M; Keown, PA; Lei, L; Mayne, TJ; Poulin-Costello, M, 2010
)
1.13
"Epoetin alfa treatment is optional for patients with cancer-related anemia and hemoglobin levels>10 g/dL and <12 g/dL, depending on clinical circumstances."( Epoetin alfa therapy for patients with hematologic malignancies and mild anemia.
Straus, DJ, 2003
)
2.48
"Epoetin alfa treatment was well tolerated."( Epoetin alfa corrects anemia and improves quality of life in patients with hematologic malignancies receiving non-platinum chemotherapy.
de Wasch, G; Freund, M; Littlewood, TJ; Nortier, J; Pawlicki, M; Rapoport, B; Schuette, W; Vercammen, E; Wils, J, 2003
)
2.48
"Epoetin alfa treatment in patients with a variety of malignancies has been shown to decrease transfusion requirements and improve hemoglobin levels and quality-of-life efficacy parameters."( Efficacy of epoetin alfa in a retrospective non-stratified subgroup analysis of a breast cancer cohort receiving non-platinum chemotherapy.
Bajetta, E; da Costa, RM; Guastalla, JP; Janmohamed, R; Matulonis, U; Reinhardt, U; Vercammen, E,
)
1.23
"Epoetin alfa treatment was well tolerated."( Efficacy of epoetin alfa in a retrospective non-stratified subgroup analysis of a breast cancer cohort receiving non-platinum chemotherapy.
Bajetta, E; da Costa, RM; Guastalla, JP; Janmohamed, R; Matulonis, U; Reinhardt, U; Vercammen, E,
)
1.23
"Epoetin alfa treatment was started on average at an Hb level of 10.6g/dl for NSCLC and 10.4g/dl for SCLC, respectively."( Anaemia management with epoetin alfa in lung cancer patients in The Netherlands.
Biesma, B; Brok, RG; Melissant, CF; van de Werf, PR, 2007
)
1.37
"The Epoetin alfa treatment would continue for a total of 16 weeks."( Antianemic effect of once weekly regimen of epoetin alfa 40,000 units in anemic cancer patients receiving chemotherapy.
Sriuranpong, V; Suwanrusme, H; Voravud, N, 2007
)
1.08
"Epoetin alfa treatment was also associated with significantly higher reticulocyte counts and serum erythropoietin levels in the preoperative period compared with placebo."( Use of epoetin alfa in autologous blood donation programs for patients scheduled for elective cardiac surgery.
Althaus, U; Galliker, B; Haeberli, A; Nydegger, UE; Rosenmund, A; Spirig, P; Walpoth, B, 1996
)
1.47
"Epoetin alfa treatment plus either oral or IV iron supplementation significantly increased total RBC production, Hb, Hct, and reticulocytes over the values seen with the respective placebo treatments (p = 0.0001). "( Role of oral versus IV iron supplementation in the erythropoietic response to rHuEPO: a randomized, placebo-controlled trial.
Gassmann-Mayer, C; Hayes-Licitra, SA; Megens, JG; Musto, P; Nogarin, L; Olijhoek, G; Vercammen, E, 2001
)
1.75
"Treatment with epoetin alfa resulted in significant increases in hemoglobin (P<0.0001)."( Treating anemia in older adults with heart failure with a preserved ejection fraction with epoetin alfa: single-blind randomized clinical trial of safety and efficacy.
Chakraborty, B; Helmke, S; Mancini, D; Maurer, MS; Teruya, S, 2013
)
0.95
"Treatment with epoetin alfa also improved health-related quality of life in anemic cancer patients undergoing chemotherapy, and several controlled studies have documented increases in quality-of-life scores correlated with increases in hemoglobin."( Chemotherapy-induced cognitive dysfunction: a clearer picture.
O'Shaughnessy, JA, 2003
)
0.66
"Treatment with epoetin alfa for this mixed anemia significantly improved hemoglobin levels and quality of life, and enabled adequate dosages of ribavirin to be maintained."( Epoetin alfa for the treatment of combination therapy-induced hemolytic anemia in patients infected with hepatitis C virus.
Chawla, S; Rivkin, AM, 2005
)
2.11
"Treatment with epoetin alfa has repeatedly been shown to improve the quality of life (QoL) of cancer patients with anaemia. "( Meta-analysis of the effects of epoetin alfa treatment on quality of life in anaemic cancer patients.
, 2005
)
0.96
"Treatment with epoetin alfa, an erythropoiesis-stimulating agent, as a means of reducing transfusion requirements has been studied in the critically ill and in patients receiving long-term mechanical ventilation."( Anemia in the long-term ventilator-dependent patient with respiratory failure.
Silver, MR, 2005
)
0.67
"Treatment with epoetin alfa as a single weekly dose significantly increased Hb levels in patients with cancer who were undergoing radiotherapy. "( Once-weekly dose of epoetinum alfa in cancer patients with anemia receiving radiotherapy.
Carrizosa, CL; de Dios Sáez Garrido, J; Delgado Pérez, JM; Ocaña, CV; Ots, PM; Pérez, AR, 2005
)
0.68
"Treatment with epoetin alfa is associated with an increase in the incidence of thrombotic events."( Efficacy and safety of epoetin alfa in critically ill patients.
An, R; Bowers, PJ; Burton, P; Corwin, HL; Corwin, MJ; Fabian, TC; Gettinger, A; Heard, S; Klausner, MA; May, A; Pearl, RG, 2007
)
0.99
"Treatment with epoetin alfa led to an increase (albeit nonsignificant) in the number of AB units predonated compared with i.v."( Epoetin alfa plus autologous blood donation in patients with a low hematocrit scheduled to undergo orthopedic surgery.
Tryba, M, 1996
)
2.08
"Treatment with epoetin alfa has also been shown to increase Hb and HCT levels and improve QOL in anemic cancer patients undergoing chemotherapy."( Epoetin alfa use in gynecology. Past, present and future.
Bachmann, GA, 2001
)
2.09
"Treatment with epoetin alfa was well tolerated."( Epoetin alfa in patients not on chemotherapy - Canadian data.
Burdette-Radoux, S; Couture, F; Dolan, S; Kovacs, M; Lau, CY; McKenzie, M; Quirt, I; Robeson, C; Tang, SC, 2002
)
2.1

Toxicity

Epoetin alfa is effective and safe in the treatment of chemotherapy-associated anemia. The most frequently reported grade 3 or 4 treatment-emergent adverse events with luspatercept (≥3% patients) were anaemia, pneumonia, neutropenia, hypertension, iron overload, COV.

ExcerptReferenceRelevance
" We prospectively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment."( Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial.
Adhikarla, R; Cavallo, G; Charytan, C; Gagnon, S; Levin, N; Spinowitz, BS; Van Wyck, DB, 2000
)
0.31
" We assessed safety by recording blood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control period."( Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial.
Al-Saloum, M; Charytan, C; Gagnon, S; Hafeez, T; Levin, N; Van Wyck, DB, 2001
)
0.31
" Early placebo-controlled, randomized studies, as well as recent large, community-based trials in thousands of patients, have consistently shown recombinant human erythropoietin (rHuEPO, epoetin alfa) to be effective and safe in the treatment of chemotherapy-associated anemia."( The use of epoetin alfa in chemotherapy patients: a consistent profile of efficacy and safety.
Itri, LM, 2002
)
0.9
" This article provides an overview of the recent history and growing understanding of ESA-associated PRCA together with current approaches to the management of this rare side effect of an otherwise valuable therapy."( Adverse event issue management: what have we learnt from pure red cell aplasia (PRCA)?
Macdougall, IC, 2005
)
0.33
" Adverse events were comparable between treatment groups."( Double-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapy.
Feusner, J; Hinds, PS; Hockenberry, M; Hord, JD; Rackoff, WR; Razzouk, BI; Williams, D, 2006
)
0.55
"Clinical data have repeatedly shown that the erythropoiesis stimulating agents (ESAs) Epoetin alfa and darbepoetin alfa are safe and efficacious to treat anemia in patients on dialysis when used in accordance with the product label The safety profile of ESAs has recently been updated based on reports from clinical investigations that studied off-label uses of ESAs at doses designed to raise the Hb to above 13."( Safety of erythropoiesis stimulating agents in patients on dialysis: current issues for nephrology nurses.
Carter, B; Keen, M,
)
0.35
" Erythropoietin seems to act as an anti-oxidant, diminishing the toxic oxidative effects of VCM on renal tissues."( Novel evidence suggesting an anti-oxidant property for erythropoietin on vancomycin-induced nephrotoxicity in a rat model.
Aslan, C; Cetin, H; Ciris, M; Oktem, F; Olgar, S; Ozguner, F; Uz, E, 2007
)
0.34
"Studies showing an adverse effect of ESA therapy on patient survival generally exhibit considerable methodological deficiencies."( Erythropoiesis-stimulating agents: favorable safety profile when used as indicated.
Dunst, J; Nowrousian, MR; Vaupel, P, 2008
)
0.35
"When used as indicated, ESAs are valuable and safe drugs for the treatment of anemia and do not negatively affect patient survival."( Erythropoiesis-stimulating agents: favorable safety profile when used as indicated.
Dunst, J; Nowrousian, MR; Vaupel, P, 2008
)
0.35
" Primary (safety) endpoints were the occurrence of anti-erythropoietin antibodies and the evaluation of adverse events (AEs)."( Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia.
Baldamus, C; Bronn, A; Koytchev, R; Krivoshiev, S; Siebert-Weigel, M; Wolf-Pflugmann, M, 2008
)
0.35
" Deep vein thrombosis was diagnosed by Doppler result or adverse event report."( An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis.
Enny, C; Jones, SC; Langholff, W; Leitz, G; Stowell, CP, 2009
)
0.59
"1%) in the standard of care group had a diagnosis of deep vein thrombosis either by Doppler or by adverse event report with normal Doppler."( An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis.
Enny, C; Jones, SC; Langholff, W; Leitz, G; Stowell, CP, 2009
)
0.59
" Aside from these two events, reported adverse events were as expected for patients with Stage III - V CKD and similar in both treatment groups."( Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study.
Eckardt, KU; Haag-Weber, M; Hörl, WH; Roger, SD; Roth, K; Vetter, A, 2012
)
0.38
" This article reviews the published data on the effectiveness of intravenous ascorbic acid in increasing the hemoglobin levels of patients with hyporesponse to epoetin alfa, as well as adverse effects of the administration of intravenous ascorbic acid specifically in relation to hyperoxalemia."( Is intravenous ascorbic acid an effective and safe option for increasing hemoglobin levels in patients with a hyporesponse to epoetin alfa?
Kear, TM,
)
0.53
"Using the EMA dossiers and journal publications, this article reviews clinical safety data for these products, with emphasis on serious/severe adverse events and a special consideration of immunogenicity, venous thromboembolism, and mortality."( Clinical safety of biosimilar recombinant human erythropoietins.
Abraham, I; MacDonald, K, 2012
)
0.38
" Adverse findings for both ior(®) EPOCIM and Eprex(®) were similar and were a consequence of thrombotic events (ulcerative skin lesions, swollen hock joints/lameness, stomach ulcers) and decreased body weight gains, all known adverse reactions to this class of drug in rats."( Safety and biosimilarity of ior(®) EPOCIM compared with Eprex(®) based on toxicologic, pharmacodynamic, and pharmacokinetic studies in the Sprague-Dawley rat.
Bolger, GT; Ledon, N; Pucaj, K; Riddle, K; Taylor, SR, 2014
)
0.4
" The primary efficacy variable for both studies was change in blood hemoglobin (Hb) level from baseline to each post-baseline visit, and safety outcomes included adverse events (AEs)."( Long-Term Efficacy and Safety of Molidustat for Anemia in Chronic Kidney Disease: DIALOGUE Extension Studies.
Akizawa, T; Bernhardt, T; Berns, JS; Iekushi, K; Krueger, T; Macdougall, IC; Staedtler, G; Taguchi, M, 2019
)
0.51
" Cumulative probabilities of recording an adverse event, either in terms of lack of effectiveness or safety issue, were the same for two switching categories CONCLUSIONS: In this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes."( Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.
Addis, A; Belleudi, V; Cananzi, P; Davoli, M; Gini, R; Ientile, V; Ingrasciotta, Y; Pastorello, M; Scondotto, S; Tari, M; Traversa, G; Trifirò, G; Trotta, F, 2019
)
0.51
" In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups."( Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study.
An, WS; Cho, WY; Chung, W; Do, JY; Jeon, JS; Jin, K; Joo, KW; Kang, DH; Kang, GW; Kim, DJ; Kim, JK; Kim, SW; Kim, Y; Kim, YL; Lee, CH; Lee, JP; Lee, JS; Lee, KW; Lee, KY; Oh, DJ; Park, SK; Shin, SK; Son, SH, 2020
)
0.56
"The aim was to explore the adverse event (AE) reporting patterns and detect disproportionate reporting signals for cancer supportive care biosimilars in the US compared to their originator biologics."( Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.
Almahasis, S; Qian, J; Tanni, KA; Truong, CB, 2021
)
0.62
"The US Food and Drug Administration Adverse Event Reporting System database (January 1, 2004-March 31, 2020) was used to identify AE reports for filgrastim, pegfilgrastim, and epoetin alpha by type of product (originator biologics vs."( Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.
Almahasis, S; Qian, J; Tanni, KA; Truong, CB, 2021
)
0.62
" Prespecified adverse events of interest following administration, including blood transfusions requirement, blood pressure and hemoglobin excursions, the relationship between C - Reactive Protein (CRP) and hemoglobin, were assessed."( Comparative Efficacy and Safety Study of Darbepoetin Alfa
El-Ashmawy, NE; Ibrahim, AO; Khedr, EG; Kotb, NS; Salem, F, 2022
)
0.98
" There were no significant differences in the incidence of adverse events between the EPIAO® and EPREX® groups."( Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study.
Alexandrov, IV; Davydkin, IL; Isachkina, AN; Khadikova, NG; Kvitkova, LV; Li, M; Li, X; Miao, B; Mironova, TP; Omelchenko, AM; Perlin, DV; Selyutin, AA; Shilo, VY; Shutov, EV; Solovyova, OM; Tutin, AP; Vareesangthip, K; Vetchinnikova, ON; Zuev, AV, 2022
)
0.72
" Overall, 527 adverse events of special interest (AESI) including PRCA occurred in 418 (6."( Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study.
Fowler, H; Gomez Perez, S; Guilatco, R; Iwanowitsch, A; Kohnle, M; Patsialas, S; Salts, S; Xia, FR, 2023
)
0.91
" The most frequently reported grade 3 or 4 treatment-emergent adverse events with luspatercept (≥3% patients) were hypertension, anaemia, dyspnoea, neutropenia, thrombocytopenia, pneumonia, COVID-19, myelodysplastic syndromes, and syncope; and with epoetin alfa were anaemia, pneumonia, neutropenia, hypertension, iron overload, COVID-19 pneumonia, and myelodysplastic syndromes."( Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial.
Cluzeau, T; Degulys, A; Della Porta, MG; Dimicoli-Salazar, S; Fenaux, P; Garcia-Manero, G; Giuseppi, AC; Hayati, S; Jonasova, A; Keeperman, KL; Komrokji, RS; Kreitz, S; Li, J; Lin, CC; Paolini, S; Platzbecker, U; Pozharskaya, V; Prebet, T; Rose, S; Santini, V; Shetty, JK; Shortt, J; Tiong, IS; Valcarcel, D; Vodala, S; Zeidan, AM; Zhang, J, 2023
)
1.35
"HIF-PHIs may be a convenient and safe alternative to ESAs in patients with NDD-CKD and anemia."( An updated meta-analysis on the efficacy and safety of hypoxia-inducible factor prolyl hydroxylase inhibitor treatment of anemia in nondialysis-dependent chronic kidney disease.
Jia, L; Li, P; Zhang, HL; Zhao, H, 2023
)
0.91

Pharmacokinetics

The pharmacokinetic properties of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) compared to a reference product were analyzed after a single intravenous bolus injection of 10,000 IU in a two-period crossover design in 24 healthy volunteers. At each of the 3 time points evaluated, the terminal half-life of darbepoets alfa was 2 to 3 times longer and the clearance approximately 4 times slower than those of epoetins.

ExcerptReferenceRelevance
" The half-life in the beta-phase was prolonged at lower doses of antiserum."( Immunological response to repeated administration of recombinant human erythropoietin in rats: biphasic effect on its pharmacokinetics.
Kamiyama, H; Kato, M; Kato, Y; Kumaki, K; Miura, K; Okazaki, A; Sugiyama, Y, 1997
)
0.3
" Standard pharmacokinetic methods were employed for analysis of the serum concentration time data."( Pharmacokinetics of intraperitoneal epoetin alfa in patients on peritoneal dialysis using an 8-hour "dry dwell" dosing technique.
Johnson, CA; Kosorok, MR; Taylor, CA; Zimmerman, SW, 1999
)
0.58
"The pharmacodynamic responses were equivalent between groups despite expected differences in total erythropoietin exposure."( Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly.
Cheung, W; Gunawardena, K; Minton, N, 2001
)
0.58
"The aim of this multicenter, randomized, open-label study was to compare the pharmacokinetic and pharmacodynamic profiles of darbepoetin alfa, a new erythropoiesis-stimulating protein, and recombinant human erythropoietin (epoetin) after repeated intravenous dosing in patients with chronic kidney disease receiving hemodialysis."( Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis.
Allon, M; Heatherington, AC; Kaupke, C; Kleinman, K; Maroni, BJ; Messer-Mann, L; Olson, K; Walczyk, M, 2002
)
0.78
" Pharmacokinetic profiles were measured during weeks 1 and 12 and at hemoglobin steady state (defined as a hemoglobin concentration within the target range for 4 consecutive weeks after week 12 with no change in study drug dose) or between weeks 36 and 40, whichever occurred first."( Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis.
Allon, M; Heatherington, AC; Kaupke, C; Kleinman, K; Maroni, BJ; Messer-Mann, L; Olson, K; Walczyk, M, 2002
)
0.57
"At each of the 3 time points evaluated, the terminal half-life of darbepoetin alfa was 2 to 3 times longer and the clearance approximately 4 times slower than those of epoetin."( Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis.
Allon, M; Heatherington, AC; Kaupke, C; Kleinman, K; Maroni, BJ; Messer-Mann, L; Olson, K; Walczyk, M, 2002
)
0.81
"The pharmacokinetic and pharmacodynamic profiles and safety data for darbepoetin alfa demonstrate that it can be administered less frequently than epoetin in patients with chronic kidney disease receiving hemodialysis, thus simplifying anemia management."( Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis.
Allon, M; Heatherington, AC; Kaupke, C; Kleinman, K; Maroni, BJ; Messer-Mann, L; Olson, K; Walczyk, M, 2002
)
0.81
"A pharmacokinetic and pharmacodynamic (PK/PD) model for recombinant human erythropoietin (Epoetin alfa) in healthy subjects was developed to describe the time profiles of changes in serum Epoetin alfa and the pharmacological responses of percent reticulocytes, total red blood cell counts, and hemoglobin after single and multiple subcutaneous administration of Epoetin alfa."( Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects.
Cheung, WK; Jusko, WJ; Krzyzanski, W; Minton, N; Wacholtz, MC, 2005
)
0.55
" No significant correlations were observed between pharmacokinetic parameters and pharmacodynamic effects."( Pharmacokinetics and pharmacodynamics of intravenous epoetin alfa in children with cancer.
Burghen, E; Freeman, BB; Hinds, P; Iacono, LC; Razzouk, BI; Stewart, CF, 2006
)
0.58
" Interesting but insignificant trends were noted in pharmacodynamic effects."( Pharmacokinetics and pharmacodynamics of intravenous epoetin alfa in children with cancer.
Burghen, E; Freeman, BB; Hinds, P; Iacono, LC; Razzouk, BI; Stewart, CF, 2006
)
0.58
"To describe the erythropoietin pharmacokinetic profile after once-weekly epoetin alfa treatment in critically ill patients."( Pharmacokinetics and pharmacodynamics of once-weekly subcutaneous epoetin alfa in critically ill patients: results of a randomized, double-blind, placebo-controlled trial.
Beaver, JS; Creteur, J; Diltoer, M; Hubloue, I; Piagnerelli, M; Roman, A; Spapen, HD; Stevens, E; Vercammen, E; Vincent, JL, 2006
)
0.8
" We compared the two epoetins in two 12-week efficacy studies (S1, S2) with twice-weekly dosing, and a single-dose crossover pharmacokinetic (PK) study in severely anemic hemodialysis patients."( Comparison of two epoetin brands in anemic hemodialysis patients: results of two efficacy trials and a single-dose pharmacokinetic study.
Milutinović, S; Plavljanić, E; Trkulja, V, 2006
)
0.33
" This open-label, randomized study was performed to characterize the pharmacokinetic and pharmacodynamic profiles of four dosing regimens of epoetin alfa administered subcutaneously in anemic patients who had chronic kidney disease and were not on dialysis."( Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis.
Beaver, JS; Massarella, J; McGowan, T; Vaccaro, NM; Wolfson, M, 2008
)
0.78
"Extended dosing interval regimens of epoetin alfa yielded modest pharmacokinetic differences but a similar pharmacodynamic response, suggesting that less frequent, higher dosages of epoetin alfa may be as effective as the current three-times-weekly regimen in anemic patients who have chronic kidney disease and are not on dialysis."( Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis.
Beaver, JS; Massarella, J; McGowan, T; Vaccaro, NM; Wolfson, M, 2008
)
0.86
"The pharmacokinetic properties of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) compared to a reference product (epoetin alfa, CAS 113427-24-0) were analyzed after a single intravenous bolus injection of 10,000 IU in a two-period crossover design in 24 healthy volunteers."( Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 1st Communication: A monocentric, open, randomized, single dose, two-period crossover trial in healthy volunteers.
Arsova, S; Bronn, A; Dimitrova, V; Kirkov, V; Koytchev, R; Kromminga, A; Richter, W; Siebert-Weigel, M; Wolf-Pflugmann, M, 2008
)
0.76
"The subcutaneous bioavailability of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) and the pharmacokinetic properties of this drug compared to a reference product (epoetin alfa, CAS 113427-24-0) were analyzed after a single intravenous bolus injection or subcutaneous injection of 10,000 IU in a three-period crossover design in 48 healthy volunteers."( Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 2nd Communication: A monocentric, double-blind, randomized, single dose, three-period crossover trial in healthy volunteers.
Arsova, S; Bronn, A; Dimitrova, V; Kirkov, V; Koytchev, R; Kromminga, A; Richter, W; Siebert-Weigel, M; Wolf-Pflugmann, M, 2008
)
0.75
"To describe the pharmacokinetic profiles of six different dosing regimens for epoetin alfa, and whether more rapid and robust reticulocytosis can be elicited with more frequent administration of epoetin alfa in anemic critically ill patients."( Pharmacokinetics and pharmacodynamics of six epoetin alfa dosing regimens in anemic critically ill patients without acute blood loss.
Arroliga, AC; Beaver, JS; Guntupalli, KK; Kelly, K; Langholff, W; Marino, K, 2009
)
0.84
" The pharmacokinetics of epoetin alfa did not predict pharmacodynamic response in anemic critically ill patients."( Pharmacokinetics and pharmacodynamics of six epoetin alfa dosing regimens in anemic critically ill patients without acute blood loss.
Arroliga, AC; Beaver, JS; Guntupalli, KK; Kelly, K; Langholff, W; Marino, K, 2009
)
0.92
"The aim of this study was to compare the pharmacokinetic and pharmacodynamic characteristics of a new recombinant human erythropoietin (test) formulation with an existing branded (reference) formulation after a single subcutaneous administration."( Pharmacokinetic and pharmacodynamic comparison of two recombinant human erythropoietin formulations after single subcutaneous administration: an open-label, sequence-randomized, two-treatment crossover study in healthy Korean male volunteers.
Jang, IJ; Kim, BH; Kim, KP; Kim, TE; Shin, SG; Yu, KS, 2010
)
0.36
" Serial blood samples were taken up to 120 hours after drug administration for the pharmacokinetic assessments and up to 240 hours for reticulocyte counts as the pharmacodynamic end point."( Pharmacokinetic and pharmacodynamic comparison of two recombinant human erythropoietin formulations after single subcutaneous administration: an open-label, sequence-randomized, two-treatment crossover study in healthy Korean male volunteers.
Jang, IJ; Kim, BH; Kim, KP; Kim, TE; Shin, SG; Yu, KS, 2010
)
0.36
"In this small, selected group of healthy male volunteers, there were no significant differences in pharmacokinetic parameters or effects on reticulocytes between a test formulation and a reference formulation of recombinant human erythropoietin."( Pharmacokinetic and pharmacodynamic comparison of two recombinant human erythropoietin formulations after single subcutaneous administration: an open-label, sequence-randomized, two-treatment crossover study in healthy Korean male volunteers.
Jang, IJ; Kim, BH; Kim, KP; Kim, TE; Shin, SG; Yu, KS, 2010
)
0.36
" A dense-sampling 48-hour pharmacokinetic profile was recorded at steady state after 11 doses of 100 IU epoetin alfa per kg of bodyweight."( Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study.
Lissy, M; Ode, M; Roth, K, 2011
)
0.8
" Moreover, an equivalent pharmacodynamic response was achieved with all compared epoetin alfa products, as confirmed by the hemoglobin AUEC ratio's 90% CI falling within the predefined acceptance margins of 96."( Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study.
Lissy, M; Ode, M; Roth, K, 2011
)
0.81
"The aim of this study was to develop an integrated pharmacokinetic and pharmacodynamic (PK/PD) model and assess the comparability between epoetin alfa HEXAL/Binocrit (HX575) and a comparator epoetin alfa by a model-based approach."( Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575.
Balser, S; Berghout, A; Fink, M; Krzyzanski, W; Lowe, PJ; Yan, X, 2012
)
0.79
"Our objective was to show, using two examples, that a pharmacokinetic (PK) similarity analysis can be performed using nonlinear mixed-effects models (NLMEM)."( Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling.
Balser, S; Dubois, A; Gsteiger, S; Mentré, F; Pigeolet, E; Pillai, G; Steimer, JL, 2012
)
0.38
" The relevant pharmacokinetic parameters were calculated after noncompartmental pharmacokinetic analysis using Kinetica software (Thermo Scientific, ver."( The pharmacokinetics of recombinant human erythropoietin in Balkan endemic nephropathy patients.
Djukanović, L; Ležaić, V; Marić, I; Miljković, B; Pejovic, V; Petković, N; Simić-Ogrizović, S; Vučićević, K, 2013
)
0.39
"020) and elimination half-life (50."( The pharmacokinetics of recombinant human erythropoietin in Balkan endemic nephropathy patients.
Djukanović, L; Ležaić, V; Marić, I; Miljković, B; Pejovic, V; Petković, N; Simić-Ogrizović, S; Vučićević, K, 2013
)
0.39
"Pharmacokinetic analysis of beta-erythropoietin detected a significantly longer elimination half-life in BEN than in non BEN patients."( The pharmacokinetics of recombinant human erythropoietin in Balkan endemic nephropathy patients.
Djukanović, L; Ležaić, V; Marić, I; Miljković, B; Pejovic, V; Petković, N; Simić-Ogrizović, S; Vučićević, K, 2013
)
0.39
"This study examined the safety, pharmacodynamic (PD), and pharmacokinetic (PK) biosimilarity of the human recombinant erythropoietin (EPO) products ior(®) EPOCIM and Eprex(®) following a 28-day repeated intravenous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period."( Safety and biosimilarity of ior(®) EPOCIM compared with Eprex(®) based on toxicologic, pharmacodynamic, and pharmacokinetic studies in the Sprague-Dawley rat.
Bolger, GT; Ledon, N; Pucaj, K; Riddle, K; Taylor, SR, 2014
)
0.4
"A population pharmacokinetic pharmacodynamic (PK/PD) model describing the effect of epoetin alfa on hemoglobin (Hb) response in hemodialysis patients was developed."( Assessment of hemoglobin responsiveness to epoetin alfa in patients on hemodialysis using a population pharmacokinetic pharmacodynamic model.
Doshi, S; Mould, DR; Perez Ruixo, JJ; Wu, L, 2015
)
0.9
" This study was planned to demonstrate the pharmacokinetic and pharmacodynamic comparability of PDA10 to an existing epoetin alfa (Eprex) after a single intravenous administration to healthy adult male volunteers."( Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study.
Cho, DY; Oh, M; Yoon, J, 2015
)
0.63
" Plasma erythropoietin concentrations were measured using an enzyme-linked immunosorbent assay and the pharmacokinetic parameters of the two treatments were compared."( Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study.
Cho, DY; Oh, M; Yoon, J, 2015
)
0.42
"PDA10 and Eprex met the regulatory criteria for bioequivalence with respect to their pharmacokinetic profiles and pharmacodynamic actions."( Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study.
Cho, DY; Oh, M; Yoon, J, 2015
)
0.42
" The primary PD end point was the geometric mean ratio (GMR) of the 2 treatments for area under the effect curve for Hb from day 1 through 48 hours after the final dose of study drug administration on day 26, and the primary PK end point was the GMR of the 2 treatments for AUC0-48 and Cmax for epoetin after the final dose of study drug on day 26."( Pharmacodynamic and Pharmacokinetic Equivalences of Epoetin Hospira and Epogen(®) After Multiple Subcutaneous Doses to Healthy Male Subjects.
Kumbhat, S; Martin, N; Ramaiya, A; Reid, S; Stalker, D; Zhang, J, 2016
)
0.43
"The purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen."( Pharmacokinetic and Pharmacodynamic Equivalence of Epoetin Hospira and Epogen After Single Subcutaneous Doses to Healthy Male Subjects.
Martin, NE; Ramaiya, A; Reid, S; Stalker, D; Wisemandle, WA, 2016
)
0.43
" The primary PK end points were the geometric mean ratios (GMRs) of the 2 treatments for AUC0-t and Cmax based on the BAEC, and the primary PD end points were the GMRs of the 2 treatments for AUC0-t and Cmax for reticulocyte percentage."( Pharmacokinetic and Pharmacodynamic Equivalence of Epoetin Hospira and Epogen After Single Subcutaneous Doses to Healthy Male Subjects.
Martin, NE; Ramaiya, A; Reid, S; Stalker, D; Wisemandle, WA, 2016
)
0.43
" The primary objective was to compare the pharmacokinetic profile of different formulations of epoetin alfa after a single subcutaneous administration to healthy volunteers of 40 000 IU of Eprex/Erypo® and Hemax® PFS."( Pharmacokinetic and pharmacodynamic study of three products of epoetin alfa as single subcutaneous dose in healthy volunteers.
Beider, L; di Girolamo, G; Diez, RA; Fornari, MC; González Bagnes, MF; González, CD; González, E; Keller, GA, 2023
)
1.37

Compound-Compound Interactions

ExcerptReferenceRelevance
" Therefore, we conducted a 6-month, prospective, randomized trial comparing low-dose rHuEPO alone and in combination with androgens for the treatment of the anemia of end-stage renal failure."( A 6-month study of low-dose recombinant human erythropoietin alone and in combination with androgens for the treatment of anemia in chronic hemodialysis patients.
Buhsmer, JP; Burke, JF; Dunn, SR; Gaughan, WJ; Liss, KA; Mangold, AM; Michael, B, 1997
)
0.3
"In the current meta-analysis of published literature, erythroid response (ER) rates with EPO as a single agent versus its combination with granulocyte-colony-stimulating factor (G-CSF) or granulocyte-macrophage-colony-stimulating factor (GM-CSF) were compared."( An assessment of erythroid response to epoetin alpha as a single agent versus in combination with granulocyte- or granulocyte-macrophage-colony-stimulating factor in myelodysplastic syndromes using a meta-analysis approach.
Duh, MS; Lefebvre, P; Moyo, V; Mundle, S; Rastogi, R; Vekeman, F, 2009
)
0.35
"001) or in combination with G-CSF/GM-CSF (50."( An assessment of erythroid response to epoetin alpha as a single agent versus in combination with granulocyte- or granulocyte-macrophage-colony-stimulating factor in myelodysplastic syndromes using a meta-analysis approach.
Duh, MS; Lefebvre, P; Moyo, V; Mundle, S; Rastogi, R; Vekeman, F, 2009
)
0.35
"In the current meta-analysis, higher doses of EPO demonstrated better ER rates compared with EPO at standard doses alone or in combination with G-CSF/GM-CSF."( An assessment of erythroid response to epoetin alpha as a single agent versus in combination with granulocyte- or granulocyte-macrophage-colony-stimulating factor in myelodysplastic syndromes using a meta-analysis approach.
Duh, MS; Lefebvre, P; Moyo, V; Mundle, S; Rastogi, R; Vekeman, F, 2009
)
0.35

Bioavailability

The subcutaneous bioavailability of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) and the pharmacokinetic properties of this drug compared to a reference product were analyzed after a single intravenous bolus injection.

ExcerptReferenceRelevance
" However, bioavailability is improved by instilling the dose into a dry peritoneum."( Pharmacokinetics of intraperitoneal epoetin alfa in patients on peritoneal dialysis using an 8-hour "dry dwell" dosing technique.
Johnson, CA; Kosorok, MR; Taylor, CA; Zimmerman, SW, 1999
)
0.58
" In hemodialysis patients, subcutaneous epoetin omega apparently provides greater bioavailability and anti-anemic effect per administered dose (IU) than epoetin alpha."( Comparison of two epoetin brands in anemic hemodialysis patients: results of two efficacy trials and a single-dose pharmacokinetic study.
Milutinović, S; Plavljanić, E; Trkulja, V, 2006
)
0.33
"The subcutaneous bioavailability of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) and the pharmacokinetic properties of this drug compared to a reference product (epoetin alfa, CAS 113427-24-0) were analyzed after a single intravenous bolus injection or subcutaneous injection of 10,000 IU in a three-period crossover design in 48 healthy volunteers."( Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 2nd Communication: A monocentric, double-blind, randomized, single dose, three-period crossover trial in healthy volunteers.
Arsova, S; Bronn, A; Dimitrova, V; Kirkov, V; Koytchev, R; Kromminga, A; Richter, W; Siebert-Weigel, M; Wolf-Pflugmann, M, 2008
)
0.75
"The results show, for the first time in a prospective randomized clinical study, equivalent bioavailability at steady state and similar potency of the US-marketed Epogen® and the European-marketed Binocrit®."( Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study.
Lissy, M; Ode, M; Roth, K, 2011
)
0.58

Dosage Studied

Little is known about epoetin alfa (EPO) dosing at dialysis centers after implementation of the US Medicare prospective payment system and revision of the EPO label in 2011. The approved dosing interval for currently available erythropoiesis-stimulating agents (ESAs) is 2 to 3 times weekly.

ExcerptRelevanceReference
") treatment with epoetin alfa 300 IU/kg twice weekly for 3 weeks was the optimum dosage for facilitation of AB donation and minimization of the decrease in Hct prior to elective orthopedic surgery."( Epoetin alfa for autologous blood donation in patients with rheumatoid arthritis and concomitant anemia.
Mercuriali, F, 1996
)
2.08
" However, the optimum dose and dosage regimen remains to be defined."( Autologous blood donation plus epoetin alfa in nonanemic orthopedic surgery patients.
Baudoux, E, 1996
)
0.58
"The optimum dosage of subcutaneous (s."( Use of epoetin alfa in autologous blood donation programs for patients scheduled for elective cardiac surgery.
Althaus, U; Galliker, B; Haeberli, A; Nydegger, UE; Rosenmund, A; Spirig, P; Walpoth, B, 1996
)
0.75
" A randomized, multicenter trial was conducted comparing the safety and efficacy of a weekly Epoetin alfa dosing regimen in patients with hemoglobin levels > or = 10 to < or = 13 g/dL scheduled to undergo major elective orthopedic arthroplasty, with a daily regimen previously shown to be effective."( A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery.
Di Cesare, P; Frei, D; Friedman, RJ; Goldberg, MA; Guilfoyle, M; Jove, M; McCutchen, JW; Poss, R; Young, D, 1996
)
0.75
" Optimal dosing regimens and surgical patients most likely to benefit fro Epoetin alfa therapy must be established."( Improving the efficacy of preoperative autologous blood donation in patients with low hematocrit: a randomized, double-blind, controlled trial of recombinant human erythropoietin.
Abels, RI; Bolgiano, DC; Goodnough, LT; Hellman, RM; Johnston, MF; Price, TH; Sacher, RA; Vogler, WR, 1996
)
0.52
" On the basis of these results, perioperative Epoetin alfa therapy in conjunction with iron supplementation may have a place as an adjunct to elective orthopedic surgery, particularly if dosing regimens less frequent than once daily can be established."( Use of recombinant human erythropoietin in the perioperative period of orthopedic surgery.
Faris, P, 1996
)
0.55
" We evaluated several dosing regimens and schedules for perioperative epoetin alfa administration."( Perioperative epoetin alfa increases red blood cell mass and reduces exposure to transfusions: results of randomized clinical trials.
Goldberg, MA, 1997
)
0.89
" Reductions in epoetin alpha dosage were made during the study if Hb level increased to >15 g dl(-1)."( Epoetin alpha prevents anaemia and reduces transfusion requirements in patients undergoing primarily platinum-based chemotherapy for small cell lung cancer.
Bell, DR; De Campos, ES; Ewers, SB; Morant, R; Rosso, R; Schatzmann, E; Steward, WP; Stocker, H; Sundal, E; Thatcher, N; Vansteenkiste, JF; Varghese, G, 1999
)
0.3
" The current study was designed to determine whether absorption after administration into a dry peritoneum is improved by extending the dry dosing period from 4 to 8 hours."( Pharmacokinetics of intraperitoneal epoetin alfa in patients on peritoneal dialysis using an 8-hour "dry dwell" dosing technique.
Johnson, CA; Kosorok, MR; Taylor, CA; Zimmerman, SW, 1999
)
0.58
" Only patients with a serum ferritin level greater than 1,000 microg/L were excluded; patients with a serum ferritin level below 150 microg/L were given a more aggressive IV dosing regimen to get into range for the standard protocol."( Beneficial effects of adopting an aggressive intravenous iron policy in a hemodialysis unit.
Chandler, G; Elston, O; Harchowal, J; Macdougall, IC, 1999
)
0.3
" dosing is undesirable."( Comparison of intraperitoneal and subcutaneous epoetin alfa in peritoneal dialysis patients.
Bhattacharya, A; Burkart, J; Johnson, CA; Kosorok, MR; Taylor, CA; Wakeen, M; Zimmerman, SW,
)
0.39
"To determine the impact of two different recombinant human erythropoietin (epoetin alfa) dosing strategies on the number of red blood cell (RBC) transfusions, and explore relationships between specific patient and drug regimen variables with epoetin alfa therapy outcomes."( Factors associated with successful epoetin alfa therapy in premature infants.
Reiter, PD; Rosenberg, AA; Valuck, RJ, 2000
)
0.81
"Infants who received epoetin alfa therapy three times weekly for more than one week were categorized into two epoetin alfa dosing strategy groups: group A (300-749 units/kg/wk) and group B (750-1200 units/kg/wk)."( Factors associated with successful epoetin alfa therapy in premature infants.
Reiter, PD; Rosenberg, AA; Valuck, RJ, 2000
)
0.9
" No significant impact on outcome was attributed to overall dosing strategy (group A vs."( Factors associated with successful epoetin alfa therapy in premature infants.
Reiter, PD; Rosenberg, AA; Valuck, RJ, 2000
)
0.58
"Epoetin alfa dosing strategy, as defined in our study, did not significantly affect the number of transfusions."( Factors associated with successful epoetin alfa therapy in premature infants.
Reiter, PD; Rosenberg, AA; Valuck, RJ, 2000
)
2.03
" Three open-label community-based studies of epoetin alfa in cancer-related anemia (two using three-times-weekly dosing and one using once-weekly dosing) in more than 7,000 patients have been performed."( Management of cancer-related anemia: epoetin alfa and quality of life.
Soignet, S, 2000
)
0.84
"To determine whether the response to recombinant erythropoietin is dose dependent in men undergoing radical prostatectomy and to elucidate the relative cost-effectiveness of two dosing regimens."( Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy.
Lepor, H; Nieder, AM; Rosenblum, N, 2001
)
0.31
" The 300 IU/kg dosing regimen was significantly more cost effective than the 600 IU/kg dosing regimen."( Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy.
Lepor, H; Nieder, AM; Rosenblum, N, 2001
)
0.31
" Based on the results of this study, the clinical benefits and the adverse event profile of once-weekly epoetin alfa therapy in community-based practice are similar to those observed in the historical experience with the three-times-weekly dosage schedule."( Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three-times-weekly dosing.
Cleeland, CS; Einhorn, LH; Gabrilove, JL; Livingston, RB; Sarokhan, B; Winer, E, 2001
)
0.78
" Recent data indicate that several factors, including time on dialysis, Epoetin alfa dosing practices, peritoneal dialysis modality, younger age, African American race, and some comorbidities, may increase the risk for lower hemoglobin levels."( Hyporesponse to Epoetin alfa: patients at risk. Case study of the anemic patient.
Deziel, SM, 2002
)
0.89
" The efficacy and safety of epoetin alfa did not vary according to dosing frequency (1 vs."( Benefits of epoetin alfa in anemic breast cancer patients receiving chemotherapy.
Blasi, MV; Demetri, GD; Gabrilove, JL; Glaspy, J; Hill, RJ, 2002
)
0.99
" A large community-based trial has demonstrated that the more convenient once-weekly dosing schedule resulted in good efficacy and safety profiles."( The use of epoetin alfa in chemotherapy patients: a consistent profile of efficacy and safety.
Itri, LM, 2002
)
0.7
" The purpose of this randomized, double-blind, noninferiority study is to determine whether darbepoetin alfa is as effective as epoetin for the treatment of anemia in hemodialysis patients when administered at a reduced dosing frequency."( Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients.
Beatey, R; Lindberg, JS; Maroni, BJ; McDermott-Vitak, A; Nissenson, AR; Picarello, N; Soroka, SD; Swan, SK; Wang, C, 2002
)
0.81
"These results show that darbepoetin alfa maintains hemoglobin concentrations as effectively and safely as epoetin in patients with CKD, but with a reduced dosing frequency."( Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients.
Beatey, R; Lindberg, JS; Maroni, BJ; McDermott-Vitak, A; Nissenson, AR; Picarello, N; Soroka, SD; Swan, SK; Wang, C, 2002
)
0.88
" Dosage should be initiated at 10 000 IU three times/week or 40 000 IU once/week and be titrated to maintain hemoglobin at 12 g/dl."( Management of disease-related anemia in patients with multiple myeloma or chronic lymphocytic leukemia: epoetin treatment recommendations.
Blade, J; Dammacco, F; Degos, L; Itri, L; Kyle, R; Liso, V; Littlewood, TJ; Ludwig, H; Mandelli, F; Meloni, G; Molica, S; Osterborg, A; Pangalis, GA; Rai, K; San Miguel, J; Schmitt, B; Voliotis, D, 2002
)
0.31
" Nursing knowledge and management of Epoetin alfa dosing and administration techniques, peritonitis and other infections, and iron supplementation may help improve anemia-related outcomes in peritoneal dialysis patients."( Anemia management practices in peritoneal dialysis patients. Case study of the anemic patient.
MacCracken, MA, 2001
)
0.58
"The data from this study suggest that this dosing regimen of epoetin alfa is effective and safe in pediatric cancer patients with chemotherapy-related anemia."( Is epoetin alfa a treatment option for chemotherapy-related anemia in children?
Akyüz, C; Büyükpamukçu, M; Kutluk, T; Varan, A, 2002
)
1.18
" Darbepoetin alfa is a new erythropoietic protein with greater biologic activity and a longer dosing interval than those of r-HuEPO."( Darbepoetin alfa, a new therapy for the management of anemia of chronic kidney disease.
Hudson, JQ; Sameri, RM, 2002
)
1.39
" Recombinant HuEPO produces a hemoglobin response in 50-60% of patients with cancer; however, to obtain this response rate, frequent dosing is required."( Overview of cancer-related anemia: focus on the potential role of darbepoetin alfa.
Valley, AW, 2002
)
0.55
" These properties allow patients to be treated with longer dosing intervals than with r-HuEPO."( Dose conversion from recombinant human erythropoietin to darbepoetin alfa: recommendations from clinical studies.
Scott, SD, 2002
)
0.56
" Less strong evidence supports an alternative weekly (40 000 U/wk) dosing regimen, based on common clinical practice."( Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.
Bennett, CL; Browman, GP; Cella, D; Djulbegovic, B; Goode, MJ; Gordon, MS; Jakubowski, AA; Lee, SJ; Lichtin, AE; Miller, CB; Rarick, MU; Regan, DH; Rizzo, JD; Seidenfeld, J; Woolf, SH, 2002
)
0.31
" They should be aware of clinical trials that have suggested advantages of improved dosing schedules and new applications for epoetin alfa."( Epoetin alfa: current and future indications and nursing implications.
Buchsel, PC; Murphy, BJ; Newton, SA,
)
1.78
" Dosing was discontinued for 3 patients prior to receiving all 24 doses because of gastric residuals (n = 1; 5 mL/kg), stage I NEC (n = 1; 10 mL/kg), or symptomatic patent ductus arteriosus (n = 1; 20 mL/kg)."( Tolerance of simulated amniotic fluid in premature neonates.
Ashmeade, TL; Auerbach, DA; Beltz, SE; Calhoun, DA; Christensen, RD; Hudak, ML; Maheshwari, A; Sullivan, SE, 2002
)
0.31
"The aim of this multicenter, randomized, open-label study was to compare the pharmacokinetic and pharmacodynamic profiles of darbepoetin alfa, a new erythropoiesis-stimulating protein, and recombinant human erythropoietin (epoetin) after repeated intravenous dosing in patients with chronic kidney disease receiving hemodialysis."( Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis.
Allon, M; Heatherington, AC; Kaupke, C; Kleinman, K; Maroni, BJ; Messer-Mann, L; Olson, K; Walczyk, M, 2002
)
0.78
" Further research is ongoing with less frequent dosing regimens."( Epoetin alfa as a supportive measure in hematologic malignancies.
Straus, DJ, 2002
)
1.76
"Fixed dosing is potentially more convenient than weight-based dosing for both patients and physicians."( Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin alpha in anemic cancer patients receiving platinum-based chemotherapy.
Gasparini, G; Granetto, C; Lampignano, M; Mantovani, G; Martoni, A; Mattioli, R; Pezzella, G; Porrozzi, S; Ricci, S; Tacconi, F; Testore, F,
)
0.13
" Further evaluation of alternative epoetin alfa dosing schedules and use of epoetin alfa in treating anemia in patients with specific hematologic malignancies is ongoing."( Epoetin alfa therapy for patients with hematologic malignancies and mild anemia.
Straus, DJ, 2003
)
2.04
"QW dosing of epoetin alfa is as effective as TIW dosing in increasing Hb levels, which was associated with improved QOL in anemic HIV-positive patients."( Once-weekly epoetin alfa dosing is as effective as three times-weekly dosing in increasing hemoglobin levels and is associated with improved quality of life in anemic HIV-infected patients.
Bowers, P; Goon, B; Grossman, HA; Leitz, G, 2003
)
1.07
"0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p=0."( Once-weekly epoetin alfa improves anemia and facilitates maintenance of ribavirin dosing in hepatitis C virus-infected patients receiving ribavirin plus interferon alfa.
Bini, EJ; Bowers, PJ; Bräu, N; Dieterich, DT; Hassanein, TI; Sulkowski, MS; Wasserman, R, 2003
)
0.94
" These data were used to determine the initial dose and dosing schedule, dose changes, and changes in hemoglobin concentrations after 4, 8, and 12 weeks of treatment, adjusted for red blood cell (RBC) transfusions, and the incidence of RBC transfusions over time."( A multicenter retrospective cohort study of practice patterns and clinical outcomes of the use of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
Adamson, R; Rossi, G; Schwartzberg, L; Shiffman, R; Stolshek, B; Tomita, D, 2003
)
0.53
"2%]) received an initial dosage of 200 microg q2wk."( A multicenter retrospective cohort study of practice patterns and clinical outcomes of the use of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
Adamson, R; Rossi, G; Schwartzberg, L; Shiffman, R; Stolshek, B; Tomita, D, 2003
)
0.53
" Clinical considerations, dosing equivalency, direct and indirect costs, payer mix, and reimbursement level are issues that should be considered by a multidisciplinary team."( Considerations in darbepoetin alfa cost and reimbursement: a model for pharmacy managers.
Anderson, ER; Gibson, G, 2003
)
0.63
" Results from this pilot study suggest that higher initial once-weekly dosing of epoetin alfa followed by less frequent maintenance dosing appears to be feasible for treating anemia in cancer patients undergoing chemotherapy."( Epoetin alfa 60,000 U once weekly followed by 120,000 U every 3 weeks increases and maintains hemoglobin levels in anemic cancer patients undergoing chemotherapy.
Kuzur, M; Liggett, W; Miranda, F; Patton, J; Porter, L; Varsos, H, 2004
)
1.99
" Ongoing research is now evaluating ways to improve the response rate to epoetin alfa, the potential benefits of alternative dosing regimens and early treatment intervention, and nonanemia-related indications (e."( The evolving role of epoetin alfa in cancer therapy.
Henry, DH, 2004
)
0.87
" Additional studies regarding patients most likely to benefit from EPO therapy, the most effective dosing regimen, and use of adjunctive therapies are needed."( Use of epoetin alfa in critically ill patients.
Camamo, JM; Erstad, BL; Pajoumand, M, 2004
)
0.78
" The longer dosing intervals offered by these new preparations may decrease healthcare expenses and enhance patient adherence."( Managing hematologic toxicities: novel therapies.
Nirenberg, A, 2003
)
0.32
"Although direct comparative trials have not been performed with these agents, information published in the last several years regarding their clinical efficacy, safety, and dosing is sufficient, in most cases, to compare costs."( Clinical and economic comparison of epoetin alfa and darbepoetin alfa.
Boggie, D; DeLattre, M; Morreale, A; Plowman, B; Schaefer, M, 2004
)
0.6
" Recent clinical trials in the nephrology and oncology therapeutic areas are summarized, highlighting study designs, dosing regimens, patient entry criteria, study endpoints, and published results."( Clinical and economic comparison of epoetin alfa and darbepoetin alfa.
Boggie, D; DeLattre, M; Morreale, A; Plowman, B; Schaefer, M, 2004
)
0.6
"Therapeutic substitution with darbepoetin alfa was started according to the US Oncology Pharmacy and Therapeutics Committee's recommended dosing guidelines: anemic patients with cancer received a starting dosage of darbepoetin alfa 200 microg every 2 weeks regardless of whether or not they had previously received epoetin alfa."( Evaluation of the US Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 microg every 2 weeks in both naïve patients and patients switched from epoetin alfa.
Alley, JL; Giffin, SA; Scheifele, AC; Smith, SL; Thames, WA; Yao, B, 2004
)
0.82
" No variation in transfusion rates was observed across weight categories in patients who received a fixed dosage of darbepoetin alfa."( Evaluation of the US Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 microg every 2 weeks in both naïve patients and patients switched from epoetin alfa.
Alley, JL; Giffin, SA; Scheifele, AC; Smith, SL; Thames, WA; Yao, B, 2004
)
0.75
"A darbepoetin alfa starting dosage of 200 microg subcutaneously every 2 weeks administered according to US Oncology-recommended dosing guidelines is effective in treating chemotherapy-induced anemia in both epoetin alfa-naive patients and those switched from epoetin alfa."( Evaluation of the US Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 microg every 2 weeks in both naïve patients and patients switched from epoetin alfa.
Alley, JL; Giffin, SA; Scheifele, AC; Smith, SL; Thames, WA; Yao, B, 2004
)
1.02
" However, recent studies suggest that epoetin alfa can increase hemoglobin levels and facilitate maintenance of RBV dosage in patients with chronic hepatitis C who became anemic during standard combination therapy."( Role of epoetin alfa in maintaining ribavirin dose.
Afdhal, NH, 2004
)
1.03
" Anaemia in patients treated with interferon plus RBV combination therapy can be managed effectively and safely with once weekly epoetin alfa without sacrificing optimal dosing of RBV."( Epoetin alfa treatment for acute anaemia during interferon plus ribavirin combination therapy for chronic hepatitis C.
Bräu, N, 2004
)
1.97
" We conclude that there is no basis for inferring the survival benefits (or detriments) of increasing a patient's hematocrit by adjusting the dosing of epoetin."( Improved survival with higher hematocrits: where is the evidence?
Cotter, DJ; Stefanik, K; Thamer, M; Zhang, Y,
)
0.13
" The secondary aim was to assess whether the frequency of dosing (once, twice or thrice weekly) influenced the Hb concentration response."( Haemoglobin response to subcutaneous versus intravenous epoetin alfa administration in iron-replete haemodialysis patients.
Becker, GJ; Kent, AB; Leikis, MJ; McMahon, LP, 2004
)
0.57
" Similar significant changes in the Hb concentration were seen at different dosing frequencies."( Haemoglobin response to subcutaneous versus intravenous epoetin alfa administration in iron-replete haemodialysis patients.
Becker, GJ; Kent, AB; Leikis, MJ; McMahon, LP, 2004
)
0.57
" The current study was conducted to evaluate the clinical safety and efficacy of a less frequent dosing regimen (once weekly) in this population."( Once-weekly epoetin alfa for treating the anemia of chronic kidney disease.
Fink, JC; Garcia-Mayol, L; Provenzano, R; Suchinda, P; Von Hartitzsch, B; Woollen, SB; Zabaneh, R, 2004
)
0.7
" Other, smaller studies using different dosing regimens in critically ill patients have also demonstrated that epoetin alfa can decrease the need for transfusion."( Is there a place for epoetin alfa in managing anemia during critical illness?
Givens, M; Lapointe, M, 2004
)
0.85
" Because of the scarce amount of evidence and the diversity of dosing regimens used used, no strict recommendations can be drawn from this review."( Is there a place for epoetin alfa in managing anemia during critical illness?
Givens, M; Lapointe, M, 2004
)
0.64
"Results of this study suggest that epoetin alfa at a dose of 40,000 IU administered five times over 2 weeks may confer even higher response rates than those seen with standard dosing regimens."( Effectiveness and safety of an induction therapy with epoetin alfa in anemic cancer patients receiving concomitant chemotherapy.
Accettura, C; Beccaglia, P; Bertelletti, D; Cortesi, E; D'Auria, G; De Marinis, F; De Pasquale Ceratti, A; Mancuso, A; Pizzardi, N, 2004
)
0.85
" to the subcutaneous route required an increase in dosage and in substantial additional cost."( Epoetin in haemodialysis patients: impact of change from subcutaneous to intravenous routes of administration.
Decaudin, B; Gautier, S; Lemaitre, V; Urbina, MA, 2004
)
0.32
" The indicated dose of epoetin alfa is 150-300 IU/kg three times per week, but it is commonly dosed at 40,000-60,000 IU once weekly based on trial data and extensive clinical use."( Treatment of cancer-related anemia with epoetin alfa: a review.
Bajetta, E; Bidoli, P; Buzzoni, R; De Candis, D; De Dosso, S; Del Vecchio, M; Ferrari, L; Ferrario, E, 2004
)
0.9
" Although peak serum concentrations of all compounds were inversely proportional to body weight, the percentage of change during dialysis was not related to dosage or body weight."( Effects of different dialysis membranes on serum concentrations of epoetin alfa, darbepoetin alfa, enoxaparin, and iron sucrose during dialysis.
Chester, K; McMahon, LP; Walker, RG, 2004
)
0.56
" No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS)."( What is the practical conversion dose when changing from epoetin alfa to darbepoetin outside of clinical trials?
Cooper, B; Roger, SD, 2004
)
0.57
"The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter."( What is the practical conversion dose when changing from epoetin alfa to darbepoetin outside of clinical trials?
Cooper, B; Roger, SD, 2004
)
0.82
" In recent years, concerns have been raised over the inconvenience and costs associated with the conventional three-times weekly (tiw) epoetin dosing regimen."( Optimising anaemia management with epoetin beta.
Morère, JF; Reed, N, 2004
)
0.32
" A Cox proportional hazard regression analysis, adjusted for baseline variables, and a 5-knot cubic regression spline were used to model the dose-response relationship between epoetin and all-cause mortality."( Epoetin requirements predict mortality in hemodialysis patients.
Cotter, DJ; Kaufman, J; Stefanik, K; Thamer, M; Zhang, Y, 2004
)
0.32
" In contrast to conventional wisdom, this study suggests that epoetin dosing requirements could provide important prognostic information beyond that predicted by hematocrit alone."( Epoetin requirements predict mortality in hemodialysis patients.
Cotter, DJ; Kaufman, J; Stefanik, K; Thamer, M; Zhang, Y, 2004
)
0.32
" In the near future we expect that a wider range of epoetins, drug patent expiry, a more appropriate patient selection criteria and an improved dosage schedule may help increase the efficiency of cancer-related anaemia management."( Clinical and economic impact of epoetins in cancer care.
Barosi, G; Marchetti, M, 2004
)
0.32
"For individuals with chemotherapy-related anemia, the clinical effectiveness of epoetin alfa (EPO) dosed once weekly ([QW], 40,000 units per dose) has been demonstrated to be indistinguishable from that observed with thrice-weekly dosing ([TIW], 10,000 units per dose)."( Cost-minimization analysis of once-weekly versus thrice-weekly epoetin alfa for chemotherapy-related anemia.
Crémieux, PY; Fastenau, JM; Fendrick, AM; Kosicki, G; Piech, CT,
)
0.6
"To conduct a cost-minimization analysis comparing QW and TIW EPO dosing from a societal perspective."( Cost-minimization analysis of once-weekly versus thrice-weekly epoetin alfa for chemotherapy-related anemia.
Crémieux, PY; Fastenau, JM; Fendrick, AM; Kosicki, G; Piech, CT,
)
0.37
" In the absence of cost differences between regimens, the noneconomic advantages of less-frequent dosing intervals should make weekly dosing increasingly attractive to patients, clinicians, and payers."( Cost-minimization analysis of once-weekly versus thrice-weekly epoetin alfa for chemotherapy-related anemia.
Crémieux, PY; Fastenau, JM; Fendrick, AM; Kosicki, G; Piech, CT,
)
0.37
"This study evaluated the impact of a new epoetin alfa dosing regimen on quality of life (QOL), transfusion requirements, and hemoglobin (Hb) levels in 133 patients with low-risk myelodysplastic syndrome (MDS) and Hb < or =10 g/dl."( Impact of a new dosing regimen of epoetin alfa on quality of life and anemia in patients with low-risk myelodysplastic syndrome.
Azzarà, A; Balleari, E; Capochiani, E; Clavio, M; Cortelezzi, A; D'Arena, G; De Biasi, E; Ferrari, D; Francesconi, M; Grossi, A; Latagliata, R; Mitra, ME; Monarca, B; Musto, P; Niscola, P; Pagnini, D; Pecorari, P; Perego, D; Petti, MC; Pisani, F; Reyes, MT; Scaramella, G; Spadano, A; Spiriti, MA; Volpe, E, 2005
)
0.87
" Dose adjustments effectively treat these hematologic side effects, but the resulting suboptimal dosing and potential impact on virologic response are major concerns."( The use of growth factors to manage the hematologic side effects of PEG-interferon alfa and ribavirin.
Collantes, RS; Younossi, ZM, 2005
)
0.33
" The aim of this study was to determine whether successful management of anemia could be maintained by changing the dosing schedule of epoetin alfa from 2 or 3 times per week to once-weekly administration via not only the subcutaneous (s."( Efficacy of once-weekly epoetin alfa.
Barre, P; Barth, C; Reichel, H; Suranyi, MG, 2004
)
0.83
" There was a 46% drop in exposure of EPO from the first to the subsequent dosing events."( Population pharmacokinetics of erythropoietin in critically ill subjects.
Chakraborty, A; Cheung, W; Guilfoyle, M; Morgan, N; Natarajan, J; Vercammen, E, 2005
)
0.33
" The most common initial dosage of darbepoetin alfa was 200 microg every two weeks (61% of darbepoetin alfa recipients), and the most common initial dosage of epoetin alfa was 40,000 units weekly (72%)."( Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
Boccia, RV; Davidson, SL; Green, L; Herrington, JD; Smith, RE; Tomita, DK, 2005
)
0.93
"The most common initial dosage of darbepoetin alfa for CIA was 200 microg every two weeks, and the most common initial dosage of epoetin alfa was 40,000 units weekly."( Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
Boccia, RV; Davidson, SL; Green, L; Herrington, JD; Smith, RE; Tomita, DK, 2005
)
0.93
" Postprotocol data showed statistically significant improvements in epoetin alfa dosing and monitoring and in the use of adjunctive therapy."( Epoetin alfa protocol and multidisciplinary blood-conservation program for critically ill patients.
Martin, BS; Pell, LJ; Shirk, MB, 2005
)
2.01
" Several studies have been carried out to determine the optimum schedule of dosing to obtain maximum patient benefit."( Phase III clinical trials with darbepoetin: implications for clinicians.
Glaspy, J, 2005
)
0.33
" In case of patients with Hb level exceeding > 14 g/dL or in case of non-response, the dosage was reconsidered."( The impact of weekly dosing of epoetin alfa on the haematological parameters and on the quality of life of anaemic cancer patients.
Argyriou, AA; Argyriou, K; Heras, P; Karagiannis, S; Mitsibounas, D; Papapetropoulos, S, 2005
)
0.61
" Activity varied with treatment regimen (1 microg darbepoetin alfa congruent with 800 U for 3 times weekly dosing to 8,000 U for a single injection)."( Comparison of epoetin alfa and darbepoetin alfa biological activity under different administration schedules in normal mice.
Begley, CG; Browne, JK; Egrie, JC; Elliott, S; Hartley, C; Khaja, R; McElroy, P; Molineux, G; Sasu, BJ; Schultz, H, 2005
)
0.94
"We performed a phase I study of two fixed dosing schemes of cisplatin, a DNA cross-linker, with intravenous escalating topotecan, a DNA-topoisomerase I inhibitor."( Phase I trial of intravenous cisplatin-topotecan chemotherapy for three consecutive days in patients with advanced solid tumors: parallel topotecan escalation in two fixed platinum dosing schemes.
Briasoulis, E; Karavassilis, V; Mauri, D; Pavlidis, N; Pentheroudakis, G; Rammou, D; Tzamakou, E, 2005
)
0.33
" There are five major considerations for the 'optimal' route of epoetin administration: efficacy; dosing frequency; convenience; safety and tolerability; and cost."( Optimizing anaemia management with subcutaneous administration of epoetin.
Besarab, A, 2005
)
0.33
"The effectiveness of extended dosing of epoetin alfa beyond once-weekly (QW) has not been well explored in patients being treated for anaemia of chronic kidney disease (CKD)."( Extended epoetin alfa dosing in chronic kidney disease patients: a retrospective review.
Bhaduri, S; Curzi, M; Germain, M; Klausner, M; Ram, CV; Tang, KL, 2005
)
1.01
"A retrospective chart review was conducted to assess the efficacy of extended epoetin alfa dosing in patients being treated for CKD-related anaemia."( Extended epoetin alfa dosing in chronic kidney disease patients: a retrospective review.
Bhaduri, S; Curzi, M; Germain, M; Klausner, M; Ram, CV; Tang, KL, 2005
)
0.97
"5 years; 79% white, 54% female) who received extended epoetin alfa dosing for a mean of 10."( Extended epoetin alfa dosing in chronic kidney disease patients: a retrospective review.
Bhaduri, S; Curzi, M; Germain, M; Klausner, M; Ram, CV; Tang, KL, 2005
)
0.99
"Data from private community nephrology practices showed that extended epoetin alfa dosing effectively maintained Hb > or =11."( Extended epoetin alfa dosing in chronic kidney disease patients: a retrospective review.
Bhaduri, S; Curzi, M; Germain, M; Klausner, M; Ram, CV; Tang, KL, 2005
)
0.98
"The purpose of this study was to compare erythropoietin dosage requirements during subcutaneous versus intravenous administration in a hemodialysis population."( Conversion from subcutaneous to intravenous erythropoietin in a hemodialysis population.
Collins, DM; Penner, SB; Vercaigne, LM, 2005
)
0.33
"To determine whether extended epoetin alfa dosing schedules of up to once every four weeks are as effective as weekly dosing in maintaining hemoglobin (Hb) levels in patients with anemia of chronic kidney disease (CKD)."( Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study.
Bhaduri, S; Provenzano, R; Singh, AK, 2005
)
1.03
" Patients were randomized to one of four subcutaneously administered epoetin alfa dosing regimens: 10,000 units (U) once weekly (QW), 20,000 U every two weeks (Q2W), 30,000 U every three weeks (Q3W) or 40,000 U every four weeks (Q4W)."( Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study.
Bhaduri, S; Provenzano, R; Singh, AK, 2005
)
0.98
" Quality of life was maintained or improved from baseline to final within each dosing group."( Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study.
Bhaduri, S; Provenzano, R; Singh, AK, 2005
)
0.75
"Approximately 90% of patients dosed once every two weeks and over 75% of patients dosed once every three or four weeks maintained mean Hb levels > or = 11."( Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study.
Bhaduri, S; Provenzano, R; Singh, AK, 2005
)
0.75
"African-American non-smokers exhibit a diminished response to standard epoetin alfa dosing than non-smokers in other races."( Racial variations in erythropoietic response to epoetin alfa in chronic kidney disease and the impact of smoking.
Brown, J; Fink, JC; Hsu, VD; Jones-Burton, C; Seliger, SL; Stackiewicz, L, 2005
)
0.82
" These cost-savings are largely due to reduced utilization of these expensive biotechnology products with implementation of a dosing protocol."( Darbepoetin alfa therapeutic interchange protocol for anemia in dialysis.
Brophy, DF; Kockler, DR; Lee, S; Proeschel, LA; Ripley, EB, 2005
)
0.89
" This study examined dosing and hematologic outcomes with these agents in community oncology clinics."( Retrospective observational study of patients with chemotherapy-related anemia receiving erythropoietic agents.
Fastenau, J; Mark, TL; McKenzie, RS; Piech, CT, 2005
)
0.33
" Eleven patients required erythropoietin; their mean ribavirin dosage was higher but mean ribavirin concentration was lower compared to the 11 patients who did not require erythropoietin factor."( Ribavirin levels in post liver transplant patients treated for recurrent hepatitis C viral infection.
Fung, J; Jain, A; Kashyap, R; Marcos, A; Vekatramanan, R; Yelochan, B, 2005
)
0.33
" Head-to-head trials are comparing erythropoietic agents in a randomised setting; other trials are evaluating optimal dosage schedules."( Evaluating erythropoietic agents for the treatment of anaemia in the oncology setting.
Gascón, P, 2005
)
0.33
"We compared the erythropoietin-alpha dosage requirements during subcutaneous administration (3 months pre-switch) and intravenous administration (months 4-6 post-switch)."( Erythropoietin-alpha dosage requirements in a provincial hemodialysis population: effect of switching from subcutaneous to intravenous administration.
Bernstein, KN; Collins, DM; Raymond, CB; Skwarchuk, DE; Vercaigne, LM, 2006
)
0.33
" However, the optimal epoetin dosing schedule is unknown."( Darbepoetin alfa: new indication/new dosage. No proven advantage in chemotherapy-induced anaemia.
, 2005
)
0.89
" Three large, open-label, community studies of epoetin alfa for the treatment of chemotherapy-related anemia were retrospectively analyzed to assess the association of early hemoglobin response to subsequent transfusion requirements, subsequent hemoglobin response, quality of life, and epoetin alfa dosage administered over the study."( Benefits associated with an early hemoglobin response to epoetin alfa therapy in the treatment of chemotherapy-related anemia.
Campos, SM; Duh, MS; Lefebvre, P; Rosberg, J, 2005
)
0.83
" All children required dosage increases to 900 IU/kg due to no response."( Pharmacokinetics and pharmacodynamics of intravenous epoetin alfa in children with cancer.
Burghen, E; Freeman, BB; Hinds, P; Iacono, LC; Razzouk, BI; Stewart, CF, 2006
)
0.58
" In myeloid disorders such as myelodysplasia, response to single-agent recombinant human erythropoietin is disappointing but significant synergism with granulocyte colony stimulating factor has been demonstrated and different dosing regimens may also improve response."( Epoetin alfa: basic biology and clinical utility in cancer patients.
Collins, G; Littlewood, T, 2005
)
1.77
" These data warrant a randomized prospective trial in gynecologic oncology patients with careful attention to the timing of initiation of treatment, dosing regimens, and titration of growth factor."( Effectiveness of darbepoetin alfa versus epoetin alfa for the treatment of chemotherapy induced anemia in patients with gynecologic malignancies.
Barnes, MN; Case, AS; Kilgore, LC; Rocconi, RP, 2006
)
0.65
" Use of this drug in existing patients treated with rHu-EPO (epoetin alfa; EPO) requires conversion dosing and the potential for serious alterations in previously stable and satisfactory hemoglobin levels."( Developing an algorithm to convert erythropoietin dosing to darbepoetin alfa.
Capelli, JP; Kushner, H, 2006
)
0.81
" At the end of six months, there was an analysis of the data to determine if the results warranted an adjustment in the DPO dose and if so, what the adjusted dosing factor should be."( Developing an algorithm to convert erythropoietin dosing to darbepoetin alfa.
Capelli, JP; Kushner, H, 2006
)
0.57
" The approved 30,000 IU once-weekly dosing regimen (as opposed to the 10,000 IU three-times weekly regimen) provides greater convenience and may result in improved treatment compliance."( Epoetin beta in oncology: examining the current evidence.
Ludwig, H, 2006
)
0.33
" Neither epoetin dosage nor hemoglobin level was associated with cardiovascular adverse events or death."( Effect of early correction of anemia on the progression of CKD.
Fouqueray, B; Frei, D; Gassmann-Mayer, C; Hörl, WH; Levin, A; McClellan, WM; Roger, SD; Rossert, J, 2006
)
0.33
" The objective of this study was to investigate dosing patterns, hematologic outcomes, and intervention costs with EPO and DARB in anemic CKD patients treated in an ambulatory care setting."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in predialysis chronic kidney disease patients with anemia.
McKenzie, RS; Mody, SH; Papatheofanis, FJ; Piech, CT; Suruki, RY, 2006
)
0.33
" Once-weekly and extended dosing (> or = Q2W) was common in both groups."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in predialysis chronic kidney disease patients with anemia.
McKenzie, RS; Mody, SH; Papatheofanis, FJ; Piech, CT; Suruki, RY, 2006
)
0.33
"Extended dosing (Q2W) was common in EPO- and DARB-treated patients with CKD-related anemia, with EPO-treated patients experiencing a significantly greater hematologic response (at Weeks 4, 8, and 12)."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in predialysis chronic kidney disease patients with anemia.
McKenzie, RS; Mody, SH; Papatheofanis, FJ; Piech, CT; Suruki, RY, 2006
)
0.33
" Less frequent dosing offers potential benefits for patients, caregivers and health care providers."( Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial.
Boccia, RV; Bosserman, L; Glaspy, J; Hu, E; Lloyd, RE; Patel, R; Rossi, G; Tomita, D; Vadhan-Raj, S, 2006
)
0.6
" The open-label dosing and the patient attrition rate did not appear to influence overall study results."( Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia.
Charu, V; Gordan, LN; Henry, DH; Wilhelm, FE; Williams, D; Woodman, RC; Xie, J, 2006
)
0.61
"Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia."( Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia.
Charu, V; Gordan, LN; Henry, DH; Wilhelm, FE; Williams, D; Woodman, RC; Xie, J, 2006
)
0.61
"We performed a prospective multicentre clinical trial in iron-replete haemodialysis patients to evaluate the efficacy of weekly low-dose (50 mg) intravenous iron sucrose administration for 6 months to maintain the iron status, and to examine the effect on epoetin dosage needed to maintain stable haemoglobin values in these patients."( Weekly low-dose treatment with intravenous iron sucrose maintains iron status and decreases epoetin requirement in iron-replete haemodialysis patients.
Ambühl, PM; Binet, I; Dickenmann, M; Keusch, G; Lüthi, L; Schiesser, D; Schmidli, M; Tsinalis, D; Wüthrich, RP, 2006
)
0.33
"A regular 50 mg weekly dosing schedule of iron sucrose maintains stable iron stores and haemoglobin levels in haemodialysed patients and allows considerable dose reductions for epoetins."( Weekly low-dose treatment with intravenous iron sucrose maintains iron status and decreases epoetin requirement in iron-replete haemodialysis patients.
Ambühl, PM; Binet, I; Dickenmann, M; Keusch, G; Lüthi, L; Schiesser, D; Schmidli, M; Tsinalis, D; Wüthrich, RP, 2006
)
0.33
" Darbepoetin alfa effectively alleviates CKD-associated anaemia with less frequent dosing than recombinant human erythropoietin (EPO)."( Effectiveness of weekly darbepoetin alfa in the treatment of anaemia of HIV-infected haemodialysis patients.
Boquinhas, H; Carrera, F; Jorge, C; Lucas, C; Pais, MJ, 2006
)
1.14
"Lower doses of darbepoetin alfa at extended dosing interval is as safe and effective as EPO-alfa for treating anaemia, suggesting that darbepoetin alfa is a more cost-effective therapeutic alternative to EPO-alfa in the management of anaemia associated with HIV infection in subjects receiving haemodialysis."( Effectiveness of weekly darbepoetin alfa in the treatment of anaemia of HIV-infected haemodialysis patients.
Boquinhas, H; Carrera, F; Jorge, C; Lucas, C; Pais, MJ, 2006
)
0.96
"We conclude that a higher initial dosing of epoetin alpha appears to be an efficient schedule for treating anemia in cancer patients undergoing chemotherapy, conferring higher response rates than those seen with standard doses."( An induction dose of epoetin alpha of 40 000 IU daily for three consecutive days increases and maintains hemoglobin levels in anemic cancer patients undergoing chemotherapy.
Ceccherini, R; Dellach, C; Foladore, S; Leita, M; Milani, S; Mustacchi, G; Sisto, M, 2006
)
0.33
"Post hoc subset analyses were conducted for 2 studies: a prospective, multicenter survey evaluating the prevalence of anemia in patients with CKD (the Prevalence of Anemia in Early Renal Insufficiency [PAERI] study) and a prospective, multicenter, open-label trial evaluating the efficacy and safety of QW epoetin alfa for the treatment of anemia associated with CKD (the Clinical Evaluation of Procrit Dosed Once Weekly in Patients With Anemia Due to Early Renal Insufficiency [POWER] study)."( Prevalence and treatment of anemia with once-weekly epoetin alfa in patients with diabetes and chronic kidney disease.
Lorber, DL; McClellan, W; Provenzano, R,
)
0.56
"AMPS (Aranesp Monthly Preference Study) consisted of two studies of similar design, each with a 2-week screening/baseline period, a 20-week QM darbepoetin alfa dosing period, and an 8-week follow-up period."( Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis.
Audhya, P; Crouch, T; Hoggard, J; Levine, M; McMurray, S; Prathikanti, R; Scarlata, D, 2006
)
0.83
" Of the patients converted from once-weekly Epoetin alfa, 86% (138/161) preferred darbepoetin alfa QM, and of all patients who expressed a preference, regardless of previous Epoetin alfa dosing frequency, 96% (305/319) preferred QM darbepoetin alfa."( Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis.
Audhya, P; Crouch, T; Hoggard, J; Levine, M; McMurray, S; Prathikanti, R; Scarlata, D, 2006
)
0.89
"This study investigated dosing patterns and costs associated with the use of erythropoietic-stimulating therapy (EST) in patients with CKD not on dialysis who were newly starting EPO or DARB therapy in managed care organizations."( Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations.
Duh, MS; Gosselin, A; Lefebvre, P; Mody, SH; Scott McKenzie, R; Tak Piech, C, 2006
)
0.33
" The mean dosing interval was determined for both groups."( Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations.
Duh, MS; Gosselin, A; Lefebvre, P; Mody, SH; Scott McKenzie, R; Tak Piech, C, 2006
)
0.33
" Use of extended dosing (> or =q2wk) was common in both groups (63."( Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations.
Duh, MS; Gosselin, A; Lefebvre, P; Mody, SH; Scott McKenzie, R; Tak Piech, C, 2006
)
0.33
"The majority of these CKD patients newly started on EST in managed care organizations received extended dosing regimens (> or =q2wk) of EPO or DARB."( Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations.
Duh, MS; Gosselin, A; Lefebvre, P; Mody, SH; Scott McKenzie, R; Tak Piech, C, 2006
)
0.33
" Extended dosing of ESP has potential advantages for the patient and may also improve resource utilization."( Practical approach to the diagnosis and treatment of anemia associated with CKD in elderly.
Agarwal, AK, 2006
)
0.33
"To investigate dosing patterns and drug costs of erythropoietic agents and assess the frequency of outpatient nephrologist visits in an elderly population with pre-dialysis chronic kidney disease (pCKD) newly initiated on epoetin alfa (EPO) or darbepoetin alfa (DARB)."( Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.
Bookhart, BK; Duh, MS; Gosselin, A; Lefebvre, P; McKenzie, RS; Mody, SH; Piech, CT, 2006
)
0.52
" The average dosing interval for both EPO and DARB was calculated and classified as once weekly (qw), every 2 weeks (q2w) or every 3 weeks or less frequently (> or = q3w)."( Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.
Bookhart, BK; Duh, MS; Gosselin, A; Lefebvre, P; McKenzie, RS; Mody, SH; Piech, CT, 2006
)
0.33
" Extended dosing (every 2 weeks or less frequently: > or = q2w) during treatment was observed in both groups (EPO: qw 49."( Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.
Bookhart, BK; Duh, MS; Gosselin, A; Lefebvre, P; McKenzie, RS; Mody, SH; Piech, CT, 2006
)
0.33
"Based on this analysis of claims data from more than 30 US healthcare plans, extended dosing (> or = q2w) of EPO and DARB was common in elderly pCKD patients treated with erythropoietic agents, with significantly higher weekly drug costs observed in the DARB group compared with the EPO group."( Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.
Bookhart, BK; Duh, MS; Gosselin, A; Lefebvre, P; McKenzie, RS; Mody, SH; Piech, CT, 2006
)
0.33
"This analysis was a post hoc evaluation of epoetin alfa dosage requirements in a subgroup of patients from the Effect of early Correction of Anemia on the Progression of CKD study."( Prevalence and predictors of epoetin hyporesponsiveness in chronic kidney disease patients.
Frei, D; Gassmann-Mayer, C; McClellan, W; Rossert, J, 2007
)
0.6
"Of the 93 patients evaluated in this subgroup analysis, 14 (15%) were hyporesponsive to epoetin (maximum dosage >100 IU/kg/week during stabilization)."( Prevalence and predictors of epoetin hyporesponsiveness in chronic kidney disease patients.
Frei, D; Gassmann-Mayer, C; McClellan, W; Rossert, J, 2007
)
0.34
" Front loading with weekly doses of either erythropoietic agent followed by a three-week-long dosing interval for maintenance treatment may be used to quickly correct anemia, improve convenience, and reduce costs."( Anemia in cancer and critical care patients: pharmacoeconomic considerations.
Reeder, CE, 2007
)
0.34
" Moreover, studies suggest consistently that a 'front-loading' dosing regimen with epoetin alfa does not convey improved speed of Hb response over epoetin beta administered according to current clinical practice guidelines."( Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins.
Oberhoff, C, 2007
)
0.56
" Data from randomised, double-blind, placebo-controlled studies, and large, non-randomised, open-label, community-based studies, along with almost 15 years of practical experience, support the assertion that epoetin alfa administered at a dosage of 150-300 U/kg three times weekly or 40,000-60,000U once weekly, both of which are US FDA-approved dose administration schedules, can effectively and safely achieve anaemia treatment goals for the majority of patients with lymphoid malignancies."( Guidelines and recommendations for the management of anaemia in patients with lymphoid malignancies.
Henry, DH, 2007
)
0.53
" We reviewed data showing the feasibility and effectiveness of treatment with the erythropoiesis-stimulating protein darbepoetin alfa at extended dosing intervals to treat anemia in patients with cancer receiving multicycle chemotherapy."( Darbepoetin alfa: an effective treatment with flexible and simplified dosing for anemia in patients with cancer.
Natale, JJ; Stevenson, JG, 2007
)
1.11
") dosage requirements is a notable characteristic of darbepoetin-alpha (DPO), as opposed to other epoetins (EPOs)."( Long-term intravenous epoetin-alpha / darbepoetin-alpha ratio in iron-replete hemodialysis patients.
Icardi, A; Romano, U; Sacco, P; Salvatore, F,
)
0.13
" DPO weekly mean dosage decreased from 40."( Long-term intravenous epoetin-alpha / darbepoetin-alpha ratio in iron-replete hemodialysis patients.
Icardi, A; Romano, U; Sacco, P; Salvatore, F,
)
0.13
" Of these patients, 806 had dosing data for at least 1 month before switch through to 6 months post switch (6 month cohort)."( Dose of epoetin alfa used in haemodialysis patients when switching from subcutaneous to intravenous administration.
Pussell, BA; Walker, R, 2007
)
0.77
" Centre and dosing frequency of epoetin alfa before switch were determinants of increased dose."( Dose of epoetin alfa used in haemodialysis patients when switching from subcutaneous to intravenous administration.
Pussell, BA; Walker, R, 2007
)
1.06
" The frequency of dosing was higher in the epoetin alfa group (1."( Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare?
Pussell, BA; Walker, R, 2007
)
0.86
" The type of facility (profit, chain, and affiliation status) at which a patient receives dialysis might affect epoetin dosing patterns and has implications for future epoetin policies."( Dialysis facility ownership and epoetin dosing in patients receiving hemodialysis.
Cotter, D; Dong, F; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2007
)
0.34
" Dosing adjustments also differed by type of facility."( Dialysis facility ownership and epoetin dosing in patients receiving hemodialysis.
Cotter, D; Dong, F; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2007
)
0.34
"Dialysis facility organizational status and ownership are associated with variation in epoetin dosing in the United States."( Dialysis facility ownership and epoetin dosing in patients receiving hemodialysis.
Cotter, D; Dong, F; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2007
)
0.34
" Initial dose of drug was 150 units/kg/week subcutaneously, two or three times a week and dosage was adjusted to maintain the Hb at 10-12g%."( 12-week clinical effects of erythropoietin espogen in end stage renal patients undergoing hemodialysis.
Tasanarong, A; Thitiarchakul, S, 2007
)
0.34
" Mean weekly of Espogen dosage was 8390 +/- 2452."( 12-week clinical effects of erythropoietin espogen in end stage renal patients undergoing hemodialysis.
Tasanarong, A; Thitiarchakul, S, 2007
)
0.34
" With the introduction of the longer-acting erythropoiesis-stimulating agent darbepoetin alfa, there has been growing interest in longer dosing intervals for erythropoiesis-stimulating agents."( Extended dosing intervals with erythropoiesis-stimulating agents in chronic kidney disease: a review of clinical data.
Carrera, F; Disney, A; Molina, M, 2007
)
0.57
"The purpose of this study was to evaluate the safety and efficacy of epoetin alfa (EPO) at an initial dose of 60,000 Units (U) once weekly (QW) followed by extended dosing of 80,000 U every 3 weeks (Q3W) in patients with chemotherapy-induced anemia (CIA)."( An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy.
Montoya, VP; Wilhelm, FE; Williams, D; Woodman, RC; Xie, J, 2007
)
0.84
"Anemic patients (hemoglobin [Hb] < or = 11 g/dl) receiving Q3W chemotherapy for nonmyeloid malignancy were enrolled in this prospective, open-label, single-arm study to receive EPO 60,000 U subcutaneously (SC) QW (initial dosing phase [IDP]) until a target Hb level of 12 g/dl was reached (maximum 12 weeks)."( An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy.
Montoya, VP; Wilhelm, FE; Williams, D; Woodman, RC; Xie, J, 2007
)
0.6
"These results suggest that initiation of EPO 60,000 U SC QW is effective in the treatment of CIA and that EPO 80,000 U SC Q3W can be an effective extended dosing option."( An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy.
Montoya, VP; Wilhelm, FE; Williams, D; Woodman, RC; Xie, J, 2007
)
0.6
" Extended dosing of darbepoetin alfa and the new agent continuous erythropoiesis receptor activator appears effective."( Pharmacist's role in managing anemia in patients with chronic kidney disease: potential clinical and economic benefits.
Gilmartin, C, 2007
)
0.65
"The NKF recommendations for ESA use are general and include dosing based on the measured and target hemoglobin concentrations, the rate of increase in hemoglobin, and clinical circumstances, with the route and frequency of administration determined by the CKD stage, treatment setting, efficacy, and ESA class."( Update on clinical practice recommendations and new therapeutic modalities for treating anemia in patients with chronic kidney disease.
Grabe, DW, 2007
)
0.34
" Variable costs were those which varied with dosing frequency."( Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.
Attard, C; Churchill, DN; Goeree, R; Kallich, J; Macarios, D, 2007
)
0.34
"66, if patients were converted to less frequent dosing using darbepoetin alfa."( Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.
Attard, C; Churchill, DN; Goeree, R; Kallich, J; Macarios, D, 2007
)
0.58
" Less frequent monitoring of iron therapy and less frequent dosing could decrease costs by CAD 678."( Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.
Attard, C; Churchill, DN; Goeree, R; Kallich, J; Macarios, D, 2007
)
0.34
"To compare the efficacy of extended epoetin alfa dosing in maintaining hemoglobin (Hb) concentrations in patients with and without diabetes as the primary cause of chronic kidney disease."( Hemoglobin maintenance with use of extended dosing of epoetin alfa in patients with diabetes and anemia of chronic kidney disease.
Provenzano, R; Singh, AK,
)
0.65
" Patients received 1 of 4 epoetin alfa dosing regimens administered subcutaneously for up to 16 weeks: 10,000 U once weekly (QW), 20,000 U every 2 weeks (Q2W), 30,000 U every 3 weeks (Q3W), or 40,000 U every 4 weeks (Q4W)."( Hemoglobin maintenance with use of extended dosing of epoetin alfa in patients with diabetes and anemia of chronic kidney disease.
Provenzano, R; Singh, AK,
)
0.68
" The percentage of patients achieving Hb maintenance, stratified by epoetin alfa dosing regimen, was similar in patients with and those without diabetes: QW (90."( Hemoglobin maintenance with use of extended dosing of epoetin alfa in patients with diabetes and anemia of chronic kidney disease.
Provenzano, R; Singh, AK,
)
0.62
" These results demonstrated that patients with diabetes responded in a similar manner as patients without diabetes to extended dosing of epoetin alfa up to Q4W."( Hemoglobin maintenance with use of extended dosing of epoetin alfa in patients with diabetes and anemia of chronic kidney disease.
Provenzano, R; Singh, AK,
)
0.58
" Here we have investigated the dose-response to rhEPO and compared the effects of rhEPO with those of carbamylated rhEPO (CEPO) in a model of cerebral stroke in rats."( Post-ischemic treatment with erythropoietin or carbamylated erythropoietin reduces infarction and improves neurological outcome in a rat model of focal cerebral ischemia.
Chopp, M; Heavner, G; Kapke, A; Lu, M; Pool, C; Renzi, M; Rhodes, K; Wang, Y; Zhang, RL; Zhang, ZG, 2007
)
0.34
"To evaluate the effectiveness, the safety, and the quality of life by using once weekly dosing of Epoetin alfa (Eprex, Janssen-cilag) 40,000 units in the treatment of anemia in cancer patients receiving chemotherapy."( Antianemic effect of once weekly regimen of epoetin alfa 40,000 units in anemic cancer patients receiving chemotherapy.
Sriuranpong, V; Suwanrusme, H; Voravud, N, 2007
)
0.82
"Once weekly dosing of Epoetin alfa 40,000 units therapy is safe and effective in remodeling anemia and significantly improves the quality of life in cancer patients receiving chemotherapy."( Antianemic effect of once weekly regimen of epoetin alfa 40,000 units in anemic cancer patients receiving chemotherapy.
Sriuranpong, V; Suwanrusme, H; Voravud, N, 2007
)
0.92
"To compare real-world dosing patterns, drug costs, and hematologic outcome in anemic chronic kidney disease (CKD) patients, not receiving dialysis, who switched from darbepoetin alfa (DARB) to epoetin alfa (EPO) in a community practice setting."( Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa.
Bickimer, T; Bookhart, BK; Hymes, J; Jackson, JH; Mody, SH; Tak Piech, C, 2007
)
0.74
" The goal of this study was to assess and compare EPO- and DARB-treated CKD patients with respect to dosing patterns, hematologic outcomes, and associated costs."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in anemic predialysis chronic kidney disease patients from an observational study.
Bookhart, B; McKenzie, RS; Mody, S; Papatheofanis, F; Piech, CT; Smith, C,
)
0.13
" Selection criteria included patients newly initiated on EPO or DARB between July 2002 and December 2003 who had at least 24 weeks of dosing and hematologic laboratory data available."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in anemic predialysis chronic kidney disease patients from an observational study.
Bookhart, B; McKenzie, RS; Mody, S; Papatheofanis, F; Piech, CT; Smith, C,
)
0.13
" Extended dosing (defined as > or =Q2W) was common in both groups."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in anemic predialysis chronic kidney disease patients from an observational study.
Bookhart, B; McKenzie, RS; Mody, S; Papatheofanis, F; Piech, CT; Smith, C,
)
0.13
"Extended dosing frequency (> or = Q2W) was common in both groups."( Dosing patterns, hematologic outcomes, and costs of erythropoietic agents in anemic predialysis chronic kidney disease patients from an observational study.
Bookhart, B; McKenzie, RS; Mody, S; Papatheofanis, F; Piech, CT; Smith, C,
)
0.13
"There are limited data suggesting that initiation of epoetin alfa at extended dosing intervals of every 2, 3, or 4 wk may be efficacious for treating anemia in patients who have chronic kidney disease and are not on dialysis (CKD-NOD)."( Epoetin alfa once every 2 weeks is effective for initiation of treatment of anemia of chronic kidney disease.
Benz, R; Kelly, K; Schmidt, R; Wolfson, M, 2007
)
2.03
" Dosage was adjusted to maintain Hb +/-1."( Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly.
Balla, J; Beyer, U; Csiky, B; Ehrhard, P; Harris, K; Locatelli, F; Ryckelynck, JP; Sulowicz, W, 2007
)
0.34
"The inpatient dosing patterns and treatment costs in cancer and predialysis chronic kidney disease (CKD) patients treated with erythropoietic agents from a hospital pharmacy perspective were studied."( Dose and cost comparison of erythropoietic agents in the inpatient hospital setting.
Duh, MS; Lefebvre, P; McKenzie, RS; Mody, SH; Piech, CT; Vekeman, F; Watson, SH, 2007
)
0.34
"To demonstrate the effectiveness of once-weekly (QW) rHuEPO dosing to effect improved hemoglobin levels, decreased transfusion use, and improved functional outcomes and QOL in pediatric leukemic patients (ALL) receiving maintenance chemotherapy."( Once weekly recombinant human erythropoietin treatment for cancer-induced anemia in children with acute lymphoblastic leukemia receiving maintenance chemotherapy: a randomized case-controlled study.
Abdelrazik, N; Fouda, M, 2007
)
0.34
"EPO administration to renal patients is much more costly in Sweden than in the UK, primarily due to the higher dosage of EPO and iron supplementation used in Sweden."( Cost-effectiveness analysis of treatment with epoietin-alpha for patients with anaemia due to renal failure: the case of Sweden.
Glenngård, AH; Persson, U; Schön, S, 2008
)
0.35
" More frequent dosing with epoetin alfa is recommended by the labeled administration guidelines because it has a shorter half-life than darbepoetin alfa."( Use of erythropoiesis-stimulating agents in patients with anemia of chronic kidney disease: overcoming the pharmacological and pharmacoeconomic limitations of existing therapies.
Coyne, DW; Wish, JB, 2007
)
0.64
" Dosage was adjusted to maintain patients' Hb within +/-1."( C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks.
Adamis, H; Azer, M; Beyer, U; Coyne, DW; Dalal, S; Fraticelli, M; Lok, CE; Rosansky, S; Spinowitz, B; Villa, G, 2008
)
0.35
" We estimated the dose-response relationship for the average epoetin dose and hematocrit during a 3-month initiation and subsequent 3-month maintenance phase using a marginal structural model to adjust for measured time-dependent confounding by indication."( The effect of epoetin dose on hematocrit.
Cotter, D; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2008
)
0.35
" The erythropoietin dosage regimes in different types of hepatic resections in living kindred donors were proposed."( [Application of recombinant erythropoietin during preparation for hepatic transplantation operation from the living kindred donor].
Dykhovichnaia, NIu; Gusev, AV; Kotenko, OG; Mazur, AP; Popov, AO, 2007
)
0.34
" Erythropoietic drug costs were calculated using unit wholesale acquisition cost multiplied by the number of units or micrograms while comparing the following dosing regimens: EPO 3 times weekly, EPO once weekly, and DARB once weekly."( Cost analytic model to determine the least costly inpatient erythropoiesis stimulating therapy regimen.
Decter, A; Duh, MS; Greco, T; Kang, YJ; Mody, SH; Naeem, A; Piech, CT; Sikand, H; Watson, SH, 2008
)
0.35
" The approved dosing interval for currently available erythropoiesis-stimulating agents (ESAs) is 2 to 3 times weekly for epoetin alfa (EPO) and every 1 to 2 weeks for darbepoetin alfa (DARB)."( Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study.
Dennis, VW; Law, A; Nurko, S; Spirko, R, 2007
)
0.76
"This study investigated patterns of actual ESA use (doses and dosing intervals) and hemoglo- bin (Hb) control in adult outpatients with CKD not requiring dialysis at the Cleveland Clinic Foundation anemia clinic."( Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study.
Dennis, VW; Law, A; Nurko, S; Spirko, R, 2007
)
0.55
"The clinical charts and electronic records of adult outpatients with CKD who initiated ESA therapy before March 2005 were reviewed to identify the initial, dominant (used for the longest consecutive period), and final dosing intervals and mean weekly doses of EPO and DARB."( Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study.
Dennis, VW; Law, A; Nurko, S; Spirko, R, 2007
)
0.55
" The most common initial dosing intervals were qwk for EPO (66."( Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study.
Dennis, VW; Law, A; Nurko, S; Spirko, R, 2007
)
0.55
"The patterns of ESA usage in adult outpatients with CKD at this center indicated that clinicians extended dosing intervals beyond those in the approved prescribing information."( Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study.
Dennis, VW; Law, A; Nurko, S; Spirko, R, 2007
)
0.55
" However, in the Phase III trial providing the basis for this new dosage recommendation, more than 70% of patients required a 40% reduction in the dosage, resulting in an average dose of 375 microg every three weeks."( Extended-dosage-interval regimens of erythropoietic agents in chemotherapy-induced anemia.
Baribeault, D; Muller, RJ, 2007
)
0.34
"This analysis was limited to prevalent hemodialysis patients, and inhospital EPO dosing information was unavailable."( Exploring relative mortality and epoetin alfa dose among hemodialysis patients.
Acquavella, JF; Bradbury, BD; Critchlow, CW; Heagerty, P; Keen, M; Rothman, KJ; Wang, O, 2008
)
0.63
" The subsequently introduced epoetin analogue, darbepoetin alpha, with a prolonged serum half-life, allowed for extended dosing intervals and less frequent administration."( Darbepoetin alpha coming of age.
Cinieri, S; Gamucci, T; Lorusso, V; Pedrazzoli, P; Secondino, S; Silvestris, N,
)
0.13
"To report the design, methodology, implementation and initial results of the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry, the first US patient registry to collect and report on practice patterns and outcomes associated with erythropoiesis-stimulating therapy (EST) for anaemia management in oncology patients."( Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients.
Bookhart, B; Larholt, K; McKenzie, RS; Pashos, CL; Piech, CT; Wang, Q, 2008
)
0.35
" Results from this registry should provide patients, clinicians and healthcare decision makers with a better understanding of the relationship between EST dosage and outcomes in the clinical setting."( Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients.
Bookhart, B; Larholt, K; McKenzie, RS; Pashos, CL; Piech, CT; Wang, Q, 2008
)
0.35
" Although the clinical approach tested in this study is not consistent with current prescribing recommendations, the results confirm the efficacy of prolonged dosing intervals (every 2-4 weeks) in maintaining optimal Hb levels and QOL in anemic HIV-infected patients."( Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients.
Leitz, GJ; Levine, AM; Salvato, P, 2008
)
0.72
"The objective of this study was to examine, from the perspective of a third-party payer, patterns of use and costs of DA and EA in patients with CRA, using episode-based methodology to account for differences in assumed duration of effect and frequency of dosing with these products."( Use of darbepoetin alfa and epoetin alfa in clinical practice in patients with cancer-related anemia.
Berger, A; Edelsberg, J; Kallich, J; Oster, G, 2008
)
0.74
" Dosing was titrated individually to achieve a stable, target Hb concentration of 11-12 g/dL."( Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia.
Czekalski, S; Koytchev, R; Krivoshiev, S; Manitius, J; Scigalla, P; Todorov, VV, 2008
)
0.35
" This open-label, randomized study was performed to characterize the pharmacokinetic and pharmacodynamic profiles of four dosing regimens of epoetin alfa administered subcutaneously in anemic patients who had chronic kidney disease and were not on dialysis."( Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis.
Beaver, JS; Massarella, J; McGowan, T; Vaccaro, NM; Wolfson, M, 2008
)
0.78
"Extended dosing interval regimens of epoetin alfa yielded modest pharmacokinetic differences but a similar pharmacodynamic response, suggesting that less frequent, higher dosages of epoetin alfa may be as effective as the current three-times-weekly regimen in anemic patients who have chronic kidney disease and are not on dialysis."( Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis.
Beaver, JS; Massarella, J; McGowan, T; Vaccaro, NM; Wolfson, M, 2008
)
0.86
" Renal programs across Canada should consider dosage conversion ratios in addition to drug acquisition costs when considering a formulary decision about erythropoiesis stimulating agents."( Conversion from epoetin alfa to darbepoetin alfa within the Manitoba Renal Program: evaluation of dose ratios.
Bernstein, KN; Lesperance, EM; Raymond, CB; Skwarchuk, DE; Vercaigne, LM; Wazny, LD,
)
0.48
" The revisions include revised safety information, new Epoetin alfa dosing recommendations, and revised information on health-related quality of life (HRQoL)."( Revisions in the prescribing information for Epoetin alfa: implications for nephrology nurses and patients on dialysis.
Hayslip, D,
)
0.64
" The choice of ESA should consider safety of subcutaneous administration, cost-effectiveness, and dosing frequency, all of which may affect compliance with ESA administration."( Latest strategy in renal anemia management in peritoneal dialysis patients.
Lo, WK, 2008
)
0.35
") dosing schedules."( Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.
Cannella, G; Conte, F; De Ferrari, G; Filippini, A; Formica, M; Locatelli, F; Lombardi, L; Messa, P; Naso, A; Rossi, E; Rotolo, U; Villa, G,
)
0.39
" epoetin alfa with conventional dosing regimens."( Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.
Cannella, G; Conte, F; De Ferrari, G; Filippini, A; Formica, M; Locatelli, F; Lombardi, L; Messa, P; Naso, A; Rossi, E; Rotolo, U; Villa, G,
)
1.3
" Prospective studies are needed to confirm this relationship and determine safe dosing algorithms for patients unable to achieve target hemoglobin."( Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes.
Barnhart, HX; Califf, RM; Inrig, JK; Patel, UD; Reddan, DN; Sapp, S; Singh, AK; Szczech, LA, 2008
)
0.35
" Recombinant human erythropoietin was administered intraperitoneally at 6 hours and at 3 and 7 days post-TBI (5000 U/kg body weight, total dosage 15,000 U/kg)."( Effects of erythropoietin on reducing brain damage and improving functional outcome after traumatic brain injury in mice.
Chopp, M; Goussev, A; Lu, D; Mahmood, A; Qu, C; Schallert, T; Xiong, Y, 2008
)
0.35
" Study variables by setting included ESA use, prescriber specialty, and dosage regimen."( Use and prescribing patterns for erythropoiesis-stimulating agents in inpatient and outpatient hospital settings.
Audhya, P; Brophy, DF; Comstock, T; Feng, A; Johnson, PE; Jorgenson, J; Siegel, J, 2008
)
0.35
" The dosage of epoetin zeta was stable throughout the course of the trial."( Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia.
Baldamus, C; Bronn, A; Koytchev, R; Krivoshiev, S; Siebert-Weigel, M; Wolf-Pflugmann, M, 2008
)
0.35
" In March 2007, the FDA changed the labeling of the ESAs to add boxed warnings, updated in November 2007, to include the following key points: (a) ESAs should be used only to treat anemia that occurs in patients with cancer while they are undergoing chemotherapy; (b) treatment with ESAs should be stopped when chemotherapy ends; and (c) dosing ESAs to an Hb target of 12 gm per dL or greater has resulted in more rapid cancer progression or shortened overall survival in patients with breast, head and neck, lymphoid, cervical, and non-small cell lung malignancies."( Use of erythropoiesis-stimulating agents among chemotherapy patients with hemoglobin exceeding 12 grams per deciliter.
Fraeman, K; Luo, W; Nordstrom, BL; Nordyke, RJ; Whyte, JL,
)
0.13
" The Centers for Medicare & Medicaid Services has decreased ESA dosing recommendations in the Medicare claims policy for ESAs."( The controversy surrounding hemoglobin and erythropoiesis-stimulating agents: what should we do now?
Singh, AK, 2008
)
0.35
"157 prevalent-hemodialysis subjects were analyzed from an open-label, randomized study that compared the intravenous to the subcutaneous route of epoetin with identical weight-based dosing algorithm."( Route of epoetin administration influences hemoglobin variability in hemodialysis patients.
Hirter, A; Kaufman, J; Keithi-Reddy, SR; Patel, T; Reda, D; Singh, A, 2009
)
0.35
" Data on ESA doses, dosing frequencies, hemoglobin levels, and red blood cell (RBC) transfusions were abstracted from electronic medical records."( A US multicenter, retrospective, observational study of erythropoiesis-stimulating agent utilization in anemic, critically ill patients admitted to the intensive care unit.
Audhya, P; Brophy, GM; Lottenberg, L; Scarlata, D; Shapiro, MJ; Sheehan, V, 2008
)
0.35
" The most commonly prescribed dosing frequency with darbepoietin alfa was once weekly (88."( A US multicenter, retrospective, observational study of erythropoiesis-stimulating agent utilization in anemic, critically ill patients admitted to the intensive care unit.
Audhya, P; Brophy, GM; Lottenberg, L; Scarlata, D; Shapiro, MJ; Sheehan, V, 2008
)
0.35
" We wished to evaluate the effect of protocol adherence to EPO and intravenous iron dosing on achieving the desired range of hemoglobin levels."( Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients.
Chan, K; Hlatky, M; Lafayette, R; Moran, J, 2009
)
0.35
"A cohort of hemodialysis patients was studied to evaluate the rate of adherence to EPO and iron dosing protocols over a 5 month period."( Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients.
Chan, K; Hlatky, M; Lafayette, R; Moran, J, 2009
)
0.35
"Among 2114 patients, we found that adherence to both the EPO and iron dosing protocol resulted in the greatest probability of achieving the target hemoglobin range (56 +/- 5% in anemia protocol adherent patients versus 42 +/- 7% in non adherent patients)."( Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients.
Chan, K; Hlatky, M; Lafayette, R; Moran, J, 2009
)
0.35
"To describe the pharmacokinetic profiles of six different dosing regimens for epoetin alfa, and whether more rapid and robust reticulocytosis can be elicited with more frequent administration of epoetin alfa in anemic critically ill patients."( Pharmacokinetics and pharmacodynamics of six epoetin alfa dosing regimens in anemic critically ill patients without acute blood loss.
Arroliga, AC; Beaver, JS; Guntupalli, KK; Kelly, K; Langholff, W; Marino, K, 2009
)
0.84
" Erythropoietin exposure was approximately ten times greater for IV dosing than for subcutaneous dosing."( Pharmacokinetics and pharmacodynamics of six epoetin alfa dosing regimens in anemic critically ill patients without acute blood loss.
Arroliga, AC; Beaver, JS; Guntupalli, KK; Kelly, K; Langholff, W; Marino, K, 2009
)
0.61
"In this study of anemic critically ill patients treated with epoetin alfa, all dosing regimens were well tolerated and appeared to effect reticulocytosis, with a peak at day 11 or 15 in most patients."( Pharmacokinetics and pharmacodynamics of six epoetin alfa dosing regimens in anemic critically ill patients without acute blood loss.
Arroliga, AC; Beaver, JS; Guntupalli, KK; Kelly, K; Langholff, W; Marino, K, 2009
)
0.85
"The common finding that low achieved hemoglobin in observational studies and high target hemoglobin in randomized trials each were associated with increased mortality and high epoetin dosage has suggested the possibility that high epoetin dosage might explain the increased mortality risk."( Estimated effect of epoetin dosage on survival among elderly hemodialysis patients in the United States.
Cotter, D; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2009
)
0.35
" We estimated the association between cumulative average epoetin dosage and survival through the subsequent 9 mo by using inverse probability weighting to adjust for time-dependent confounding by indication."( Estimated effect of epoetin dosage on survival among elderly hemodialysis patients in the United States.
Cotter, D; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2009
)
0.35
"Survival was similar throughout the entire follow-up period for the three hypothetical treatment regimens selected: Low dosage 15,000 U/wk, medium dosage 30,000 U/wk, and high dosage 45,000 U/wk."( Estimated effect of epoetin dosage on survival among elderly hemodialysis patients in the United States.
Cotter, D; Hernán, MA; Kaufman, J; Thamer, M; Zhang, Y, 2009
)
0.35
" Dosing regimens were obtained from registration clinical trials."( Budget impact analysis of darbepoetin alfa every 3 weeks versus epoetin alfa every week for the treatment of chemotherapy-induced anaemia from a US payer's perspective.
Adams, JL; Glaspy, JA; Kallich, JD; Mafilios, MS; Rubin, RJ; Viswanathan, HN; Wang, SM, 2008
)
0.63
"The difference in risk estimates between the adjusted linear regression and the IV regression suggests that the short-term mortality related to EPO dosing may be largely attributable to confounding-by-indication for higher doses."( Greater Epoetin alfa (EPO) doses and short-term mortality risk among hemodialysis patients with hemoglobin levels less than 11 g/dL.
Bradbury, BD; Brookhart, MA; Critchlow, CW; Do, TP; Winkelmayer, WC, 2009
)
0.79
"To reduce the risk of potential bias, DCB and different patient characteristics should be taken into account when using retrospective claims data to conduct cost comparisons between agents that have significant differences in dosing schedule."( The impact of methodological approach on cost findings in comparison of epoetin alfa with darbepoetin alfa.
Kallich, J; Long, SR; Marder, WD; Song, X; Sullivan, SD, 2009
)
0.59
" These data lack clinical variables, such as baseline haemoglobin (Hb) level, which are likely to influence choice of ESA, dosing and costs."( The importance of clinical variables in comparative analyses using propensity-score matching: the case of ESA costs for the treatment of chemotherapy-induced anaemia.
Eremina, D; Hess, G; Hill, J; Hulnick, S; Kallich, J; Polsky, D; Roumm, A; Whyte, JL, 2009
)
0.35
"A 16-week dose-response study and a 32-week follow-Up study were combined."( Maintaining high hemoglobin levels improved the left ventricular mass index and quality of life scores in pre-dialysis Japanese chronic kidney disease patients.
Akaishi, M; Akiba, T; Akizawa, T; Aonuma, K; Fukuhara, S; Gejyo, F; Hada, Y; Hirakata, H; Hiroe, M; Iino, Y; Inaguma, D; Morita, S; Nishi, S; Saito, A; Suzuki, M; Tsubakihara, Y; Watanabe, Y, 2010
)
0.36
"In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD)."( A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Rao, S; Wolfson, M, 2009
)
0.81
"Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects."( A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Rao, S; Wolfson, M, 2009
)
0.93
" Clinical experience demonstrates that the dose conversion ratio (DCR) between epoetin alfa and darbepoetin alfa is nonproportional across the dosing spectrum."( Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease.
Agarwal, A; Cangialose, CB; Gandra, SR; Gitlin, M; Horowitz, J; Huang, F,
)
0.36
"Extended-interval dosing of epoetin alfa (EPO) is commonly used to treat anemia in patients with chronic kidney disease (CKD)."( A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Sun, S; Wolfson, M, 2010
)
0.87
"430 anemic subjects with stage 3 to 4 CKD receiving a stable QW dose of EPO were randomized 1:1:2 to QW, Q2W, and Q4W dosing for 36 weeks."( A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Sun, S; Wolfson, M, 2010
)
0.58
"Both the Q2W and Q4W dosing groups were noninferior to the QW group."( A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Sun, S; Wolfson, M, 2010
)
0.58
"Q2W and Q4W EPO dosing maintained Hb levels in subjects with stage 3 to 4 CKD."( A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia.
Bowers, P; Fu, M; Gartenberg, G; Pergola, PE; Sun, S; Wolfson, M, 2010
)
0.58
", a continuous erythropoietin receptor activator, offers once-monthly dosing without compromising haemoglobin control."( Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study.
Backs, W; Dellana, F; Dellanna, F; Fassbinder, W; Fliser, D; Kleophas, W; Kraatz, U; Strack, G; Winkler, RE; Wizemann, V, 2010
)
0.36
"9%) of the 354 evaluable patients, respectively, with no differences observed between patients formerly receiving epoetin or darbepoetin or different dosing frequencies."( Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study.
Backs, W; Dellana, F; Dellanna, F; Fassbinder, W; Fliser, D; Kleophas, W; Kraatz, U; Strack, G; Winkler, RE; Wizemann, V, 2010
)
0.36
" administration using pre-filled syringes was shown to be practical, convenient and offer good control of haemoglobin levels, regardless of the previous type of therapy or dosing frequency."( Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study.
Backs, W; Dellana, F; Dellanna, F; Fassbinder, W; Fliser, D; Kleophas, W; Kraatz, U; Strack, G; Winkler, RE; Wizemann, V, 2010
)
0.36
" Primary endpoints were the mean Hb level and the mean weekly epoetin dosage during the last 4 weeks of treatment."( Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia.
Bronn, A; Czekalski, S; Koytchev, R; Krivoshiev, S; Pljesa, S; Schiller, A; Siebert-Weigel, M; Wizemann, V; Wolf-Pflugmann, M, 2010
)
0.36
" The mean weekly epoetin dosage per body weight over the last 4 weeks of treatment was 97."( Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia.
Bronn, A; Czekalski, S; Koytchev, R; Krivoshiev, S; Pljesa, S; Schiller, A; Siebert-Weigel, M; Wizemann, V; Wolf-Pflugmann, M, 2010
)
0.36
"3% higher than baselines for the two dosing regimen."( Time-dependent clearance and hematological pharmacodynamics upon erythropoietin multiple dosing in rats.
Ait-Oudhia, S; Krzyzanski, W; Scherrmann, JM, 2010
)
0.36
" Ribavirin dosage was reduced in 12 patients, and peginterferon dosage was reduced in 2 patients."( Aggressive use of ribavirin and prolonged course of peginterferon to improve the rate of viral response in liver transplant patients with recurrent hepatitis C viral infection.
Black, M; Burke, M; Jain, AB; Singhal, A, 2010
)
0.36
" EPO and darbepoetin alfa have a non-proportional dose conversion relationship across the dosing spectrum."( Estimate of maintenance EPO to darbepoetin alfa dose conversion ratio in a hospital-based dialysis patient population.
Gandra, SR; Khan, I; Petersen, J; Sharma, A; Yee, J, 2010
)
1.01
"The management of anaemia in chronic kidney disease (CKD) to achieve current guideline goals is difficult and is hindered by multiple factors, including problems with the scheduling and adjustment of dosing of erythropoiesis-stimulating agents (ESAs) and the frequency of required ESA administration to achieve target haemoglobin (Hgb) levels."( Conversion from epoetin alfa to darbepoetin alfa for management of anaemia in a community chronic kidney disease centre: a retrospective cohort study.
Cernii, A; Finkelstein, FO; Gobin, J; McLean, R; Simon, DB, 2011
)
0.72
"To analyse the impact of dosing decisions for continuous erythropoietin receptor activator (C."( Dosing strategies for conversion of haemodialysis patients from short-acting erythropoiesis stimulating agents to once-monthly C.E.R.A.: experience from the MIRACEL study.
Bockreiss, N; Bozkurt, F; Dellanna, F; Fliser, D; Graf, S; Schettler, V; Winkler, RE, 2011
)
0.37
"To assess the clinical and economic outcomes among patients with chemotherapy-induced anemia (CIA) treated with United States Food and Drug Administration-approved fixed dosing regimens of erythropoiesis-stimulating agents (ESA)."( Outcomes of erythropoiesis-stimulating agents in cancer patients with chemotherapy-induced anemia.
Fraser, KA; Larholt, K; McKenzie, RS; Pashos, CL; Piech, CT; Senbetta, M, 2012
)
0.38
"Data were employed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) registry to evaluate CIA patients who were initiated on either epoetin alfa (EPO) 40,000 Units (U) or darbepoetin alfa (DARB) 500 micrograms (mcg) between January 1, 2006 and May 8, 2009."( Outcomes of erythropoiesis-stimulating agents in cancer patients with chemotherapy-induced anemia.
Fraser, KA; Larholt, K; McKenzie, RS; Pashos, CL; Piech, CT; Senbetta, M, 2012
)
0.57
" Although widely believed that the dosage requirements are the same, we undertook a retrospective analysis to investigate whether the dosage requirements in chronic renal failure patients were comparable for both preparations."( Comparison of the therapeutic efficacy of epoetin beta and epoetin alfa in maintenance phase hemodialysis patients.
Abeygunasekara, SC; Ali, GR; Loughnan, A, 2011
)
0.61
" Dosing was based on the Hb concentration measurement obtained by HemoCue Hb201+System (Quest Diagnostics; Madison, NJ) at the time of the scheduled dose."( An open-label, randomized, multicenter, controlled study of epoetin alfa for the treatment of anemia of chronic kidney disease in the long term care setting.
Langholff, W; McGowan, T; Patel, M; Thimons, DG; Winston, JL, 2012
)
0.62
"0 g/dL at any time during the study); the time to the Hb response; the proportion of subjects who received a transfusion and the number of units of transfused; the proportion of epoetin alfa-treated subjects converting to Q4W dosing; and the proportion of subjects who converted to Q4W dosing and remained on Q4W dosing through the end of the study."( An open-label, randomized, multicenter, controlled study of epoetin alfa for the treatment of anemia of chronic kidney disease in the long term care setting.
Langholff, W; McGowan, T; Patel, M; Thimons, DG; Winston, JL, 2012
)
0.81
" We investigated Epo dosage effect (up to 1000 U/kg) on hematocrit, body weight, body composition, glucose metabolism, food intake, and physical activity, during high-fat diet-induced obesity."( The effects of erythropoietin dose titration during high-fat diet-induced obesity.
Alnaeeli, M; Foskett, A; Noguchi, CT; Teng, R; Wang, L, 2011
)
0.37
"Frequent dosing and requirements for dose adjustments of erythropoiesis-stimulating agents (ESAs) create significant burdens for healthcare providers and have been associated with hemoglobin (Hb) cycling, hampering maintenance of target Hb levels."( Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease.
Canaud, B; de Francisco, A; Mann, JF; Nassar, G, 2011
)
0.37
" Dosage was adjusted to maintain Hb ± 1 g/dl of baseline and 10 - 13."( Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease.
Canaud, B; de Francisco, A; Mann, JF; Nassar, G, 2011
)
0.37
" q4w and 572 with comparator ESA at their usual dosing interval."( Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease.
Canaud, B; de Francisco, A; Mann, JF; Nassar, G, 2011
)
0.37
" Uptake of (14)C-2-deoxy-D-glucose indicated that animals dosed with CNTO 530 transported more glucose into skeletal muscle and heart relative to control animals."( A novel EPO receptor agonist improves glucose tolerance via glucose uptake in skeletal muscle in a mouse model of diabetes.
Bugelski, PJ; Deutsch, HA; Dubell, WH; Havekes, LM; James, IE; Makropoulos, DA; Ort, TA; Picha, KM; Pieterman, EJ; Scully, MS; van den Hoek, AM; Wertheimer, JD, 2011
)
0.37
"Randomized trials of hemoglobin targeting in chronic kidney disease suggest that erythropoiesis-stimulating agent (ESA) dosing increases mortality risk, but dosing intensity is confounded by hemoglobin concentration."( Association of mean weekly epoetin alfa dose with mortality risk in a retrospective cohort study of Medicare hemodialysis patients.
Collins, AJ; Gilbertson, DT; Weinhandl, ED, 2011
)
0.67
"Using Medicare claims, we conducted a retrospective cohort study of mortality risk associated with epoetin alfa (EPO) dosing in prevalent hemodialysis patients (n = 137,918), 2000-2004."( Association of mean weekly epoetin alfa dose with mortality risk in a retrospective cohort study of Medicare hemodialysis patients.
Collins, AJ; Gilbertson, DT; Weinhandl, ED, 2011
)
0.88
"ESA dosing may be directly associated with risk of death, but the nature of the association likely varies according to hemoglobin concentration."( Association of mean weekly epoetin alfa dose with mortality risk in a retrospective cohort study of Medicare hemodialysis patients.
Collins, AJ; Gilbertson, DT; Weinhandl, ED, 2011
)
0.67
" We evaluated a dosing algorithm and potential confounders' effect on Hb and blood pressure (BP) in a clinical trial."( A dosing algorithm for erythropoietin alpha in older adults with heart failure and a preserved ejection fraction.
Altincatal, A; Helmke, S; Macarthur, RB; Maurer, MS; Teruya, S, 2013
)
0.39
"The currently employed dosing algorithm, which adjusts the administration of ESA based on the absolute hemoglobin and weekly change in hemoglobin increases Hb with relatively a low weekly dose of ESA without significant effects on BP."( A dosing algorithm for erythropoietin alpha in older adults with heart failure and a preserved ejection fraction.
Altincatal, A; Helmke, S; Macarthur, RB; Maurer, MS; Teruya, S, 2013
)
0.39
" These agents are a mainstay in MDS therapy, but many issues are still open in terms of the initiation of therapy, the optimal dosage of erythropoietic stimulating agents (ESAs), the most efficient type of ESA, and the duration and outcome of such treatments."( Clinical use of erythropoietic stimulating agents in myelodysplastic syndromes.
Santini, V, 2011
)
0.37
" Despite widespread usage of these agents, there is no generally accepted "standard dosing algorithm" for treating anemia in HDD-CKD patients."( Anemia management in patients receiving chronic hemodialysis.
Diaz-Buxo, JA; Mullon, C; Ofsthun, NJ; Thakuria, M,
)
0.13
" Further simulations suggested that once-weekly and thrice-weekly subcutaneous dosing regimens would result in similar efficacy."( Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575.
Balser, S; Berghout, A; Fink, M; Krzyzanski, W; Lowe, PJ; Yan, X, 2012
)
0.59
" Efficacy endpoints were mean absolute change in Hb from baseline to end of Week 13 and mean weekly epoetin dosage in Weeks 11 - 13."( Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study.
Eckardt, KU; Haag-Weber, M; Hörl, WH; Roger, SD; Roth, K; Vetter, A, 2012
)
0.38
" Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records."( How much are biosimilars used in southern Italy?: a retrospective analysis of epoetin utilization in the local health unit of Messina in the years 2010-2011.
Arcoraci, V; Cananzi, P; Cannata, A; Caputi, AP; Coppolino, S; Ferrara, R; Loiacono, C; Savica, V; Schuemie, M; Sgroi, C; Trifirò, G, 2012
)
0.38
" In 2006, a 500-μg dose and new dosing schedule was approved for DA in the United States."( Utilization and cost in clinical practice of darbepoetin alfa and epoetin alfa for anemia concomitant with chemotherapy.
Berger, A; Corey-Lisle, PK; Lord, C; Oster, G; Williams, GR, 2012
)
0.63
" We monitored hemoglobin, feritin, saturation of transferin (TSAT), dose of LSE, number of change in dosage and number of transfusion."( [Treatment of renal anemia in hemodialysis patients in General Hospital Bjelovar from 2007 to 2010].
Basić-Jukić, N; Dzapo, M; Janković, RI; Kurtović, I; Lovcić, P; Lovcić, V; Vujić, J, 2011
)
0.37
" Further examination of the use and dosing of erythropoietin-stimulating agents and intravenous iron, their impact on haemoglobin levels related to patient comorbidities and subsequent cost effectiveness of protocols is required."( Anaemia management protocols in the care of haemodialysis patients: examining patient outcomes.
MacLeod, ML; MacMillan, PD; Ogborn, MR; Salyers, V; Saunders, S, 2013
)
0.39
" The ESA dosage was recorded monthly."( Ergocalciferol decreases erythropoietin resistance in children with chronic kidney disease stage 5.
Boonyapapong, P; Rianthavorn, P, 2013
)
0.39
"The erythropoiesis-stimulating agents (ESAs), darbepoetin alfa (DA), and epoetin alfa (EA) differ with respect to dosing schedule in chemotherapy-induced anemia."( Synchronization of administrations of chemotherapy and erythropoiesis-stimulating agents and frequency of associated healthcare visits.
Corey-Lisle, PK; De, AP; Hess, GP; Hill, JW; McGarvey, N; Shreay, S, 2013
)
0.64
" No significant differences between groups were found in maximal Epo concentration, time to maximum Epo concentration, area under the curve from time of dosing extrapolated to infinity, clearance, mean residence time of Epo between groups both before and after adjustment."( The pharmacokinetics of recombinant human erythropoietin in Balkan endemic nephropathy patients.
Djukanović, L; Ležaić, V; Marić, I; Miljković, B; Pejovic, V; Petković, N; Simić-Ogrizović, S; Vučićević, K, 2013
)
0.39
" Side effects of anemia treatment, considering frequency and dosage of treatment as well as targeted hemoglobin levels when utilizing ESAs, greatly impact overall well-being and the quality of life."( Emerging drugs for treatment of anemia of chronic kidney disease.
Bennett, CL; Chen, B; Kessler, S; Lebby, A; Magwood, JS; Norris, L, 2013
)
0.39
" Despite equivocal longer-term outcomes in clinical studies investigating EPO as a renoprotective agent in AKI, optimal clinical dosing and administration have not been established."( Remote conditioning or erythropoietin before surgery primes kidneys to clear ischemia-reperfusion-damaged cells: a renoprotective mechanism?
Devonald, MA; Dunford, LJ; Gardner, DS; Hodi, Z; McCulloch, TA; O'Sullivan, S; Sleeman, P; Welham, SJ, 2014
)
0.4
" Consistent with national data, the findings from this study indicate that from 2010 to 2013, HBDCs modified anemia management practices for dialysis patients, as evidenced by reductions in mean monthly Hb levels and ESA dosing and by increases in iron biomarkers and dosing."( Anemia management trends in hospital-based dialysis centers (HBDCs), 2010 to 2013.
Acharya, A; Chang, CL; Coritsidis, GN; Gitlin, M; Hill, J; Lafayette, RA; Maglinte, GA; Saxena, A, 2014
)
0.4
" Comparisons of differing dosing schedules and routes of administration were compared in small numbers of participants and studies."( Darbepoetin for the anaemia of chronic kidney disease.
Craig, JC; Navaneethan, SD; Palmer, SC; Saglimbene, V; Strippoli, GF, 2014
)
0.4
"For consumers, clinicians and funders, considerations such as drug cost and availability and preferences for dosing frequency might be considered as the basis for individualising anaemia care due to lack of data for comparative differences in clinical benefits and harms."( Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
Craig, JC; Mavridis, D; Palmer, SC; Saglimbene, V; Salanti, G; Strippoli, GF; Tonelli, M; Wiebe, N, 2014
)
0.4
" Our aim was to determine changes in epoetin dosing and hematocrit levels in response to PPS by different types of dialysis providers."( Major declines in epoetin dosing after prospective payment system based on dialysis facility organizational status.
Cotter, D; Hernán, MA; Kaufman, J; Kshirsagar, O; Thamer, M; Zhang, Y, 2014
)
0.4
"Major declines in epoetin use, dosing and achieved hematocrit levels were observed after PPS."( Major declines in epoetin dosing after prospective payment system based on dialysis facility organizational status.
Cotter, D; Hernán, MA; Kaufman, J; Kshirsagar, O; Thamer, M; Zhang, Y, 2014
)
0.4
" The PD model described 2 subpopulations, one whose Hb response reflected epoetin alfa dosing and a second whose response was unrelated to epoetin alfa dosing."( Assessment of hemoglobin responsiveness to epoetin alfa in patients on hemodialysis using a population pharmacokinetic pharmacodynamic model.
Doshi, S; Mould, DR; Perez Ruixo, JJ; Wu, L, 2015
)
0.91
" Further, in the polaprezinc group, ESA dosage and ERI were significantly decreased at 10 months and nine months, respectively, as compared with the baseline value."( Oral zinc supplementation reduces the erythropoietin responsiveness index in patients on hemodialysis.
Abe, M; Higuchi, T; Kikuchi, F; Kobayashi, H; Maruyama, N; Okada, K; Soma, M; Tei, R, 2015
)
0.42
" Extended-interval ESA dosing (administration less than once weekly) is common with DA, but previous studies suggested that EA might also be administered less often than weekly."( A randomized comparison of once weekly epoetin alfa to extended schedule epoetin or darbepoetin in chemotherapy-associated anemia.
Anderson, DM; Dakhil, SR; Johnson, DB; Loprinzi, CL; Mattar, BI; Moore, DF; Nikcevich, D; Novotny, PJ; Sloan, JA; Steensma, DP, 2015
)
0.69
"Previous research suggests that erythropoiesis stimulating agent (ESA) administration in dialysis is a time-consuming task and switching to less frequently dosed ESAs may offer operational efficiencies."( Time savings of weekly versus three-times-per-week administration of erythropoiesis stimulating agents in United States dialysis patients.
Anderson, ER; Ashfaq, A; Caloyeras, JP; Emerson, LC; Reitan, JF; Spry, LA; Stephens, JM, 2016
)
0.43
"Results should not be generalized to other countries, ESAs and/or dosing frequencies."( Time savings of weekly versus three-times-per-week administration of erythropoiesis stimulating agents in United States dialysis patients.
Anderson, ER; Ashfaq, A; Caloyeras, JP; Emerson, LC; Reitan, JF; Spry, LA; Stephens, JM, 2016
)
0.43
" An abrupt decline in erythropoietin dosing and hemoglobin concentration began in late 2010."( Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.
Ashfaq, A; Beaubrun, AC; Bradbury, BD; Brookhart, MA; Chertow, GM; Collins, AJ; Gilbertson, DT; Herzog, CA; Liu, J; Monda, KL; Pollock, A; Rothman, KJ; Sturmer, T; Winkelmayer, WC, 2016
)
1.88
"Little is known about epoetin alfa (EPO) dosing at dialysis centers after implementation of the US Medicare prospective payment system and revision of the EPO label in 2011."( Effects of Epoetin Alfa Titration Practices, Implemented After Changes to Product Labeling, on Hemoglobin Levels, Transfusion Use, and Hospitalization Rates.
Beaubrun, AC; Bradbury, BD; Collins, AJ; Gilbertson, DT; Li, S; Molony, JT; Monda, KL, 2016
)
1.14
"Approximately 412,000 adult hemodialysis patients with Medicare Parts A and B as primary payer in 2009 to 2012 to describe EPO dosing and hemoglobin patterns; of these, about 70,000 patients clustered in about 1,300 dialysis facilities to evaluate facility-level EPO titration practices and patient-level outcomes in 2012."( Effects of Epoetin Alfa Titration Practices, Implemented After Changes to Product Labeling, on Hemoglobin Levels, Transfusion Use, and Hospitalization Rates.
Beaubrun, AC; Bradbury, BD; Collins, AJ; Gilbertson, DT; Li, S; Molony, JT; Monda, KL, 2016
)
0.82
"Facility EPO titration practices when hemoglobin levels were <10 and >11g/dL (grouped treatment variable) determined from monthly EPO dosing and hemoglobin level patterns."( Effects of Epoetin Alfa Titration Practices, Implemented After Changes to Product Labeling, on Hemoglobin Levels, Transfusion Use, and Hospitalization Rates.
Beaubrun, AC; Bradbury, BD; Collins, AJ; Gilbertson, DT; Li, S; Molony, JT; Monda, KL, 2016
)
0.82
" One subject in each treatment group had a positive recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout study conduct with negative immunoglobulin M and neutralizing antibodies and with no evidence of clinical deterioration or of impact on PD, PK, or safety profile."( Pharmacodynamic and Pharmacokinetic Equivalences of Epoetin Hospira and Epogen(®) After Multiple Subcutaneous Doses to Healthy Male Subjects.
Kumbhat, S; Martin, N; Ramaiya, A; Reid, S; Stalker, D; Zhang, J, 2016
)
0.43
" One subject had a positive anti- recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout the conduct of the study with negative neutralizing antibodies and with no evidence of clinical deterioration or impact on the pharmacokinetics, pharmacodynamics, or safety."( Pharmacokinetic and Pharmacodynamic Equivalence of Epoetin Hospira and Epogen After Single Subcutaneous Doses to Healthy Male Subjects.
Martin, NE; Ramaiya, A; Reid, S; Stalker, D; Wisemandle, WA, 2016
)
0.43
" There were no significant differences in final haemoglobin (Hb) levels when dosing every two weeks was compared with weekly dosing (4 studies, 785 participants: MD -0."( Short-acting erythropoiesis-stimulating agents for anaemia in predialysis patients.
Elserafy, N; Esezobor, CI; Hahn, D; Hodson, EM; Webster, AC, 2017
)
0.46
"Epoetin alpha given at higher doses for extended intervals (two or four weekly) is non-inferior to more frequent dosing intervals in maintaining final Hb levels with no significant differences in adverse effects in non-dialysed CKD patients."( Short-acting erythropoiesis-stimulating agents for anaemia in predialysis patients.
Elserafy, N; Esezobor, CI; Hahn, D; Hodson, EM; Webster, AC, 2017
)
0.46
" Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common."( Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia.
Bennett, CL; Chen, B; Cotter, D; Dickson, M; Hikmet, N; Hrushesky, W; Knopf, KB; Lebby, AA; Norris, LB; Noxon, V; Qureshi, ZP; Schooley, B; Thamer, M; Yang, YT; Yarnold, PR, 2017
)
0.46
" Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010."( Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia.
Bennett, CL; Chen, B; Cotter, D; Dickson, M; Hikmet, N; Hrushesky, W; Knopf, KB; Lebby, AA; Norris, LB; Noxon, V; Qureshi, ZP; Schooley, B; Thamer, M; Yang, YT; Yarnold, PR, 2017
)
0.46
"We explicitly emulated a target trial of three ‎erythropoietin dosing strategies (aimed at achieving a low, middle, or high hematocrit) and estimated the observational analog of the per-protocol effect."( Comparing the Effectiveness of Dynamic Treatment Strategies Using Electronic Health Records: An Application of the Parametric g-Formula to Anemia Management Strategies.
Hernán, MA; Thamer, M; Young, JG; Zhang, Y, 2018
)
0.48
" Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD)."( Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease.
Craig, JC; Natale, P; Palmer, SC; Ruospo, M; Saglimbene, VM; Strippoli, GF, 2017
)
0.46
" HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes."( Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study
.
Abraham, I; Combe, C; Dellanna, F; Goldsmith, D; Hoebel, N; Krendyukov, A; London, G; MacDonald, K; Mann, J; Zaoui, P, 2018
)
0.48
" Dosing was adjusted according to the epoetin alfa prescribing information."( Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease.
Fishbane, S; Kumbhat, S; Martin, NE; Singh, B; Wisemandle, WA, 2018
)
1.13
"For patients with anemia undergoing hemodialysis, erythropoiesis-stimulating agents (ESAs) are typically dosed via precise algorithms."( Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis.
Ahuja, A; Guilatco, R; Hymes, J; Maddux, FW; Thadhani, R, 2018
)
0.83
"Switching to RetacritTM was non-inferior to continuing -Epogen® in maintaining hemoglobin levels in patients receiving hemodialysis, when both ESAs were dosed using a specified algorithm (ClinicalTrials."( Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis.
Ahuja, A; Guilatco, R; Hymes, J; Maddux, FW; Thadhani, R, 2018
)
0.83
" The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10-12 g/dL during the last 4 weeks of treatment."( Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.
Abbasi, MR; Amini, S; Azmandian, J; Ezzatzadegan Jahromi, S; Nasiri, AA; Ossareh, S; Pourfarziani, V; Sanadgol, H; Shahvaroughi Farahani, A, 2018
)
0.72
" Further, the controller satisfactorily handles the following challenging problems in simulations: bleedings, missed administrations and dosing errors."( Optimal EPO dosing in hemodialysis patients using a non-linear model predictive control approach.
Fuertinger, DH; Kappel, F; Kotanko, P; Rogg, S; Volkwein, S, 2019
)
0.51
"The ability to control dosage regimens of erythropoiesis-stimulating agents (ESAs) to maintain a desired hemoglobin (HGB) target is still elusive."( Population Pharmacodynamic Modeling of Epoetin Alfa in End-Stage Renal Disease Patients Receiving Maintenance Treatment Using Bayesian Approach.
Krzyzanski, W; Meaney, CJ; Nguyen, LM; Panesar, M; Rao, GG, 2020
)
0.83
"Our study showed that DPA was more effective and well tolerated in achieving and maintaining Hb levels with lower dosing frequency compared to EPA."( Comparative Efficacy and Safety Study of Darbepoetin Alfa
El-Ashmawy, NE; Ibrahim, AO; Khedr, EG; Kotb, NS; Salem, F, 2022
)
0.98
"This study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia."( A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure.
Chang, JH; Goh, BL; Jeon, JS; Kim, SG; Kim, SH; Lim, CS; Lim, SK; Morad, Z; Visvanathan, R, 2021
)
0.62
"The Medicare reimbursement policy and Food and Drug Administration-recommended erythropoietin-stimulating agent dosing changes were associated with lower erythropoietin-stimulating agent use and lower hemoglobin levels."( Medicare Bundled Payment Policy on Anemia Care, Major Adverse Cardiovascular Events, and Mortality among Adults Undergoing Hemodialysis.
Desai, R; Goodin, A; Gopal, S; Henry, L; Hincapie-Castillo, J; Liu, X; Mohandas, R; Park, H; Pepine, CJ; Smith, SM, 2022
)
0.72
"Anemia Studies in Chronic Kidney Disease: Erythropoiesis via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Three Times Weekly Dosing in Dialysis (ASCEND-TD), NCT03400033."( Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients: ASCEND-TD: A Phase 3 Randomized, Double-Blind, Noninferiority Trial.
Bailey, CK; Cobitz, AR; Connaire, J; Coyne, DW; DiMino, TL; Huang, C; Kim, SG; Lopes, RD; Orias, M; Patel, V; Rastogi, A; Shah, S; Singh, AK; Wanner, C, 2022
)
0.72
" A blinded placebo cohort followed the same dosing pattern, administering saline instead of EPO."( EPO and the athlete biological passport: Hematological results from a placebo-controlled, boosting and microdose EPO administration in male recreational athletes.
Crouch, AK; Eichner, D; Husk, J; Miller, GD, 2022
)
0.72
" Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO®/EPREX® in parallel groups."( Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study.
Alexandrov, IV; Davydkin, IL; Isachkina, AN; Khadikova, NG; Kvitkova, LV; Li, M; Li, X; Miao, B; Mironova, TP; Omelchenko, AM; Perlin, DV; Selyutin, AA; Shilo, VY; Shutov, EV; Solovyova, OM; Tutin, AP; Vareesangthip, K; Vetchinnikova, ON; Zuev, AV, 2022
)
0.72
" There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline."( Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study.
Alexandrov, IV; Davydkin, IL; Isachkina, AN; Khadikova, NG; Kvitkova, LV; Li, M; Li, X; Miao, B; Mironova, TP; Omelchenko, AM; Perlin, DV; Selyutin, AA; Shilo, VY; Shutov, EV; Solovyova, OM; Tutin, AP; Vareesangthip, K; Vetchinnikova, ON; Zuev, AV, 2022
)
0.72
" The current treatments for anemia include iron therapy and erythropoiesis-stimulating agents (ESAs); however, the relatively short half-lives of the ESAs epoetin alfa/beta or darbepoetin alfa may require more frequent dosing and hospital visits compared with the ESA known as continuous erythropoietin receptor activator (C."( Subcutaneous C.E.R.A. for the Maintenance Treatment of Anemia in Pediatric Patients With CKD: A Phase 2, Open-Label, Single-Arm, Multicenter Study.
Drozdz, D; Meyer Reigner, S; Tirodkar, C; Warady, BA, 2023
)
1.11
"To determine the effectiveness of pharmacy consultation in managing epoetin alfa-epbx dosing for inpatients on hemodialysis."( Pharmacist-driven epoetin alfa-epbx dosing for hospitalized patients.
Heierman, T; Linn, E; Morrison, H; Sanchez, M, 2023
)
1.48
"Pharmacist-driven ESA dosing was associated with significant decreases in ESA average acquisition cost and average total dose per patient."( Pharmacist-driven epoetin alfa-epbx dosing for hospitalized patients.
Heierman, T; Linn, E; Morrison, H; Sanchez, M, 2023
)
1.24
"We retrospectively analyzed the association between ESA dose and mortality in the monthly dosing range of 0-43,000 U of equivalent epoetin alfa in 304 Taiwan hemodialysis patients by using Cox proportional hazard model and cubic spline model."( Extremely Low Dose of Erythropoiesis-Stimulating Agent May Be Associated with Increased Mortality in Hemodialysis Patients.
Chiu, YL; Hsu, SP; Lin, MC; Pai, MF; Pan, SY; Peng, YS; Shu, KH; Tsai, WC; Tung, KT; Wang, SH; Wu, HY; Yang, CW; Yang, JY, 2023
)
1.11
" The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period."( Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients.
Angginy, N; Dwitanto, K; Sutandar, W, 2023
)
0.91
"05), also for the mean changes of weekly dosage between groups (1091."( Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients.
Angginy, N; Dwitanto, K; Sutandar, W, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,745)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990273 (15.64)18.7374
1990's109 (6.25)18.2507
2000's853 (48.88)29.6817
2010's413 (23.67)24.3611
2020's97 (5.56)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 98.56

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index98.56 (24.57)
Research Supply Index7.73 (2.92)
Research Growth Index5.05 (4.65)
Search Engine Demand Index181.60 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (98.56)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials388 (20.54%)5.53%
Reviews324 (17.15%)6.00%
Case Studies94 (4.98%)4.05%
Observational19 (1.01%)0.25%
Other1,064 (56.33%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (506)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar. [NCT02049346]Phase 4327 participants (Actual)Interventional2012-03-31Completed
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysi [NCT00077610]Phase 3673 participants (Actual)Interventional2004-02-29Completed
An Open Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery [NCT00350519]Phase 437 participants (Actual)Interventional2006-08-31Terminated(stopped due to The study was stopped due to slow enrollment)
An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy [NCT00354341]Phase 3170 participants (Actual)Interventional2002-09-30Completed
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage [NCT03914690]Phase 2316 participants (Actual)Interventional2014-07-31Completed
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction [NCT00367991]Phase 244 participants (Actual)Interventional2006-11-30Completed
An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy [NCT00048048]Phase 265 participants (Actual)Interventional2002-03-31Completed
Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease [NCT01105494]6,000 participants (Actual)Observational2008-12-31Completed
A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis [NCT01147666]Phase 2161 participants (Actual)Interventional2010-05-17Completed
A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy [NCT01586052]Phase 111 participants (Actual)Interventional2012-06-30Completed
Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT [NCT03308448]Phase 393 participants (Actual)Interventional2018-01-06Completed
A Phase 1 Study Comparing the Pharmacokinetics of Epoetin Hospira and Epoetin Alfa (Amgen) When Administered Intravenously in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment [NCT01170078]Phase 1107 participants (Actual)Interventional2010-07-31Completed
Randomized Placebo-controlled Trial to Assess the Efficacy of Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO) in the Survival of Patients With Acute-on-chronic Liver Failure (ACLF) [NCT01383460]Phase 355 participants (Actual)Interventional2011-07-31Completed
Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial [NCT00827021]Phase 3656 participants (Actual)Interventional2009-07-31Completed
A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic [NCT01066000]Phase 433 participants (Actual)Interventional2009-10-31Terminated
A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat [NCT03400033]Phase 3407 participants (Actual)Interventional2018-09-05Completed
Colorado-Oregon Altitude Study [NCT05734716]Phase 4121 participants (Actual)Interventional2021-02-17Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes [NCT01381809]Phase 3130 participants (Actual)Interventional2011-10-31Completed
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT) [NCT02802592]Phase 1/Phase 24 participants (Actual)Interventional2015-05-31Terminated(stopped due to Loss of funding)
A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis. [NCT00422513]Phase 3260 participants (Actual)Interventional2007-03-31Terminated(stopped due to Strategic decision unrelated to safety or efficacy)
A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy [NCT01374373]Phase 430 participants (Actual)Interventional2011-06-30Completed
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study [NCT02140736]2,333 participants (Actual)Observational2009-09-30Completed
Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes [NCT03700515]72 participants (Anticipated)Interventional2019-09-04Recruiting
A Randomized, Open-label Study to Evaluate the Effect of Daprodustat on Blood Pressure in Subjects With Anemia Associated With Chronic Kidney Disease on Hemodialysis Switched From a Stable Dose of an Erythropoiesis-stimulating Agent [NCT03029247]Phase 2105 participants (Actual)Interventional2017-07-27Completed
Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population. [NCT01265680]600 participants (Actual)Interventional2012-02-29Completed
A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regula [NCT05629598]Phase 2150 participants (Anticipated)Interventional2022-04-13Recruiting
Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial [NCT01290328]100 participants (Anticipated)Interventional2011-02-28Terminated(stopped due to low enrollment, termination of funding)
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease [NCT03842254]Early Phase 16 participants (Actual)Interventional2019-01-25Completed
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Preterm Infants 401-1250 Grams: Two Multi-Center, Randomized, Double-Masked, Placebo Controlled Studies [NCT01203514]Phase 2/Phase 3318 participants (Actual)Interventional1997-08-31Completed
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers [NCT03822884]Phase 124 participants (Actual)Interventional2016-09-30Completed
A Phase I Single Centre Open Label Trial to Investigate the Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta (NeoRecormon®) in Healthy Japanese and Caucasian Male Subjects [NCT01085552]Phase 123 participants (Actual)Interventional2007-11-30Completed
Evaluation of the Diagnostic/Therapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic/Autoimmune Neutropenia CIN/AIN) and Identification of Predictive and Prognostic Marke [NCT05931718]200 participants (Anticipated)Observational2021-06-01Recruiting
Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot) [NCT01093820]Phase 28 participants (Actual)Interventional2010-04-30Completed
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia [NCT00090753]Phase 31,228 participants (Actual)Interventional2004-10-31Completed
Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis [NCT01049711]152 participants (Actual)Observational2009-11-30Completed
Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy [NCT03317210]Phase 450 participants (Actual)Interventional2002-09-01Completed
Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery [NCT02210949]Phase 47 participants (Actual)Interventional2014-08-31Terminated(stopped due to Low inclusion rate)
The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial [NCT03882060]60 participants (Actual)Interventional2019-04-08Active, not recruiting
Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA [NCT02547454]393 participants (Actual)Observational2008-12-31Completed
The Effect of Local Erythropoietin 3000 and 6000 Units on the Treatment of Conjunctival and Scleral Avascular Lesions: A Multicenter Clinical Trial [NCT05476042]Phase 2/Phase 360 participants (Anticipated)Interventional2022-08-14Enrolling by invitation
Combined ErythroPoietin and Iron Therapy for AnemiC Patients With Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve REplacement- The EPICURE Trial A Prospective Double Blind Randomized Trial [NCT02390102]Phase 3117 participants (Actual)Interventional2012-06-30Completed
Optimized EPO Treatment of Neonatal Anemia [NCT02075970]Phase 262 participants (Actual)Interventional2014-06-30Completed
Prevention of Acute Kidney Injury (AKI) by Erythropoietin (EPO) in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial [NCT00654992]Phase 2/Phase 371 participants (Actual)Interventional2006-09-30Completed
A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies [NCT05301517]Phase 3159 participants (Actual)Interventional2022-03-16Completed
A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa [NCT02817555]Phase 450 participants (Actual)Interventional2010-09-30Completed
[NCT02036073]Phase 4490 participants (Actual)Interventional2009-01-31Completed
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study [NCT02251041]Phase 272 participants (Actual)Interventional2014-09-30Completed
A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients [NCT00004914]Phase 20 participants Interventional2000-01-31Completed
A Randomized Double-Blinded Phase II Study to Determine Treatment Protocol for Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia [NCT03528564]Phase 24 participants (Actual)Interventional2019-07-01Terminated(stopped due to The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.)
Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis [NCT01111630]Phase 460 participants (Anticipated)Interventional2009-10-31Completed
A Prospective, Randomized, Double Blind, Parallel Group Study to Evaluate a 1:1 Dose Conversion From EPREX to EPIAO in Term of Clinical Efficacy and Safety in Subjects With End-Stage Renal Disease on Haemodialysis [NCT02947438]Phase 3207 participants (Actual)Interventional2015-12-31Completed
A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients [NCT00258440]7 participants (Actual)Interventional2003-05-31Terminated(stopped due to Sponsor discontinued funding of the study)
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in He [NCT00048035]Phase 291 participants (Actual)Interventional2002-03-31Completed
Phase 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Converting From Epoetin Alfa (FO2RWARD-2) [NCT03799627]Phase 2175 participants (Actual)Interventional2019-01-31Completed
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA. [NCT00680563]Phase 34 participants (Actual)Interventional2009-04-30Terminated
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid�) Alone and in Combination With Epoetin Alfa (Procrit�) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia [NCT00843882]Phase 3247 participants (Actual)Interventional2009-01-29Active, not recruiting
Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention [NCT01364402]Phase 3142 participants (Anticipated)Interventional2011-08-31Recruiting
Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis [NCT01144117]Phase 256 participants (Anticipated)Interventional2009-11-30Recruiting
Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period. [NCT01154491]Phase 3303 participants (Actual)Interventional2010-06-30Completed
Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) [NCT03715881]Phase 299 participants (Anticipated)Interventional2018-12-01Recruiting
An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa [NCT01121237]2,086 participants (Actual)Observational2010-02-28Completed
A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex [NCT03408639]Phase 3156 participants (Actual)Interventional2016-06-22Completed
Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage [NCT03786289]Phase 134 participants (Actual)Interventional2018-12-03Completed
Effect of Erythropoietin on Red Blood Cell Requirement in Children With Hemolytic Uremic Syndrome: a Randomized Controlled Trial [NCT03776851]Phase 424 participants (Actual)Interventional2019-01-01Completed
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients [NCT03867071]60 participants (Actual)Interventional2005-10-31Completed
A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Diseas [NCT01191983]Phase 4102 participants (Actual)Interventional2010-08-13Completed
Identification of New Serum Markers for Detection of Abuse With Erythropoietin [NCT01320449]35 participants (Actual)Interventional2011-08-31Completed
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury [NCT04588311]Phase 32,500 participants (Anticipated)Interventional2020-11-09Recruiting
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury A Follow-up Study of an International Randomised Controlled Trial [NCT03061565]356 participants (Actual)Observational2017-08-01Completed
A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury [NCT00987454]Phase 3606 participants (Actual)Interventional2010-05-31Completed
Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity [NCT00593801]219 participants (Actual)Interventional1998-05-31Completed
Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Recombinant Human Erythropoietin in Male Adults. [NCT04954989]Phase 152 participants (Anticipated)Interventional2023-01-31Not yet recruiting
The Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Patients With Treatment Resistant Depression and in Patients With Remitted Bipolar Disorder - a Proof of Concept Study [NCT00916552]Phase 283 participants (Actual)Interventional2009-09-30Completed
Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia [NCT01023035]Phase 3687 participants (Actual)Interventional2009-12-07Completed
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients [NCT00628043]Phase 3160 participants (Anticipated)Interventional2008-05-31Completed
A One Year, Open Label, Multicenter Trial of LBH589 Alone or in Combination With ESA in Red Blood Cell Transfusion-dependent LOW and INT-1 MDS Patients Being Either Refractory to ESA or With a Low Probability of Response - the GErman PAnobinostat Low Risk [NCT01034657]Phase 234 participants (Actual)Interventional2009-11-30Terminated(stopped due to The study was terminated due to lack of efficacy of single agent LBH589 in the 4 month open label core phase and due to enrollment difficulties.)
Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial [NCT00719407]Phase 124 participants (Actual)Interventional2010-01-31Completed
An Open-Label, Randomized Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Subjects With Chronic Kidney Disease [NCT00641589]Phase 140 participants (Actual)Interventional2006-01-31Completed
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity [NCT00744445]Phase 246 participants (Actual)Interventional1993-10-31Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia [NCT00737464]Phase 4132 participants (Actual)Interventional2008-08-26Completed
Single-Center, Open-Label, Sequential Trial to Test the Efficacy, Safety and Tolerability of Epoetin Alfa in Patients With Friedreich's Ataxia [NCT00631202]Phase 210 participants (Anticipated)Interventional2008-02-29Completed
Quality of Life Related Response to Treatment in Anemic Cancer Patients Receiving Recormon and Efficacy of the Drug Dosage 30,000 IU Once Weekly in Patients With Lymphoproliferative Disorders [NCT00776425]Phase 4117 participants (Actual)Interventional2007-01-31Completed
AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa [NCT00597753]Phase 3803 participants (Actual)Interventional2007-09-30Completed
Tracing Changed Production of Red Blood Cells [NCT05833477]12 participants (Actual)Interventional2022-10-28Completed
Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v. [NCT00632125]Phase 41,695 participants (Actual)Interventional2008-07-31Completed
NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis [NCT02827266]Phase 3122 participants (Actual)Interventional2005-10-31Completed
Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects. [NCT03572647]Phase 140 participants (Actual)Interventional2012-11-30Completed
Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects. A Randomized Controlled Clinical Study [NCT05360511]Early Phase 124 participants (Anticipated)Interventional2022-07-01Recruiting
Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy [NCT03303573]164 participants (Actual)Observational2013-01-01Completed
Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants - a Randomized, Double-blind, Placebo-controlled, Prospective, and Multicenter Clinical Study [NCT02076373]Phase 3120 participants (Actual)Interventional2014-03-31Active, not recruiting
Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin as Erythropoietic Agents for Treatment of Anemia in Pediatric Chronic Kidney Disease Patients [NCT04959578]Phase 450 participants (Actual)Interventional2018-02-01Completed
Effect of Administration of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Patients With Persistent Symptoms During the Subacute Period After TBI [NCT02148367]Phase 20 participants (Actual)Interventional2014-09-30Withdrawn(stopped due to Publication of recent trials showing no effect of EPO in TBI.)
Prospective, Open-label, Multicenter Clinical Study for the Efficacy and Safety of Recombinant Human Erythropoietin in the Treatment of Anemia in Patients With Lymphoma [NCT04910594]Phase 3130 participants (Anticipated)Interventional2021-04-01Recruiting
Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (rHuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With Chemotherapy [NCT02767765]Phase 361 participants (Actual)Interventional2003-06-30Completed
Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure [NCT01184495]Phase 374 participants (Actual)Interventional2008-04-30Completed
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome. [NCT02031289]Phase 41,003 participants (Actual)Interventional2013-12-31Completed
An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA) [NCT00123149]Phase 20 participants (Actual)InterventionalWithdrawn
A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Al [NCT00717821]Phase 3421 participants (Actual)Interventional2008-08-31Completed
A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia [NCT00517881]Phase 329 participants (Actual)Interventional2007-06-30Terminated(stopped due to The study was terminated due to the slow recruitment rate.)
A Single-Arm Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia [NCT00517413]Phase 3163 participants (Actual)Interventional2007-10-31Completed
An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia [NCT00954486]0 participants (Actual)Interventional2008-12-31Withdrawn(stopped due to Difficulty in identifying interested subjects.)
A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis [NCT00454246]Phase 3111 participants (Actual)Interventional2007-04-30Terminated(stopped due to Strategic decision unrelated to safety or efficacy)
Effect of Erythropoietin on Renal Function After Kidney Transplantation [NCT00425698]Phase 2/Phase 388 participants (Actual)Interventional2007-02-28Completed
A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialy [NCT00077623]Phase 3572 participants (Actual)Interventional2004-03-31Completed
A Randomized, Open-Label, Comparative Study of Epoetin Alfa (PROCRIT) 80,000 Units or 120,000 Units Q3W (Every 3 Weeks) Versus Darbepoetin Alfa (ARANESP) 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy [NCT00386152]Phase 2235 participants (Actual)Interventional2006-11-30Terminated(stopped due to No safety signals were noted. The study was stopped because it was no longer consistent with the company's scientific and strategic focus.)
A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia [NCT00660023]Phase 3124 participants (Actual)Interventional2008-08-31Completed
A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia. [NCT00661505]Phase 3132 participants (Actual)Interventional2008-05-14Completed
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant [NCT00815867]Phase 3108 participants (Actual)Interventional2007-10-31Completed
An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or [NCT00450333]Phase 3407 participants (Actual)Interventional2006-10-30Terminated(stopped due to The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
Phase II Randomized Trial With A Modified Dose & Schedule of Subcutaneously Administered Azacitidine & Erythropoietin v Azacitidine Alone in Patients With Low-Risk Myelodysplastic Syndromes (Less Than 11% Marrow & Peripheral Blood Blasts) [NCT00379912]Phase 215 participants (Actual)Interventional2006-09-30Terminated(stopped due to Insufficient response rate)
"Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion Op Maat (TOMaat) Study" [NCT00998088]Phase 42,598 participants (Actual)Interventional2004-05-31Completed
An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Ana [NCT00605293]Phase 3101 participants (Actual)Interventional2008-01-31Completed
[NCT02745990]440 participants (Anticipated)Interventional2016-05-31Enrolling by invitation
Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life [NCT00060398]Phase 3282 participants (Anticipated)Interventional2004-09-29Completed
The Effect of Intravenous Erythropoietin Treatment on Cognition During Hypoglycemia in Patients With Type 1 Diabetes. [NCT00615368]11 participants (Actual)Interventional2008-05-31Completed
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group [NCT00617474]Phase 150 participants (Anticipated)Interventional2008-03-31Not yet recruiting
An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis [NCT00546481]Phase 380 participants (Actual)Interventional2007-11-30Completed
A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis [NCT02652806]Phase 3305 participants (Actual)Interventional2015-12-31Completed
Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD) [NCT01010802]Phase 110 participants (Actual)Interventional2008-08-31Completed
A Randomized, Comparative Study of HEMAX PFS® Versus EPREX/ ERYPO® in the Treatment of Anemia With Epoetin Alfa in Patients With Predialysis Chronic Kidney Disease [NCT04036253]Phase 3120 participants (Anticipated)Interventional2018-02-28Active, not recruiting
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery [NCT00513240]Phase 1/Phase 262 participants (Actual)Interventional2006-09-30Completed
A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA [NCT01015352]Phase 298 participants (Actual)Interventional2009-02-28Completed
Augmentation of Medical Readiness and Physical Performance at High Altitude Using Pharmacological Countermeasures [NCT05300477]Phase 418 participants (Anticipated)Interventional2022-05-27Recruiting
An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease [NCT00462384]Phase 339 participants (Actual)Interventional2008-02-29Terminated(stopped due to Strategic decision unrelated to safety or efficacy)
A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections. [NCT00442416]Phase 380 participants (Actual)Interventional2007-02-28Terminated(stopped due to Strategic decision unrelated to safety or efficacy)
A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Extended Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, With the Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects With Chronic Kidney Diseas [NCT00440466]Phase 3430 participants (Actual)Interventional2007-07-31Completed
A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants [NCT00334737]Phase 2102 participants (Actual)Interventional2006-06-30Completed
Multicenter Study for the Evaluation of Efficacy and Safety of NeoRecormon® Therapy Administered as 30000 IU Subcutaneously in Anemic Patients With Breast Cancer Treated With Chemotherapy [NCT02761642]Phase 2200 participants (Actual)Interventional2004-02-29Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia [NCT00642850]Phase 3188 participants (Actual)Interventional2007-11-30Completed
Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma [NCT00577096]120 participants (Actual)Interventional2001-10-31Completed
An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients [NCT00922610]Phase 428 participants (Actual)Interventional2009-02-28Completed
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial) [NCT02603406]Phase 244 participants (Actual)Interventional2016-07-15Completed
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers [NCT00687518]14 participants (Anticipated)Interventional2008-03-31Recruiting
A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia [NCT00550680]Phase 3208 participants (Actual)Interventional2008-01-31Completed
Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty [NCT01012063]54 participants (Actual)Interventional2008-08-31Completed
Phase 4, Multicenter, Randomized, Open-Lable, Active-Controlled Study of the Efficacy and Safty of HIF-PHI for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in Incident-Dialysis Patients [NCT04134026]Phase 4400 participants (Anticipated)Interventional2022-10-20Not yet recruiting
A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA [NCT00576628]Phase 3133 participants (Actual)Interventional2008-05-31Completed
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as [NCT02624141]Phase 410 participants (Actual)Interventional2006-04-30Terminated(stopped due to The study was terminated due to low recruitment)
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model - A Randomised Cross-over Study to Evaluate if Infusion of a Single Dose of EPO Protects Against Ischemia-reperfusion Injury in Man [NCT00691613]12 participants (Anticipated)Interventional2010-07-31Not yet recruiting
A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO [NCT00664066]3 participants (Actual)Observational2008-04-25Terminated(stopped due to The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia [NCT02554942]Phase 428 participants (Actual)Interventional2004-06-30Completed
A Randomized, Double-blind, Placebo-Controlled Study Evaluating Weekly Epoetin Alfa (PROCRIT�) Administration on Hemoglobin Response and Safety in Diabetic Subjects With the Anemia of Chronic Kidney Disease (CKD) [NCT00240734]Phase 211 participants (Actual)Interventional2005-03-31Terminated(stopped due to This study was stopped for slow enrollment after enrolling only 11 of 180 patients in six months time.)
An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis [NCT00717366]Phase 264 participants (Actual)Interventional2008-07-31Completed
''Erythropoietin Gel as an Adjunct to Split-Thickness Apically Positioned Flap in Augmentation of Attached Gingiva'' (A Randomized Controlled Clinical Study) [NCT05683782]Phase 420 participants (Anticipated)Interventional2022-10-01Recruiting
A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Pegolsihematide for the Correction of Anemia in Patients With CRF Undergoing Dialysis and Previously Treated With ESAs [NCT02586402]Phase 260 participants (Anticipated)Interventional2015-10-31Recruiting
An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia. [NCT02569515]Phase 458 participants (Actual)Interventional2004-10-31Completed
A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis [NCT00642304]Phase 320 participants (Actual)Interventional2008-03-27Completed
A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia [NCT00576303]Phase 3200 participants (Actual)Interventional2008-04-30Completed
German Multicenter EPO Stroke Trial (Phase II/III) [NCT00604630]Phase 2/Phase 3522 participants (Actual)Interventional2003-01-31Completed
AFX01-15: A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Undergoing Hemodialysis and Not on Erythropoiesis Stimu [NCT00680043]Phase 2114 participants (Actual)Interventional2008-06-30Completed
An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia. [NCT00773331]Phase 3281 participants (Actual)Interventional2009-07-31Completed
A Randomized, Open Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens, Once-Weekly and Every-Two-Weeks, With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney [NCT00440557]Phase 3375 participants (Actual)Interventional2006-09-30Completed
Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation [NCT05907499]Phase 376 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dial [NCT00642967]Phase 3127 participants (Actual)Interventional2008-06-30Completed
A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA [NCT00773513]Phase 42,825 participants (Actual)Interventional2008-12-12Completed
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes [NCT00910858]Phase 1/Phase 240 participants (Actual)Interventional2005-01-31Completed
Erythropoietin Monotherapy for Brain Regeneration in Neonatal Encephalopathy in Low and Middle-Income Countries [NCT05395195]Phase 3504 participants (Anticipated)Interventional2022-12-31Recruiting
Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction [NCT04343170]44 participants (Anticipated)Interventional2023-11-01Active, not recruiting
Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial [NCT00476619]Phase 417 participants (Actual)Interventional2004-09-30Terminated(stopped due to The exclusion criteria were stringent and enrollment was slow.)
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia [NCT00699348]Phase 3351 participants (Actual)Interventional2008-07-31Completed
Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction [NCT00882466]Phase 458 participants (Actual)Interventional2008-05-31Completed
Double-blind Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Allogenic Umbilical Cord Blood and Erythropoietin for Children With Cerebral Palsy [NCT01193660]105 participants (Actual)Interventional2010-05-31Completed
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly [NCT02564094]Phase 454 participants (Actual)Interventional2005-02-28Completed
Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone [NCT02731378]Phase 4603 participants (Anticipated)Interventional2016-12-31Not yet recruiting
Early Treatment With Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants: Comparison of High and Low Dose [NCT00910234]Phase 1/Phase 2100 participants (Anticipated)Interventional2009-08-31Not yet recruiting
A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability in Dialysis Patients With Chronic Renal Anemia. [NCT00560404]Phase 3233 participants (Actual)Interventional2008-04-30Completed
An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia. [NCT00560547]Phase 30 participants (Actual)Interventional2007-10-31Withdrawn(stopped due to The study was cancelled before any patients were enrolled, due to operational reasons.)
A Randomized, Double Blind, Placebo Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syndromes at Risk For Tran [NCT00695396]Phase 325 participants (Actual)Interventional2008-06-30Terminated(stopped due to The study was stopped due to low subject enrollment. No safety issue or other concern factored into this decision.)
A Prospective Randomised Controlled Trial to Study the Effects of Recombinant Human Erythropoietin on the Progression of Atherosclerosis, Cardiovascular Function, Nutrition and Residual Renal Function in Pre-dialysis Chronic Renal Failure Patients [NCT00563355]66 participants (Actual)Interventional2001-02-28Completed
The Effect of Erythropoietin on Platelet Activation Markers: a Prospective Study in Healthy Volunteers [NCT01392612]Phase 412 participants (Actual)Interventional2006-11-30Completed
Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients [NCT04013646]Phase 1/Phase 224 participants (Anticipated)Interventional2019-05-02Recruiting
Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration [NCT04073849]Early Phase 124 participants (Actual)Interventional2019-07-15Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis [NCT00922116]Phase 4191 participants (Actual)Interventional2009-04-30Completed
Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study [NCT06178835]Phase 476 participants (Actual)Interventional2017-09-12Completed
Human Recombinant Erythropoietin (HrEPO) in Asphyxia Neonatorum: A Pilot Trial [NCT00945789]Phase 1/Phase 245 participants (Actual)Interventional2007-10-31Completed
A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy. [NCT00321919]Phase 3605 participants (Actual)Interventional2000-07-31Completed
Effect of Erythropoietin on Neonatal Hypoxic Ischemic Encephalopathy [NCT00808704]Phase 1/Phase 2167 participants (Actual)Interventional2003-08-31Completed
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery [NCT01066351]Phase 3200 participants (Anticipated)Interventional2010-01-31Enrolling by invitation
Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI) [NCT00423020]Phase 472 participants InterventionalRecruiting
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 18 Week Pilot Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) on the Development of Peripheral Neuropathy in Patients Receiving Combination Taxane and Platinum-Based Ch [NCT00267007]Phase 232 participants (Actual)Interventional2006-06-30Terminated(stopped due to Slow enrollment)
A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy [NCT00388336]Phase 257 participants (Actual)Interventional2004-02-29Completed
A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia [NCT00545571]Phase 3120 participants (Actual)Interventional2007-10-31Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients Not Currently Treated With ESA. [NCT00661388]Phase 375 participants (Actual)Interventional2008-08-31Completed
The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia [NCT00524407]Phase 4273 participants (Actual)Interventional1996-07-31Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Trea [NCT00737711]Phase 4189 participants (Actual)Interventional2008-07-31Completed
A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialy [NCT00737477]Phase 396 participants (Actual)Interventional2008-09-30Completed
Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO) [NCT00642668]Phase 435 participants (Actual)Interventional2008-06-30Completed
Generation of Positive Biological Samples to Epoetin for Doping Control. [NCT02920372]Phase 12 participants (Actual)Interventional2016-11-30Completed
A Randomized, Open-Label Study to Assess the Safety of Epoetin Alfa Manufactured by Deep Tank Technology and Epoetin Alfa Manufactured by Roller Bottle Technology in Subjects With Chronic Kidney Disease Not on Dialysis [NCT00156962]Phase 3850 participants (Anticipated)Interventional2005-04-30Terminated(stopped due to Regulatory decision not to proceed)
An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting [NCT00337935]Phase 2157 participants (Actual)Interventional2006-07-31Completed
RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa [NCT00416624]Phase 2239 participants (Actual)Interventional2007-05-31Completed
An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment. [NCT00413894]Phase 3424 participants (Actual)Interventional2007-03-31Completed
Treatment Program for Anemia in AIDS Patients [NCT00002022]0 participants InterventionalCompleted
Clinical and Biological Evaluation of Azacitidine in Transfusion-dependent Patients With Low and Intermediate-1 Risk MDS, and Low-risk CMML, Who Are Either Refractory to or Not Eligible for Treatment With Erythropoietin +/- G-CSF [NCT01048034]Phase 230 participants (Actual)Interventional2010-01-31Completed
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO050 [NCT00364832]Phase 2137 participants (Actual)Interventional2001-10-31Completed
A Phase 1b, Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease [NCT03992066]Phase 146 participants (Actual)Interventional2019-05-28Completed
Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital [NCT00511901]Phase 422 participants (Actual)Interventional2005-11-30Terminated(stopped due to Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated)
A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy [NCT00338286]Phase 32,098 participants (Actual)Interventional2006-03-02Completed
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury [NCT00313716]Phase 2/Phase 3200 participants (Actual)Interventional2006-04-30Completed
An Open-Label, Randomized, Parallel-Group Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery [NCT00211146]Phase 3680 participants (Actual)Interventional1998-04-30Completed
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study [NCT01886443]Phase 110 participants (Actual)Interventional2013-08-31Completed
[NCT01889056]Phase 1/Phase 232 participants (Anticipated)Interventional2013-02-28Active, not recruiting
[NCT01902511]60 participants (Actual)Interventional2013-07-31Completed
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy [NCT00266617]Phase 286 participants (Actual)InterventionalCompleted
An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing Chemotherapy [NCT00283465]Phase 4316 participants (Actual)Interventional1999-11-30Completed
A Phase 2, Multicenter, Open-label, Randomized, Active-Controlled Study of Efficacy and Safety of AND017 in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis [NCT05265325]Phase 2120 participants (Anticipated)Interventional2023-05-03Recruiting
A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy [NCT00210587]Phase 351 participants (Actual)Interventional2005-02-28Completed
An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week Epoetin Alfa (PROCRIT)in the Treatment of Subjects With the Anemia of Chronic Kidney Disease (CKD) [NCT00210743]Phase 267 participants (Actual)Interventional2004-05-31Completed
Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor [NCT00559195]Phase 240 participants (Anticipated)Interventional2005-11-30Completed
"A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysp [NCT05949684]Phase 3360 participants (Anticipated)Interventional2023-10-24Recruiting
Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial [NCT01962571]Phase 3108 participants (Actual)Interventional2014-11-25Completed
Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy Combined With Erythropoietin in Children With Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled Clinical Trial [NCT01991145]92 participants (Actual)Interventional2013-11-26Completed
Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia. [NCT00364455]Phase 356 participants (Actual)Interventional2002-12-31Completed
Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial [NCT02002039]Phase 2/Phase 3100 participants (Actual)Interventional2012-06-30Completed
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery [NCT00254436]Phase 350 participants (Actual)Interventional2001-10-31Terminated
Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients [NCT00666835]Phase 3478 participants (Actual)Interventional2004-04-30Completed
A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations [NCT00624312]Phase 20 participants (Actual)Interventional2008-02-29Withdrawn
[NCT00006136]Phase 215 participants Interventional1999-03-31Completed
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3) [NCT00390832]Phase 3138 participants (Actual)Interventional2006-12-31Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia [NCT01156363]Phase 486 participants (Actual)Interventional2010-10-31Completed
Pilot Study to Assess the Effect of Low Dose Epoetin Beta Administered for Six Month in Patients With Ischemic Heart Failure Subjected to Percutaneous Coronary Intervention (PCI) [NCT00568542]Phase 428 participants (Actual)Interventional2006-05-31Completed
Prognostic Value of Serum Erythropoietin Level,Ferritin Level and Fibrinogen in Adult Low Risk MDS [NCT04573686]50 participants (Anticipated)Observational2021-01-01Not yet recruiting
High-Dose Erythropoietin in Very Low Birth Weight Infants for the Potential Treatment of Prematurity-Related Cerebral Hemorrhagic-Ischemic Injury: A Phase II Safety/Tolerability Study [NCT00589953]Phase 222 participants (Actual)Interventional2007-07-31Terminated
A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant. [NCT00576602]Phase 41 participants (Actual)Interventional2007-12-31Terminated(stopped due to poor recruitment)
A Randomized Controlled, Single-blind, Proof-of-concept-study to Investigate the Protective Effects of Early Treatment With C.E.R.A. in Patients With Chronic Kidney Disease on Renal Disease Progression (PRIMAVERA-Study) [NCT01194154]Phase 2241 participants (Actual)Interventional2010-09-30Completed
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia [NCT00882713]Phase 3202 participants (Actual)Interventional2009-02-28Completed
Impact of Erythropoietin on Hematological Adaptations and Physical Performance [NCT05078138]Phase 48 participants (Actual)Interventional2021-09-01Completed
Erythropoietin as an add-on Treatment for Cognitive Side-effects of Electroconvulsive Therapy [NCT03339596]Phase 260 participants (Actual)Interventional2017-06-26Completed
A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA [NCT01342640]Phase 470 participants (Actual)Interventional2011-07-18Completed
Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit [NCT00622934]Phase 220 participants (Anticipated)Interventional2007-07-31Recruiting
A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of EPORON® and EPREX® After Subcutaneous Administration in Healthy Male Volunteers [NCT02580006]Phase 142 participants (Anticipated)Interventional2015-11-30Not yet recruiting
Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men [NCT00793767]10 participants (Anticipated)Interventional2009-01-31Completed
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial [NCT06135259]Phase 318 participants (Anticipated)Interventional2023-12-20Not yet recruiting
An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kid [NCT00869856]Phase 30 participants (Actual)Interventional2009-04-30Withdrawn(stopped due to investigation of adverse events in a related clinical study)
Randomized Trial of Erythropoietin to Prevent Death From Cerebral Impairment During Severe Malaria [NCT00697164]Phase 2/Phase 3120 participants (Anticipated)Interventional2007-10-31Recruiting
AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin [NCT00597584]Phase 3823 participants (Actual)Interventional2007-10-31Completed
Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment [NCT01168349]1,060 participants (Actual)Observational2010-01-31Completed
EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study. [NCT01423955]Phase 275 participants (Actual)Interventional2011-10-31Completed
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Usi [NCT02608060]Phase 44 participants (Actual)Interventional2006-09-30Terminated(stopped due to Due to poor enrollment this study was terminated prematurely.)
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-Dialysis Patients With Chronic Renal Anaemia [NCT00773968]Phase 3140 participants (Actual)Interventional2008-09-30Completed
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067]Phase 310 participants (Actual)Interventional2008-04-30Terminated(stopped due to Italian Medicines Agency decision)
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS): A Randomized, Double-Blind, Placebo Controlled Proof-of-Concept Clinical Trial. [NCT00336466]Phase 232 participants Interventional2004-09-30Completed
Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa. [NCT00337441]Phase 262 participants Interventional2003-01-31Active, not recruiting
An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Weekly or Every Four Week Regimen [NCT00337948]Phase 2129 participants (Actual)Interventional2003-02-28Completed
An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks) [NCT00338299]Phase 251 participants (Actual)Interventional2003-08-31Completed
An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen [NCT00338416]Phase 2115 participants (Actual)Interventional2003-03-31Completed
The Possible Influence of Erythropoietin and Early Iron Supplements on the Prevalence and Severity of Retinopathy of Prematurity and Other Short Term Outcome of Prematurity [NCT00339001]400 participants Observational2006-04-30Recruiting
Comparative Pharmacokinetic and Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Anemic Critically Ill Patients Randomized to One of Six Dose Regimens for 15 Days [NCT00210756]Phase 260 participants (Actual)Interventional2004-02-29Completed
A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients With Anemia of Chronic Disease (ACD) Receiving Epoetin Alfa (PROCRIT�) [NCT00210795]Phase 212 participants (Actual)Interventional2004-06-30Terminated(stopped due to This study was stopped due to slow enrollment after enrolling only 12 of 80 patients over 14 months time.)
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum [NCT00189371]Phase 3300 participants Interventional2004-02-29Terminated
An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon [NCT00413101]Phase 450 participants (Actual)InterventionalCompleted
A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease W [NCT01975818]Phase 2201 participants (Actual)Interventional2013-10-28Completed
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects [NCT00368238]Phase 296 participants Interventional2005-10-31Completed
A Double-blind, Randomized, Placebo-controlled, Clinical Trial to Test the Efficacy of Epoetin Alfa on Physical Performance of Friedreich Ataxia Patients. [NCT01493973]Phase 256 participants (Actual)Interventional2013-01-31Completed
An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure [NCT00338000]Phase 4292 participants (Actual)Interventional2001-06-30Completed
An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT (Epoetin Alfa) [NCT00338468]Phase 413 participants (Actual)Interventional2003-11-30Terminated(stopped due to The study was stopped early due to slow enrollment.)
A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy [NCT00350090]Phase 398 participants (Actual)Interventional2002-09-30Terminated(stopped due to This study was stopped early due to slow enrollment.)
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid [NCT00437450]Phase 299 participants Interventional2004-10-31Active, not recruiting
A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon [NCT00440063]Phase 40 participants InterventionalTerminated
Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta). [NCT00491868]Phase 3134 participants (Actual)Interventional2007-06-30Completed
Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2 [NCT00478517]Phase 120 participants Interventional2007-05-31Withdrawn
High-dose Erythropoietin for Asphyxia and Encephalopathy [NCT02811263]Phase 3500 participants (Actual)Interventional2017-01-31Completed
Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease [NCT00495365]Phase 48 participants (Actual)Interventional2003-06-30Terminated(stopped due to This study was stopped due to slow enrollment)
An Open Label Study to Evaluate the Effect of Intravenous Erythropoietin on Erythropoietin Receptor Signaling and Markers for Apoptosis, Myocardial Damage and Renal Dysfunction in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery [NCT00524901]Phase 210 participants (Actual)Interventional2007-09-30Completed
A Randomized, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-associated Sensory Neuropathy [NCT00528593]Phase 20 participants (Actual)Interventional2007-11-30Withdrawn(stopped due to lack of pharmaceutical support)
Systemic Erythropoietin Injection in Patients Having Optic Atrophy [NCT04680143]Phase 1/Phase 210 participants (Actual)Interventional2020-09-01Completed
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump [NCT00542568]Phase 1/Phase 219 participants (Actual)Interventional2008-08-31Completed
"A Study in Early Renal Insufficiency Patients to Assess the Effect of Maintaining Three Different Hemoglobin Levels With the Use of Erythropoetin Alpha on Left Ventricular Hypertrophy and Dilation and Quality if Life; The Cardiac Results of Early Treatme [NCT00446576]Phase 3176 participants (Actual)Interventional1999-11-30Completed
A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Long-term Treatment of Subjects With Anemia Associated With Chronic Kidney Disea [NCT02064426]Phase 288 participants (Actual)Interventional2014-03-13Completed
A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D) [NCT04215120]Phase 3392 participants (Actual)Interventional2020-01-04Completed
Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit. [NCT05018364]80 participants (Actual)Observational2020-08-01Completed
A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease [NCT03903809]Phase 3175 participants (Actual)Interventional2019-06-20Active, not recruiting
A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy [NCT00003600]Phase 3344 participants (Actual)Interventional1998-12-31Completed
A Study to Determine the Impact of Hemoglobin Maintenance and Other Interventional Strategies to Prevent or Delay the Progression of Left Ventricular Mass Growth in Subjects With Early Renal Insufficiency. [NCT00364260]Phase 3172 participants (Actual)Interventional1997-12-31Completed
A Randomized, Open-Label Study Assessing the Efficacy of Initiating PROCRIT (Epoetin Alfa) Dosing at Q2W vs. PROCRIT Dosing at QW in Anemic HIV-infected Subjects [NCT00246298]Phase 231 participants (Actual)Interventional2005-10-31Terminated(stopped due to OBI business decision not to complete any additional research in HIV.)
Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA) [NCT00104169]Phase 20 participants (Actual)Interventional2004-08-31Terminated(stopped due to No subject accrual)
A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemoth [NCT00070382]Phase 314 participants (Actual)Interventional2003-08-31Completed
An Open Label, Randomized, Multicenter, Phase II Study To Determine Hemoglobin Dose Response, Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell L [NCT00072059]Phase 20 participants Interventional2003-07-31Completed
Erythropoietin Protect the Cerebral Blood Flow and Oxygenation During Simulated Dive? [NCT00265486]12 participants (Anticipated)Observational2005-08-31Recruiting
A Parallel Group Placebo-Controlled Study to Determine an Effective Dose Regimen for EPREX� (Epoetin Alfa) Sterile Solution to Reduce Transfusion Requirements in Patients Undergoing Major Elective Orthopedic Surgery [NCT00269971]Phase 30 participants (Actual)Interventional1996-05-31Withdrawn
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00270010]Phase 272 participants (Actual)InterventionalCompleted
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia [NCT00270049]Phase 2195 participants (Actual)Interventional1990-11-30Completed
A Double-Blind, Placebo-Controlled Study to Determine Whether Procrit� (Epoetin Alfa) Can Reduce Peri-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery [NCT00270088]Phase 3316 participants (Actual)Interventional1993-04-30Completed
Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy [NCT00270127]Phase 3375 participants (Actual)Interventional1996-08-31Completed
A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy [NCT00270166]Phase 3201 participants (Actual)Interventional1995-02-28Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00270283]Phase 2102 participants (Actual)Interventional1988-07-31Completed
Evaluation of Synergy of Combining Hydroxyurea With Recombinant Human Erythropoietin Glycoform Alpha (Rhu Erythropoietin-alpha) on Fetal Hemoglobin Synthesis in Patients With Sickle Cell Anemia [NCT00270478]Phase 17 participants (Actual)Interventional2005-12-21Completed
Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure. [NCT00399269]Phase 3100 participants (Actual)Interventional2006-12-31Completed
A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease [NCT00077597]Phase 3182 participants (Actual)Interventional2004-02-29Completed
Influence of G-CSF and EPO on Associative Learning and Motor Skills [NCT00298597]Phase 2180 participants (Anticipated)Interventional2006-03-31Completed
[NCT00083486]Phase 30 participants Interventional2004-02-29Terminated
Effect of Early Correction of Anemia on the Progression of Chronic Renal Insufficiency (ECAP) [NCT00312871]Phase 4217 participants (Actual)Interventional2001-02-28Terminated(stopped due to Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX.)
A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy [NCT00327535]Phase 2153 participants (Actual)Interventional2006-05-31Completed
An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients [NCT00317902]Phase 4292 participants (Actual)Interventional2002-10-31Completed
Resistance to ErythroPoietin Effectiveness Algorithm Trial [NCT00319150]Phase 36 participants (Actual)Interventional2006-10-31Terminated(stopped due to New evidence and trouble recruiting)
The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial [NCT05167734]Phase 2100 participants (Anticipated)Interventional2021-11-30Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects [NCT00091910]Phase 31,460 participants (Actual)Interventional2003-09-30Completed
Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ). [NCT00433615]Phase 3124 participants (Actual)Interventional2007-02-28Completed
Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn [NCT01732146]Phase 3120 participants (Actual)Interventional2013-03-28Completed
A Phase 2, Randomized, Open-Label Study To Assess The Safety And Efficacy Of Weekly (QW) Or Once Every Two Week (Q2W) Dosing Of Epoetin Alfa (PROCRIT) in Anemic Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) [NCT00446602]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to Due to company decision to focus resources on a larger, controlled study in this patient population.)
A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction [NCT00449488]Phase 2529 participants (Actual)Interventional2007-01-31Completed
A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks [NCT00481624]Phase 20 participants (Actual)Interventional2007-05-31Withdrawn(stopped due to The study was stopped because of lack of funding.)
Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia [NCT00482716]Phase 380 participants (Anticipated)Interventional2007-01-31Active, not recruiting
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy [NCT00120692]Phase 20 participants Interventional2002-10-31Completed
High Dose Erythropoietin for Neonates With Asphyxia [NCT00491413]Phase 115 participants (Anticipated)InterventionalNot yet recruiting
Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta) [NCT00492427]Phase 3187 participants (Actual)Interventional2007-06-30Completed
A Multicenter, Non-Randomized, Open-Label Study to Evaluate Efficacy and Safety of Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome Red Cell Transfusion Dependent With Low or Intermediate -1 Risk. [NCT00495547]Phase 216 participants (Actual)Interventional2009-02-28Terminated
Effects of Systemic Erythropoietin Therapy on Cerebral Autoregulation and Incidence of Delayed Ischemic Deficits in Patients With Aneurysmal Subarachnoid Hemorrhage [NCT00140010]Phase 280 participants (Actual)Interventional2005-04-30Completed
A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy [NCT00144495]Phase 3104 participants (Actual)Interventional2004-02-29Completed
A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy [NCT00144482]Phase 3122 participants (Actual)Interventional2003-12-31Completed
A Phase II Randomised Trial to Investigate the Safety and Efficacy of Recombinant Human Erythropoietin on Infarct Size in Patients Undergoing Primary Percutaneous Coronary Angioplasty for ST-Segment Elevation Myocardial Infarction [NCT00149058]Phase 2124 participants Interventional2005-10-31Not yet recruiting
A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life [NCT00400686]31 participants (Actual)Interventional2003-09-30Completed
Erythropoietin and Pediatric Cardiac Surgery [NCT00451698]9 participants (Actual)Interventional2007-10-31Terminated(stopped due to Inadequate patient enrollment)
A Double Blinded, Placebo Controlled, Pilot Study to Evaluate the Safety of Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa [NCT00626574]Phase 43 participants (Actual)Interventional2007-07-31Terminated(stopped due to This study is terminated as a result of data from a study that showed increased mortality in stroke patients.)
Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy [NCT00656448]Phase 351 participants (Actual)Interventional2008-03-31Completed
A Randomized Multi-Center Study to Determine the Safety and Efficacy of Erythropoietin Plus Pentoxifylline Versus Erythropoietin Alone for the Treatment of Anemia in Subjects With End Stage Renal Disease on Maintenance Hemodialysis [NCT01102218]Phase 248 participants (Actual)Interventional2010-08-31Terminated(stopped due to Lack of statistical difference between both arms of the trial.)
A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy. [NCT00148421]Phase 30 participants InterventionalCompleted
A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy [NCT00315484]Phase 4358 participants (Actual)Interventional2003-02-28Completed
A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants [NCT01235923]Phase 220 participants (Actual)Interventional2006-04-30Completed
Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy. [NCT00210600]Phase 2186 participants (Actual)Interventional2005-05-31Completed
A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Initiated At 40,000 Units Every Week Versus 80,000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy [NCT00210834]Phase 2310 participants (Actual)Interventional2004-05-31Completed
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy [NCT00211133]Phase 3939 participants (Actual)Interventional2000-06-30Completed
A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer [NCT00246597]Phase 337 participants (Actual)Interventional2002-12-31Terminated(stopped due to Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.)
A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease Who Are on Hemodialysis. [NCT00924781]Phase 239 participants (Actual)Interventional2009-06-30Terminated
An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4 [NCT00437723]Phase 490 participants (Actual)InterventionalCompleted
A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis [NCT00442793]Phase 3265 participants (Actual)Interventional2007-05-31Completed
Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia [NCT00495378]Phase 425 participants (Actual)Interventional2002-11-30Terminated(stopped due to This study was stopped due to slow enrollment after enrolling 25 of 200 patients.)
A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma [NCT00049348]Phase 20 participants Interventional2003-10-13Completed
Frequent, Low-Dose Erythropoietin: A Mechanistic Approach to Mitigate Adverse Cardiovascular Effects of Erythropoietin Therapy in Patients With Chronic Kidney Disease [NCT03277183]Phase 45 participants (Actual)Interventional2017-11-02Terminated(stopped due to Lack of enrollment)
The Effect of PROCRIT on Hemoglobin and Hematocrit and the Relationship to Postoperative Function, Vigor and Strength in Patients Undergoing Primary Total Joint Arthroplasty: A Randomized, Parallel Group, Open-Label Trial [NCT00401869]Phase 4289 participants (Actual)Interventional1999-02-28Completed
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy [NCT00120679]Phase 20 participants Interventional2002-10-31Completed
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy [NCT00121030]Phase 20 participants Interventional2002-10-31Completed
Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis (VISION PROTECT) [NCT00355095]Phase 240 participants (Actual)Interventional2006-08-31Completed
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery [NCT00036400]Phase 360 participants (Actual)Interventional2001-12-31Completed
Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/l With Erythropoietin Versus Above 100 g/l Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer [NCT00017004]Phase 3114 participants (Actual)Interventional2001-08-31Completed
A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma [NCT00017277]Phase 347 participants (Actual)Interventional2001-03-31Terminated(stopped due to low accrual)
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 [NCT00398749]1,927 participants (Actual)Observational2005-10-31Completed
A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease [NCT00081484]Phase 3336 participants (Actual)Interventional2004-06-30Completed
Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia [NCT00003681]Phase 250 participants (Anticipated)Interventional1998-08-31Active, not recruiting
[NCT00083434]Phase 30 participants Interventional2004-02-29Terminated(stopped due to This study was stopped because of an inadequate rate of enrollment.)
The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome [NCT05857891]40 participants (Anticipated)Interventional2023-05-20Recruiting
An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer [NCT00022386]Phase 40 participants InterventionalCompleted
Erythropoietin to Improve Critical Care Patient Outcomes: Feasibility Study of a Multicenter, Randomized, Placebo-controlled Trial of Subcutaneous Erythropoietin Injection for Intensive Care Patients [NCT05080049]Phase 342 participants (Actual)Interventional2022-01-28Active, not recruiting
Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery [NCT02984111]97 participants (Actual)Interventional2016-01-31Completed
A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer [NCT00028938]Phase 31 participants (Actual)Interventional2002-01-01Completed
Effects of Erythropoietin on Cognitive Functions and Neural Activity in Cognitively Impaired Remitted Patients With Bipolar Disorder or Recurrent Depressive Disorder and Healthy People: Study Protocol for a Randomized, Controlled Trial [NCT03315897]Phase 2103 participants (Actual)Interventional2017-07-05Completed
A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue [NCT00052221]0 participants (Actual)Interventional2003-05-20Withdrawn
A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes [NCT00053001]Phase 20 participants Interventional2001-06-30Completed
An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia) [NCT00210730]Phase 32 participants (Actual)Interventional2004-06-30Terminated(stopped due to This study was stopped early due to slow enrollment.)
Correction of Hemoglobin and Outcomes In Renal Insufficiency [NCT00211120]Phase 41,432 participants (Actual)Interventional2002-03-31Terminated(stopped due to Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and <5% chance that the study would show benefit for higher Hb.)
An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD). Protocol Addendum: Due to Space Constraints, See Detailed Description for Full Ti [NCT00212875]Phase 2267 participants (Actual)Interventional2005-09-30Completed
Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy [NCT00216541]Phase 4110 participants (Actual)Interventional2003-08-31Completed
Recombinant Human Erythropoietin (r-HuEPO) in the Prevention of Neurologic Sequelae From Malignant Spinal Cord Compression: a Multi-Center, Placebo-Controlled, Phase 2 Randomized Study [NCT00220675]Phase 2/Phase 37 participants (Actual)Interventional2005-08-31Terminated(stopped due to Insufficient accrual)
A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CK [NCT00146224]Phase 3420 participants (Anticipated)Interventional2005-09-30Completed
An Open-Label, Single-Arm Study to Assess the Safety of Epoetin Alfa Manufactured by a Deep Tank Technology in Subjects With Chronic Kidney Disease Receiving Dialysis [NCT00156949]Phase 3580 participants (Actual)Interventional2005-04-30Completed
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation [NCT00157300]Phase 492 participants (Actual)Interventional2005-07-31Completed
A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer [NCT00058331]Phase 3365 participants (Actual)Interventional2003-06-30Completed
A Randomized Clinical Trial Comparing Two Management Strategies for Treatment of Neutropenia and Anemia Associated With Pegylated Interferon Plus Ribavirin Treatment of Compensated Chronic Hepatitis C in Adult Subjects Infected With HIV. [NCT00194857]Phase 40 participants Interventional2002-02-28Terminated
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events. [NCT00535925]Phase 4850 participants (Actual)Interventional2005-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Recombinant Human Erythropoietin (Epoetin Alfa (PROCRIT®)) on Functional Outcomes in Anemic, Critically Ill, Trauma Subjects [NCT00210626]Phase 2192 participants (Actual)Interventional2005-08-31Terminated
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy [NCT00875004]27 participants (Actual)Interventional2007-12-07Terminated(stopped due to After two years of trial initiation, only 27 out of 300 patients were included. During this period, the international recommendations for the use of COOL were modified.)
The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients [NCT03683810]Phase 150 participants (Anticipated)Interventional2019-01-14Recruiting
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT) [NCT00737893]Phase 256 participants (Actual)Interventional2017-07-01Completed
Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome [NCT00356733]Phase 362 participants (Actual)Interventional2007-01-31Completed
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis [NCT03835507]Phase 1/Phase 264 participants (Anticipated)Interventional2016-06-20Recruiting
A Randomized, Double-blinded, Active Controlled, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics, Pharmacodynamics and Safety of GBPD002 and Eprex® After Subcutaneous Administration in Healthy Adult Volunteers. [NCT05585658]Phase 1/Phase 242 participants (Actual)Interventional2021-10-16Completed
A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients With Idiopathic Anemia of Aging (IAA) Receiving Epoetin Alfa (PROCRIT�) [NCT00228995]Phase 29 participants (Actual)Interventional2004-06-30Terminated(stopped due to This study was stopped due to slow enrollment after enrolling only 9 of 80 patients over 14 months time.)
Neuroprotective Effect of High Dose Erythropoietin in Very Preterm Infants [NCT00413946]Phase 2420 participants (Actual)Interventional2006-01-31Completed
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis [NCT00236964]Phase 378 participants Interventional2001-02-28Completed
Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients [NCT00260052]Phase 2/Phase 30 participants (Actual)Interventional2003-07-31Withdrawn(stopped due to PI has left institution)
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of of PROCRIT� (Epoetin Alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty [NCT00236405]Phase 26 participants (Actual)Interventional2005-03-31Terminated(stopped due to The study was terminated due to poor enrollment.)
A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT� (Epoetin Alfa) [NCT00236678]Phase 229 participants (Actual)Interventional2004-07-31Terminated(stopped due to This study was terminated due to slow enrollment, despite protocol amendments to change the entrance criteria.)
A Double-Blind, Phase II, Placebo-Controlled Study to Determine the Safety and Efficacy of r-HuEPO in Reducing Transfusion Requirements in Patients Undergoing Total Hip Joint Replacement Surgery [NCT00269958]Phase 2208 participants (Actual)InterventionalCompleted
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy [NCT00269997]Phase 272 participants (Actual)InterventionalCompleted
A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery [NCT00270036]Phase 21 participants (Actual)Interventional1991-04-30Completed
[NCT00238043]Phase 32,000 participants (Anticipated)Interventional2005-08-31Active, not recruiting
Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation [NCT05669079]Phase 3100 participants (Anticipated)Interventional2023-08-01Not yet recruiting
EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE). [NCT00264108]492 participants (Actual)Observational2005-06-30Completed
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study. [NCT01685359]Phase 180 participants (Actual)Interventional2013-02-28Completed
[NCT00284271]Phase 265 participants (Actual)Interventional2004-01-31Completed
An Open-label, Randomized Pilot Study to Compare the Effectiveness of Peginterferon-alfa-2b Plus Ribavirin to Peginterferon-alfa-2b Plus Epoetin-alfa and Two Doses of Ribavirin in the Treatment of Chronic Hepatitis C Virus Infection [NCT00248339]Phase 3150 participants (Actual)Interventional2002-05-31Completed
Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels (110- 129 g/L and 130 - 149 g/L) on Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes and With Chronic Kidney Disease [NCT00279084]204 participants Interventional2004-01-31Active, not recruiting
Recombinant Human Erythropoietin (R-HuEPO) in Non-Anemic Patients Scheduled for Orthopedic or Cardiovascular Surgery, to Facilitate Presurgical Autologous Blood Donation (A Double-blind, Randomized, Dose Finding Study) [NCT00270075]Phase 2/Phase 380 participants (Actual)Interventional1990-01-31Completed
Recombinant Human Erythropoietin (r-HuEPO) in Patients With Low Hematocrit Levels to Facilitate Presurgical Autologous Blood Donation in Patients Undergoing Orthopedic Surgery (An Open-label Dose Finding Study) [NCT00270114]Phase 2/Phase 355 participants (Actual)InterventionalCompleted
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00270270]Phase 263 participants (Actual)InterventionalCompleted
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy [NCT00255749]Phase 289 participants (Actual)Interventional2005-08-31Completed
Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREX�/ERYPO� on Left Ventricular Structure in Early Hemodialysis Patients (RWJ-22512) [NCT00261521]Phase 3596 participants (Actual)Interventional2000-02-29Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy [NCT00261677]Phase 3224 participants (Actual)Interventional2000-08-31Completed
Phase 4 Study on the Efficacy of Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function [NCT00418119]Phase 410 participants Interventional2007-01-31Not yet recruiting
Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin [NCT00262379]Phase 3229 participants (Actual)Interventional2005-12-31Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00269945]Phase 260 participants (Actual)InterventionalCompleted
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of r-HuEPO, Administered Subcutaneously, in Chronic Anemia Induced by Advanced Cancer [NCT00269984]Phase 256 participants (Actual)InterventionalCompleted
Recombinant Human Erythropoietin (R-HuEPO) in Non-Anemic Patients Scheduled for Selective Orthopedic and Vascular Surgery or Reductive Mammoplasty to Facilitate Presurgical Autologous Blood Donation Combined With Normo-Volemic Hemodilution (NVHD) [NCT00270023]Phase 2/Phase 3112 participants (Actual)InterventionalCompleted
A Double-Blind, Placebo-Controlled Study to Determine Whether R-HuEPO Can Facilitate Presurgical Autologous Blood Donation in Patients With Low Hematocrit Levels [NCT00270062]Phase 377 participants (Actual)Interventional1989-05-31Completed
A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension [NCT00270101]Phase 3156 participants (Actual)Interventional1995-01-31Completed
A Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of Multiple Doses of R-HuEPO in Facilitating Presurgical Autologous Blood Donation [NCT00270140]Phase 317 participants (Actual)Interventional1989-09-30Completed
A Double-Blind, Placebo-Controlled Study to Determine Whether R-huEPO Can Facilitate Presurgical Autologous Blood Donation and to Determine Its Safety for This Purpose [NCT00270179]Phase 317 participants (Actual)InterventionalCompleted
Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass [NCT00273767]Phase 250 participants (Actual)Interventional2006-01-31Completed
Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa [NCT00322413]Phase 380 participants Interventional1997-01-31Completed
Erythropoietin Role in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial [NCT03401710]134 participants (Actual)Interventional2018-04-16Terminated(stopped due to For very slow recruitment)
Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy [NCT00294203]Phase 140 participants (Actual)Interventional2006-02-28Completed
A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA) [NCT00306267]Phase 261 participants (Actual)Interventional2006-03-31Terminated(stopped due to Study stopped as it would not address important survival concerns raised in other recently conducted clinical studies.)
The Clinical Study for Evaluating The Safety And Efficacy Of Epodion® During Maintenance Period Until Evaluation Period On CKD (Chronic Kidney Disease) Patients: An Open Label, Randomized, Active Drug-Comparative, Parallel-Designed, Multi-Center Clinical [NCT05373303]82 participants (Actual)Interventional2019-11-07Completed
A Randomized, Open-Label Clinical Evaluation of PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease [NCT00307814]Phase 2519 participants (Actual)Interventional2002-01-31Completed
A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT� (Epoetin Alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy [NCT00341055]Phase 369 participants (Actual)Interventional2003-06-30Completed
Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20) [NCT00310232]Phase 370 participants (Actual)Interventional2001-02-28Terminated(stopped due to Recommendation of DSMB for safety issue, increased mortality with study drug.)
Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation [NCT00425126]Phase 476 participants (Actual)Interventional2007-02-28Completed
The Influence of the Pre-Therapeutic Increase in the Hemoglobin Level in the Blood Through Erythropoietin to the Therapy Results of the Primary Radiation Therapy for Carcinoma of the Cervix [NCT00348738]Phase 3300 participants (Anticipated)Interventional2000-07-31Active, not recruiting
Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind [NCT01650415]Phase 211 participants (Actual)Interventional2014-09-30Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia [NCT00002042]0 participants InterventionalCompleted
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized Study. [NCT01664195]Phase 128 participants (Anticipated)Interventional2013-02-28Not yet recruiting
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study. [NCT01664221]Phase 180 participants (Anticipated)Interventional2013-02-28Not yet recruiting
Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness [NCT01665781]Phase 439 participants (Actual)Interventional2012-08-31Completed
Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Compared to Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease. [NCT01695759]Phase 392 participants (Actual)Interventional2013-12-31Terminated
A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera® [NCT01756612]551 participants (Actual)Observational2012-11-21Completed
[NCT01823029]387 participants (Actual)Interventional2012-11-30Completed
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847]Phase 1/Phase 2117 participants (Actual)Interventional2015-02-28Completed
Single-arm, Open Study to Investigate the Efficacy, Safety and Tolerability of Monthly Subcutaneously Administered C.E.R.A. in Patients With Renal Anemia Not Yet Subject to Dialysis and Not Yet Permanently Treated With ESAs [NCT00559637]Phase 3184 participants (Actual)Interventional2008-01-31Completed
An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿ [NCT00551291]Phase 210 participants (Actual)Interventional2007-08-31Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00002073]0 participants InterventionalCompleted
Induction Chemotherapy With Taxotere, Cisplatin and 5-Fluorouracil Followed by Concomitant Cetuximab and Radiation for Locoregionally Advanced Squamous Cell Cancer of the Head and Neck: A Phase II Trial [NCT01467115]Phase 21 participants (Actual)Interventional2010-03-31Completed
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents [NCT03140722]Phase 22 participants (Actual)Interventional2017-05-02Terminated(stopped due to Revised study design.)
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics for Healthy Subjects in the Phase Ⅰ Clinical Study [NCT02356419]Phase 140 participants (Anticipated)Interventional2014-09-30Recruiting
A Randomized, Active Comparator-Controlled, Parallel-Group, Single-Blind, Multicenter, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex) in the Treatment of Anemia Associated With Chroni [NCT03521713]Phase 3214 participants (Anticipated)Interventional2016-03-01Recruiting
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema [NCT03821168]Phase 2/Phase 358 participants (Anticipated)Interventional2019-03-01Recruiting
Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial [NCT02564796]Phase 24 participants (Actual)Interventional2016-11-30Terminated(stopped due to COVID)
Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy [NCT04469777]Phase 1/Phase 220 participants (Actual)Interventional2019-04-01Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00002302]0 participants InterventionalCompleted
Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation [NCT03010579]Phase 470 participants (Anticipated)Interventional2016-10-31Recruiting
A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery [NCT00014222]Phase 32,104 participants (Actual)Interventional2000-12-04Completed
Preterm Erythropoietin Neuroprotection Trial (PENUT Trial) [NCT01378273]Phase 3941 participants (Actual)Interventional2013-12-31Completed
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients [NCT05325073]Phase 420 participants (Anticipated)Interventional2022-02-18Recruiting
Proliferative Effects of Erythropoietin on Human Endometrium [NCT03060603]14 participants (Actual)Observational2017-02-23Completed
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients [NCT03004209]Phase 40 participants (Actual)Interventional2016-12-31Withdrawn
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy [NCT00236951]Phase 3224 participants (Actual)Interventional2003-02-28Completed
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561]Phase 2/Phase 318 participants (Anticipated)Interventional2022-04-05Recruiting
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED) [NCT00938314]Phase 296 participants (Actual)Interventional2009-08-31Terminated(stopped due to Slow Enrollment)
The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury [NCT03007537]101 participants (Actual)Interventional2015-10-01Terminated(stopped due to lack of funds)
Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use [NCT02596945]223 participants (Actual)Observational2009-07-31Completed
Non-interventional, Observational Study to Investigate the Efficiency and Safety of Mircera in Patients With a Kidney Transplant [NCT02538107]290 participants (Actual)Observational2007-09-30Completed
Assessing Combination Hydroxyurea and Exogenous Erythropoietin in Sickle Cell Disease [NCT05451940]Phase 1/Phase 215 participants (Anticipated)Interventional2023-05-25Recruiting
Renal Effects of Erythropoietin in Humans [NCT01584921]Phase 116 participants (Actual)Interventional2012-03-31Completed
A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD) [NCT01596855]Phase 296 participants (Actual)Interventional2011-09-30Completed
Phase III Study, Multi-center, Open, Randomized, to Assess the Impact of Early Starting Erythropoetin in the Reduction of Transfusions Blood and Improvement of Quality of Life and Fatigue in Children Under Chemotherapy Treatment. [NCT05704894]Phase 3320 participants (Anticipated)Interventional2023-05-31Not yet recruiting
Efficacy of Treating Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF) on Ventricular Function, Exercise Capacity and Health Status [NCT00286182]Phase 256 participants (Actual)Interventional2007-07-31Completed
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subj [NCT03682536]Phase 3363 participants (Actual)Interventional2019-01-02Active, not recruiting
Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest [NCT01369732]Phase 466 participants (Actual)Interventional2011-05-31Completed
An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With low-and Int-1-risk Myelodysplastic Syndrome. [NCT01868477]Phase 228 participants (Actual)Interventional2014-01-28Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00002072]0 participants InterventionalCompleted
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis [NCT02278341]Phase 3838 participants (Actual)Interventional2014-11-21Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy [NCT00002071]0 participants InterventionalCompleted
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized Crossover Study. [NCT01685333]Phase 128 participants (Actual)Interventional2013-02-28Completed
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in Patients With AIDS or Advanced ARC and Anemia [NCT00002303]0 participants InterventionalCompleted
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or [NCT00002255]Phase 10 participants InterventionalCompleted
Preventing Adverse Outcomes of Neonatal Hypoxic Ischaemic Encephalopathy With Erythropoietin: A Phase III Randomised Placebo Controlled Multicentre Clinical Trial [NCT03079167]Phase 3313 participants (Actual)Interventional2016-05-14Active, not recruiting
Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes [NCT00003138]Phase 3118 participants (Actual)Interventional1998-03-04Completed
A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck [NCT00004917]Phase 30 participants Interventional2000-06-30Completed
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy [NCT00005787]Phase 13 participants (Actual)Interventional1999-09-30Terminated(stopped due to Per PI due to poor/inadequate accrual.)
A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis [NCT02253654]Phase 4216 participants (Actual)Interventional2015-04-01Completed
Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya [NCT03162588]Phase 1/Phase 237 participants (Actual)Interventional2010-05-01Completed
A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment [NCT01473407]Phase 3612 participants (Actual)Interventional2012-01-31Completed
A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis [NCT01478971]Phase 3184 participants (Actual)Interventional2011-10-31Completed
A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q [NCT03223961]Phase 3124 participants (Anticipated)Interventional2018-03-26Recruiting
An Open Label Phase I/II Study of Recombinant Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With AIDS or ARC [NCT00002281]24 participants InterventionalCompleted
Effect of Erythropoietin and Hypothermia on Management of Neonatal Hypoxic Ischemic Encephalopathy [NCT03163589]Phase 340 participants (Anticipated)Interventional2017-12-01Not yet recruiting
Erythropoietin in Methanol Associated Optic Neuropathy [NCT02376881]Phase 324 participants (Anticipated)Interventional2015-03-31Active, not recruiting
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients [NCT02052310]Phase 31,043 participants (Actual)Interventional2014-02-11Completed
A Prospective, Observational, Non-inferiority Study to Assess the Effectiveness of a Biosimilar Epoetin Alfa in Maintaining Haemoglobin Levels in Stable 'End Stage Renal Failure' Patients on Haemodialysis [NCT02341547]44 participants (Anticipated)Observational2015-02-28Not yet recruiting
An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis [NCT01940484]98 participants (Actual)Observational2009-08-31Completed
[NCT00000587]Phase 20 participants Interventional1988-09-30Completed
Prospective, Multicenter, Single-blind, Randomized, Controlled Clinical Trial on Safety and Efficacy of a Novel Topical Formulation Containing Erythropoietin for the Treatment of Diabetic Foot Ulcers [NCT02361931]Phase 1/Phase 220 participants (Actual)Interventional2016-03-21Completed
Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia: a Multicenter Randomized Controlled Study [NCT05911438]419 participants (Anticipated)Interventional2023-07-31Not yet recruiting
Effect of Early Application of Recombinant Human Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome [NCT03110341]Phase 3400 participants (Anticipated)Interventional2017-04-10Recruiting
A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy [NCT01099202]109 participants (Actual)Interventional2003-03-31Completed
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis [NCT01737879]Phase 441 participants (Actual)Interventional2012-10-31Terminated(stopped due to Terminated: Test article, Omontys, was recalled from the market; Enrollment has halted prematurely and will not resume; participants are no longer being treated)
Biological Predictive Factors of Response to Erythropoiesis Stimulating Agent (ESA) in Low Risk Myelodysplastic Syndromes (MDS) Patients [NCT03598582]Phase 470 participants (Actual)Interventional2013-01-01Completed
Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease [NCT01693029]Phase 3435 participants (Actual)Interventional2012-09-30Completed
Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy [NCT01809314]1,167 participants (Actual)Observational2008-03-31Completed
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients [NCT01576341]Phase 3417 participants (Actual)Interventional2012-04-30Completed
The Benefits of a Preoperative Anemia Management Program [NCT01888003]51 participants (Actual)Interventional2013-04-30Terminated
Iron Sucrose Combined With rHuEPO and Ascorbic Acid on Perioperative Allogeneic Red Blood Cell Infusion in Patients Undergoing Elective Major Cardiac Surgery [NCT05353348]370 participants (Anticipated)Interventional2023-02-15Recruiting
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis [NCT00236938]Phase 3121 participants (Actual)Interventional2002-07-31Completed
Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients [NCT01519947]Phase 487 participants (Actual)Interventional2012-05-30Completed
Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions [NCT00378352]Phase 2223 participants (Actual)Interventional2005-09-30Completed
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS [NCT00520468]Phase 215 participants (Actual)Interventional2004-06-30Completed
A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects With Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia [NCT01394991]Phase 4504 participants (Actual)Interventional2006-01-31Completed
Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy [NCT01736215]33 participants (Actual)Observational2010-11-30Terminated(stopped due to This study was terminated regarding to slow enrollment.)
The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial [NCT00003341]Phase 3275 participants (Anticipated)Interventional1997-12-31Completed
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study [NCT01913340]Phase 1/Phase 250 participants (Actual)Interventional2013-09-30Completed
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients [NCT00701714]Phase 3337 participants (Actual)Interventional2007-09-30Terminated(stopped due to investigation of adverse events)
A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Subcutaneous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment [NCT01473420]Phase 3320 participants (Actual)Interventional2012-01-17Completed
Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients [NCT02335593]Phase 264 participants (Actual)Interventional2014-12-31Completed
The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis [NCT02504294]Phase 3432 participants (Actual)Interventional2015-07-13Completed
A Prospective, Randomized, Double Blind, Parallel Group Study to Establish the Therapeutic Equivalence of EPIAO® With the Standard Treatment EPREX® in Subjects With Chronic Kidney Disease (CKD) Related Anaemia Not Yet on Dialysis [NCT02522975]Phase 416 participants (Actual)Interventional2015-08-31Terminated
A Phase 1, Open-label, Randomized, Single Dose, Crossover Study Evaluating The Pharmacokinetics Of Epoetin Following Administration Of Epoetin Hospira Multiple Dose Vial (Mdv) Product Compared To Epoetin Hospira Single Dose Vial (Sdv) Product As Subcutane [NCT03398473]Phase 168 participants (Actual)Interventional2018-01-25Completed
Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery [NCT06012760]480 participants (Anticipated)Interventional2023-08-30Recruiting
A Prospective Open-Label Study of the Effectiveness of Epoetin Beta for Treating Anemic Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome (MDS) [NCT02145026]Phase 4100 participants (Actual)Interventional2014-08-06Completed
A Phase 3, Open-label, Multicenter, Long-term Safety Study Of Subcutaneous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment [NCT01628120]Phase 3170 participants (Actual)Interventional2012-05-31Completed
The Effect of High Dose Erythropoietin in Acute Renal Failure [NCT03102021]Phase 225 participants (Actual)Interventional2006-03-31Completed
A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease [NCT04502537]200 participants (Anticipated)Observational2021-02-01Recruiting
Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation [NCT02496377]100 participants (Actual)Interventional2014-08-29Completed
Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera® [NCT02238080]197 participants (Actual)Observational2009-12-31Completed
Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients [NCT02428686]Phase 250 participants (Actual)Interventional2010-06-30Completed
A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis [NCT02273726]Phase 3741 participants (Actual)Interventional2015-01-15Completed
A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients [NCT02174731]Phase 32,133 participants (Actual)Interventional2014-07-01Completed
A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment [NCT01628107]Phase 3406 participants (Actual)Interventional2012-07-16Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003138 (3) [back to overview]Overall Survival
NCT00003138 (3) [back to overview]Proportion of Patients Free of Transfusion at 4 Months
NCT00003138 (3) [back to overview]Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months
NCT00014222 (2) [back to overview]Disease Free Survival
NCT00014222 (2) [back to overview]Overall Survival
NCT00048035 (6) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00048035 (6) [back to overview]Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
NCT00048035 (6) [back to overview]Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
NCT00048035 (6) [back to overview]Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
NCT00048035 (6) [back to overview]Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
NCT00048035 (6) [back to overview]Mean Change in Pulse Rate
NCT00048048 (7) [back to overview]Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time
NCT00048048 (7) [back to overview]Heart Rate Over Time
NCT00048048 (7) [back to overview]Number of Participants With Any Serious Adverse Events and Any Adverse Events
NCT00048048 (7) [back to overview]Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen
NCT00048048 (7) [back to overview]Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen
NCT00048048 (7) [back to overview]The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
NCT00048048 (7) [back to overview]Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
NCT00077610 (8) [back to overview]Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
NCT00077610 (8) [back to overview]The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
NCT00077610 (8) [back to overview]Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
NCT00077610 (8) [back to overview]Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
NCT00077610 (8) [back to overview]Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
NCT00077610 (8) [back to overview]Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
NCT00077610 (8) [back to overview]Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
NCT00077610 (8) [back to overview]Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
NCT00077623 (9) [back to overview]Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
NCT00077623 (9) [back to overview]Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
NCT00077623 (9) [back to overview]Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
NCT00077623 (9) [back to overview]Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
NCT00077623 (9) [back to overview]Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
NCT00077623 (9) [back to overview]Number of Participants With Red Blood Cell Transfusions
NCT00077623 (9) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00077623 (9) [back to overview]Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
NCT00077623 (9) [back to overview]Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
NCT00090753 (2) [back to overview]Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
NCT00090753 (2) [back to overview]Percentage of Patients Who Had at Least 1 Adverse Event
NCT00210626 (2) [back to overview]Return to Usual Activity (RTUA)
NCT00210626 (2) [back to overview]SF-36 PF Score
NCT00236938 (4) [back to overview]The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
NCT00236938 (4) [back to overview]The Mean Change From Baseline to the Highest Ferritin up to Day 71
NCT00236938 (4) [back to overview]Mean Change From Baseline to the Highest Hemoglobin up to Day 71
NCT00236938 (4) [back to overview]The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
NCT00236951 (1) [back to overview]Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
NCT00258440 (2) [back to overview]Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.
NCT00258440 (2) [back to overview]Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
NCT00267007 (2) [back to overview]The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.
NCT00267007 (2) [back to overview]The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.
NCT00286182 (1) [back to overview]Change in Left Ventricular End-diastolic Volume
NCT00313716 (5) [back to overview]Glasgow Outcome Scale
NCT00313716 (5) [back to overview]Disability Rating Scale
NCT00313716 (5) [back to overview]Incidence of Adult Respiratory Distress Syndrome (ARDS)
NCT00313716 (5) [back to overview]Incidence of Infection
NCT00313716 (5) [back to overview]Mortality Rate
NCT00321919 (18) [back to overview]Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs
NCT00321919 (18) [back to overview]Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)
NCT00321919 (18) [back to overview]Mean Values of Echocardiography Parameters
NCT00321919 (18) [back to overview]Mean Values of Body Surface Area
NCT00321919 (18) [back to overview]Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire
NCT00321919 (18) [back to overview]Mean Change From Baseline in Left Ventricular Volume (LV Volume )
NCT00321919 (18) [back to overview]Mean Change From Baseline in Left Ventricular Mass Index (LVMI)
NCT00321919 (18) [back to overview]Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)
NCT00321919 (18) [back to overview]Total Number of Cardiovascular Intervention
NCT00321919 (18) [back to overview]Median Time to First Hospitalization Due to Cardiovascular Events
NCT00321919 (18) [back to overview]Median Time to First Cardiovascular Intervention
NCT00321919 (18) [back to overview]Median Time to First Cardiovascular Event
NCT00321919 (18) [back to overview]Median Time to Death Due to All Causes
NCT00321919 (18) [back to overview]Duration of Hospitalization for Cardiovascular Events
NCT00321919 (18) [back to overview]Median Time to Death Due to Cardiovascular Events
NCT00321919 (18) [back to overview]Number of Participants Who Died Due to All Causes
NCT00321919 (18) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00321919 (18) [back to overview]Number of Participants Who Died Due to Cardiovascular Events
NCT00334737 (9) [back to overview]Volume of Transfusions
NCT00334737 (9) [back to overview]Object Permanence Scores at 18-22 Months
NCT00334737 (9) [back to overview]Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)
NCT00334737 (9) [back to overview]Hematocrit
NCT00334737 (9) [back to overview]Incidence of Retinopathy of Prematurity Stage 3 or Greater
NCT00334737 (9) [back to overview]Reticulocyte Count
NCT00334737 (9) [back to overview]Number of Transfusions During Hospitalization
NCT00334737 (9) [back to overview]Composite Cognitive Score at 18-22 Months Corrected Age
NCT00334737 (9) [back to overview]Epo Concentrations
NCT00337935 (3) [back to overview]The Number of Patients Achieved a Hemoglobin Response.
NCT00337935 (3) [back to overview]Time to Hemoglobin Response
NCT00337935 (3) [back to overview]Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)
NCT00338286 (5) [back to overview]Overall Survival
NCT00338286 (5) [back to overview]Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)
NCT00338286 (5) [back to overview]Progression Free Survival
NCT00338286 (5) [back to overview]Time to Tumor Progression
NCT00338286 (5) [back to overview]Overall Response Rate (ORR)
NCT00350519 (4) [back to overview]Hemoglobin Change From Baseline to End of Study
NCT00350519 (4) [back to overview]Hospital Length of Stay
NCT00350519 (4) [back to overview]Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
NCT00350519 (4) [back to overview]Number of pRBC Units Transfused During Study
NCT00354341 (6) [back to overview]Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
NCT00354341 (6) [back to overview]Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
NCT00354341 (6) [back to overview]Fractional Myocardial Shortening (FS)
NCT00354341 (6) [back to overview]Left Ventricular Ejection Fraction (LVEF)
NCT00354341 (6) [back to overview]Left Ventricular End Diastolic Volume Index (LVEDVI)
NCT00354341 (6) [back to overview]Left Ventricular End Systolic Volume Index (LVESVI)
NCT00364832 (6) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00364832 (6) [back to overview]Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
NCT00364832 (6) [back to overview]Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
NCT00364832 (6) [back to overview]Mean Change in Pulse Rate
NCT00364832 (6) [back to overview]Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
NCT00364832 (6) [back to overview]Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
NCT00367991 (4) [back to overview]Bleeding Time
NCT00367991 (4) [back to overview]Platelet Function Assay Closure Time
NCT00367991 (4) [back to overview]Serum Markers of Myocyte Damage
NCT00367991 (4) [back to overview]Serum Markers of Apoptosis
NCT00378352 (9) [back to overview]Vital Signs
NCT00378352 (9) [back to overview]Hemoglobin Levels
NCT00378352 (9) [back to overview]Infarct Size in the Territory of the Infarct Related Artery
NCT00378352 (9) [back to overview]Infarct Size in the Territory of the Infarct Related Artery
NCT00378352 (9) [back to overview]LV Volume Indexed to BSA
NCT00378352 (9) [back to overview]LV Mass Indexed to BSA
NCT00378352 (9) [back to overview]LV Ejection Fraction
NCT00378352 (9) [back to overview]Number of Participants With Clinical Events
NCT00378352 (9) [back to overview]Reticulocyte Counts
NCT00379912 (6) [back to overview]Overall Response After Cycle 3
NCT00379912 (6) [back to overview]Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
NCT00379912 (6) [back to overview]BclXL Expression
NCT00379912 (6) [back to overview]Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
NCT00379912 (6) [back to overview]Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone
NCT00379912 (6) [back to overview]Overall Response Rate After Six Cycles
NCT00386152 (4) [back to overview]Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study
NCT00386152 (4) [back to overview]Number of Patients (Hb >= 11 g/dL) During Study.
NCT00386152 (4) [back to overview]Time to Achieve Hb >= 11 g/dL During Study
NCT00386152 (4) [back to overview]Hemoglobin (Hb) Change From Baseline to Study Week 7
NCT00400686 (3) [back to overview]Number of Patients With an at Least 1gm/dL Increase in Hgb
NCT00400686 (3) [back to overview]Change From Baseline in Hemoglobin at Day 28
NCT00400686 (3) [back to overview]Number of Patients With an at Least 2gm/dL Increase in Hgb
NCT00413894 (12) [back to overview]Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
NCT00413894 (12) [back to overview]Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
NCT00413894 (12) [back to overview]Percentage of Participants Requiring Erythrocyte Transfusions
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Fluctuations Within Screening Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Fluctuations Within Evaluation Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase
NCT00413894 (12) [back to overview]Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
NCT00416624 (12) [back to overview]Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations
NCT00416624 (12) [back to overview]The Percentage of Participants With Dose Omitted Due to Hematologic Reason
NCT00416624 (12) [back to overview]The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions
NCT00416624 (12) [back to overview]Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
NCT00416624 (12) [back to overview]Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
NCT00416624 (12) [back to overview]Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations
NCT00416624 (12) [back to overview]Weekly Change in Hemoglobin Levels
NCT00416624 (12) [back to overview]The Percentage of Participants Who Exhibit a Hematopoietic Response
NCT00416624 (12) [back to overview]The Total RBC Transfusion Needed
NCT00416624 (12) [back to overview]Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL
NCT00416624 (12) [back to overview]The Percentage of Participants Reported Grade 3 or 4 Adverse Events
NCT00416624 (12) [back to overview]Mean Hemoglobin Change From Week 1 to Week 16
NCT00422513 (2) [back to overview]The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
NCT00422513 (2) [back to overview]Number of Participants Assessed for AEs
NCT00425698 (1) [back to overview]Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)
NCT00440466 (9) [back to overview]Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment
NCT00440466 (9) [back to overview]Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
NCT00440466 (9) [back to overview]Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
NCT00440466 (9) [back to overview]Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
NCT00440466 (9) [back to overview]Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
NCT00440466 (9) [back to overview]Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
NCT00440466 (9) [back to overview]Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
NCT00440466 (9) [back to overview]Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
NCT00440466 (9) [back to overview]Number of Participants Who Died
NCT00440557 (8) [back to overview]Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22
NCT00440557 (8) [back to overview]Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment
NCT00440557 (8) [back to overview]Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9
NCT00442416 (15) [back to overview]Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
NCT00442416 (15) [back to overview]Mean Change From Baseline in Temperature
NCT00442416 (15) [back to overview]Mean Change From Baseline in Total Iron-binding Capacity
NCT00442416 (15) [back to overview]Mean Change From Baseline in Transferrin Saturation
NCT00442416 (15) [back to overview]Number of Participants With Anti-erythropoietin Antibody in Human Serum
NCT00442416 (15) [back to overview]Number of Participants With Anti-RO0503821 Antibody in Human Serum
NCT00442416 (15) [back to overview]Number of Participants With Any AEs, Any Serious Adverse Events and Death
NCT00442416 (15) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00442416 (15) [back to overview]Percentage of Participants With Safety-Related Hb Measures
NCT00442416 (15) [back to overview]Mean Change From Baseline in Weight
NCT00442416 (15) [back to overview]Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
NCT00442416 (15) [back to overview]Mean Change From Baseline in Ferritin
NCT00442416 (15) [back to overview]Mean Change From Baseline in Iron
NCT00442416 (15) [back to overview]Mean Change From Baseline in Pulse Rate
NCT00442416 (15) [back to overview]Mean Change From Baseline in Serum Transferrin
NCT00451698 (2) [back to overview]Length of Hospitalization
NCT00451698 (2) [back to overview]Biochemical Markers of Heart Damage
NCT00454246 (1) [back to overview]Number of Participants Assessed for AEs and SAEs
NCT00462384 (5) [back to overview]Time to Achievement of Response
NCT00462384 (5) [back to overview]Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
NCT00462384 (5) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
NCT00462384 (5) [back to overview]Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
NCT00462384 (5) [back to overview]Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
NCT00511901 (8) [back to overview]FACIT Measurement System Fatigue Scale
NCT00511901 (8) [back to overview]Grip Strength
NCT00511901 (8) [back to overview]Motor-FIM Score
NCT00511901 (8) [back to overview]POMS Depression-Dejection Scale
NCT00511901 (8) [back to overview]Short Physical Performance Battery (SPPB) Score
NCT00511901 (8) [back to overview]Activity Counts
NCT00511901 (8) [back to overview]Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
NCT00511901 (8) [back to overview]Length of Stay in Subacute Rehabilitation Facility
NCT00513240 (4) [back to overview]Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI
NCT00513240 (4) [back to overview]Scores on Bayley Scales of Infant Development III at Age 1 Years.
NCT00513240 (4) [back to overview]EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).
NCT00513240 (4) [back to overview]Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose (Maximum EPO Plasma Concentration)
NCT00517413 (18) [back to overview]Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
NCT00517413 (18) [back to overview]Mean Ferritin Levels Over Time
NCT00517413 (18) [back to overview]Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP
NCT00517413 (18) [back to overview]Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP
NCT00517413 (18) [back to overview]Mean C-Reactive Protein Levels Over Time
NCT00517413 (18) [back to overview]Mean White Blood Cells and Thrombocyte Levels Over Time
NCT00517413 (18) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events
NCT00517413 (18) [back to overview]Mean Transferrin Saturation Levels Over Time
NCT00517413 (18) [back to overview]Mean Albumin and Transferrin Levels Over Time
NCT00517413 (18) [back to overview]Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
NCT00517413 (18) [back to overview]Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP
NCT00517413 (18) [back to overview]Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP
NCT00517413 (18) [back to overview]Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP
NCT00517413 (18) [back to overview]Mean Phosphate and Potassium Levels Over Time
NCT00517413 (18) [back to overview]Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
NCT00517413 (18) [back to overview]Mean Monthly Dose of C.E.R.A During the DTP and EEP
NCT00517413 (18) [back to overview]Mean Hematocrit Levels Over Time
NCT00517413 (18) [back to overview]Mean Haemoglobin Levels Over Time
NCT00517881 (7) [back to overview]Percentage of Participants With Red Blood Cell Transfusion During the Study
NCT00517881 (7) [back to overview]Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
NCT00517881 (7) [back to overview]Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
NCT00517881 (7) [back to overview]Change in Hemoglobin Concentration Between Reference (SVP) and EEP
NCT00517881 (7) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
NCT00517881 (7) [back to overview]Percentage of Participants Requiring Any Dose Adjustment
NCT00517881 (7) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00520468 (1) [back to overview]Number of Participants With Response
NCT00535925 (2) [back to overview]"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"
NCT00535925 (2) [back to overview]"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"
NCT00545571 (10) [back to overview]Mean Change in Time-Adjusted Hb From Baseline to EEP
NCT00545571 (10) [back to overview]Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)
NCT00545571 (10) [back to overview]Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
NCT00545571 (10) [back to overview]Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP
NCT00545571 (10) [back to overview]Mean Dose of Mircera/CERA During the DTP and LTSP
NCT00545571 (10) [back to overview]Mean Excursions Above or Below Target Range for Hb During the LTSP
NCT00545571 (10) [back to overview]Mean Time Spent Above or Below the Target Range for Hb During the LTSP
NCT00545571 (10) [back to overview]Percentage of Hb Values Above or Below the Target Range During the LTSP
NCT00545571 (10) [back to overview]Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP
NCT00545571 (10) [back to overview]Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)
NCT00546481 (8) [back to overview]Mean Change From Baseline in Hemoglobin Concentration at Week 24
NCT00546481 (8) [back to overview]Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24
NCT00546481 (8) [back to overview]Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24
NCT00546481 (8) [back to overview]Number of Participants Who Received Red Blood Cells Transfusions up to Week 49
NCT00546481 (8) [back to overview]Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24
NCT00546481 (8) [back to overview]Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
NCT00546481 (8) [back to overview]Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24
NCT00546481 (8) [back to overview]Number of Participants With Any Adverse Events and Serious Adverse Events
NCT00550680 (6) [back to overview]Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
NCT00550680 (6) [back to overview]Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion
NCT00550680 (6) [back to overview]Mean Time Spent in the Target Range for Hb During the EEP
NCT00550680 (6) [back to overview]Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
NCT00550680 (6) [back to overview]Mean Change in Time-Adjusted Hb From Baseline to EEP
NCT00550680 (6) [back to overview]Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP
NCT00551291 (3) [back to overview]Mean Number of Blood Transfusions Per Visit
NCT00551291 (3) [back to overview]Percentage of Participants With at Least One Adverse Event (AE)
NCT00551291 (3) [back to overview]Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
NCT00559637 (8) [back to overview]Duration of Hemoglobin Values in the Range of 11-13 g/dL
NCT00559637 (8) [back to overview]Total Number of Dose Adjustments
NCT00559637 (8) [back to overview]Total Number of Red Blood Cell (RBC) Transfusions
NCT00559637 (8) [back to overview]Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL
NCT00559637 (8) [back to overview]Duration of Hemoglobin Values in the Range of 11-12 g/dL
NCT00559637 (8) [back to overview]Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)
NCT00559637 (8) [back to overview]Change From Baseline in Hemoglobin Value to the Evaluation Phase
NCT00559637 (8) [back to overview]Time to Increase of Hemoglobin Value to Over 11 g/dL
NCT00560404 (19) [back to overview]Mean Values of Hematocrit at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Hemoglobin Concentration at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Mean Corpuscular Volume at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Transferrin Saturation at Baseline and Week 36
NCT00560404 (19) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events
NCT00560404 (19) [back to overview]Mean Values of Ferritin Concentration at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period
NCT00560404 (19) [back to overview]Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period
NCT00560404 (19) [back to overview]Number of Participants Received Red Blood Cells Transfusions
NCT00560404 (19) [back to overview]Number of Participants Who Required Dose Adjustments During the Dose Titration Period
NCT00560404 (19) [back to overview]Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
NCT00560404 (19) [back to overview]Number of Participants With Abnormal Changes in ECG From Baseline to Week 40
NCT00560404 (19) [back to overview]Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40
NCT00560404 (19) [back to overview]Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period
NCT00560404 (19) [back to overview]Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
NCT00560404 (19) [back to overview]Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
NCT00560404 (19) [back to overview]Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
NCT00576303 (6) [back to overview]Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP
NCT00576303 (6) [back to overview]Number of Participants With Red Blood Cell Transfusion
NCT00576303 (6) [back to overview]Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP
NCT00576303 (6) [back to overview]Percentage of Participants Maintaining Average Hemoglobin Concentration Within +- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
NCT00576303 (6) [back to overview]Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP
NCT00576303 (6) [back to overview]Mean Change in Hb Concentration From Baseline to the EEP
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity
NCT00576628 (17) [back to overview]Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period
NCT00576628 (17) [back to overview]Number of Participants With Red Blood Cells Transfusions.
NCT00576628 (17) [back to overview]Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP
NCT00576628 (17) [back to overview]The Number of Participants Who Required Dose Adjustments During the Dose Titration Period
NCT00576628 (17) [back to overview]The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
NCT00576628 (17) [back to overview]Time to Achievement of Response During the Efficacy Evaluation Period
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter : Hb Concentration
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter : Hematocrit
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter : Serum Creatinine
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter: C Reactive Protein
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameter: Ferritin Concentration
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameters: Transferrin Saturation
NCT00576628 (17) [back to overview]Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count
NCT00576628 (17) [back to overview]Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
NCT00577096 (10) [back to overview]Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Long Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Short Term)
NCT00577096 (10) [back to overview]Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
NCT00577096 (10) [back to overview]Number of Stem Cell Collection Attempts (Long Term)
NCT00577096 (10) [back to overview]Total Number of Days of Stem Cell Collection (Short Term)
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
NCT00577096 (10) [back to overview]Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
NCT00597584 (3) [back to overview]Mean Change in Hemoglobin Between Baseline and the Evaluation Period
NCT00597584 (3) [back to overview]Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
NCT00597584 (3) [back to overview]Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
NCT00597753 (3) [back to overview]Mean Change in Hemoglobin Between Baseline and the Evaluation Period
NCT00597753 (3) [back to overview]Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
NCT00597753 (3) [back to overview]Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
NCT00605293 (6) [back to overview]Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
NCT00605293 (6) [back to overview]Change in Hb Concentrations Between Baseline SVP and the EEP
NCT00605293 (6) [back to overview]Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
NCT00605293 (6) [back to overview]Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP
NCT00605293 (6) [back to overview]Mean Time Spent in Hb Range 10-12 g/dL
NCT00605293 (6) [back to overview]Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP
NCT00626574 (1) [back to overview]Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping
NCT00632125 (1) [back to overview]Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
NCT00642304 (6) [back to overview]Percentage of Participants With Blood Transfusion
NCT00642304 (6) [back to overview]Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
NCT00642304 (6) [back to overview]Mean Change in Hb Concentration Between SVP and the EEP
NCT00642304 (6) [back to overview]Percentage of Participants With Dose Adjustment
NCT00642304 (6) [back to overview]Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
NCT00642304 (6) [back to overview]Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
NCT00642668 (5) [back to overview]Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
NCT00642668 (5) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
NCT00642668 (5) [back to overview]Percentage of Participants With Adverse Events
NCT00642668 (5) [back to overview]Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
NCT00642668 (5) [back to overview]Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
NCT00642850 (7) [back to overview]Change in Hemoglobin Concentration Between Reference (SVP) and EEP
NCT00642850 (7) [back to overview]Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
NCT00642850 (7) [back to overview]Number of Participants With Red Blood Cell Transfusion During the Study
NCT00642850 (7) [back to overview]Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
NCT00642850 (7) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
NCT00642850 (7) [back to overview]Number of Participants With Anti-epoetin Antibody
NCT00642850 (7) [back to overview]Percentage of Participants Requiring Any Dose Adjustment
NCT00654992 (2) [back to overview]Change in Estimated Glomerular Filtration Rate (eGFR)
NCT00654992 (2) [back to overview]Number of Participants Who Had AKI (Acute Kidney Injury)
NCT00656448 (2) [back to overview]Number of Participants With Complete Remission
NCT00656448 (2) [back to overview]Median Number of Participant Transfusions Required During 12 Weeks of Treatment
NCT00660023 (8) [back to overview]Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
NCT00660023 (8) [back to overview]Mean Change in Time-Adjusted Hb From Baseline to EEP
NCT00660023 (8) [back to overview]Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
NCT00660023 (8) [back to overview]Number of Participants Receiving Blood Transfusion During the DTP and EEP
NCT00660023 (8) [back to overview]Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
NCT00660023 (8) [back to overview]Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
NCT00660023 (8) [back to overview]Mean Time Spent in the Target Range for Hb During the EEP
NCT00660023 (8) [back to overview]Number of Blood Transfusions During the DTP and EEP
NCT00661388 (18) [back to overview]Mean Time to Achievement of Response During the EEP
NCT00661388 (18) [back to overview]The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP
NCT00661388 (18) [back to overview]Mean Change From Baseline in Albumin Concentration Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in C-Reactive Protein Concentration Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Creatinine Concentration Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Ferritin Concentration Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Hb Concentration Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Hematocrit Level Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in Transferrin Saturation Over Time
NCT00661388 (18) [back to overview]Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
NCT00661388 (18) [back to overview]Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
NCT00661388 (18) [back to overview]Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
NCT00661388 (18) [back to overview]Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
NCT00661388 (18) [back to overview]Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
NCT00661388 (18) [back to overview]Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP
NCT00661505 (23) [back to overview]Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
NCT00661505 (23) [back to overview]Number of Participants Taking Concomitant Medications
NCT00661505 (23) [back to overview]Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
NCT00661505 (23) [back to overview]Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in Hematocrit at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in Ferritin at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
NCT00661505 (23) [back to overview]Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Number of Participants With Reports of Anti-erythropoietin Antibodies
NCT00661505 (23) [back to overview]Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change From Baseline in Weight at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
NCT00661505 (23) [back to overview]Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
NCT00661505 (23) [back to overview]Number of Participants With Any Adverse Events and Serious Adverse Events
NCT00666835 (2) [back to overview]Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population
NCT00666835 (2) [back to overview]To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.
NCT00680043 (3) [back to overview]Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods
NCT00680043 (3) [back to overview]Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods
NCT00680043 (3) [back to overview]Mean Change in Hemoglobin Between Baseline and the Evaluation Period
NCT00695396 (3) [back to overview]RBC Transfusion From Day 29 Through the End of Study
NCT00695396 (3) [back to overview]Red Blood Cell (RBC) Transfusion
NCT00695396 (3) [back to overview]Transfusion Dependent
NCT00699348 (6) [back to overview]Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
NCT00699348 (6) [back to overview]Percentage of Participants Requiring Any Dose Adjustment
NCT00699348 (6) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range
NCT00699348 (6) [back to overview]Change in Hemoglobin Concentration Between Reference SVP and EEP
NCT00699348 (6) [back to overview]Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
NCT00699348 (6) [back to overview]Number of Participants With Red Blood Cell Transfusion During the Study
NCT00701714 (3) [back to overview]Weekly Epoetin Dose
NCT00701714 (3) [back to overview]Immunogenicity
NCT00701714 (3) [back to overview]Change in Hemoglobin Level
NCT00717366 (9) [back to overview]Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
NCT00717366 (9) [back to overview]Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
NCT00717366 (9) [back to overview]Maximum Observed Serum Concentration (Cmax) of MIRCERA
NCT00717366 (9) [back to overview]Change in Average Hb Concentration Between Baseline and Evaluation Period
NCT00717366 (9) [back to overview]Time to Reach Cmax (Tmax) of MIRCERA
NCT00717366 (9) [back to overview]Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
NCT00717366 (9) [back to overview]Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
NCT00717366 (9) [back to overview]Number of Participants With Blood Transfusions
NCT00717366 (9) [back to overview]Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
NCT00737464 (18) [back to overview]Mean Values of Serum Ferritin Over Time
NCT00737464 (18) [back to overview]Mean Values of Serum Sodium and Serum Potassium Over Time
NCT00737464 (18) [back to overview]Mean Values of Transferrin Over Time
NCT00737464 (18) [back to overview]Mean Values of Transferrin Saturation Over Time
NCT00737464 (18) [back to overview]Mean Values of White Blood Cells and Platelets Over Time
NCT00737464 (18) [back to overview]Number of Participants With Abnormal Electrocardiogram
NCT00737464 (18) [back to overview]Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
NCT00737464 (18) [back to overview]Mean Values of Hypochromic Red Blood Cells Over Time
NCT00737464 (18) [back to overview]Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
NCT00737464 (18) [back to overview]Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
NCT00737464 (18) [back to overview]Mean Change From Baseline in Heart Rate Over Time
NCT00737464 (18) [back to overview]Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
NCT00737464 (18) [back to overview]Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
NCT00737464 (18) [back to overview]Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
NCT00737464 (18) [back to overview]Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
NCT00737464 (18) [back to overview]Mean Values of Serum Albumin and Serum Globulin Over Time
NCT00737464 (18) [back to overview]Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
NCT00737464 (18) [back to overview]Mean Corpuscular Volume Levels Over Time
NCT00737477 (13) [back to overview]Percentage of Participants Requiring Blood Transfusions
NCT00737477 (13) [back to overview]Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
NCT00737477 (13) [back to overview]Change in Hb Value From Baseline to the EEP
NCT00737477 (13) [back to overview]Absolute Change in Dose of Mircera/CERA by Study Week
NCT00737477 (13) [back to overview]Number of Dose Adjustments of Mircera/CERA
NCT00737477 (13) [back to overview]Percent Change in Dose of Mircera/CERA by Study Week
NCT00737477 (13) [back to overview]Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
NCT00737477 (13) [back to overview]Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
NCT00737477 (13) [back to overview]Percentage of Participants With Down Excursions
NCT00737477 (13) [back to overview]Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
NCT00737477 (13) [back to overview]Percentage of Participants With Hb Values Within Target Range During the EEP
NCT00737477 (13) [back to overview]Percentage of Participants With Up Excursions
NCT00737477 (13) [back to overview]Percentage of Participants With Cycles or Excursions
NCT00737711 (28) [back to overview]Mean Serum Albumin Over Time
NCT00737711 (28) [back to overview]Mean Serum Alkaline Phosphatase Over Time
NCT00737711 (28) [back to overview]Mean Serum Bilirubin Over Time
NCT00737711 (28) [back to overview]Mean Serum Creatinine Over Time
NCT00737711 (28) [back to overview]Mean Serum Ferritin Over Time
NCT00737711 (28) [back to overview]Mean Serum Iron Over Time
NCT00737711 (28) [back to overview]Mean Serum Phosphate Over Time
NCT00737711 (28) [back to overview]Mean Serum Potassium Over Time
NCT00737711 (28) [back to overview]Mean Serum Sodium Over Time
NCT00737711 (28) [back to overview]Mean Total Iron-binding Capacity Over Time
NCT00737711 (28) [back to overview]Mean Transferrin Over Time
NCT00737711 (28) [back to overview]Mean Transferrin Saturation Over Time
NCT00737711 (28) [back to overview]Mean Value of Mean Corpuscular Volume Over Time
NCT00737711 (28) [back to overview]Mean White Blood Cell Count Over Time
NCT00737711 (28) [back to overview]Number of Participants With Abnormal Electrocardiogram
NCT00737711 (28) [back to overview]Number of Participants With Adverse Events, Serious Adverse Events and Deaths
NCT00737711 (28) [back to overview]Number of Participants With Reports of Blood Transfusions
NCT00737711 (28) [back to overview]Mean Serum Globulin Over Time
NCT00737711 (28) [back to overview]Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
NCT00737711 (28) [back to overview]Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
NCT00737711 (28) [back to overview]Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
NCT00737711 (28) [back to overview]Number of Participants With Reports of Anti-Epoetin Antibodies
NCT00737711 (28) [back to overview]Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
NCT00737711 (28) [back to overview]Mean Alanine Aminotransferase Over Time
NCT00737711 (28) [back to overview]Mean Aspartate Transaminase Over Time
NCT00737711 (28) [back to overview]Mean Blood Urea Nitrogen Over Time
NCT00737711 (28) [back to overview]Mean Hypochromic Red Blood Cells Over Time
NCT00737711 (28) [back to overview]Mean Platelet Count Over Time
NCT00737893 (22) [back to overview]Patient Score on the Overall IIEF Questionnaire
NCT00737893 (22) [back to overview]Hemoglobin Level at 2 Weeks After Surgery
NCT00737893 (22) [back to overview]Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
NCT00737893 (22) [back to overview]Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
NCT00737893 (22) [back to overview]Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
NCT00737893 (22) [back to overview]Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
NCT00737893 (22) [back to overview]Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
NCT00737893 (22) [back to overview]Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
NCT00737893 (22) [back to overview]Number of Participants Requiring Transfusion During Hospitalization
NCT00737893 (22) [back to overview]Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
NCT00737893 (22) [back to overview]Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
NCT00737893 (22) [back to overview]Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
NCT00737893 (22) [back to overview]Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
NCT00737893 (22) [back to overview]Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
NCT00737893 (22) [back to overview]Patient Score on the Overall IIEF Questionnaire
NCT00737893 (22) [back to overview]Patient Score on the Overall IIEF Questionnaire
NCT00737893 (22) [back to overview]Patient Score on the Overall IIEF Questionnaire
NCT00737893 (22) [back to overview]Patient Score on the Quality of Erection Questionnaire (QEQ)
NCT00737893 (22) [back to overview]Patient Score on the Quality of Erection Questionnaire (QEQ)
NCT00737893 (22) [back to overview]Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
NCT00737893 (22) [back to overview]Patient Score on the Quality of Erection Questionnaire (QEQ)
NCT00737893 (22) [back to overview]Patient Score on the Quality of Erection Questionnaire (QEQ)
NCT00773513 (8) [back to overview]Time to Non-Fatal and Fatal Stroke
NCT00773513 (8) [back to overview]Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
NCT00773513 (8) [back to overview]Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
NCT00773513 (8) [back to overview]Percentage of Participants With Gastrointestinal Bleeding
NCT00773513 (8) [back to overview]Percentage of Participants With Thromboembolic Events
NCT00773513 (8) [back to overview]Time to All-Cause Mortality
NCT00773513 (8) [back to overview]Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
NCT00773513 (8) [back to overview]Time to Non-Fatal and Fatal Myocardial Infarction
NCT00773968 (6) [back to overview]Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP
NCT00773968 (6) [back to overview]Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)
NCT00773968 (6) [back to overview]Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP
NCT00773968 (6) [back to overview]Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)
NCT00773968 (6) [back to overview]Percentage of Participants Who Required Red Blood Cell Transfusions
NCT00773968 (6) [back to overview]Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
NCT00843882 (9) [back to overview]Duration of Major Erythroid Response (MER)
NCT00843882 (9) [back to overview]Time to Major Erythroid Response (MER)
NCT00843882 (9) [back to overview]Proportion of Patients With Cytogenetic Response
NCT00843882 (9) [back to overview]Proportion of Patients With Bone Marrow Response
NCT00843882 (9) [back to overview]Pretreatment Endogenous Erythropoietin Level
NCT00843882 (9) [back to overview]Proportion of Patients With Minor Erythroid Response
NCT00843882 (9) [back to overview]Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy
NCT00843882 (9) [back to overview]Proportion of Patients With Major Erythroid Response (MER) Among Those With Chromosome 5q31.1 Deletion
NCT00843882 (9) [back to overview]Proportion of Patients With Major Erythroid Response (MER)
NCT00882713 (19) [back to overview]Mean Change From Baseline in Pulse Rate Over Time
NCT00882713 (19) [back to overview]Mean Change From Baseline in Weight Over Time
NCT00882713 (19) [back to overview]Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
NCT00882713 (19) [back to overview]Mean Hematocrit Levels Over Time
NCT00882713 (19) [back to overview]Mean Hemoglobin Levels Over Time
NCT00882713 (19) [back to overview]Mean Phosphate and Potassium Levels Over Time
NCT00882713 (19) [back to overview]Mean Transferrin Saturation Levels Over Time
NCT00882713 (19) [back to overview]Mean White Blood Cells and Thrombocytes Over Time
NCT00882713 (19) [back to overview]Number of Participants With Any Adverse Events or Serious Adverse Events
NCT00882713 (19) [back to overview]Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
NCT00882713 (19) [back to overview]Mean Ferritin Levels Over Time
NCT00882713 (19) [back to overview]Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
NCT00882713 (19) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
NCT00882713 (19) [back to overview]Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
NCT00882713 (19) [back to overview]Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
NCT00882713 (19) [back to overview]Mean Albumin Levels Over Time
NCT00882713 (19) [back to overview]Mean C-Reactive Protein Levels Over Time
NCT00882713 (19) [back to overview]Mean Change From Baseline in Blood Pressure Over Time
NCT00882713 (19) [back to overview]Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
NCT00910858 (10) [back to overview]Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)
NCT00910858 (10) [back to overview]Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide
NCT00910858 (10) [back to overview]Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose
NCT00910858 (10) [back to overview]Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level
NCT00910858 (10) [back to overview]Percentage of Participants With a Erythroid Response Across All Phases
NCT00910858 (10) [back to overview]PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)
NCT00910858 (10) [back to overview]PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose
NCT00910858 (10) [back to overview]PK Phase: Terminal Half-life (t1/2)
NCT00910858 (10) [back to overview]Time to Grade 4 Neutropenia or Thrombocytopenia
NCT00910858 (10) [back to overview]PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide
NCT00922116 (6) [back to overview]Change in Hemoglobin Concentration Between SVP and the EEP
NCT00922116 (6) [back to overview]Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
NCT00922116 (6) [back to overview]Average Dose of Mircera Per Month
NCT00922116 (6) [back to overview]Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
NCT00922116 (6) [back to overview]Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
NCT00922116 (6) [back to overview]Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
NCT00924781 (6) [back to overview]Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
NCT00924781 (6) [back to overview]Number of Participants With Composite Events of Infusion Reactions
NCT00924781 (6) [back to overview]Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
NCT00924781 (6) [back to overview]Change From Baseline in Hg Level at Week 12
NCT00924781 (6) [back to overview]Change From Baseline in Hemoglobin (Hg) Level at Week 4
NCT00924781 (6) [back to overview]Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
NCT00938314 (12) [back to overview]NIHSS Change From Baseline at Day 30
NCT00938314 (12) [back to overview]Trails A Test Change From Baseline at Day 90
NCT00938314 (12) [back to overview]Trails B Test Change From Baseline at Day 90
NCT00938314 (12) [back to overview]Action Research Arm Test (ARAT) Change From Baseline at Day 90
NCT00938314 (12) [back to overview]Barthel Index at Day 90
NCT00938314 (12) [back to overview]National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
NCT00938314 (12) [back to overview]NIHSS Response >=4 at Day 90
NCT00938314 (12) [back to overview]Modified Rankin Scale (mRS) Response <=2 at Day 90
NCT00938314 (12) [back to overview]Boston Naming Test (BNT) Change From Baseline at Day 90
NCT00938314 (12) [back to overview]Gait Velocity Test Change From Baseline at Day 90
NCT00938314 (12) [back to overview]Geriatric Depression Scale at Day 90
NCT00938314 (12) [back to overview]Line Cancellation Test Change From Baseline at Day 90
NCT01023035 (2) [back to overview]Percentage of Participants Who Discontinued Treatment
NCT01023035 (2) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR)
NCT01034657 (9) [back to overview]Mean Single Scoring Values of the IPSS - Randomized Phase
NCT01034657 (9) [back to overview]Percentage of Participants With Objective Response During the Randomized Phase
NCT01034657 (9) [back to overview]Mean Single Scoring Values of the IPSS - Core Phase
NCT01034657 (9) [back to overview]Frequency Distribution of IPSS Score Status - Randomized Phase
NCT01034657 (9) [back to overview]Frequency Distribution of IPSS Score Status - Core Phase
NCT01034657 (9) [back to overview]Percentage of Participants With Objective Response During Core Phase
NCT01034657 (9) [back to overview]Percentage of Participants With HI-E - Randomized Phase
NCT01034657 (9) [back to overview]Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase
NCT01034657 (9) [back to overview]Overall Survival (OS) - Overall Period
NCT01066000 (8) [back to overview]Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
NCT01066000 (8) [back to overview]Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
NCT01066000 (8) [back to overview]Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
NCT01066000 (8) [back to overview]Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
NCT01066000 (8) [back to overview]Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
NCT01066000 (8) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events
NCT01066000 (8) [back to overview]Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
NCT01066000 (8) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT01099202 (2) [back to overview]Mean Number of RBC Units Transfused During Initial 5 Months of Treatment
NCT01099202 (2) [back to overview]Number of PRBC Transfusions During Initial 5 Months of Treatment
NCT01102218 (1) [back to overview]Change in Erythropoietin Dose
NCT01147666 (18) [back to overview]Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
NCT01147666 (18) [back to overview]Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
NCT01147666 (18) [back to overview]Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
NCT01147666 (18) [back to overview]Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
NCT01147666 (18) [back to overview]Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
NCT01147666 (18) [back to overview]Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
NCT01147666 (18) [back to overview]Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
NCT01147666 (18) [back to overview]Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
NCT01147666 (18) [back to overview]Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
NCT01147666 (18) [back to overview]Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
NCT01147666 (18) [back to overview]Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
NCT01147666 (18) [back to overview]Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
NCT01147666 (18) [back to overview]Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
NCT01147666 (18) [back to overview]Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
NCT01147666 (18) [back to overview]Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
NCT01147666 (18) [back to overview]Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
NCT01147666 (18) [back to overview]Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
NCT01147666 (18) [back to overview]Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
NCT01156363 (5) [back to overview]Mean Time Participants Spent Having Hb Concentration Within Target Range
NCT01156363 (5) [back to overview]Percentage of Participants Requiring Dose Adjustments
NCT01156363 (5) [back to overview]Mean Monthly Hb Values
NCT01156363 (5) [back to overview]Change in Hb Concentration Between Reference and Treatment Period
NCT01156363 (5) [back to overview]Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
NCT01168349 (32) [back to overview]Relative Percent Change in Hb Concentration From Baseline Over the Study Period
NCT01168349 (32) [back to overview]Percentage of Participants With Vitamins Prescription
NCT01168349 (32) [back to overview]Percentage of Participants With Subcutaneous (SC) Route of Administration
NCT01168349 (32) [back to overview]Percentage of Participants With Early Treatment Response: Day 21 to 42
NCT01168349 (32) [back to overview]Karnofsky Performance Status (KPS): Baseline
NCT01168349 (32) [back to overview]Percentage of Participants With At Least 1 Sick Leave
NCT01168349 (32) [back to overview]Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
NCT01168349 (32) [back to overview]Mean Starting Dose of NeoRecormon® Injection
NCT01168349 (32) [back to overview]Percentage of Participants With Professional Activity: Baseline
NCT01168349 (32) [back to overview]Percentage of Participants With Pre-specified Dose and Frequency of Injections
NCT01168349 (32) [back to overview]Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
NCT01168349 (32) [back to overview]Mean Number of RBC Units
NCT01168349 (32) [back to overview]Percentage of Participants With Adequate Iron Status
NCT01168349 (32) [back to overview]Time to First RBC Transfusions
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
NCT01168349 (32) [back to overview]Mean Number of RBC Transfusions
NCT01168349 (32) [back to overview]Mean Number of Days of Sick Leave
NCT01168349 (32) [back to overview]KPS: Week 4 to 6
NCT01168349 (32) [back to overview]KPS: Week 24 to 28
NCT01168349 (32) [back to overview]KPS: Week 12 to 16
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
NCT01168349 (32) [back to overview]Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
NCT01168349 (32) [back to overview]Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
NCT01168349 (32) [back to overview]Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
NCT01168349 (32) [back to overview]Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
NCT01168349 (32) [back to overview]Percentage of Participants With Modifications of NeoRecormon® Regimen
NCT01168349 (32) [back to overview]Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
NCT01168349 (32) [back to overview]Percentage of Participants With Early Treatment Response: Day 28 to 42
NCT01193660 (11) [back to overview]Changes in Functional Performance in Daily Activities
NCT01193660 (11) [back to overview]Changes in Functional Independence in Daily Activities
NCT01193660 (11) [back to overview]Changes in Cognitive Neurodevelopmental Outcome
NCT01193660 (11) [back to overview]Changes in Motor Performance
NCT01193660 (11) [back to overview]Changes in Brain MRI
NCT01193660 (11) [back to overview]Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
NCT01193660 (11) [back to overview]Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
NCT01193660 (11) [back to overview]Changes in Standardized Gross Motor Function
NCT01193660 (11) [back to overview]Changes in Muscle Strength
NCT01193660 (11) [back to overview]Changes in Motor Neurodevelopmental Outcome
NCT01193660 (11) [back to overview]Changes in Hand Function
NCT01194154 (7) [back to overview]Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01194154 (7) [back to overview]Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24
NCT01194154 (7) [back to overview]Change From Baseline in Serum Creatinine Concentration at Month 24
NCT01194154 (7) [back to overview]Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24
NCT01194154 (7) [back to overview]Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)
NCT01194154 (7) [back to overview]Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
NCT01194154 (7) [back to overview]Change From Baseline in Serum Cystatin C Concentration at Month 24
NCT01235923 (2) [back to overview]Baseline Retic Count
NCT01235923 (2) [back to overview]Reticulocyte Count
NCT01342640 (3) [back to overview]Change From Baseline in Mean Hb Concentration at Week 20
NCT01342640 (3) [back to overview]Change From Baseline in Mean Hb Concentration at Week 28
NCT01342640 (3) [back to overview]Change From Baseline in Mean Hb Concentration at Week 24
NCT01369732 (1) [back to overview]Incidence of Acute Kidney Injury Based on RIFLE Criteria
NCT01378273 (4) [back to overview]Number of Participants With a Serious Adverse Events (SAE)
NCT01378273 (4) [back to overview]Number of Participants With Death or Severe Neurodevelopmental Impairment (NDI) at 22-26 Months Corrected Age
NCT01378273 (4) [back to overview]Biomarkers
NCT01378273 (4) [back to overview]Imaging
NCT01394991 (8) [back to overview]Red Blood Cell Transfusions
NCT01394991 (8) [back to overview]Mortality
NCT01394991 (8) [back to overview]Number of Hemoglobin Responders
NCT01394991 (8) [back to overview]Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16
NCT01394991 (8) [back to overview]Number of Positively Adjudicated Thrombovascular Events
NCT01394991 (8) [back to overview]Number of Suspected Thrombovascular Events
NCT01394991 (8) [back to overview]Time to First Positively Adjudicated Thrombovascular Event
NCT01394991 (8) [back to overview]Time to First Suspected Thrombovascular Event
NCT01473407 (24) [back to overview]Mean Weekly Hemoglobin Level From Week 21 to Week 24
NCT01473407 (24) [back to overview]Mean Weekly Hemoglobin Level Through 24 Weeks
NCT01473407 (24) [back to overview]Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event
NCT01473407 (24) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
NCT01473407 (24) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Physical Examination
NCT01473407 (24) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Vital Signs
NCT01473407 (24) [back to overview]Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level
NCT01473407 (24) [back to overview]Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
NCT01473407 (24) [back to overview]Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range
NCT01473407 (24) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
NCT01473407 (24) [back to overview]Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
NCT01473407 (24) [back to overview]Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
NCT01473407 (24) [back to overview]Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)
NCT01473407 (24) [back to overview]Number of Participants With Treatment Related Adverse Events (AEs)
NCT01473407 (24) [back to overview]Percentage of Participants Who Received Blood Transfusions
NCT01473407 (24) [back to overview]Percentage of Participants Who Required Permanent Dose Changes of Study Medication
NCT01473407 (24) [back to overview]Percentage of Participants Who Required Temporary Dose Changes of Study Medication
NCT01473407 (24) [back to overview]Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level
NCT01473407 (24) [back to overview]Mean Weekly Dosage of Study Medication From Week 21 to Week 24
NCT01473407 (24) [back to overview]Mean Weekly Dosage of Study Medication Through 24 Weeks
NCT01473407 (24) [back to overview]Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range
NCT01473407 (24) [back to overview]Number of Participants With Treatment-Emergent Adverse Events by Severity
NCT01473407 (24) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01473407 (24) [back to overview]Total Dose of Study Medication Administered
NCT01473420 (27) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Physical Examination
NCT01473420 (27) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
NCT01473420 (27) [back to overview]Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event
NCT01473420 (27) [back to overview]Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
NCT01473420 (27) [back to overview]Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
NCT01473420 (27) [back to overview]Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
NCT01473420 (27) [back to overview]Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
NCT01473420 (27) [back to overview]Number of Participants With Treatment Related Adverse Events (AEs)
NCT01473420 (27) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
NCT01473420 (27) [back to overview]Percentage of Participants With General Tolerability
NCT01473420 (27) [back to overview]Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Local Tolerability
NCT01473420 (27) [back to overview]Number of Participants With Treatment-Emergent Adverse Events by Severity
NCT01473420 (27) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01473420 (27) [back to overview]Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period
NCT01473420 (27) [back to overview]Total Dose of Study Medication Administered: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
NCT01473420 (27) [back to overview]Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
NCT01473420 (27) [back to overview]Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period
NCT01473420 (27) [back to overview]Percentage of Participants Who Received Blood Transfusions: Maintenance Period
NCT01473420 (27) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Vital Signs
NCT01478971 (5) [back to overview]Percentage of Participants Undergoing Conversion to Peginesatide Injection
NCT01478971 (5) [back to overview]Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
NCT01478971 (5) [back to overview]Peginesatide Dosing
NCT01478971 (5) [back to overview]Percentage of Participants Who Received at Least One Intravenous Iron Dose
NCT01478971 (5) [back to overview]Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL
NCT01519947 (4) [back to overview]Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
NCT01519947 (4) [back to overview]Change in Hemoglobin Concentration
NCT01519947 (4) [back to overview]Percentage of Participants With Adverse Events
NCT01519947 (4) [back to overview]Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
NCT01576341 (2) [back to overview]Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
NCT01576341 (2) [back to overview]Anti-Erythropoietin (EPO) Antibodies
NCT01628107 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels
NCT01628107 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
NCT01628107 (22) [back to overview]Number of Participants Who Received Concomitant Medication
NCT01628107 (22) [back to overview]Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48
NCT01628107 (22) [back to overview]Mean Hemoglobin Levels: Over Week 1 to 48
NCT01628107 (22) [back to overview]Mean Hematocrit Levels: Over Week 1 to 48
NCT01628107 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
NCT01628107 (22) [back to overview]Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
NCT01628107 (22) [back to overview]Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
NCT01628107 (22) [back to overview]Percentage of Participants With Hemoglobin Level Outside the Target Range
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
NCT01628107 (22) [back to overview]Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
NCT01628107 (22) [back to overview]Mean Hematocrit Levels for Interval of 12 Weeks
NCT01628107 (22) [back to overview]Mean Hemoglobin Levels for Interval of 12 Weeks
NCT01628107 (22) [back to overview]Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
NCT01628107 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
NCT01628107 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
NCT01628107 (22) [back to overview]Percentage of Participants Who Received Blood Transfusions
NCT01628120 (22) [back to overview]Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies
NCT01628120 (22) [back to overview]Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
NCT01628120 (22) [back to overview]Mean Hemoglobin Levels: Over Week 1 to 48
NCT01628120 (22) [back to overview]Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
NCT01628120 (22) [back to overview]Number of Participants Who Received Concomitant Medication
NCT01628120 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
NCT01628120 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels
NCT01628120 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
NCT01628120 (22) [back to overview]Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
NCT01628120 (22) [back to overview]Percentage of Participants Who Received Blood Transfusions
NCT01628120 (22) [back to overview]Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
NCT01628120 (22) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
NCT01628120 (22) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
NCT01628120 (22) [back to overview]Percentage of Participants With Hemoglobin Level Outside Target Range
NCT01628120 (22) [back to overview]Mean Hematocrit Levels for Interval of 12 Weeks
NCT01628120 (22) [back to overview]Mean Hematocrit Levels: Over Week 1 to 48
NCT01628120 (22) [back to overview]Mean Hemoglobin Levels for Interval of 12 Weeks
NCT01693029 (4) [back to overview]Mean Weekly Dose During Evaluation Period (Week 21-28)
NCT01693029 (4) [back to overview]Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
NCT01693029 (4) [back to overview]Incidence of Antibody Formation Against Epoetin
NCT01693029 (4) [back to overview]Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
NCT01736215 (9) [back to overview]Reticulocyte Count
NCT01736215 (9) [back to overview]Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)
NCT01736215 (9) [back to overview]Percentage of Participants With Response to Erythropoietin Treatment
NCT01736215 (9) [back to overview]Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4
NCT01736215 (9) [back to overview]Serum Hematocrit Level
NCT01736215 (9) [back to overview]Transferring Iron Binding Capacity (TIBC)
NCT01736215 (9) [back to overview]Serum Iron Level
NCT01736215 (9) [back to overview]Serum Hemoglobin Level
NCT01736215 (9) [back to overview]Serum Ferritin Level
NCT01737879 (2) [back to overview]Peginesatide Dose by Visit
NCT01737879 (2) [back to overview]Hemoglobin Concentration by Visit
NCT01783847 (2) [back to overview]Number of Participants With Change/Improvement Visual Acuity From the Beseline
NCT01783847 (2) [back to overview]Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4
NCT01809314 (3) [back to overview]Percentage of Participants Who Required Blood Transfusions During the Study
NCT01809314 (3) [back to overview]Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
NCT01809314 (3) [back to overview]Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
NCT01868477 (15) [back to overview]Summary of Erythroid Response Within 24 Weeks in Participants Randomized to EPO at Baseline and Not Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Hemoglobin (Hb) From Baseline for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Hemoglobin (Hb) From Baseline for Erythropoietin Alpha Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Serum Ferritin up to 24 Weeks for Erythropoietin Alpha Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Platelets and Neutrophil Levels up to 24 Weeks
NCT01868477 (15) [back to overview]Summary of Hematologic Improvement in Patients Randomized to EPO+DFX and EPO Alone, Within 24 Weeks of Treatment (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Serum Ferritin up to 24 Weeks for EPO+DFX at 12 Weeks Arm (Full Analysis Set)
NCT01868477 (15) [back to overview]Summary of Erythroid Response in Participants Randomized to EPO Alone at Baseline and Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)
NCT01868477 (15) [back to overview]Absolute Change in Hemoglobin Values up to 24 Weeks
NCT01868477 (15) [back to overview]Absolute Change From Baseline to Post-baseline Value for Hemoglobin(g/dL)(Full Analysis Set)
NCT01868477 (15) [back to overview]Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)
NCT01888003 (2) [back to overview]Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
NCT01888003 (2) [back to overview]Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
NCT01913340 (9) [back to overview]Alberta Infant Motor Scale (AIMS)
NCT01913340 (9) [back to overview]Growth Parameters: Head Circumference
NCT01913340 (9) [back to overview]Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age
NCT01913340 (9) [back to overview]Growth Parameters: Weight
NCT01913340 (9) [back to overview]Moderate to Severe Neurodevelopmental Impairment
NCT01913340 (9) [back to overview]Brain Injury, as Determined by Neonatal Brain MRI
NCT01913340 (9) [back to overview]Markers of Organ Function
NCT01913340 (9) [back to overview]Warner Initial Developmental Evaluation (WIDEA)
NCT01913340 (9) [back to overview]Growth Parameters: Height
NCT01940484 (14) [back to overview]Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
NCT01940484 (14) [back to overview]Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 3 (Month 2)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 7 (Month 6)
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
NCT01940484 (14) [back to overview]Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 6 (Month 5)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 5 (Month 4)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 4 (Month 3)
NCT01940484 (14) [back to overview]Mean Hemoglobin Value at Visit 2 (Month 1)
NCT02052310 (14) [back to overview]Percentage of Participants With Exacerbation of Hypertension During Weeks 28 to 52
NCT02052310 (14) [back to overview]Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)
NCT02052310 (14) [back to overview]Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 36), Censoring for Rescue Therapy
NCT02052310 (14) [back to overview]Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52
NCT02052310 (14) [back to overview]Time to Achieve the First Hb Response up to Week 24 Censoring for Rescue Therapy
NCT02052310 (14) [back to overview]Time to First Exacerbation of Hypertension During Weeks 28 to 52
NCT02052310 (14) [back to overview]Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)
NCT02052310 (14) [back to overview]Time to First RBC Transfusion
NCT02052310 (14) [back to overview]US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)
NCT02052310 (14) [back to overview]Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population)
NCT02052310 (14) [back to overview]US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)
NCT02052310 (14) [back to overview]Percentage of Participants With Hb ≥10.0 g/dL Averaged Over Weeks 28 to 36 and 28 to 52, Regardless of Rescue Therapy
NCT02052310 (14) [back to overview]Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12
NCT02052310 (14) [back to overview]Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24
NCT02145026 (4) [back to overview]Percentage of Participants With Platelet Response (in Participants With Pre-Treatment Platelets <100*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria
NCT02145026 (4) [back to overview]Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria
NCT02145026 (4) [back to overview]Percentage of Participants With Adverse Events
NCT02145026 (4) [back to overview]Percentage of Participants With Neutrophil Response (in Participants With Pre-Treatment Neutrophil <1.0*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria
NCT02174731 (8) [back to overview]Time-To-First Administration of RBC Transfusion as Rescue Therapy
NCT02174731 (8) [back to overview]Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
NCT02174731 (8) [back to overview]Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)
NCT02174731 (8) [back to overview]Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24
NCT02174731 (8) [back to overview]Mean Monthly IV Iron Use From Week 36 to End of Study (EOS)
NCT02174731 (8) [back to overview]Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52
NCT02174731 (8) [back to overview]Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52
NCT02174731 (8) [back to overview]Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period
NCT02238080 (9) [back to overview]Serum IL-6 Level
NCT02238080 (9) [back to overview]Serum Hemoglobin Level
NCT02238080 (9) [back to overview]Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
NCT02238080 (9) [back to overview]Serum CRP Level
NCT02238080 (9) [back to overview]Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
NCT02238080 (9) [back to overview]Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
NCT02238080 (9) [back to overview]Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
NCT02238080 (9) [back to overview]Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
NCT02238080 (9) [back to overview]Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
NCT02253654 (8) [back to overview]Hemoglobin Intra-subject Variability
NCT02253654 (8) [back to overview]Number of RBC Units Transfused Overall and During Each Study Period
NCT02253654 (8) [back to overview]Percentage of Participants With Hemoglobin Excursions at Each Visit
NCT02253654 (8) [back to overview]Percentage of Participants With Transfusion Events Overall and During Each Study Period
NCT02253654 (8) [back to overview]Weekly Epoetin Alfa Dose at Each Visit
NCT02253654 (8) [back to overview]Hemoglobin Rate of Change at Each Visit
NCT02253654 (8) [back to overview]Hemoglobin Concentration at Each Visit
NCT02253654 (8) [back to overview]Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
NCT02273726 (11) [back to overview]Average Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52
NCT02273726 (11) [back to overview]Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants With Mean Hb 10.0 to 12.0 g/dL Averaged Over Weeks 28 to 36, Censoring for Rescue Therapy
NCT02273726 (11) [back to overview]Time to First Exacerbation of Hypertension During Weeks 28 to 52
NCT02273726 (11) [back to overview]Time to First RBC Transfusion
NCT02273726 (11) [back to overview]US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy
NCT02273726 (11) [back to overview]Change From Baseline in Hb Levels Averaged Over Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)
NCT02273726 (11) [back to overview]Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28
NCT02273726 (11) [back to overview]Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28
NCT02273726 (11) [back to overview]Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28
NCT02273726 (11) [back to overview]Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol
NCT02273726 (11) [back to overview]US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy
NCT02278341 (45) [back to overview]Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104
NCT02278341 (45) [back to overview]Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal
NCT02278341 (45) [back to overview]Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28
NCT02278341 (45) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02278341 (45) [back to overview]Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
NCT02278341 (45) [back to overview]Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
NCT02278341 (45) [back to overview]Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
NCT02278341 (45) [back to overview]Time to First Hospitalization
NCT02278341 (45) [back to overview]Time to First Occurrence of an Increase in Blood Pressure
NCT02278341 (45) [back to overview]Time to First Occurrence of an Increase in Blood Pressure
NCT02278341 (45) [back to overview]Time to First RBC Transfusion
NCT02278341 (45) [back to overview]Time to First Use of IV Iron Supplementation
NCT02278341 (45) [back to overview]Time to First Use of Rescue Therapy
NCT02278341 (45) [back to overview]"Change From BL to the Average of Weeks 12 to 28 in Anemia Subscale (AnS) (Additional Concerns) of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score"
NCT02278341 (45) [back to overview]Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]
NCT02278341 (45) [back to overview]Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28
NCT02278341 (45) [back to overview]Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28
NCT02278341 (45) [back to overview]Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28
NCT02278341 (45) [back to overview]Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28
NCT02278341 (45) [back to overview]Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28
NCT02278341 (45) [back to overview]Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)]
NCT02278341 (45) [back to overview]Change From BL to the Average of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score
NCT02278341 (45) [back to overview]Change From BL to the Average of Weeks 12 to 28 in SF-36 Physical Component Score (PCS)
NCT02278341 (45) [back to overview]Change From BL to the Average Value of Weeks 12 to 28 in Total FACT-An Score
NCT02278341 (45) [back to overview]Mean Monthly Intravenous (IV) Iron Use
NCT02278341 (45) [back to overview]Mean Monthly Number of RBC Packs Per Participant
NCT02278341 (45) [back to overview]Mean Monthly Volume of RBC Transfusion Per Participant
NCT02278341 (45) [back to overview]Number of Days of Hospitalization Per Year
NCT02278341 (45) [back to overview]Number of Hospitalizations
NCT02278341 (45) [back to overview]Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy
NCT02278341 (45) [back to overview]Percentage of Participants With Hb Response During Weeks 28 to 36
NCT02278341 (45) [back to overview]Percentage of Participants With Oral Iron Use Only
NCT02278341 (45) [back to overview]Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)
NCT02278341 (45) [back to overview]Change From BL in Hb to Each Postdosing Time Point
NCT02278341 (45) [back to overview]Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy
NCT02278341 (45) [back to overview]Change From BL in Serum Ferritin
NCT02278341 (45) [back to overview]Change From BL in Serum Hepcidin
NCT02278341 (45) [back to overview]Change From BL in Transferrin Saturation (TSAT)
NCT02278341 (45) [back to overview]Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio
NCT02278341 (45) [back to overview]Change From BL to Each Post-dosing Study Visit in Total Cholesterol
NCT02278341 (45) [back to overview]Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio
NCT02278341 (45) [back to overview]Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)
NCT02278341 (45) [back to overview]Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)
NCT02278341 (45) [back to overview]Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol
NCT02278341 (45) [back to overview]Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
NCT02504294 (2) [back to overview]Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
NCT02504294 (2) [back to overview]Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
NCT02538107 (12) [back to overview]Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
NCT02538107 (12) [back to overview]Hemoglobin Level Based on the Type of Kidney Transplantation Performed
NCT02538107 (12) [back to overview]Hemoglobin Level Based on the Presence of Inflammatory Diseases
NCT02538107 (12) [back to overview]Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
NCT02538107 (12) [back to overview]Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
NCT02538107 (12) [back to overview]Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
NCT02538107 (12) [back to overview]Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
NCT02547454 (25) [back to overview]Number of Dose Adaptations
NCT02547454 (25) [back to overview]Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
NCT02547454 (25) [back to overview]Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
NCT02547454 (25) [back to overview]Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
NCT02547454 (25) [back to overview]Percentage of Participants With Dose 0
NCT02547454 (25) [back to overview]Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
NCT02547454 (25) [back to overview]Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
NCT02547454 (25) [back to overview]Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
NCT02547454 (25) [back to overview]Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
NCT02547454 (25) [back to overview]Percentage of Participants With Iron Replacement
NCT02596945 (3) [back to overview]Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
NCT02596945 (3) [back to overview]Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
NCT02596945 (3) [back to overview]Average Duration in Days Mircera Was Administered at a Stable Dose
NCT02761642 (8) [back to overview]Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
NCT02761642 (8) [back to overview]Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline
NCT02761642 (8) [back to overview]Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline
NCT02761642 (8) [back to overview]Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline
NCT02761642 (8) [back to overview]Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
NCT02761642 (8) [back to overview]Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL
NCT02761642 (8) [back to overview]Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks
NCT02761642 (8) [back to overview]Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores
NCT02767765 (6) [back to overview]Percentage of Participants With Response to Treatment
NCT02767765 (6) [back to overview]Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment
NCT02767765 (6) [back to overview]Percentage of Participants Who Required Transfusion
NCT02767765 (6) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4
NCT02767765 (6) [back to overview]Time to Response
NCT02767765 (6) [back to overview]Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment
NCT02811263 (9) [back to overview]Number of Participants With Epilepsy
NCT02811263 (9) [back to overview]Number of Participants With Death or Neurodevelopmental Impairment
NCT02811263 (9) [back to overview]MR Evidence of Brain Injury - Brain Injury Score
NCT02811263 (9) [back to overview]Bayley III Language Score
NCT02811263 (9) [back to overview]Number of Participants With Behavioral Abnormalities Determined by the Externalizing Score of the Child Behavior Checklist
NCT02811263 (9) [back to overview]Number of Participants Experiencing Cortical Visual Impairment, Per Parent/Caregiver Report, Compared Between the Epo and Placebo Groups.
NCT02811263 (9) [back to overview]Number of Participants Experiencing Hearing Impairment Requiring Hearing Aids, Per Parent/Caregiver Report, Compared Between the Epo and Placebo Groups.
NCT02811263 (9) [back to overview]Serial Circulating Biomarkers of Inflammation/Brain Injury
NCT02811263 (9) [back to overview]Bayley III Cognitive Score
NCT02817555 (6) [back to overview]Cost of Erythropoiesis Stimulating Agent
NCT02817555 (6) [back to overview]Iron Cost
NCT02817555 (6) [back to overview]Hemoglobin
NCT02817555 (6) [back to overview]Iron Dose
NCT02817555 (6) [back to overview]Transferrin Saturation (TSAT)
NCT02817555 (6) [back to overview]Ferritin
NCT03007537 (2) [back to overview]Number of Participants With Renal Replacement Therapy
NCT03007537 (2) [back to overview]Number of Participants With Acute Kidney Injury
NCT03029247 (57) [back to overview]AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57
NCT03029247 (57) [back to overview]Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1
NCT03029247 (57) [back to overview]Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
NCT03029247 (57) [back to overview]Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT03029247 (57) [back to overview]Absolute Values for Temperature
NCT03029247 (57) [back to overview]Absolute Values for Pulse Rate
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC)
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameter: Hematocrit
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameter: Erythrocyte Distribution Width
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV)
NCT03029247 (57) [back to overview]Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr)
NCT03029247 (57) [back to overview]Absolute Values for Electrocardiogram (ECG) Mean Heart Rate
NCT03029247 (57) [back to overview]Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)
NCT03029247 (57) [back to overview]Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin
NCT03029247 (57) [back to overview]Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium
NCT03029247 (57) [back to overview]Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
NCT03029247 (57) [back to overview]Absolute Values for Clinical Chemistry Parameters: Albumin and Protein
NCT03029247 (57) [back to overview]Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs)
NCT03029247 (57) [back to overview]Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57
NCT03029247 (57) [back to overview]Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57
NCT03029247 (57) [back to overview]Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1
NCT03029247 (57) [back to overview]AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57
NCT03029247 (57) [back to overview]AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1
NCT03029247 (57) [back to overview]Number of Participants Who Discontinued the Study Treatment
NCT03029247 (57) [back to overview]Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
NCT03029247 (57) [back to overview]Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
NCT03029247 (57) [back to overview]Number of Participants With Any Serious Adverse Events (SAEs)
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2531398
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2506104
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2506102
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2487818
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2391220
NCT03029247 (57) [back to overview]Plasma Concentrations of Daprodustat
NCT03029247 (57) [back to overview]Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401
NCT03029247 (57) [back to overview]Change From Pre-dose in SBP, DBP and MAP at Day 1
NCT03029247 (57) [back to overview]Change From Pre-dose in HR at Day 1
NCT03029247 (57) [back to overview]Change From Baseline Values for Vital Signs: SBP and DBP
NCT03029247 (57) [back to overview]Change From Baseline Values for Temperature
NCT03029247 (57) [back to overview]Change From Baseline Values for Pulse Rate
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameter: Hematocrit
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width
NCT03029247 (57) [back to overview]Change From Baseline Values for Hematology Parameter: Ery. MCV
NCT03029247 (57) [back to overview]Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB
NCT03029247 (57) [back to overview]Change From Baseline Values for ECG Mean Heart Rate
NCT03029247 (57) [back to overview]Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin
NCT03029247 (57) [back to overview]Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium
NCT03029247 (57) [back to overview]Plasma Concentrations of Metabolite GSK2531401
NCT03029247 (57) [back to overview]Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST
NCT03029247 (57) [back to overview]Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein
NCT03029247 (57) [back to overview]Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1
NCT03029247 (57) [back to overview]Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57
NCT03140722 (1) [back to overview]Number of Participants With Treatment-emergent Adverse Events
NCT03400033 (13) [back to overview]Change From Baseline in SBP, DBP and MAP at End of Treatment
NCT03400033 (13) [back to overview]Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S)
NCT03400033 (13) [back to overview]Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)
NCT03400033 (13) [back to overview]Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria
NCT03400033 (13) [back to overview]Number of Participants With at Least One BP Exacerbation Event During the Study
NCT03400033 (13) [back to overview]Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
NCT03400033 (13) [back to overview]Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)
NCT03400033 (13) [back to overview]Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)
NCT03400033 (13) [back to overview]Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)
NCT03400033 (13) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52
NCT03400033 (13) [back to overview]Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)
NCT03400033 (13) [back to overview]Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant
NCT03400033 (13) [back to overview]Change From Baseline in Hemoglobin Levels at Week 52
NCT03408639 (12) [back to overview]The Proportion of Patients With Treatment Success
NCT03408639 (12) [back to overview]The Proportion of Patients With Maintenance Success
NCT03408639 (12) [back to overview]The Proportion of Patients With Any Permanent or Transient Dose Change
NCT03408639 (12) [back to overview]The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
NCT03408639 (12) [back to overview]The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks
NCT03408639 (12) [back to overview]The Proportion of Patients Needed Blood Transfusions
NCT03408639 (12) [back to overview]The Percentage of Patients With Hematocrit Measurements More Than 30%
NCT03408639 (12) [back to overview]The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
NCT03408639 (12) [back to overview]The Incidence of Hb Levels Above 13 g/dl
NCT03408639 (12) [back to overview]The Incidence of Adverse Events
NCT03408639 (12) [back to overview]Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment
NCT03408639 (12) [back to overview]Mean Hb Change Level During the Last Four Weeks of Treatment
NCT03799627 (41) [back to overview]Mean Change From Baseline in Ferritin Concentration
NCT03799627 (41) [back to overview]Mean Change From Baseline in Hepcidin Concentration
NCT03799627 (41) [back to overview]Mean Change From Baseline in Iron Concentration
NCT03799627 (41) [back to overview]Mean Change From Baseline in Reticulocyte Count
NCT03799627 (41) [back to overview]Mean Change From Baseline in Total Iron Binding Capacity
NCT03799627 (41) [back to overview]Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
NCT03799627 (41) [back to overview]Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
NCT03799627 (41) [back to overview]Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
NCT03799627 (41) [back to overview]Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Number of Participants With Hb Values Within the Target Range at the SEP
NCT03799627 (41) [back to overview]Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing
NCT03799627 (41) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT03799627 (41) [back to overview]Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
NCT03799627 (41) [back to overview]Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Number of Participants With Hb Values Within the Target Range at the PEP
NCT03799627 (41) [back to overview]Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Number of Participants Classified as Hb Outliers
NCT03799627 (41) [back to overview]Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
NCT03799627 (41) [back to overview]Mean Change in Hb Between Baseline and the SEP
NCT03799627 (41) [back to overview]Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12
NCT03799627 (41) [back to overview]Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation
NCT03799627 (41) [back to overview]Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue
NCT03799627 (41) [back to overview]Number of Participants Requiring Red Blood Cell (RBC) Transfusion
NCT03799627 (41) [back to overview]Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP
NCT03799627 (41) [back to overview]Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP
NCT03799627 (41) [back to overview]Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
NCT03799627 (41) [back to overview]Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
NCT03822884 (6) [back to overview]Reticulocyte Response: AUC 0-120h
NCT03822884 (6) [back to overview]Reticulocyte Response: Cmax
NCT03822884 (6) [back to overview]AUC0-∞
NCT03822884 (6) [back to overview]Tmax
NCT03822884 (6) [back to overview]AUC0-t
NCT03822884 (6) [back to overview]Cmax

Overall Survival

Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact. (NCT00003138)
Timeframe: Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafter

InterventionMonths (Median)
Supportive Care31
Erythropoietin37

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Proportion of Patients Free of Transfusion at 4 Months

Whether a patient required transfusion or not at 4 months was recorded. (NCT00003138)
Timeframe: Assessed at 4 months

InterventionProportion of patients (Number)
Supportive Care0.459
Erythropoietin0.714

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Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months

The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point. (NCT00003138)
Timeframe: Assessed at 4 months

InterventionScores on a scale (Mean)
Supportive Care84.1
Erythropoietin84.33

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Disease Free Survival

Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence. (NCT00014222)
Timeframe: 13 years

,,
InterventionParticipants (Count of Participants)
Disease RecurrenceNo recurrence
Arm 1: CEF141560
Arm 2: EC/T135566
Arm 3: AC/T191511

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Overall Survival

Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up. (NCT00014222)
Timeframe: 13 years

,,
InterventionParticipants (Count of Participants)
DeathAlive
Arm 1: CEF123578
Arm 2: EC/T107594
Arm 3: AC/T146556

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Number of Participants With Marked Laboratory Abnormalities

Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L). (NCT00048035)
Timeframe: Up to Week 126

,,,,,
InterventionParticipants (Number)
Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15)Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15)Potassium -High; (n = 15, 15, 15, 15 , 16 , 15)Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15)Platelets - High; (n = 15, 15, 15, 15 , 16 , 15)Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15)WBC - High; (n = 15, 15, 15, 15 , 16 , 15)WBC - Low; (n = 15, 15, 15, 15 , 16 , 15)Basophils - High; (n = 15, 15, 14, 15 , 16 , 15)Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15)Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15)Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15)Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15)Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15)Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15)ALAT - High; (n = 15, 15, 15, 15 , 16 , 15)ALP - High; (n = 15, 15, 15, 15 , 16 , 15)ASAT - High; (n = 15, 15, 15, 15 , 16 , 15)Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15)Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15)Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9)Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9)
Cohort 1 (RO0503821 [0.25/150 1x/Week])3000000000000000100100
Cohort 2 (RO0503821 [0.25/150 1x/2week])1100000000030000000000
Cohort 3 (RO0503821 [0.4/150 1x/Week])3110010100020001110000
Cohort 4 (RO0503821 [0.4/150 1x/2week])4000010100010010000000
Cohort 5 (RO0503821 [0.6/150 1x/Week])4220000000020000000000
Cohort 6 (RO0503821 [0.6/150 1x/2week])2000000000030000101000

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Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths

An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. (NCT00048035)
Timeframe: Up to Week 126

,
InterventionParticipants (Number)
Any AEsAny SAEsDeaths
RO0503821 (1x/2Week)37202
RO0503821 (1x/Week)42203

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Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis

Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). (NCT00048035)
Timeframe: From Baseline (Day -28 to Day 1) to Week 126

,,,,,
Interventionmm HG (Mean)
DBP- before dialysisDBP - After dialysisSBP - before dialysisSBP - After dialysis
Cohort 1 (RO0503821 [0.25/150 1x/Week])-24-16
Cohort 2 (RO0503821 [0.25/150 1x/2week])-1053
Cohort 3 (RO0503821 [0.4/150 1x/Week])-10-0-15-3
Cohort 4 (RO0503821 [0.4/150 1x/2week])-8-8-15-13
Cohort 5 (RO0503821 [0.6/150 1x/Week])-6-6-11-6
Cohort 6 (RO0503821 [0.6/150 1x/2week])-10-0-15-3

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Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value. (NCT00048035)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Interventiong/dL (Median)
Cohort 1 (RO0503821 [0.25/150 1x/Week])-0.29
Cohort 2 (RO0503821 [0.25/150 1x/2week])-0.92
Cohort 3 (RO0503821 [0.4/150 1x/Week])-0.04
Cohort 4 (RO0503821 [0.4/150 1x/2week])-0.46
Cohort 5 (RO0503821 [0.6/150 1x/Week])0.86
Cohort 6 (RO0503821 [0.6/150 1x/2week])-0.07

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Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen

Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value. (NCT00048035)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Interventiong/dL (Median)
Cohort 1 (RO0503821 [0.25/150 1x/Week])-1.50
Cohort 2 (RO0503821 [0.25/150 1x/2week])-3.01
Cohort 3 (RO0503821 [0.4/150 1x/Week])-0.32
Cohort 4 (RO0503821 [0.4/150 1x/2week])-1.62
Cohort 5 (RO0503821 [0.6/150 1x/Week])2.73
Cohort 6 (RO0503821 [0.6/150 1x/2week])-0.07

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Mean Change in Pulse Rate

Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported. (NCT00048035)
Timeframe: Up to Week 126

InterventionBpM (Mean)
Cohort 1 (RO0503821 [0.25/150 1x/Week])-1
Cohort 2 (RO0503821 [0.25/150 1x/2week])1
Cohort 3 (RO0503821 [0.4/150 1x/Week])2
Cohort 4 (RO0503821 [0.4/150 1x/2week])3
Cohort 5 (RO0503821 [0.6/150 1x/Week])-1
Cohort 6 (RO0503821 [0.6/150 1x/2week])3

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Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time

Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only. (NCT00048048)
Timeframe: Up to Week 125

,,
Interventionparticipants (Number)
Platelets - High, n = 16, 15, 19Platelets - Low, n = 16, 15, 19WBC - High, n = 16, 15, 19Eosinophils - High, n = 15, 15, 19Lymphocytes - Low, n = 15, 15, 19Monocytes - High, n = 15, 15, 19Neutrophils - High, n = 15, 15, 19Neutrophils - Low, n = 15, 15, 19ALT - High, n = 22, 21, 22ALP - High, n = 22, 21, 22AST - High, n = 22, 21, 22Total bilirubin - High, n = 22, 21, 22Albumin - Low, n = 22, 21, 22Phosphate - High , n = 12, 13, 14Phosphate - Low, n = 12, 13, 14Potassium - High, n = 22, 21, 22Potassium - Low, n = 22, 21, 22
RO0503821 (1x/2week)10012032101006120
RO0503821 (1x/3week)03121130122121120
RO0503821 (1x/Week)00002000112027231

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Heart Rate Over Time

Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. (NCT00048048)
Timeframe: Up to Week 125

Interventionbpm (Mean)
RO0503821 (1x/Week)65.6
RO0503821 (1x/2week)68.4
RO0503821 (1x/3week)75.4

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Number of Participants With Any Serious Adverse Events and Any Adverse Events

An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. (NCT00048048)
Timeframe: Up to Week 125

,,
Interventionparticipants (Number)
Participants with SAEsParticipants with AEs
RO0503821 (1x/2Week)921
RO0503821 (1x/3week)1222
RO0503821 (1x/Week)1122

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Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen

Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. (NCT00048048)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Interventiong/dL (Median)
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)31.10
Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)39.10
Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)36.95
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)28.40
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)34.70
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)40.50
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)32.70
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)37.75
Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)39

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Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen

Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. (NCT00048048)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

InterventionCells x10^3/UL (Median)
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)71.80
Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)46.30
Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)44.70
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)51.80
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)72.80
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)59.20
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)25.20
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)38.45
Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)56.20

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The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes

The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. (NCT00048048)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Interventiongram/deciliter (g/dL) (Median)
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)0.48
Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)1.08
Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)1.34
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)0.17
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)0.27
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)2.17
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)0.41
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)0.83
Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week)1.28

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Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1). (NCT00048048)
Timeframe: From Baseline (Day -28 to Day 1) to Week 125

,,,,,,,,
InterventionmmHg (Mean)
DBPSBP
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)212
Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)52
Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)65
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)62
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)28
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)-3-11
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)66
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)-23
Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)4-3

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Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.

The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. (NCT00077610)
Timeframe: Baseline, Week 29 to Week 36

Interventionparticipants (Number)
RO0503821 (1x/2 Weeks)133
RO0503821 (1x/4 Weeks)127
Epoetin (1-3x/Weeks)138

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The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

The number of participants who received RBC transfusions during the titration and evaluation periods were reported . (NCT00077610)
Timeframe: Week 1 to Week 36

Interventionparticipants (Number)
RO0503821 (1x/2 Weeks)21
RO0503821 (1x/4 Weeks)16
Epoetin (1-3x/Weeks)17

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Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported. (NCT00077610)
Timeframe: Upto Week 53

,,
Interventionparticipants (Number)
Number of participants with adverse eventsNumber of participants with serious adverse eventsNumber of deaths
Epoetin (1-3x/Weeks)2149917
RO0503821 (1x/2 Weeks)20310119
RO0503821 (1x/4 Weeks)2028715

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Mean Change in Blood Pressure From Baseline at Week 36 and Week 52

Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD). (NCT00077610)
Timeframe: Baseline, Week 36 and Week 52

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Change in SBP, BD at Wk 36 (n=189, 178,196)Change in SBP, BD at Wk 52 (n=168, 166, 180)Change in DBP, BD at Wk 36 (n=189, 178, 195)Change in DBP, BD at Wk 52 (n=168, 166, 179)Change in SBP, AD at Wk 36 (n=189, 177, 196)Change in SBP, AD at Wk 52 (n=167, 168, 179)Change in DBP, AD at Wk 36 (n=189, 177, 196)Change in DBP, AD at Wk 52 (n=167, 168, 178)
Epoetin (1-3x/Weeks)311-1-01-2-3
RO0503821 (1x/2 Weeks)1-00132-1-1
RO0503821 (1x/4 Weeks)-2-3-3-3-1-0-0-0

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Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52

Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period. (NCT00077610)
Timeframe: Baseline, Week 36 and Week 52

,,
Interventionbeats per minute (bpm) (Mean)
Change from BL at Week 36 (n=188, 176, 193)Change from BL at Week 52 (n=168, 166, 179)
Epoetin (1-3x/Weeks)0-1
RO0503821 (1x/2 Weeks)11
RO0503821 (1x/4 Weeks)21

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Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)

Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L. (NCT00077610)
Timeframe: Up to Week 53

,,
Interventionparticipants (Number)
High Platelet (n=218, 216, 223)Low Platelet (n=218, 216, 223)High WBC (n=218, 217, 223)Low WBC (n=218, 217, 223)High RBC (n=124, 129, 89)Low RBC (n=124, 129, 89)
Epoetin (1-3x/Weeks)363500
RO0503821 (1x/2 Weeks)0140811
RO0503821 (1x/4 Weeks)1102622

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Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period

A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm. (NCT00077610)
Timeframe: Baseline, Week 29 to Week 36

Interventiongram per deciliter (g/dL) (Mean)
RO0503821 (1x/2 Weeks)-0.10
RO0503821 (1x/4 Weeks)0.01
Epoetin (1-3x/Week)-0.10

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Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes

Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L (NCT00077610)
Timeframe: Up to Week 53

,,
Interventionparticipants (Number)
High ALT. (n=218, 216, 224)High ALP (n=218, 216, 224)Low Albumin (n=218, 216, 224)High Phosphate (n=218, 216, 224)Low Phosphate (n=218, 216, 224)High Potassium (n=218, 216, 224)Low Potassium (n=218, 216, 224)High AST (n=218, 215, 224)High Blood glucose in non-diabetic (n=114,131,110)Low Blood Glucose in Non-Diabetic (n=114,131,110)
Epoetin (1-3x/Weeks)516189417363410
RO0503821 (1x/2 Weeks)41514106213310600
RO0503821 (1x/4 Weeks)214139521353331

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Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT00077623)
Timeframe: Up to week 52

,,
Interventionparticipants (Number)
Any AE'sAny SAE'sDeaths
Epoetin Reference1678512
RO0503821 (1x/2 Weeks)1717013
RO0503821 (1x/4 Weeks)1777318

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Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants. (NCT00077623)
Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

,,
Interventionmm HG (Mean)
DBP (Week 36, n=7,10,12 )DBP (Week 52, n= 8, 9, 12)SBP - (Week 36, n=7, 10, 12)SBP - (Week 52, n=8, 9,12)
Epoetin Reference22712
RO0503821 (1x/2 Weeks)2134
RO0503821 (1x/4 Weeks)-7-8-20-20

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Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants. (NCT00077623)
Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

,,
InterventionmmHG (Mean)
DBP- before dialysis (Week 36, n=150,153, 157)DBP- before dialysis (Week 52, n= 143, 136, 144)DBP - After dialysis (Week 36, n=150, 150, 157)DBP - After dialysis (Week 52, n= 141, 136, 142)SBP - before dialysis(Week 36, n=150, 153, 158)SBP - before dialysis(Week 52, n=143, 136,144)SBP - After dialysis (Week 36, n=150, 152, 158)SBP - After dialysis (Week 52, n=141, 136, 142)
Epoetin Reference12-12-11-22
RO0503821 (1x/2 Weeks)0-1101-1-11
RO0503821 (1x/4 Weeks)0-1-0043-0-2

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Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods

A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36. (NCT00077623)
Timeframe: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)

Interventiong/dL (Mean)
RO0503821 (1x/2 Weeks)-0.00
RO0503821 (1x/4 Weeks)-0.11
Epoetin Reference-0.12

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Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36. (NCT00077623)
Timeframe: Evaluation period (Week 29 to Week 36)

Interventionparticipants (Number)
RO0503821 (1x/2 Weeks)124
RO0503821 (1x/4 Weeks)111
Epoetin Reference127

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Number of Participants With Red Blood Cell Transfusions

The number of participants who received RBC transfusions were reported. (NCT00077623)
Timeframe: Up to Week 36

Interventionparticipants (Number)
RO0503821 (1x/2 Weeks)12
RO0503821 (1x/4 Weeks)20
Epoetin Reference19

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Number of Participants With Marked Laboratory Abnormalities

A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/L), platelets (100 - 550 10^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP [0 - 220 U/L]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L). (NCT00077623)
Timeframe: Up to week 52

,,
Interventionparticipants (Number)
Platelets, high; n=189,189, 188Platelets, low; n=189,189, 188RBC, high; n = 118, 112, 115RBC, low; n = 118, 112, 115WBC, high; n=189,189, 188WBC, low; n=189,189, 188ALAT, high; n=189,189, 188ALP, high; n=189,189, 188ASAT, high; n=185,189, 186Albumin, low; n=182,186, 185Phosphate, high; n=189,189, 188Phosphate, low; n=189,189, 188Potassium, high; n=189,189, 188Potassium, low; n=189,189, 188Glucose fasting, high; n=126,137, 124Glucose fasting, low; n=126,137, 124
Epoetin Reference1117354611217821838120
RO0503821 (1x/2 Weeks)080481365416841432110
RO0503821 (1x/4 Weeks)11124824118520781738420

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Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants

Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants. (NCT00077623)
Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

,,
InterventionBpM (Mean)
Pulse rate (Week 36, n=147,149, 156)Pulse rate (Week 52, n= 140, 135, 142)
Epoetin Reference62
RO0503821 (1x/2 Weeks)1-3
RO0503821 (1x/4 Weeks)41

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Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants

Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants. (NCT00077623)
Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

,,
InterventionBpM (Mean)
Pulse rate (Week 36, n=147,149, 156 )Pulse rate (Week 52, n= 140, 135, 142)
Epoetin Reference-0-0
RO0503821 (1x/2 Weeks)-0-0
RO0503821 (1x/4 Weeks)11

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Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely. (NCT00090753)
Timeframe: Baseline to the end of the study (Up to 49 Months)

Interventiong/dL (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta-0.55
Comparator ESA-0.38

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Percentage of Patients Who Had at Least 1 Adverse Event

See the adverse events section of the results for more information. (NCT00090753)
Timeframe: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta94.3
Comparator ESA93.3

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Return to Usual Activity (RTUA)

Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized. (NCT00210626)
Timeframe: Hospital Discharge to Post-Hospital Discharge Week 24

InterventionParticipants (Number)
PROCRIT9
Placebo11

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SF-36 PF Score

Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100. (NCT00210626)
Timeframe: Hospital Discharge to Post-Hospital Discharge Week 24

InterventionUnits on a scale. (Mean)
PROCRIT27.30
Placebo30.88

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The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71

(NCT00236938)
Timeframe: Change from Baseline up to Day 71

Interventionpercentage of change (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose0.7226
Group B: Erythropoietin EPO Fixed Dose Only0.4630

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The Mean Change From Baseline to the Highest Ferritin up to Day 71

(NCT00236938)
Timeframe: Change from Baseline up to Day 71

Interventionng/mL (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose545.05
Group B: Erythropoietin EPO Fixed Dose Only70.523

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Mean Change From Baseline to the Highest Hemoglobin up to Day 71

(NCT00236938)
Timeframe: Change from Baseline up to Day 71

Interventiong/dL (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose1.3
Group B: Erythropoietin EPO Fixed Dose Only.7

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The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71

(NCT00236938)
Timeframe: Change from Baseline up to Day 71

Interventionpercentage of change (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose18.176
Group B: Erythropoietin EPO Fixed Dose Only10.383

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Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).

The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8). (NCT00236951)
Timeframe: During Stage 2 (week 9 through week 21)

Interventiong/dL (Mean)
Group A: Erythropoietin + Venofer (Responders)2.6
Group B: Erythropoietin Only (Responders)1.8
Group C: Erythropoietin + Venofer (Non-responders)2.5
Group D: Erythropoietin Only (Non-responders)1.3

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Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.

(NCT00258440)
Timeframe: On study, averaging 3 to 6 months.

Interventionevents (Number)
Weekly Procrit (Epoetin Alfa) Dosing38
Interval Dosing (Epoetin Alfa) Non PK Group130

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Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks

(NCT00258440)
Timeframe: 12 weeks

Interventionparticipants (Number)
Weekly Procrit (Epoetin Alfa) Dosing0
Interval Dosing (Epoetin Alfa) Non PK Group5

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The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.

NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy. (NCT00267007)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
PROCRIT 40,000 IU QW5
Placebo6

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The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.

NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy. (NCT00267007)
Timeframe: baseline to Day 128

Interventionparticipants (Number)
PROCRIT 40,000 IU QW3
Placebo0

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Change in Left Ventricular End-diastolic Volume

This outcome measure is collected using a three dimensional echocardiography. (NCT00286182)
Timeframe: Baseline and 6 month

InterventionmL (Mean)
Erythropoietin Alpha-6
Placebo-4

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Glasgow Outcome Scale

Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead) (NCT00313716)
Timeframe: at 6 months after injury

,,,,
Interventionparticipants (Number)
Favorable outcomeUnfavorable outcome
Epo1 Group1718
Epo2 Group1740
Placebo Group3455
TT10 Group3163
TT7 Group3750

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Disability Rating Scale

Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status. (NCT00313716)
Timeframe: at 6 months

Interventionunits on a scale (Median)
TT7 Group5
TT10 Group8

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Incidence of Adult Respiratory Distress Syndrome (ARDS)

development of ARDS was a primary safety outcome for the transfusion threshold randomization (NCT00313716)
Timeframe: within 30 days after injury

,
Interventionparticipants (Number)
Developed ARDSDid not develop ARDS
TT10 Group2576
TT7 Group1683

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Incidence of Infection

occurrence of infection was a primary safety outcome for the transfusion threshold randomization (NCT00313716)
Timeframe: within 30 days after injury

,
Interventionparticipants (Number)
Developed one or more infectionsDid not develop infection
TT10 Group3665
TT7 Group2772

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Mortality Rate

mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization (NCT00313716)
Timeframe: up to 6 months after injury

,,,,
Interventionparticipants (Number)
DiedSurvived
Epo1 Group632
Epo2 Group757
Placebo Group1880
TT10 Group1784
TT7 Group1485

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Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs

Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported. (NCT00321919)
Timeframe: Up to 4 years

,
Interventionparticipants (Number)
No. of participants with at least one TtCalcium Channel Blocking AgentsLoop DiureticsAngiotensin-Converting Enzyme InhibitorsBeta-Adrenoceptor Blocking AgentsAngiotensin-II Receptor AntagonistsAlpha-Adrenoreceptor AntagonistsAntihypertensive AgentsThiazide And Related DiureticsAntianginal AgentsPotassium Sparing DiureticsAldosterone AntagonistsCardiac GlycosidesDiureticsSupplementsCalcium Compounds And RegulatorsMiscellaneous DrugsTricyclic Antidepressants
Early Epoetin Beta Therapy28720118315816989875544642121001
Late Epoetin Beta Therapy28220418015313696735240575101110

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Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)

The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented. (NCT00321919)
Timeframe: Up to 4 years

,
Interventionparticipants (Number)
From CL 0 (BL) to CL 0; n = 167, 149From CL 0 (BL) to CL I; n = 167, 149From CL 0 (BL) to CL II; n = 167, 149From CL 0 (BL) to CL III; n = 167, 149From CL 0 (BL) to CL IV; n = 167, 149From CL I (BL) to CL 0; n = 37, 43From CL I (BL) to CL I; n = 37, 43From CL I (BL) to CL II; n = 37, 43From CL I (BL) to CL III; n = 37, 43From CL I (BL) to CL IV; n = 37, 43From CL II (BL) to CL 0; n = 53, 44From CL II (BL) to CL I; n = 53, 44From CL II (BL) to CL II; n = 53, 44From CL II (BL) to CL III; n = 53, 44From CL II (BL) to CL IV; n = 53, 44From CL III (BL) to CL 0; n = 0, 0From CL III (BL)to CL I; n = 0, 0From CL III (BL)to CL II; n = 0, 0From CL III (BL)to CL III; n = 0, 0From CL III (BL)to CL IV; n = 0, 0From CL IV (BL)to CL 0; n = 0, 0From CL IV (BL)to CL I; n = 0, 0From CL IV (BL)to CL II; n = 0, 0From CL IV (BL)to CL III; n = 0, 0From CL IV (BL)to CL IV; n = 0, 0
Early Epoetin Beta Therapy4977201285000539200000000000
Late Epoetin Beta Therapy4247100344000137400000000000

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Mean Values of Echocardiography Parameters

Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented. (NCT00321919)
Timeframe: Baseline, Year 1, Year 2, Year 3, and Year 4

,
Interventioncentimeters (Mean)
LVEDD, Baseline, n = 219, 233LVEDD, Year 1, n = 170, 186LVEDD, Year 2, n = 135, 147LVEDD, Year 3, n = 74, 81LVEDD, Year 4, n = 2,11LVPWT, Baseline, n = 219, 233LVPWT, Year 1, n = 170, 186LVPWT, Year 2, n= 135, 147LVPWT, Year 3, n = 74, 81LVPWT, Year 4, n = 2,11IVSWT, Baseline, n = 219, 233IVSWT, Year 1, n = 170, 186IVSWT, Year 2, n = 135, 147IVSWT, Year 3, n = 74, 81IVSWT, Year 4, n = 2, 11LVESD, Baseline, n = 219, 233LVESD, Year 1, n = 170, 186LVESD, Year 2, n = 135, 147LVESD, Year 3, n = 74, 81LVESD, Year 4, n = 2, 11LVRWT, Baseline, n = 219, 233LVRWT, Year 1, n = 170, 186LVRWT, Year 2, n = 135, 147LVRWT, Year 3, n = 74, 81LVRWT, Year 4, n = 2, 11
Early Epoetin Beta Therapy5.054.934.955.095.211.051.021.011.011.081.181.171.121.141.302.852.762.782.882.930.420.420.410.410.41
Late Epoetin Beta Therapy4.914.944.934.885.081.051.010.991.000.921.201.131.111.121.042.742.732.752.672.840.430.410.410.420.37

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Mean Values of Body Surface Area

The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented. (NCT00321919)
Timeframe: Baseline, Year 1, Year 2, Year 3, and Year 4.

,
InterventionSquare meter (Mean)
BSA, Baseline, n = 287, 290BSA, Year 1, n = 257, 261BSA, Year 2, n = 224, 234BSA, Year 3, n = 116, 121BSA, Year 4, n = 4, 11
Early Epoetin Beta Therapy1.831.831.821.821.96
Late Epoetin Beta Therapy1.791.771.771.721.76

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Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire

The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale. (NCT00321919)
Timeframe: Baseline, Year 1, and Year 2

,
Interventionunits on a scale (Least Squares Mean)
General Health, Year 1General Health, Year 2Mental Health, Year 1Mental Health, Year 2Physical Function, Year 1Physical Function, Year 2Physical Role, Year 1Physical Role, Year 2Social Function, Year 1Social Function, Year 2Vitality Function, Year 1Vitality Function, Year 2Bodily Pain, Year 1Bodily Pain, Year 2Emotional Role, Year 1Emotional Role, Year 2
Early Epoetin Beta Therapy4.12.32.72.03.5-2.52.6-2.31.8-0.13.92.8-0.2-2.00.4-0.1
Late Epoetin Beta Therapy-0.1-1.9-2.1-0.4-2.1-2.5-5.5-7.3-3.0-3.0-0.6-1.0-2.1-1.2-4.3-2.2

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Mean Change From Baseline in Left Ventricular Volume (LV Volume )

Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value. (NCT00321919)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48

,
Interventionmilliliters per meter square (Mean)
LV Volume, Baseline; n = 218, 232LV Volume, Week 12; n = 170, 186LV Volume, Week 24; n = 134, 146LV Volume, Week 36; n = 72, 80LV Volume, Week 48; n = 2, 11
Early Epoetin Beta Therapy67.73-2.83-0.693.3414.48
Late Epoetin Beta Therapy65.113.152.624.057.91

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Mean Change From Baseline in Left Ventricular Mass Index (LVMI)

LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value. (NCT00321919)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48

,
Interventiongram/square meter (Mean)
LVMI, Baseline; n = 219, 232LVMI, Week 12; n = 171, 186LVMI, Week 24; n = 136, 146LVMI, Week 36; n = 74, 81LVMI, Week 48; n = 2, 11
Early Epoetin Beta Therapy120.32-5.06-6.58-1.302.00
Late Epoetin Beta Therapy117.97-2.87-7.59-7.53-27.27

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Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)

LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value. (NCT00321919)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48

,
Interventionpercentage (Mean)
LVEF, Baseline; n = 219, 233LVEF, Week 12; n = 170, 186LVEF, Week 24; n = 135, 147LVEF, Week 36; n = 74, 81LVEF, Week 48; n = 2,11FS, Baseline; n = 219, 232FS, Week 12; n = 196, 212FS, Week 24; n = 174, 192FS, Week 36; n = 98, 105FS, Week 48; n = 4,12
Early Epoetin Beta Therapy81.31-0.08-0.47-0.61-0.4643.670.130.110.051.00
Late Epoetin Beta Therapy81.950.08-0.230.242.8044.670.08-0.190.703.00

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Total Number of Cardiovascular Intervention

Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort. (NCT00321919)
Timeframe: Up to 4 years

Interventionnumber of cardiovascular intervention (Number)
Early Epoetin Beta Therapy21
Late Epoetin Beta Therapy18

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Median Time to First Hospitalization Due to Cardiovascular Events

Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Median)
Early Epoetin Beta TherapyNA
Late Epoetin Beta TherapyNA

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Median Time to First Cardiovascular Intervention

Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Median)
Early Epoetin Beta TherapyNA
Late Epoetin Beta TherapyNA

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Median Time to First Cardiovascular Event

The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Median)
Early Epoetin Beta TherapyNA
Late Epoetin Beta TherapyNA

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Median Time to Death Due to All Causes

Time to death due to all causes is the time determined between randomization and death due to all causes. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Median)
Early Epoetin Beta TherapyNA
Late Epoetin Beta TherapyNA

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Duration of Hospitalization for Cardiovascular Events

The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Mean)
Early Epoetin Beta Therapy33.0
Late Epoetin Beta Therapy28.2

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Median Time to Death Due to Cardiovascular Events

Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events. (NCT00321919)
Timeframe: Up to 4 years

Interventiondays (Median)
Early Epoetin Beta TherapyNA
Late Epoetin Beta TherapyNA

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Number of Participants Who Died Due to All Causes

Number of participants who died due to all causes are presented in table below. (NCT00321919)
Timeframe: Up to 4 years

,
Interventionparticipants (Number)
Total Death Events for All-causeSudden DeathCerebrovascular AccidentCardiac FailureCardiac Failure AcuteSepsisAcute Myocardial InfarctionBronchopneumoniaRespiratory FailureSeptic ShockAcute Heart FailureAcute Respiratory FailureAngina PectorisArrhythmiaCardiac ArrestCardio-Respiratory ArrestCardiopulmonary FailureCerebral InfarctionClostridial InfectionColon Cancer MetastaticEmbolic StrokeIntestinal InfarctionIntestinal IschaemiaLaryngeal CancerLung Neoplasm MalignantMetastases To LungMetastatic NeoplasmMyocardial InfarctionOesophageal CarcinomaPeripheral Vascular DisorderPneumoniaPulmonary EmbolismRenal FailureUnevaluable EventUraemic Encephalopathy
Early Epoetin Beta Therapy314211111121011111110100101101100111
Late Epoetin Beta Therapy212222211100100000001011010010011000

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Number of Participants With Marked Laboratory Abnormalities

Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche's standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L). (NCT00321919)
Timeframe: Baseline, every 3 months up to 4 years

,
Interventionparticipants (Number)
Platelets - High; n = 206, 208Platelets - Low; n = 206, 208Creatinine - High; n = 206, 208Albumin - Low; n = 201, 205Phosphate - High; n = 206, 208Phosphate - Low; n = 206, 208Potassium - High; n = 206, 208Potassium - Low; n = 206, 208
Early Epoetin Beta Therapy513140616422474
Late Epoetin Beta Therapy015128915023466

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Number of Participants Who Died Due to Cardiovascular Events

The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. (NCT00321919)
Timeframe: Up to 4 years

,
Interventionparticipants (Number)
Total Cardiovascular Death EventsCardiac FailureCardiac Failure AcuteAcute Myocardial InfarctionAngina PectorisArrhythmiaCardiac ArrestCardio-Respiratory ArrestCardiopulmonary FailureMyocardial Infarction
Early Epoetin Beta Therapy8111111110
Late Epoetin Beta Therapy6221000001

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Volume of Transfusions

(NCT00334737)
Timeframe: From birth to 36 weeks gestational age

InterventionmL/kg (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w30
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 3523
Placebo/Control51

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Object Permanence Scores at 18-22 Months

Scores are 0-3, with 3 being the best score. (NCT00334737)
Timeframe: 18-22 months

Interventionunits on a scale (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w2.8
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 352.4
Placebo/Control2.2

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Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)

(NCT00334737)
Timeframe: 18-22 months

Interventionparticipants (Number)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w4
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 355
Placebo/Control13

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Hematocrit

(NCT00334737)
Timeframe: From birth to 36 weeks gestational age

InterventionL/L (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w0.35
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 350.36
Placebo/Control0.29

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Incidence of Retinopathy of Prematurity Stage 3 or Greater

(NCT00334737)
Timeframe: From birth to 36 weeks gestational age

Interventionparticipants (Number)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w2
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 351
Placebo/Control2

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Reticulocyte Count

absolute retic count measured at the end of study (NCT00334737)
Timeframe: at day 60 of study

Intervention1000 cells per microliter (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w295
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35298
Placebo/Control130

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Number of Transfusions During Hospitalization

(NCT00334737)
Timeframe: From birth to 36 weeks gestational age

Interventionnumber of transfusions (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w1.2
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 351.2
Placebo/Control2.4

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Composite Cognitive Score at 18-22 Months Corrected Age

Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome. (NCT00334737)
Timeframe: 18-22 months

InterventionBSID III compositie cognitive score (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w96.2
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 3597.9
Placebo/Control88.7

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Epo Concentrations

(NCT00334737)
Timeframe: peak from birth to 36 weeks gestational age

InterventionmU/mL (Mean)
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w1398.9
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35515.4
Placebo/Control28.6

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The Number of Patients Achieved a Hemoglobin Response.

Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL (NCT00337935)
Timeframe: Week 0 to Week 26

Interventionparticipants (Number)
Standard of Care21
PROCRIT (Epoetin Alfa)97

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Time to Hemoglobin Response

Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment. (NCT00337935)
Timeframe: Week 0 to Week 26

InterventionDays (Median)
Standard of Care114
PROCRIT (Epoetin Alfa)41

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Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)

(NCT00337935)
Timeframe: Week 0 to Week 26

Interventiong/dL (Mean)
Standard of Care0.3
PROCRIT (Epoetin Alfa)0.9

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Overall Survival

Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock. (NCT00338286)
Timeframe: From randomization up to death from any cause (up to 8.4 years)

InterventionMonths (Median)
Standard of Care (SOC)18.0
Epoetin Alfa17.8

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Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)

Suspected TVEs were identified by investigators and relevant clinical information was collected. (NCT00338286)
Timeframe: up to 8.4 years

InterventionPercentage of participants (Number)
Standard of Care (SOC)3.72
Epoetin Alfa4.86

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Progression Free Survival

Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment. (NCT00338286)
Timeframe: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)

InterventionMonths (Median)
Standard of Care (SOC)7.4
Epoetin Alfa7.4

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Time to Tumor Progression

The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD). (NCT00338286)
Timeframe: From date of randomization to the date of the first documented PD (up to 8.4 years)

InterventionMonths (Median)
Standard of Care (SOC)7.5
Epoetin Alfa7.5

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Overall Response Rate (ORR)

Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions. (NCT00338286)
Timeframe: every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)

,
InterventionPercentage of participants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive disease (PD)Not evaluable (NE)Not available (NA)
Epoetin Alfa347321225
Standard of Care (SOC)348301315

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Hemoglobin Change From Baseline to End of Study

End of Study Hemoglobin minus baseline Hemoglobin (NCT00350519)
Timeframe: Baseline (Day-10) to end of study (Day 32)

Interventiong/dL (Mean)
PROCRIT (Epoetin Alfa)0.98
STANDARD THERAPY0.33

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Hospital Length of Stay

(NCT00350519)
Timeframe: Surgery to hospital discharge

Interventiondays (Mean)
PROCRIT (Epoetin Alfa)7.94
STANDARD THERAPY12.56

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Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions

(NCT00350519)
Timeframe: Day of surgery until hospital discharge

Interventionparticipants (Number)
PROCRIT (Epoetin Alfa)4
STANDARD THERAPY9

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Number of pRBC Units Transfused During Study

(NCT00350519)
Timeframe: Baseline (Day -10) to end of study (Day 32)

Interventionunits (Mean)
PROCRIT (Epoetin Alfa)3.5
STANDARD THERAPY6.11

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Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15

LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2). (NCT00354341)
Timeframe: Baseline, Month 15

Interventiong/m^2 (Mean)
Group 1 (Early Epoetin Beta)0.69
Group 2 (No/Late Epoetin Beta)0.10

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Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL

(NCT00354341)
Timeframe: Week 26 up to Week 64

Interventionpercentage of participants (Number)
Group 1 (Early Epoetin Beta)75.6
Group 2 (No/Late Epoetin Beta)9.9

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Fractional Myocardial Shortening (FS)

FS was calculated as: ([LVEDD - LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV. (NCT00354341)
Timeframe: Baseline, Months 6 and 15

,
Interventionpercentage of LVEDV (Mean)
Baseline (n=88, 82)Month 6 (n=84, 76)Month 15 (n=85, 79)
Group 1 (Early Epoetin Beta)36.4537.8037.58
Group 2 (No/Late Epoetin Beta)36.5838.4938.86

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Left Ventricular Ejection Fraction (LVEF)

LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV. (NCT00354341)
Timeframe: Baseline, Months 6 and 15

,
Interventionpercentage of LVEDV (Mean)
Baseline (n=57, 56)Month 6 (n=47, 53)Month 15 (n=54, 55)
Group 1 (Early Epoetin Beta)63.4457.2258.63
Group 2 (No/Late Epoetin Beta)63.8459.9259.97

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Left Ventricular End Diastolic Volume Index (LVEDVI)

LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2. (NCT00354341)
Timeframe: Baseline, Months 6 and 15

,
InterventionmL/m^2 (Mean)
Baseline (n=57, 56)Month 6 (n=47, 53)Month 15 (n=54, 55)
Group 1 (Early Epoetin Beta)61.0862.7462.26
Group 2 (No/Late Epoetin Beta)58.1360.4062.07

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Left Ventricular End Systolic Volume Index (LVESVI)

LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2). (NCT00354341)
Timeframe: Baseline, Months 6 and 15

,
InterventionmL/m^2 (Mean)
Baseline (n=57, 56)Month 6 (n=47, 53)Month 15 (n=54, 55)
Group 1 (Early Epoetin Beta)22.4026.8625.99
Group 2 (No/Late Epoetin Beta)21.0424.5425.03

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Number of Participants With Marked Laboratory Abnormalities

Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L). (NCT00364832)
Timeframe: Up to Week 126

,,,,,,,,
InterventionParticipants (Number)
SGOT, HighAlbumin, LowTotal protein, Low
Cohort A (0.4/150, 1x/ Week)100
Cohort B (0.4/150, 1x/ 3 Weeks)000
Cohort C (0.4/150, 1x/ 4 Weeks)001
Cohort D (0.8/150, 1x/ Week)000
Cohort E (0.8/150, 1x/ 3 Weeks)000
Cohort F (0.8/150, 1x/ 4 Weeks)000
Cohort G (1.2/150, 1x/ Week)001
Cohort H (1.2/150, 1x/ 3 Weeks)000
Cohort I (1.2/150, 1x/ 4 Weeks)010

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Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. (NCT00364832)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)

Interventiongram per deciliter (Median)
Cohort A (0.4/150, 1x/ Week)-0.80
Cohort B (0.4/150, 1x/ 3 Weeks)-0.60
Cohort C (0.4/150, 1x/ 4 Weeks)-0.29
Cohort D (0.8/150, 1x/ Week)0.02
Cohort E (0.8/150, 1x/ 3 Weeks)-0.14
Cohort F (0.8/150, 1x/ 4 Weeks)-0.28
Cohort G (1.2/150, 1x/ Week)0.65
Cohort H (1.2/150, 1x/ 3 Weeks)0.33
Cohort I (1.2/150, 1x/ 4 Weeks)0.22

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Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis

Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1). (NCT00364832)
Timeframe: From Baseline (Day -28 to Day 1) to Week 126

,,,,,,,,
InterventionMillimeters of Mercury (Mean)
SBP before dialysisSBP after dialysisDBP before dialysisDBP after dialysis
Cohort A (0.4/150, 1x/ Week)-10-1-3
Cohort B (0.4/150, 1x/ 3 Weeks)71014
Cohort C (0.4/150, 1x/ 4 Weeks)213-1
Cohort D (0.8/150, 1x/ Week)-8-4-3-3
Cohort E (0.8/150, 1x/ 3 Weeks)-47-20
Cohort F (0.8/150, 1x/ 4 Weeks)-6-522
Cohort G (1.2/150, 1x/ Week)-20-3-3
Cohort H (1.2/150, 1x/ 3 Weeks)1-1-05
Cohort I (1.2/150, 1x/ 4 Weeks)-7-71-5

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Mean Change in Pulse Rate

Mean change in pulse rate was reported. (NCT00364832)
Timeframe: Up to Week 126

InterventionBeats per minute (Mean)
Cohort A (0.4/150, 1x/ Week)-6
Cohort B (0.4/150, 1x/ 3 Weeks)-2
Cohort C (0.4/150, 1x/ 4 Weeks)7
Cohort D (0.8/150, 1x/ Week)-1
Cohort E (0.8/150, 1x/ 3 Weeks)-1
Cohort F (0.8/150, 1x/ 4 Weeks)2
Cohort G (1.2/150, 1x/ Week)2
Cohort H (1.2/150, 1x/ 3 Weeks)0
Cohort I (1.2/150, 1x/ 4 Weeks)1

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Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths

An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. (NCT00364832)
Timeframe: Up to Week 126

,,
InterventionParticipants (Number)
Any AEsAny SAEsDeaths
RO0503821 (1x/ 3 Weeks)33134
RO0503821 (1x/ 4 Weeks)402010
RO0503821 (1x/ Week)44157

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Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen

Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. (NCT00364832)
Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)

InterventionPercentage of Hct (Median)
Cohort A (0.4/150, 1x/ Week)-2.45
Cohort B (0.4/150, 1x/ 3 Weeks)-1.95
Cohort C (0.4/150, 1x/ 4 Weeks)-0.93
Cohort D (0.8/150, 1x/ Week)0.25
Cohort E (0.8/150, 1x/ 3 Weeks)-0.37
Cohort F (0.8/150, 1x/ 4 Weeks)-0.75
Cohort G (1.2/150, 1x/ Week)2.25
Cohort H (1.2/150, 1x/ 3 Weeks)1.22
Cohort I (1.2/150, 1x/ 4 Weeks)0.73

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Bleeding Time

An integrated measure of in vivo platelet function and tissue hemostasis. (NCT00367991)
Timeframe: Change from Day 3 to Day 10

Interventionseconds (Median)
Placebo1020
rHuEPO1020

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Platelet Function Assay Closure Time

(NCT00367991)
Timeframe: Change from Day 3 to Day 10

Interventionseconds (Median)
Placebo251
rHuEPO281

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Serum Markers of Myocyte Damage

Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory. (NCT00367991)
Timeframe: Baseline

InterventionU/L (Median)
Placebo817
rHuEPO652

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Serum Markers of Apoptosis

Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL. (NCT00367991)
Timeframe: Day 1 and Day 10

,
Interventionpg/mL (Mean)
Day 1Day 10
Placebo4560
rHuEPO5663

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Vital Signs

(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

,
InterventionmmHg (Mean)
SBP, baselineSBP at 24 hoursSBP at 48 hoursSBP, 14 daysSBP, 30 daysDBP, baselineDBP, 24 hoursDBP, 48 hoursDBP, 14 daysDBP, 30 days
Epoetin Alfa129.7118.7114.3119.2117.478.570.568.071.271.0
Placebo126.2112.9114.3115.2117.975.866.367.969.271.3

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Hemoglobin Levels

(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

,
Interventiong/dL (Mean)
Baseline24 hours48 hours14 days30 days
Epoetin Alfa13.813.413.314.114.2
Placebo13.613.113.113.513.7

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LV Volume Indexed to BSA

(NCT00378352)
Timeframe: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

,
Interventionml/m^2 (Mean)
End systolic, First CMREnd systolic, Second CMREnd diastolic, First CMREnd diastolic, Second CMR
Epoetin Alfa34.734.165.670.0
Placebo32.632.063.466.6

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LV Mass Indexed to BSA

(NCT00378352)
Timeframe: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

,
Interventiong/m^2 (Mean)
First CMRSecond CMR
Epoetin Alfa74.267.3
Placebo69.261.8

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LV Ejection Fraction

(NCT00378352)
Timeframe: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)

,
Interventionpercent (Mean)
First CMRSecond CMR
Epoetin Alfa48.252.5
Placebo48.952.0

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Number of Participants With Clinical Events

(NCT00378352)
Timeframe: from randomization to second CMR

,
InterventionParticipants (Count of Participants)
DeathRecurrent myocardial infarctionUnstaged Percutaneous Coronary InterventionCoronary Artery Bypass GraftStrokeStent thrombosisLeft Ventricular thrombusNew or worsening Congestive Heart Failur
Epoetin Alfa12601335
Placebo00010022

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Reticulocyte Counts

(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days

,
Interventionpercentage of red blood cells (Mean)
Baseline24 hours48 hours14 days30 days
Epoetin Alfa1.41.61.81.41.2
Placebo1.31.31.31.41.3

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Overall Response After Cycle 3

"Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements." (NCT00379912)
Timeframe: 3 months

Interventionpercentage of participants responding (Number)
Arm A Azacitidine + Erythropoietin50
Arm B Azacitidine33.3

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Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles

(NCT00379912)
Timeframe: Six months

,
Interventionpercentage of cells (Mean)
% apoptosis at baseline% apoptosis after three cycles% apoptosis after six cycles
Non-Responders31.1963.4338.10
Responders17.0424.7042.58

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BclXL Expression

(NCT00379912)
Timeframe: Six months

,
Interventionpercentage L27 mRNA (Mean)
BclXL Expression at baselineBclXL Expression after three cyclesBclXL Expression after six cycles
Non-Responders1.00.771.21
Responders1.01.503.89

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Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles

(NCT00379912)
Timeframe: 6 months

,
Interventioncells of BM (10e^6/ML) (Mean)
CD34 BaselineCD34 After Three CyclesCD34 After Six CyclesCD71 at BaselineCD71 After Three CyclesCD71 After Six CyclesCD36 at BaselineCD36 after Three CyclesCD36 after Six Cycles
Non-Responders.49.58.527.2310.139.695.126.083.57
Responders.86.931.1518.3227.3135.4511.6914.3321.35

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Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone

Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure. (NCT00379912)
Timeframe: 24 months

Interventionpercentage of participants (Number)
Arm A Azacitidine + Erythropoietin66.7
Arm B Azacitidine66.4

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Overall Response Rate After Six Cycles

"Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements." (NCT00379912)
Timeframe: 6 months

Interventionpercentage of participants responding (Number)
Arm B Azacitidine33.3
Arm A Azacitidine + Erythropoietin33.3

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Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study

(NCT00386152)
Timeframe: up to 16 weeks

Interventionparticipants (Number)
Epoetin Alfa (80,000 Units)12
Epoetin Alfa (120,000 Units)22
Darbepoetin Alfa (500 Mcg)17

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Number of Patients (Hb >= 11 g/dL) During Study.

(NCT00386152)
Timeframe: up to 16 weeks

Interventionparticipants (Number)
Epoetin Alfa (80,000 Units)51
Epoetin Alfa (120,000 Units)48
Darbepoetin Alfa (500 Mcg)56

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Time to Achieve Hb >= 11 g/dL During Study

(NCT00386152)
Timeframe: up to 16 weeks

Interventiondays (Median)
Epoetin Alfa (80,000 Units)37
Epoetin Alfa (120,000 Units)44
Darbepoetin Alfa (500 Mcg)36

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Hemoglobin (Hb) Change From Baseline to Study Week 7

Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication (NCT00386152)
Timeframe: Baseline (Week 1) and Week 7

Interventiong/dL (Mean)
Epoetin Alfa (80,000 Units)0.64
Epoetin Alfa (120,000 Units)0.40
Darbepoetin Alfa (500 Mcg)0.84

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Number of Patients With an at Least 1gm/dL Increase in Hgb

(NCT00400686)
Timeframe: Baseline to Day 28

Interventionparticipants (Number)
Epoetin Alfa - 80,000 U sc13

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Change From Baseline in Hemoglobin at Day 28

Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa. (NCT00400686)
Timeframe: Baseline to Day 28

Interventiong/dL (Median)
Epoetin Alfa - 80,000 U sc1.3

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Number of Patients With an at Least 2gm/dL Increase in Hgb

(NCT00400686)
Timeframe: Baseline to Day 28

Interventionparticipants (Number)
Epoetin Alfa - 80,000 U sc9

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Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase

Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. (NCT00413894)
Timeframe: Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
Without Dose Modification (n=178)With Dose Modification (n=166)
C.E.R.A88.861.5

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Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase

Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. (NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1)

Interventionpercentage of participants (Number)
Without Dose Modification (n=288)With Dose Modification (n=128)
C.E.R.A93.188.3

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Percentage of Participants Requiring Erythrocyte Transfusions

(NCT00413894)
Timeframe: Visits 1 to 10 (Months -2 to 8)

Interventionpercentage of participants (Number)
During Screening PhaseDuring Titration or Evaluation Phase
C.E.R.A0.75.0

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Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase

Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. (NCT00413894)
Timeframe: Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
Without Dose Modification (n=178)With Dose Modification (n=166)
C.E.R.A44.917.5

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Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase

Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. (NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1)

Interventionpercentage of participants (Number)
Without Dose Modification (n=288)With Dose Modification (n=128)
C.E.R.A43.421.9

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Percentage of Participants With Hb Fluctuations Within Screening Phase

Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study. (NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1)

Interventionpercentage of participants (Number)
≤ ± 1.0 g/dl> ± 1.0 to ± 1.5 g/dl> ± 1.5 to ± 2.0 g/dl
C.E.R.A90.68.70.7

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Percentage of Participants With Hb Fluctuations Within Evaluation Phase

Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study. (NCT00413894)
Timeframe: Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
≤ ± 1.0 g/dl> ± 1.0 to ± 1.5 g/d> ± 1.5 to ± 2.0 g/dl> ± 2.0 g/dlMissing
C.E.R.A82.97.92.90.55.8

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Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels

"Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.~Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted." (NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
Category ACategory BCategory CCategory D
C.E.R.A59.419.54.314.9

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Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase

(NCT00413894)
Timeframe: Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
C.E.R.A75.6

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Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase

(NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1)

Interventionpercentage of participants (Number)
C.E.R.A91.6

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Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase

(NCT00413894)
Timeframe: Visits 1 to 2 (Months -2 to -1)

Interventionpercentage of participants (Number)
C.E.R.A36.8

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Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase

(NCT00413894)
Timeframe: Visits 8 to 10 (Months 6 to 8)

Interventionpercentage of participants (Number)
C.E.R.A31.7

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Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated. (NCT00416624)
Timeframe: Weeks 4, 7, 10, 13 and 16

,,,
Interventionunits on a scale (Mean)
Fatigue NowUsual FatigueWorst FatigueBFI Interference
Darbepoetin Alfa - 500 mcg Every 3 Weeks4.74.75.34.4
Epoetin Alfa - 120k Every 3 Weeks4.64.75.44.3
Epoetin Alfa - 40k Weekly4.84.75.54.3
Epoetin Alfa - 80k Every 3 Weeks4.64.75.64.1

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The Percentage of Participants With Dose Omitted Due to Hematologic Reason

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule (NCT00416624)
Timeframe: 16 Weeks

Interventionpercentage of Participants (Number)
Epoetin Alfa - 40k Weekly63.9
Epoetin Alfa - 80k Every 3 Weeks30
Epoetin Alfa - 120k Every 3 Weeks34.5
Darbepoetin Alfa - 500 mcg Every 3 Weeks45.6

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The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule (NCT00416624)
Timeframe: 16 weeks

Interventionpercentage of participants (Number)
Epoetin Alfa - 40k Weekly27.9
Epoetin Alfa - 80k Every 3 Weeks33.3
Epoetin Alfa - 120k Every 3 Weeks22.4
Darbepoetin Alfa - 500 mcg Every 3 Weeks29.8

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Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated. (NCT00416624)
Timeframe: Weeks 4, 7, 10, 13 and 16

,,,
Interventionunits on a scale (Mean)
FACT Fatigue ConcernsFACT Nonfatigue ConcernsFACT Total Anemia
Darbepoetin Alfa - 500 mcg Every 3 Weeks49.859.453.1
Epoetin Alfa - 120k Every 3 Weeks52.661.355.6
Epoetin Alfa - 40k Weekly48.660.652.8
Epoetin Alfa - 80k Every 3 Weeks52.062.255.6

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Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated. (NCT00416624)
Timeframe: Weeks 4, 7, 10, 13 and 16

,,,
Interventionunits on a scale (Mean)
Overall QOLMental QOLPhysical QOLEmotional QOLSocial Activity LevelSpiritual QOLPain FrequencyPain SeverityFatigueAnxiety
Darbepoetin Alfa - 500 mcg Every 3 Weeks6.16.55.86.35.16.84.24.05.44.2
Epoetin Alfa - 120k Every 3 Weeks6.67.25.96.75.47.33.93.75.64.6
Epoetin Alfa - 40k Weekly6.46.95.76.55.57.44.54.15.64.1
Epoetin Alfa - 80k Every 3 Weeks6.57.05.86.85.57.44.33.85.53.9

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Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated. (NCT00416624)
Timeframe: Weeks 4, 7, 10, 13 and 16

,,,
Interventionunits on a scale (Mean)
Nausea FrequencyNausea SeverityAppetiteInsomniaPain FrequencyPain SeverityFatigueBowelConcentrationAppearanceBreathingOutlookCoughDepression
Darbepoetin Alfa - 500 mcg Every 3 Weeks1.61.62.42.42.72.12.92.32.22.21.72.42.02.0
Epoetin Alfa - 120k Every 3 Weeks1.61.42.22.32.42.02.82.31.92.01.62.11.81.8
Epoetin Alfa - 40k Weekly1.61.52.32.42.72.23.12.22.22.11.52.21.81.8
Epoetin Alfa - 80k Every 3 Weeks1.51.42.32.02.52.03.02.42.02.21.62.11.71.7

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Weekly Change in Hemoglobin Levels

To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule (NCT00416624)
Timeframe: Baseline and Week 4, 7, 10, 13, 16

,,,
Interventiong/dL (Mean)
Week 4 Minus BaselineWeek 7 Minus BaselineWeek 10 Minus BaselineWeek 13 Minus BaselineWeek 16 Minus Baseline
Darbepoetin Alfa - 500 mcg Every 3 Weeks0.41.51.51.61.9
Epoetin Alfa - 120k Every 3 Weeks0.71.11.21.31.6
Epoetin Alfa - 40k Weekly1.01.71.72.11.7
Epoetin Alfa - 80k Every 3 Weeks0.61.01.21.21.2

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The Percentage of Participants Who Exhibit a Hematopoietic Response

A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period (NCT00416624)
Timeframe: 20 weeks

InterventionPercentage of participants (Number)
Epoetin Alfa - 40k Weekly68.9
Epoetin Alfa - 80k Every 3 Weeks61.7
Epoetin Alfa - 120k Every 3 Weeks65.5
Darbepoetin Alfa - 500 mcg Every 3 Weeks66.7

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The Total RBC Transfusion Needed

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule (NCT00416624)
Timeframe: 16 weeks

Interventiong/dL (Mean)
Epoetin Alfa - 40k Weekly1.1
Epoetin Alfa - 80k Every 3 Weeks1.2
Epoetin Alfa - 120k Every 3 Weeks0.6
Darbepoetin Alfa - 500 mcg Every 3 Weeks1.1

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Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule (NCT00416624)
Timeframe: 16 weeks

Interventiondays (Median)
Epoetin Alfa - 40k Weekly32
Epoetin Alfa - 80k Every 3 Weeks50
Epoetin Alfa - 120k Every 3 Weeks49
Darbepoetin Alfa - 500 mcg Every 3 Weeks49

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The Percentage of Participants Reported Grade 3 or 4 Adverse Events

To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. (NCT00416624)
Timeframe: 16 weeks

Interventionpercentage of participants (Number)
Epoetin Alfa - 40k Weekly22
Epoetin Alfa - 80k Every 3 Weeks22
Epoetin Alfa - 120k Every 3 Weeks17
Darbepoetin Alfa - 500 mcg Every 3 Weeks13

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Mean Hemoglobin Change From Week 1 to Week 16

To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases. (NCT00416624)
Timeframe: Week 1 and Week 16

Interventiong/dL (Mean)
Epoetin Alfa - 40k Weekly11.0
Epoetin Alfa - 80k Every 3 Weeks10.3
Epoetin Alfa - 120k Every 3 Weeks10.6
Darbepoetin Alfa - 500 mcg Every 3 Weeks10.7

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The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants

A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount. (NCT00422513)
Timeframe: Baseline, Month 1 to Month 7

,
Interventionnumber of participants (Number)
Hematocrit - lowHemoglobin - lowPlatelets - lowCreatine Phosphokinase - highPotassium - highFasting Glusose - highPhosphate - highPhosphate - low
Epoetin Alfa24284820204812
Methoxy Polyethylene Glycol-epoetin Beta3236942020529

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Number of Participants Assessed for AEs

The adverse events are captured in the adverse event and serious adverse event section of this database. (NCT00422513)
Timeframe: Month 1 to 15 day follow up post month 7

Interventionnumber of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta123
Epoetin Alfa129

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Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)

Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation (NCT00425698)
Timeframe: 42 days after transplantation

Interventionml/min (Mean)
Erythropoietin47
Placebo46

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Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

(NCT00440466)
Timeframe: from baseline (Week 1) to the last 12 weeks of treatment

Interventiong/dL (Mean)
Epoetin Alfa QW-0.02
Epoetin Alfa Q2W-0.10
Epoetin Alfa Q4W-0.19

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Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)

(NCT00440466)
Timeframe: 36 weeks of treatment

Interventiong/dL (Mean)
Epoetin Alfa QW12.35
Epoetin Alfa Q2W12.48
Epoetin Alfa Q4W12.46

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Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)

(NCT00440466)
Timeframe: 36 weeks of treatment

Interventiong/dL/2 weeks (Mean)
Epoetin Alfa QW1.77
Epoetin Alfa Q2W1.69
Epoetin Alfa Q4W1.81

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Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)

(NCT00440466)
Timeframe: Weeks 13-37

InterventionProportion (Median)
Epoetin Alfa QW0.87
Epoetin Alfa Q2W0.88
Epoetin Alfa Q4W0.83

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Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

(NCT00440466)
Timeframe: 36 weeks of treatment

InterventionParticipants (Number)
Epoetin Alfa QW37
Epoetin Alfa Q2W33
Epoetin Alfa Q4W68

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Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

(NCT00440466)
Timeframe: 36 weeks of treatment

InterventionParticipants (Number)
Epoetin Alfa QW52
Epoetin Alfa Q2W57
Epoetin Alfa Q4W124

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Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise

(NCT00440466)
Timeframe: 36 weeks of treatment

InterventionParticpants (Number)
Epoetin Alfa QW84
Epoetin Alfa Q2W91
Epoetin Alfa Q4W191

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Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)

(NCT00440466)
Timeframe: 36 weeks of treatment

InterventionParticipants (Number)
Epoetin Alfa QW79
Epoetin Alfa Q2W89
Epoetin Alfa Q4W161

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Number of Participants Who Died

(NCT00440466)
Timeframe: 36 weeks of treatment

InterventionParticipants (Number)
Epoetin Alfa QW4
Epoetin Alfa Q2W3
Epoetin Alfa Q4W9

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Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22. (NCT00440557)
Timeframe: From baseline through Week 22

Interventiong/dL (Mean)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)1.81
Epoetin Alfa:Once Weekly (QW)1.59
Epoetin Alfa:Once Every Two Weeks (Q2W)1.27

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Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment

Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant. (NCT00440557)
Timeframe: From baseline to Week 22

Interventiong/dL/2 weeks (Mean)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)1.99
Epoetin Alfa:Once Weekly (QW)2.02
Epoetin Alfa:Once Every Two Weeks (Q2W)1.92

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Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment. (NCT00440557)
Timeframe: From baseline to Week 22

Interventiong/dL (Mean)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)12.87
Epoetin Alfa:Once Weekly (QW)12.61
Epoetin Alfa:Once Every Two Weeks (Q2W)12.42

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Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation. (NCT00440557)
Timeframe: From baseline to Week 22

Interventionparticipants (Number)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)119
Epoetin Alfa:Once Weekly (QW)116
Epoetin Alfa:Once Every Two Weeks (Q2W)114

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Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation. (NCT00440557)
Timeframe: From baseline to Week 22

Interventionparticipants (Number)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)87
Epoetin Alfa:Once Weekly (QW)85
Epoetin Alfa:Once Every Two Weeks (Q2W)76

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Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment

Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation. (NCT00440557)
Timeframe: From baseline to Week 22

Interventionparticipants (Number)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)47
Epoetin Alfa:Once Weekly (QW)51
Epoetin Alfa:Once Every Two Weeks (Q2W)44

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Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation. (NCT00440557)
Timeframe: From baseline to Week 22

Interventionparticipants (Number)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)106
Epoetin Alfa:Once Weekly (QW)98
Epoetin Alfa:Once Every Two Weeks (Q2W)89

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Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9

The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level. (NCT00440557)
Timeframe: From baseline to Week 9

Interventionparticipants (Number)
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)116
Epoetin Alfa:Once Weekly (QW)108
Epoetin Alfa:Once Every Two Weeks (Q2W)106

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Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure

(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

,
Interventionmillimeter of mercury (Mean)
SBP at M7 D1 (n = 9, 6)DBP at M7 D1 (n = 9, 6)SBP at M7 D15 (n = 5, 3)DBP at M7 D15 (n = 5, 3)SBP at M8 D1 (n = 2, 3)DBP at M8 D1 (n = 2, 3)SBP at M8 D15 (n = 2, 2)DBP at M8 D15 (n = 2, 2)
Epoetin Alfa92-7-25-1-6-5
RO050382133517-56-6

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Mean Change From Baseline in Temperature

(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

,
InterventionDegree Celsius (Mean)
M7 D1 (n = 9, 6)M7 D15 (n = 5, 3)M8 D1 (n = 2, 3)M8 D15 (n = 2, 2)
Epoetin Alfa-0.3-0.7-0.5-0.4
RO0503821-0.00.20.50.1

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Mean Change From Baseline in Total Iron-binding Capacity

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

,
Interventionmg per dL (Mean)
M2 (n = 18, 17)M3 (n = 17,14)M4 ( n = 12, 9)M5 (n = 9, 5)M6 (n = 7, 4)M7 (n = 4, 1)M8 (n = 0, 1)
Epoetin Alfa1.94-9.574.678.6021.253.00-43.00
RO050382120.94-3.2915.1719.679.293.25NA

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Mean Change From Baseline in Transferrin Saturation

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

,
InterventionPercentage of Transferrin Saturation (Mean)
M2 (n = 33, 31)M3 (n = 29, 29)M4 ( n = 22,24)M5 (n = 18, 17)M6 (n = 13, 10)M7 (n = 8, 6)M8 (n = 2, 3)
Epoetin Alfa4.08-2.441.363.470.39-1.8015.13
RO05038217.108.514.555.947.078.5924.13

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Number of Participants With Anti-erythropoietin Antibody in Human Serum

"Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were below the limit of quantification (BLQ) at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported." (NCT00442416)
Timeframe: Up to Month 9

,
InterventionParticipants (Number)
Quantifiable at BaselineBLQ at BaselineQuantifiable at M 9 final visit/early terminationBLQ at M 9 final visit/early termination
Epoetin Alfa137434
RO0503821233129

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Number of Participants With Anti-RO0503821 Antibody in Human Serum

"RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were BLQ at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported." (NCT00442416)
Timeframe: Up to Month 9

InterventionParticipants (Number)
Quantifiable at BaselineBLQ at BaselineQuantifiable at M 9 final visit/early terminationBLQ at M 9 final visit/early termination
RO0503821035029

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Number of Participants With Any AEs, Any Serious Adverse Events and Death

An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly. (NCT00442416)
Timeframe: Up to 9 months

,
InterventionParticipants (Number)
Any AEsAny SAEsDeath
Epoetin Alfa2320
RO050382124111

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Number of Participants With Marked Laboratory Abnormalities

Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate. (NCT00442416)
Timeframe: Up to Month 9

,
InterventionParticipants (Number)
Hematocrit - Low (n = 38, 40)Hemoglobin - Low (n = 38, 40)Platelets - High (n = 38, 40)Platelets - Low (n = 38, 40)WBCs - Low (n = 38, 40)AST - High (n = 37, 40)ALT - High (n = 38, 40)CPK- High (n = 37, 40)Alkaline phosphatase - High, (n = 37, 40)Albumin - Low (n = 38, 40)Potassium - High (n = 38, 40)Fasting glucose - High (n = 38, 40)Fasting glucose - Low (n = 38, 40)Phosphate - High (n = 38, 40)
Epoetin Alfa33101223104517
RO05038218110100171636017

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Mean Change From Baseline in Weight

(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

,
Interventionkilogram (Mean)
M7 D1 (n = 9, 6)M7 D15 (n = 5, 3)M8 D1 (n = 2, 3)M8 D15 (n = 2, 2)
Epoetin Alfa3.21.11.92.5
RO05038210.51.23.01.5

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Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period

Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to 9 months

Interventiong/dL (Mean)
RO0503821-0.32
Epoetin Alfa0.51

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Mean Change From Baseline in Ferritin

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

,
Interventionmicrogram per litre (Mean)
M2 (n = 32, 29)M3 (n = 28, 27)M4 ( n = 21,22)M5 (n = 17, 16)M6 (n = 12, 9)M7 (n = 7, 6)M8 (n = 2, 3)
Epoetin Alfa-1-37-24-70-105-120-99
RO0503821598348858655-59

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Mean Change From Baseline in Iron

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8

,
Interventionmicromole per litre (Mean)
M2 (n = 33, 31)M3 (n = 29, 29)M4 ( n = 22,24)M5 (n = 18, 17)M6 (n = 13, 10)M7 (n = 8, 6)M8 (n = 2, 3)
Epoetin Alfa1.8-1.30.20.90.6-1.37.7
RO05038213.43.92.03.12.93.411.0

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Mean Change From Baseline in Pulse Rate

(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8

,
InterventionBeats per minute (Mean)
M7 D1 (n = 9, 6)M7 D15 (n = 5, 3)M8 D1 (n = 2, 3)M8 D15 (n = 2, 2)
Epoetin Alfa-2327
RO0503821-21-7-4

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Mean Change From Baseline in Serum Transferrin

Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. (NCT00442416)
Timeframe: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

,
Interventionmilligram (mg) per dL (Mean)
M2 (n = 15, 14)M3 (n = 12,15)M4 ( n = 8, 14)M5 (n = 9, 11)M6 (n = 6, 6)M7 (n = 4, 5)M8 (n = 2, 2)
Epoetin Alfa-5.00-7.73-4.21-6.641.50-5.60-6.50
RO0503821-9.27-0.257.259.8910.502.50-15.50

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Length of Hospitalization

(NCT00451698)
Timeframe: At hospital discharge, up to 30 days

Interventiondays (Mean)
Acyanotic Placebo4.6
Acyanotic Study Drug6

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Biochemical Markers of Heart Damage

Troponin I levels (ng/ml) measured at 4 time points (NCT00451698)
Timeframe: 4 postoperative time points up to 48 hours

,
Interventionng/ml (Mean)
60 minutes post bypass4 hrs post bypass24 hrs post bypass48 hrs post bypass
Acyanotic Placebo31.127.2105.2
Acyanotic Study Drug12.31510.75.2

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Number of Participants Assessed for AEs and SAEs

The adverse events are captured in the adverse event and serious adverse event section of this database. (NCT00454246)
Timeframe: First dose of medication through 15 days post last dose (up to 8 months)

Interventionparticipants (Number)
Methoxy Polyethylene Glycol-epoetin Beta69
Epoetin Alfa26
Darbepoetin Alfa9

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Time to Achievement of Response

Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL. (NCT00462384)
Timeframe: Baseline to Week 40

Interventiondays (Mean)
Methoxy Polyethylene Glycol-epoetin Beta24.6

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Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. (NCT00462384)
Timeframe: EEP (Weeks 29 to 36)

Interventiondays (Mean)
Methoxy Polyethylene Glycol-epoetin Beta42.5

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Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented. (NCT00462384)
Timeframe: EEP (Weeks 29 to 36)

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta53.9

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Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)

The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP. (NCT00462384)
Timeframe: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)

Interventiongrams per deciliter (g/dL) (Mean)
Methoxy Polyethylene Glycol-epoetin Beta1.32

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Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented. (NCT00462384)
Timeframe: EEP (Weeks 29 to 36)

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta66.7

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FACIT Measurement System Fatigue Scale

Fatigue score ranges from 0 to 72. Lower score represents less fatigue (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization

,
InterventionScores on a Scale (Mean)
FACIT at 3 weeks (n=8; n=9)FACIT at 8 weeks (n=9; n=7)FACIT at 12 weeks (n=10; n=8)
Epoetin Alpha & Niferex35.742.338.6
Placebo & Niferex38.339.842.7

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Grip Strength

kilograms measured by hand held dynamometer (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization

,
Interventionkg (Mean)
Grip Strength at 3 weeks (n=9; n=10)Grip Strength at 8 weeks (n=9; n=7)Grip Strength at 12 weeks (n=10; n=8)
Epoetin Alpha & Niferex18.419.619.0
Placebo & Niferex19.019.417.4

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Motor-FIM Score

FIM Motor score ranges from 13 to 91 (most independent) (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization

,
InterventionScores on a Scale (Mean)
FIM at 3 weeks (n=9; n=9)FIM at 8 weeks (n=9; n=7)FIM at 12 weeks (n=10; n=8)
Epoetin Alpha & Niferex77.785.085.1
Placebo & Niferex76.981.785.2

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POMS Depression-Dejection Scale

Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed). (NCT00511901)
Timeframe: 3,8,12 weeks

,
InterventionScores on a Scale (Median)
POMS at 3 weeks (n=9; n=10)POMS at 8 weeks (n=9; n=7)POMS at 12 weeks (n=10; n=7)
Epoetin Alpha & Niferex3.500
Placebo & Niferex111

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Short Physical Performance Battery (SPPB) Score

Measure physical function scored 0 - 12 (better) (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization

,
InterventionScores on a scale (Mean)
SPPB at 3 weeks (n=9; n=9)SPPB at 8 weeks (n=9; n=7)SPPB at 12 weeks (n=10; n=8)
Epoetin Alpha & Niferex3.77.47.1
Placebo & Niferex3.47.08.0

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Activity Counts

Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity. (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization

,
InterventionCounts (Mean)
Activity Counts at 3 weeks (n=8; n=9)Activity Counts at 8 weeks (n=9; n=6)Activity Counts at 12 weeks (n=10; n=8)
Epoetin Alpha & Niferex41.5670.1777.75
Placebo & Niferex51.1358.7861.60

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Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study

(NCT00511901)
Timeframe: 8 weeks following randomization

Interventiong/dL (Mean)
Placebo & Niferex11.9
Epoetin Alpha & Niferex13.6

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Length of Stay in Subacute Rehabilitation Facility

Days from randomization to discharge (NCT00511901)
Timeframe: 12 weeks following randomization

InterventionDays (Mean)
Placebo & Niferex13.1
Epoetin Alpha & Niferex17.4

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Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI

"TMS is a measure of developmental maturity of the brain as assessed from T1 and T2-weighted images, grading myelination, cortical infolding, involution of the germinal matrix, and presence of bands of migrating glial cells. The brain MRIs were reviewed for infarction, hemorrhage, white matter injury (WMI), or dural sinovenous thrombosis (DVST). Injuries in each category are scored 0 for none, 1 for mild, 2 for moderate, 3 for severe. The score in each category is then multiplied by a proposed outcome significance multiplier. A total injury score of 0 signifies no injury, 1-5 a mild injury, 6-10 a moderate injury, and >10 a severe injury. Range of scores is 0 - 51. Lower scores indicate less injury.~The results present the relative difference of this score between the pre- and post-operative MRI. This was calculated as ((Post-operative MRI TMS - Pre-operative MRI TMS) / (Absolute(Pre-operative MRI TMS)) ). The proportion is then converted into a percentage." (NCT00513240)
Timeframe: 7 days postoperatively.

InterventionPercentage (Mean)
EPO Group12.1
Placebo Group9.44

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Scores on Bayley Scales of Infant Development III at Age 1 Years.

3 domains of the Bayley Scales of Infant Development III: Cognitive, Language and Motor Minimum score = 45, maximum score = 155; Population mean = 100, SD = 15; Higher scores are indicative of better outcomes Language scores are reflective of receptive communication and expressive communication subscales. Motor scores are reflective of fine motor and gross motor subscales. (NCT00513240)
Timeframe: 1 year postoperatively

,,
Interventionunits on a scale (Mean)
12-Month BSID-III Cognitive12-Month BSID-III Language12-Month BSID-III Motor
EPO 1000 Units/kg QDx3101.485.089.3
EPO 500 Units/kg QODx3100.992.090.5
Placebo106.392.492.6

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EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).

(NCT00513240)
Timeframe: 72 hours postoperatively.

Interventionminutes (Mean)
EPO Group0
Placebo Group0

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Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose (Maximum EPO Plasma Concentration)

(NCT00513240)
Timeframe: 24 hours after first EPO dose.

InterventionmIU/mL (Mean)
EPO Group6931

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Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time

The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

Interventionμmol/L (Mean)
Creatinine at Week 0 (n=153)Creatinine at Week 8 (n=120)Creatinine at Week 16 (n=122)Creatinine at Week 24 (n=118)Creatinine at Week 32 (n=112)Creatinine at Week 40 (n=95)Creatinine at Week 48 (n=93)Iron at Week 0 (n=159)Iron at Week 8 (n=136)Iron at Week 16 (n=133)Iron at Week 24 (n=121)Iron at Week 32 (n=110)Iron at Week 40 (n=99)Iron at Week 48 (n=97)TIBC at Week 0 (n=97)TIBC at Week 8 (n=75)TIBC at Week 16 (n=74)TIBC at Week 24 (n=76)TIBC at Week 32 (n=68)TIBC at Week 40 (n=66)TIBC at Week 48 (n=58)
C.E.R.A847.1823.4814.0822.9804.5809.7816.613.916.017.616.516.016.314.438.539.741.542.041.439.644.0

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Mean Ferritin Levels Over Time

Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

Interventionmcg/L (Mean)
Ferritin at Week 0 (n=157)Ferritin at Week 8 (n=134)Ferritin at Week 16 (n=131)Ferritin at Week 24 (n=123)Ferritin at Week 32 (n=110)Ferritin at Week 40 (n=98)Ferritin at Week 48 (n=97)
C.E.R.A591.8617.0598.8578.5583.0591.2590.3

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Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP

Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented. (NCT00517413)
Timeframe: Baseline (Week 0) to Week 24

InterventionPercentage of participants (Number)
Dose adjustment during DTPDose adjustment during EEP
C.E.R.A65.851.1

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Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP

The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented. (NCT00517413)
Timeframe: EEP (Week 16 to 24)

Interventionmcg (Mean)
C.E.R.A139.6

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Mean C-Reactive Protein Levels Over Time

C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L. (NCT00517413)
Timeframe: Baseline (Week 0), 8, 16, 24, 32, 40, and 48

Interventionmg/L (Mean)
CRP at Week 0 (n=113)CRP at Week 8 (n=102)CRP at Week 16 (n=107)CRP at Week 24 (n=104)CRP at Week 32 (n=94)CRP at Week 40 (n=84)CRP at Week 48 (n=88)
C.E.R.A54.187.5186.864.053.4250.661.7

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Mean White Blood Cells and Thrombocyte Levels Over Time

The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5*10^9 cells/L and min-max of upper limit= 9 -13.5*10^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 - 150*10^9 cells/L and min-max of upper limit= 300 - 450*10^9 cells/L. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

Intervention10^9 cells/L (Mean)
WBC at Week 0 (n=160)WBC at Week 8 (n=147)WBC at Week 16 (n=137)WBC at Week 24 (n=130)WBC at Week 32 (n=116)WBC at Week 40 (n=106)WBC at Week 48 (n=101)Thrombocyte at Week 0 (n=159)Thrombocyte at Week 8 (n=144)Thrombocyte at Week 16 (n=135)Thrombocyte at Week 24 (n=129)Thrombocyte at Week 32 (n=117)Thrombocyte at Week 40 (n=105)Thrombocyte at Week 48 (n=101)
C.E.R.A6.86.56.76.66.66.66.6219.7204.4207.4205.2207.9209.3209.0

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Number of Participants With Adverse Events and Serious Adverse Events

Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study. (NCT00517413)
Timeframe: Up to Week 52

Interventionparticipants (Number)
Participants with AEParticipants with SAE
C.E.R.A12053

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Mean Transferrin Saturation Levels Over Time

Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron*100)/(Transferrin*1.41) or TSAT=(Serum Iron*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

InterventionPercentage of Transferrin Saturation (Mean)
TSAT at Week 0 (n=135)TSAT at Week 8 (n=113)TSAT at Week 16 (n=113)TSAT at Week 24 (n=108)TSAT at Week 32 (n=96)TSAT at Week 40 (n=91)TSAT at Week 48 (n=84)
C.E.R.A34.739.846.342.139.340.236.8

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Mean Albumin and Transferrin Levels Over Time

The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 - 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

Interventiong/L (Mean)
Albumin at Week 0 (n=157)Albumin at Week 8 (n=134)Albumin at Week 16 (n=134)Albumin at Week 24 (n=124)Albumin at Week 32 (n=111)Albumin at Week 40 (n=99)Albumin at Week 48 (n=98)Transferrin at Week 0 (n=75)Transferrin at Week 8 (n=57)Transferrin at Week 16 (n=63)Transferrin at Week 24 (n=54)Transferrin at Week 32 (n==44)Transferrin at Week 40 (n=47)Transferrin at Week 48 (n=46)
C.E.R.A39.539.339.339.339.439.939.61.821.841.811.901.911.962.96

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Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter

The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP). (NCT00517413)
Timeframe: EEP (Week 16 to 24)

InterventionPercentage of participants (Number)
C.E.R.A43.7

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Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP

The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported. (NCT00517413)
Timeframe: EEP (Week 16 to 24)

InterventionPercentage of participants (Number)
C.E.R.A47.8

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Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP

The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported. (NCT00517413)
Timeframe: EEP (Week 16 to 24)

Interventiondays (Mean)
C.E.R.A30

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Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP

The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported. (NCT00517413)
Timeframe: SVP (Week -4 to -1), EEP (Week 16 to 24)

Interventiong/dL (Mean)
C.E.R.A0.08

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Mean Phosphate and Potassium Levels Over Time

The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48

Interventionmmol/L (Mean)
Phosphate at Week 0 (n=154)Phosphate at Week 8 (n=135)Phosphate at Week 16 (n=131)Phosphate at Week 24 (n=125)Phosphate at Week 32 (n=110)Phosphate at Week 40 (n=105)Phosphate at Week 48 (n=97)Potassium at Week 0 (n=159)Potassium at Week 8 (n=133)Potassium at Week 16 (n=133)Potassium at Week 24 (n=124)Potassium at Week 32 (n=110)Potassium at Week 40 (n=104)Potassium at Week 48 (n=99)
C.E.R.A1.611.691.701.681.601.591.614.904.804.904.904.804.805.00

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Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase

Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered. (NCT00517413)
Timeframe: Baseline (Week 0) to Week 44

Interventionparticipants (Number)
C.E.R.A13

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Mean Monthly Dose of C.E.R.A During the DTP and EEP

The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented. (NCT00517413)
Timeframe: Baseline (Week 0) to Week 24

Interventionmcg (Mean)
Mean monthly dose during DTPMean monthly dose during EEP
C.E.R.A142.5139.6

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Mean Hematocrit Levels Over Time

The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

InterventionProportion of red blood cells in blood (Mean)
HCT at Week 0 (n=162)HCT at Week 8 (n=151)HCT at Week 12 (n=139)HCT at Week 16 (n=141)HCT at Week 20 (n=132)HCT at Week 24 (n=132)HCT at Week 28 (n=117)HCT at Week 32 (n=119)HCT at Week 36 (n=110)HCT at Week 40 (n=110)HCT at Week 44 (n=101)HCT at Week 48 (n=103)
C.E.R.A0.350.350.360.350.350.350.360.360.360.360.350.35

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Mean Haemoglobin Levels Over Time

The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL. (NCT00517413)
Timeframe: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Interventiong/dL (Mean)
Hb at Week 0 (n=162)Hb at Week 8 (n=151)Hb at Week 12 (n=144)Hb at Week 16 (n=141)Hb at Week 20 (n=137)Hb at Week 24 (n=132)Hb at Week 28 (n=121)Hb at Week 32 (n=120)Hb at Week 36 (n= 114)Hb at Week 40 (n=110)Hb at Week 44 (n=105)Hb at Week 48 (n=103)
C.E.R.A11.411.711.711.611.511.611.811.611.711.711.511.4

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Percentage of Participants With Red Blood Cell Transfusion During the Study

Percentage of participant who required red blood cell transfusion during the study was reported. (NCT00517881)
Timeframe: Week 0 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.7

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Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported. (NCT00517881)
Timeframe: Week 17 up to Week 24

Interventiondays (Mean)
C.E.R.A.31

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Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range

Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average. (NCT00517881)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.51.7

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Change in Hemoglobin Concentration Between Reference (SVP) and EEP

The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed. (NCT00517881)
Timeframe: Week 17 up to Week 24

Interventiong/dL (Mean)
C.E.R.A.-0.3

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Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported. (NCT00517881)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.58.6

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Percentage of Participants Requiring Any Dose Adjustment

Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. (NCT00517881)
Timeframe: Week 1 up to Week 16 and Week 17 up to Week 24

Interventionpercentage of participants (Number)
DTP (n = 29)EEP (n = 26)
C.E.R.A.6231

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs. (NCT00517881)
Timeframe: Week 0 up to Week 24

Interventionparticipants (Number)
AEsSAEs
C.E.R.A.229

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Number of Participants With Response

Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response. (NCT00520468)
Timeframe: Response evaluation within first 3 months from start of therapy, then every 3 to 6 months

Interventionparticipants (Number)
Complete RemissionPartial ResponseHematologic ImprovementNo Response
Cytokine-Immunotherapy2246

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"Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs)"

number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias. (NCT00535925)
Timeframe: 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase)

InterventionParticipants (Count of Participants)
Conventional Therapy146
Intensified Therapy116

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"Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase"

Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate. (NCT00535925)
Timeframe: 13 years

InterventionParticipants (Count of Participants)
Standard of Care (SoC) Therapy150
Multifactorial Intensified Therapy191

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Mean Change in Time-Adjusted Hb From Baseline to EEP

"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL." (NCT00545571)
Timeframe: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

Interventiong/dL (Mean)
Mircera in Renal Anemia-0.4

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Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)

During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. (NCT00545571)
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

Interventiondays (Mean)
Mircera in Renal Anemia130

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Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP

Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP. (NCT00545571)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Interventionmonths (Mean)
DTP: Any Dose Change (n=90)DTP: Dose Increase (n=90)DTP: Dose Decrease (n=90)LTSP: Any Dose Change (n=67)LTSP: Dose Increase (n=67)LTSP: Dose Decrease (n=67)
Mircera in Renal Anemia1.10.40.61.50.70.8

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Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP

During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00545571)
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia48.4

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Mean Dose of Mircera/CERA During the DTP and LTSP

Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg. (NCT00545571)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Interventionmcg (Mean)
DTP (n=91)LTSP (n=72)
Mircera in Renal Anemia140133.8

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Mean Excursions Above or Below Target Range for Hb During the LTSP

During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria). (NCT00545571)
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

Interventiong/dL (Mean)
Above (n=32)Below (n=51)
Mircera in Renal Anemia0.5-0.7

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Mean Time Spent Above or Below the Target Range for Hb During the LTSP

During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria). (NCT00545571)
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

Interventiondays (Mean)
Above (n=35)Below (n=51)
Mircera in Renal Anemia4348

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Percentage of Hb Values Above or Below the Target Range During the LTSP

During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria). (NCT00545571)
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

Interventionpercentage of Hb values (Number)
Above (n=32)Below (n=51)
Mircera in Renal Anemia2238

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Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP

The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported. (NCT00545571)
Timeframe: From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52

Interventionpercentage of participants (Number)
Mircera in Renal Anemia15.4

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Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00545571)
Timeframe: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia75.6

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Mean Change From Baseline in Hemoglobin Concentration at Week 24

Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value (NCT00546481)
Timeframe: From Baseline (Day 1) to Week 24

InterventionGrams per deciliter (g/dL) (Mean)
Correction Phase: CERA2.00
Correction Phase: Epoetin Beta2.03

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Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24

Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. (NCT00546481)
Timeframe: From Baseline (Day 1) to Week 24

InterventionBeats per minute for heart rate (Mean)
Correction Phase: CERA-5.39
Correction Phase: Epoetin Beta-1.79

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Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24

Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported. (NCT00546481)
Timeframe: Up to Week 24

InterventionDays (Median)
Correction Phase: CERA84
Correction Phase: Epoetin Beta72

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Number of Participants Who Received Red Blood Cells Transfusions up to Week 49

The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels) (NCT00546481)
Timeframe: Up to Week 49

InterventionNumber of participants (Number)
Correction Phase: CERA8
Correction Phase: Epoetin Beta2
Maintenance Phase: CERA1

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Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24

Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. (NCT00546481)
Timeframe: Up to Week 24

InterventionNumber of participants (Number)
Correction Phase: CERA3
Correction Phase: Epoetin Beta3

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Percentage of Participants Who Achieved Hemoglobin Response up to Week 24

Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented (NCT00546481)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Correction Phase: CERA79.5
Correction Phase: Epoetin Beta87.8

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Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis. (NCT00546481)
Timeframe: From Baseline (Day 1) to Week 24

,
Interventionmillimeters of mercury (Mean)
Pre-dialysis: SBPPre-dialysis: DBPPost-dialysis: SBPPost-dialysis: DBP
Correction Phase: CERA2.74-1.745.260.84
Correction Phase: Epoetin Beta2.723.872.593.28

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Number of Participants With Any Adverse Events and Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. (NCT00546481)
Timeframe: Up to Week 49

,,
InterventionNumber of participants (Number)
Number of participants with any AENumber of participants with any SAE
Correction Phase: CERA3410
Correction Phase: Epoetin Beta396
Maintenance Phase: CERA518

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Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00550680)
Timeframe: Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia53.7

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Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion

The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported. (NCT00550680)
Timeframe: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

Interventionparticipants (Number)
Mircera in Renal Anemia3

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Mean Time Spent in the Target Range for Hb During the EEP

During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. (NCT00550680)
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventiondays (Mean)
Mircera in Renal Anemia34

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Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP

During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00550680)
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia53.7

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Mean Change in Time-Adjusted Hb From Baseline to EEP

"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL." (NCT00550680)
Timeframe: At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventiong/dL (Mean)
Mircera in Renal Anemia0.0

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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP

Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. (NCT00550680)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24

Interventionpercentage of participants (Number)
DTP (n=187)EEP (n=160)
Mircera in Renal Anemia6838

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Mean Number of Blood Transfusions Per Visit

(NCT00551291)
Timeframe: Up to approximately 2 years

Interventiontransfusions/visit (Mean)
Baseline (n=8)Week 12 (n=6)Week 18 (n=5)End of Study (n=3)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta4.135.832.802.33

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Percentage of Participants With at Least One Adverse Event (AE)

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. (NCT00551291)
Timeframe: Up to approximately 2 years

Interventionpercentage of participants (Number)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta90.00

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Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement

International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment. (NCT00551291)
Timeframe: Up to approximately 2 years

Interventionpercentage of participants (Number)
Week 12 (n=4)Week 18 (n=7)End of study (n=3)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta50.0071.43100.00

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Duration of Hemoglobin Values in the Range of 11-13 g/dL

The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. (NCT00559637)
Timeframe: Baseline to Month 9

Interventionmonths (Mean)
Methoxy Polyethylene Glycol-epoetin Beta3.62

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Total Number of Dose Adjustments

A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment. (NCT00559637)
Timeframe: Baseline until Month 8

Interventiondose adjustments (Number)
Total number of dose adjustmentsTotal number of dose increasesTotal number of dose reductionsTotal number of dose interruptions
Methoxy Polyethylene Glycol-epoetin Beta595249210136

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Total Number of Red Blood Cell (RBC) Transfusions

RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). (NCT00559637)
Timeframe: Baseline to Month 9

Interventionnumber of transfusions (Number)
Methoxy Polyethylene Glycol-epoetin Beta39

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Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL

Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. (NCT00559637)
Timeframe: Evaluation phase (Months 8 and 9)

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta29.21

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Duration of Hemoglobin Values in the Range of 11-12 g/dL

The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range. (NCT00559637)
Timeframe: Baseline to Month 9

Interventionmonths (Mean)
Methoxy Polyethylene Glycol-epoetin Beta2.40

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Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)

Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned. (NCT00559637)
Timeframe: Evaluation phase (Months 8 and 9)

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta10.67

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Change From Baseline in Hemoglobin Value to the Evaluation Phase

The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean. (NCT00559637)
Timeframe: Baseline, evaluation phase (Months 8 and 9)

Interventiong/dL (Mean)
Methoxy Polyethylene Glycol-epoetin Beta1.6

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Time to Increase of Hemoglobin Value to Over 11 g/dL

The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL. (NCT00559637)
Timeframe: Baseline to Month 9

Interventionmonths (Mean)
Methoxy Polyethylene Glycol-epoetin Beta2.28

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Mean Values of Hematocrit at Baseline and Week 36

Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventionfraction (Mean)
Hematocrit, Baseline, n = 112, 121Hematocrit, Week 36, n = 75, 98
C.E.R.A.0.350.35
Epoetin Alpha0.350.36

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Mean Values of Hemoglobin Concentration at Baseline and Week 36

The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventiong/dL (Mean)
Baseline, n = 112, 121Week 36; n = 75, 98
C.E.R.A.11.611.5
Epoetin Alpha11.611.7

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Mean Values of Leukocytes and Platelets Count at Baseline and Week 36

The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Intervention10^9/Litre (Mean)
Leukocytes, Baseline, n = 112, 121Leukocytes, Week 36, n = 75, 98Platelets counts, Baseline, n = 112, 121Platelets counts, Week 36, n = 75, 98
C.E.R.A.6.86.5194.8193.3
Epoetin Alpha6.66.5204.4210.6

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Mean Values of Mean Corpuscular Volume at Baseline and Week 36

Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventionfemtoliters (Mean)
Baseline; n = 112, 121Week 36; n = 74, 97
C.E.R.A.91.990.6
Epoetin Alpha92.291.6

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Mean Values of Transferrin Saturation at Baseline and Week 36

The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventionpercentage (Mean)
TS, Baseline; n = 112, 121TS, Week 36; n = 70, 91
C.E.R.A.38.044.4
Epoetin Alpha36.231.7

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Number of Participants With Adverse Events and Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. (NCT00560404)
Timeframe: Up to Week 40

,
Interventionparticipants (Number)
Any AEAny SAE
C.E.R.A.9927
Epoetin Alpha10616

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Mean Values of Ferritin Concentration at Baseline and Week 36

Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventionmicrograms per liter (Mean)
Ferritin, Baseline, n = 112,121Ferritin, Week 36, n = 72, 93
C.E.R.A.777.8736.9
Epoetin Alpha621.4609.9

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Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period

The Baseline (Safety Verification Period) was from Week - 4 to Week -1. (NCT00560404)
Timeframe: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)

Interventiong/dL (Mean)
C.E.R.A.-0.02
Epoetin Alpha0.05

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Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period

Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented. (NCT00560404)
Timeframe: EEP (Week 29 to Week 36)

Interventiondays (Mean)
C.E.R.A.30.4
Epoetin Alpha33.9

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Number of Participants Received Red Blood Cells Transfusions

The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP. (NCT00560404)
Timeframe: Up to Week 28

Interventionparticipants (Number)
C.E.R.A.8
Epoetin Alpha3

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Number of Participants Who Required Dose Adjustments During the Dose Titration Period

The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. (NCT00560404)
Timeframe: DTP (Weeks 0 to 28)

Interventionparticipants (Number)
C.E.R.A.88
Epoetin Alpha98

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Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period

The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36. (NCT00560404)
Timeframe: EEP (Weeks 29 to 36)

Interventionparticipants (Number)
C.E.R.A.35
Epoetin Alpha39

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Number of Participants With Abnormal Changes in ECG From Baseline to Week 40

Twelve-lead ECG was performed. (NCT00560404)
Timeframe: From Baseline to Week 40

Interventionparticipants (Number)
C.E.R.A.0
Epoetin Alpha0

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Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40

Vital signs included blood pressure, pulse rate and body weight. (NCT00560404)
Timeframe: From Baseline to Week 40

Interventionparticipants (Number)
C.E.R.A.0
Epoetin Alpha0

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Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period

Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period. (NCT00560404)
Timeframe: EEP (Weeks 29 to 36)

Interventionpercentage of participants (Number)
C.E.R.A.30.9
Epoetin Alpha39.4

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Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period

The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36. (NCT00560404)
Timeframe: EEP (Week 29 to Week 36)

Interventionpercentage of participants (Number)
C.E.R.A.50.7
Epoetin Alpha53.0

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Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36

The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventiongram/litre (Mean)
Albumin, Baseline, n = 111, 118Albumin, Week 36, n = 72, 92Transferrin, Baseline, n = 56, 66Transferrin, Week 36, n = 39, 49
C.E.R.A.39.239.31.651.76
Epoetin Alpha39.939.81.771.67

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Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36

The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented. (NCT00560404)
Timeframe: Baseline and Week 36

,
InterventionInternational units/Liter (Mean)
AST, Baseline, n = 109, 117AST, Week 36, n = 74, 96ALP, Baseline, n = 108, 119ALP, Week 36, n = 73, 93
C.E.R.A.16.417.2106.4116.2
Epoetin Alpha16.617.1118.0129.7

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Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36

Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36. (NCT00560404)
Timeframe: Baseline and Week 36

,
Interventionmicromoles per liter (Mean)
Creatinine, Baseline, n = 109, 116Creatinine, Week 36, n = 72, 95Potassium, Baseline, n = 112, 121Potassium, Week 36, n = 75, 99TIBC, Baseline, n = 60, 59TIBC, Week 36, n = 31, 43Iron, Baseline, n = 112, 121Iron, Week 36, n = 73, 97PTH, Baseline, n = 111, 121PTH, Week 36, n = 18, 24
C.E.R.A.850.4881.05.25.037.039.514.217.5228.3313.4
Epoetin Alpha916.6876.15.25.038.639.414.512.5217.9368.2

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Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP

All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24 (NCT00576303)
Timeframe: EEP (Week 16 to Week 24)

Interventionpercentage of participants (Number)
RO0503821 (1x/4 Weeks)63.8

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Number of Participants With Red Blood Cell Transfusion

The number of participants who underwent red blood cell transfusion was reported (NCT00576303)
Timeframe: Up to 3 years

Interventionnumber of participants (Number)
RO0503821 (1x/4 Weeks)5

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Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP

The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24 (NCT00576303)
Timeframe: EEP (Week 16 to Week 24)

Interventionnumber of days (Mean)
RO0503821 (1x/4 Weeks)34.7

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Percentage of Participants Maintaining Average Hemoglobin Concentration Within +- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24 (NCT00576303)
Timeframe: EEP (Week 16 to Week 24)

Interventionpercentage of participants (Number)
RO0503821 (1x/4 Weeks)54.5

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Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP

The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44 (NCT00576303)
Timeframe: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)

Interventionnumber of participants (Number)
DTP, No dose changeDTP, Dose increase onlyDTP, Dose decrease onlyDTP, Dose decrease and increaseDTP, Only one doseEEP, No dose changeEEP, Dose increase onlyEEP, Dose decrease onlyEEP, Dose decrease and increaseEEP, Only one doseLTSP, No dose changeLTSP, Dose increase onlyLTSP, Dose decrease onlyLTSP, Dose decrease and increaseLTSP, Only one dose
RO0503821 (1x/4 Weeks)503768413814642122394155403

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Mean Change in Hb Concentration From Baseline to the EEP

A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24 (NCT00576303)
Timeframe: Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)

Interventiong/dL (Mean)
RO0503821 (1x/4 Weeks)0.19

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Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity

The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionmicromoles/liter (Mean)
Iron, Baseline, n = 125Iron, Week 8, n = 113Iron, Week 16, n = 103Iron, Week 24, n = 96Iron, Week 32, n = 84Iron, Week 40, n = 79Iron, Week 48, n = 81TIBC, Baseline, n = 58TIBC, Week 8, n = 55TIBC, Week 16, n = 45TIBC, Week 24, n = 44TIBC, Week 32, n = 38TIBC, Week 40, n = 35TIBC, Week 48, n = 36
C.E.R.A16.014.014.915.916.615.716.449.253.753.554.850.654.051.5

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Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period

The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36. (NCT00576628)
Timeframe: From Week 29 to Week 36

Interventiondays (Mean)
C.E.R.A37.4

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Number of Participants With Red Blood Cells Transfusions.

The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. (NCT00576628)
Timeframe: Up to Week 52

Interventionparticipants (Number)
C.E.R.A1

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Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP

Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36. (NCT00576628)
Timeframe: From Week 29 to Week 36

Interventionpercentage of participants (Number)
C.E.R.A66.7

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The Number of Participants Who Required Dose Adjustments During the Dose Titration Period

The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. (NCT00576628)
Timeframe: From Week 0 to Week 28 (DTP)

Interventionparticipants (Number)
C.E.R.A61

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The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period

The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36. (NCT00576628)
Timeframe: From Week 29 to Week 36 (EEP)

Interventionparticipants (Number)
C.E.R.A34

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Time to Achievement of Response During the Efficacy Evaluation Period

The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36. (NCT00576628)
Timeframe: From Week 29 to Week 36

Interventiondays (Mean)
C.E.R.A30.8

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Mean Values of Laboratory Parameter : Hb Concentration

The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventiong/dL (Mean)
Baseline, n = 125Week 8, n = 115Week 16, n = 104Week 24, n = 101Week 32, n = 90Week 40, n = 85Week 48, n = 82
C.E.R.A10.011.712.211.612.011.811.6

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Mean Values of Laboratory Parameter : Hematocrit

Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionfraction (Mean)
Baseline, n = 124Week 8, n = 112Week 16, n = 103Week 24, n = 101Week 32, n = 90Week 40; n = 85Week 48, n = 82
C.E.R.A0.300.340.360.340.350.350.34

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Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration

The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventiongrams per liter (Mean)
Albumin, Baseline, n = 125Albumin, Week 8, n = 111Albumin, Week 16, n = 98Albumin, Week 24, n = 96Albumin, Week 32, n = 84Albumin, Week 40, n = 80Albumin, Week 48, n = 81Transferrin, Baseline, n = 86Transferrin, Week 8, n = 74Transferrin, Week 16, n = 81Transferrin, Week 24, n = 73Transferrin, Week 32, n = 67Transferrin, Week 40, n = 59Transferrin, Week 48, n = 61
C.E.R.A41.040.541.540.942.441.340.72.02.12.12.22.12.12.1

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Mean Values of Laboratory Parameter : Serum Creatinine

The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), and Week 32

Interventionmicromoles/liter (Mean)
Creatinine, Baseline, n = 125Creatinine, Week 32, n = 84
C.E.R.A317.8361.3

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Mean Values of Laboratory Parameter: C Reactive Protein

The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionmilligrams per liter (Mean)
CRP, Baseline, n = 123CRP, Week 8, n = 109CRP, Week 16, n = 101CRP, Week 24, n = 94CRP, Week 32, n = 81CRP, Week 40, n = 76CRP, Week 48, n = 79
C.E.R.A4.16.06.56.24.53.84.1

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Mean Values of Laboratory Parameter: Ferritin Concentration

The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionmicrograms per liter (Mean)
Ferritin, Baseline, n = 125Ferritin, Week 8, n = 112Ferritin, Week 16, n = 102Ferritin, Week 24, n = 94Ferritin, Week 32, n = 79Ferritin, Week 40, n = 74Ferritin, Week 48, n = 75
C.E.R.A231.6152.4149.3154.1171.8179.6187.0

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Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration

The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionmillimoles per litre (Mean)
Phosphate, Baseline, n = 124Phosphate, Week 8, n = 113Phosphate, Week 16, n = 102Phosphate, Week 24, n = 94Phosphate, Week 32, n = 85Phosphate, Week 40, n = 80Phosphate, Week 48, n = 79Potassium, Baseline, n = 125Potassium, Week 8, n=113Potassium, Week 16, n = 102Potassium, Week 24, n= 96Potassium, Week 32, n = 85Potassium, Week 40, n = 79Potassium, Week 48, n = 80
C.E.R.A1.51.61.51.61.61.61.65.15.15.15.05.15.15.2

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Mean Values of Laboratory Parameters: Transferrin Saturation

The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Interventionpercentage of saturation (Mean)
TSAT, Baseline, n = 125TSAT, Week 8, n = 113TSAT, Week 16, n = 103TSAT, Week 24, n = 96TSAT, Week 32, n = 84TSAT, Week 40, n = 79TSAT, Week 48, n = 81
C.E.R.A32.125.727.830.132.130.032.7

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Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count

The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. (NCT00576628)
Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Intervention10^9 cells/liter (Mean)
WBC, Baseline, n = 125WBC, Week 8, n = 114WBC, Week 16, n = 103WBC, Week 24, n = 97WBC, Week 32, n = 86WBC, Week 40, n = 80WBC, Week 48, n = 81Thrombocyte, Baseline, n = 125Thrombocyte, Week 8, n = 110Thrombocyte, Week 16, n = 102Thrombocyte, Week 24, n = 97Thrombocyte, Week 32, n = 85Thrombocyte, Week 40, n = 80Thrombocyte, Week 48, n = 81
C.E.R.A7.17.27.17.17.26.96.6255.4240.2237.3237.2237.0226.1222.5

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Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period

The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36. (NCT00576628)
Timeframe: Baseline (Week 0) and from Week 29 to Week 36

Interventiong/dL (Mean)
C.E.R.A1.75

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 30 weeks

InterventionRBC Transfusions (Mean)
Usual Care1.8
Exercise1.0

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionPlatelet transfusions (Mean)
Usual Care3.1
Exercise2.3

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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionPlatelet Transfusions (Mean)
Usual Care3.6
Exercise2.0

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Total Number of Days of Stem Cell Collection (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionDays (Mean)
Usual Care4.9
Exercise4.5

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Number of Stem Cell Collection Attempts (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.4
Exercise1.1

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Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 15 weeks

InterventionRBC Transfusions (Mean)
Usual Care2.3
Exercise1.8

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Number of Stem Cell Collection Attempts (Long Term)

(NCT00577096)
Timeframe: up to 30 weeks

InterventionStem Cell Collection Attempts (Mean)
Usual Care1.3
Exercise1.1

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Total Number of Days of Stem Cell Collection (Short Term)

(NCT00577096)
Timeframe: up to 15 weeks

InterventionDays (Mean)
Usual Care5.3
Exercise4.0

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 30 weeks

,
Interventiong/dl (Mean)
BaselineBefore TransplantationDuring TransplanationAt Discharge
Exercise11.712.010.811.0
Usual Care11.512.010.810.9

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Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 15 weeks

,
Interventiong/dl (Mean)
BaselineBefore transplantationDuring transplantationAt discharge
Exercise11.611.010.410.6
Usual Care12.110.810.110.6

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Mean Change in Hemoglobin Between Baseline and the Evaluation Period

The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36. (NCT00597584)
Timeframe: Baseline to Weeks 29-36

,
Interventiong/dL (Mean)
Baseline [N=542, 273]Evaluation Period [N=488, 237]Change from Baseline [N=488, 237]
Epoetin11.2111.05-0.17
Peginesatide11.2011.13-0.07

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Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)

(NCT00597584)
Timeframe: Weeks 29 to 36

Interventionpercentage of participants (Number)
Peginesatide0.635
Epoetin0.659

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Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

(NCT00597584)
Timeframe: Weeks 0 to 36

Interventionpercentage of participants (Number)
Peginesatide0.077
Epoetin0.099

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Mean Change in Hemoglobin Between Baseline and the Evaluation Period

The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36. (NCT00597753)
Timeframe: Baseline and Weeks 29-36

,
Interventiong/dL (Mean)
Baseline [N=524, 269]Evaluation Period [N=445, 248]Change from Baseline [N=445, 248]
Epoetin Alfa11.3211.25-0.09
Peginesatide11.3011.06-0.24

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Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)

(NCT00597753)
Timeframe: Weeks 29 to 36

Interventionpercentage of participants (Number)
Peginesatide0.630
Epoetin Alfa0.717

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Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods

(NCT00597753)
Timeframe: Weeks 0 to 36

Interventionpercentage of participants (Number)
Peginesatide0.103
Epoetin Alfa0.086

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Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP

Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0. (NCT00605293)
Timeframe: EEP (Week 16 to 23)

Interventionpercentage of participants (Number)
C.E.R.A45.45
Epoetin Alfa55.17

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Change in Hb Concentrations Between Baseline SVP and the EEP

Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23). (NCT00605293)
Timeframe: SVP (Week -4 to -1), EEP (Week 16 to 23)

Interventiong/dL (Mean)
C.E.R.A-0.35
Epoetin Alfa0.32

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Percentage of Participants Who Required Dose Adjustments During the DTP and EEP

(NCT00605293)
Timeframe: DTP (Week 0 to 15) and EEP (Week 16 to 23)

,
Interventionpercentage of participants (Number)
DTP: No dose change (n=65, 36)DTP: Any dose change (n=65, 36)DTP: Dose increased (n=65, 36)DTP: Dose decreased (n=65, 36)DTP: Dose decreased and increased (n=65, 36)DTP:Only one dose changed (n=65,36)EEP: No dose change (n=55, 32)EEP: Any dose change (n=55, 32)EEP: Dose increased (n=55, 32)EEP: Dose decreased (n=55, 32)EEP: Dose decreased and increased (n=55, 32)EEP: Only one dose changed (n=55, 32)
C.E.R.A30.867.718.524.624.61.560.030.920.010.90.09.1
Epoetin Alfa44.455.619.425.011.10.065.634.412.518.83.10.0

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Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP

RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels). (NCT00605293)
Timeframe: DTP (Week 0 to 15) up to EEP (Week 16 to 23)

Interventionpercentage of participants (Number)
C.E.R.A12.3
Epoetin Alfa2.8

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Mean Time Spent in Hb Range 10-12 g/dL

(NCT00605293)
Timeframe: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)

,
Interventiondays (Mean)
SVP (Week -4 to -1) (n=65, 36)DTP (Week 0 to 15) (n=65, 36)EEP (Week 16 to 23) (n=55, 32)
C.E.R.A26.767.532.2
Epoetin Alfa27.172.928.9

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Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP

Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported. (NCT00605293)
Timeframe: EEP (Week 16 to 23)

Interventionpercentage of participants (Number)
C.E.R.A32.7
Epoetin Alfa40.6

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Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping

Number of adverse events (NCT00626574)
Timeframe: First 10 days following clipping and 6 week F/U

Interventionadverse events (Number)
Procrit1
Saline2

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Percentage of Participants With Blood Transfusion

(NCT00642304)
Timeframe: Baseline up to Week 28

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta10

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Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP

The EEP was defined as Week 16 to Week 24. (NCT00642304)
Timeframe: EEP (Weeks 16 to 24)

InterventionDays (Mean)
Methoxy Polyethylene Glycol-epoetin Beta36.5

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Mean Change in Hb Concentration Between SVP and the EEP

The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. (NCT00642304)
Timeframe: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)

Interventiong/dL (Mean)
Methoxy Polyethylene Glycol-epoetin Beta0.2

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Percentage of Participants With Dose Adjustment

A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline. (NCT00642304)
Timeframe: Baseline up to Week 20

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta60

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Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)

The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24. (NCT00642304)
Timeframe: EEP (Weeks 16 to 24)

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta40

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Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP

The EEP was defined as Week 16 to Week 24. (NCT00642304)
Timeframe: EEP (Weeks 16 to 24)

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-epoetin Beta50.0

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Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range

The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL. (NCT00642668)
Timeframe: Weeks 29-36

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta41

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Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)

(NCT00642668)
Timeframe: Weeks 29-36

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta23.5

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Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT00642668)
Timeframe: Weeks 1-40

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta97

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Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)

The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP. (NCT00642668)
Timeframe: Weeks 0-36

Interventiongrams/deciliter (g/dL) (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta0.99

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Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)

(NCT00642668)
Timeframe: Weeks 29-36

Interventiondays (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta28.6

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Change in Hemoglobin Concentration Between Reference (SVP) and EEP

The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed. (NCT00642850)
Timeframe: Week -4 up to Week -1 and Week 17 up to Week 24

Interventiong/dL (Mean)
C.E.R.A.0.0

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Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. (NCT00642850)
Timeframe: Week 17 up to Week 24

Interventiondays (Mean)
C.E.R.A.32

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Number of Participants With Red Blood Cell Transfusion During the Study

Number of participant who underwent red blood cell transfusion during the study was reported. (NCT00642850)
Timeframe: Week -4 up to Week 28

Interventionparticipants (Number)
C.E.R.A.9

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Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average. (NCT00642850)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.53.3

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Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed. (NCT00642850)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.57.0

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Number of Participants With Anti-epoetin Antibody

(NCT00642850)
Timeframe: Week -4 and at early withdrawal or Week 28

Interventionparticipants (Number)
Week -4Early Withdrawal or Week 28
C.E.R.A.00

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Percentage of Participants Requiring Any Dose Adjustment

Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. (NCT00642850)
Timeframe: Week 1 to Week 16 and Week 17 to Week 24

Interventionpercentage of participants (Number)
DTP (n = 186)EEP (n = 165)
C.E.R.A.75.032.0

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Change in Estimated Glomerular Filtration Rate (eGFR)

estimated glomerular filtration rate (eGFR)as ml/min/1.73m2 (NCT00654992)
Timeframe: during the first 5 days after surgery

Interventionml/min/1.73m2 (Mean)
Erythropoietin (EPO) Group-1.5
Placebo Group-9.1

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Number of Participants Who Had AKI (Acute Kidney Injury)

number of participants who had 50% increase in serum creatinine levels from baseline (NCT00654992)
Timeframe: at any time within the first 5 days after surgery

Interventionparticipants (Number)
Erythropoietin (EPO) Group3
Placebo Group10

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Number of Participants With Complete Remission

International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. (NCT00656448)
Timeframe: After 1 course of therapy, one course is 4 weeks.

,
Interventionparticipants (Number)
Complete RemissionEarly DeathPartial Response
No Procruit: Standard Arm1834
Procrit Arm2401

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Median Number of Participant Transfusions Required During 12 Weeks of Treatment

"The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group (Procrit) and standard care group (No Procrit). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period." (NCT00656448)
Timeframe: 12 weeks

InterventionTransfusions per Participant (Median)
Procrit Arm7
No Procrit: Standard Arm7

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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP

Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP. (NCT00660023)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24

Interventionpercentage of participants (Number)
DTP (n=114)EEP (n=110)
Mircera in Renal Anemia79.848.2

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Mean Change in Time-Adjusted Hb From Baseline to EEP

"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL." (NCT00660023)
Timeframe: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventiong/dL (Mean)
Mircera in Renal Anemia-0.06

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Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP

Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg. (NCT00660023)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24

Interventionmcg (Mean)
DTP (n=114)EEP (n=110)
Mircera in Renal Anemia113100.3

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Number of Participants Receiving Blood Transfusion During the DTP and EEP

The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. (NCT00660023)
Timeframe: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

Interventionparticipants (Number)
DTP (n=114)EEP (n=110)
Mircera in Renal Anemia30

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Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP

During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00660023)
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia79.0

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Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00660023)
Timeframe: Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventionpercentage of participants (Number)
Mircera in Renal Anemia72.7

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Mean Time Spent in the Target Range for Hb During the EEP

During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days. (NCT00660023)
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Interventiondays (Mean)
Mircera in Renal Anemia43.5

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Number of Blood Transfusions During the DTP and EEP

The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported. (NCT00660023)
Timeframe: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

Interventionblood transfusions (Number)
DTP (n=114)EEP (n=110)
Mircera in Renal Anemia40

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Mean Time to Achievement of Response During the EEP

Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented. (NCT00661388)
Timeframe: From Week 29 to Week 36

InterventionDays (Mean)
C.E.R.A24.2

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The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP

The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented. (NCT00661388)
Timeframe: From Week 29 to Week 36

InterventionPercentage of participants (Number)
C.E.R.A43.9

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Mean Change From Baseline in Albumin Concentration Over Time

Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

Interventiong/L (Mean)
Week 8 (n = 62)Week 16 (n = 52)Week 24 (n = 53)Week 32 (n = 48)Week 40 (n = 45)Week 48 (n = 46)
C.E.R.A0.450.06-0.300.24-0.57-0.61

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Mean Change From Baseline in C-Reactive Protein Concentration Over Time

Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

InterventionMilligrams /L (Mean)
Week 8 (n = 55)Week 16 (n = 44)Week 24 (n = 45)Week 32 (n = 38)Week 40 (n = 42)Week 48 (n = 39)
C.E.R.A-1.82-1.800.03-0.33-1.490.86

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Mean Change From Baseline in Creatinine Concentration Over Time

Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 32, 40

InterventionMicromole/L (Median)
Week 8 (n = 4)Week 16 (n = 2)Week 32 (n = 2)Week 40 (n = 1)
C.E.R.A23.87123.67-8.4017.7

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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time

Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48

InterventionFemtoliters (Mean)
Week 8 (n = 65)Week 16 (n = 57)Week 24 (n = 55)Week 32 (n = 52)Week 48 (n = 47)
C.E.R.A0.17-1.31-1.10-0.340.97

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Mean Change From Baseline in Ferritin Concentration Over Time

Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

Interventionmcg/L (Mean)
Ferritin at Week 8 (n = 52)Ferritin at Week 16 (n = 49)Ferritin at Week 24 (n = 42)Ferritin at Week 32 (n = 39)Ferritin at Week 40 (n = 42)Ferritin at Week 48 (n = 43)
C.E.R.A-95.15-82.82-71.98-78.45-59.94-43.46

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Mean Change From Baseline in Hb Concentration Over Time

Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

Interventiong/dL (Mean)
Week 8 (n = 70)Week 16 (n = 62)Week 24 (n = 59)Week 32 (n = 55)Week 40 (n = 52)Week 48 (n = 48)
C.E.R.A1.502.031.861.851.841.59

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Mean Change From Baseline in Hematocrit Level Over Time

Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

InterventionFraction (Mean)
Week 8 (n = 70)Week 16 (n = 62)Week 24 (n = 59)Week 32 (n = 55)Week 40 (n = 51)Week 48 (n = 49)
C.E.R.A0.050.060.060.060.060.05

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Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time

Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

InterventionMillimoles /L (Mean)
Phosphate at Week 8 (n = 59)Phosphate at Week 16 (n = 48)Phosphate at Week 24 (n = 51)Phosphate at Week 32 (n = 45)Phosphate at Week 40 (n = 44)Phosphate at Week 48 (n = 43)Potassium at Week 8 (n = 63)Potassium at Week 16 (n = 54)Potassium at Week 24 (n = 53)Potassium at Week 32 (n = 49)Potassium at Week 40 (n = 46)Potassium at Week 48 (n = 47)
C.E.R.A0.110.060.070.130.060.070.120.030.02-0.040.160.03

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Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time

Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

InterventionMicromole /L (Mean)
TIBC at Week 8 (n = 62)TIBC at Week 16 (n = 53)TIBC at Week 24 (n = 52)TIBC at Week 32 (n = 47)TIBC at Week 40 (n = 45)TIBC at Week 48 (n = 46)Iron at Week 8 (n = 63)Iron at Week 16 (n = 53)Iron at Week 24 (n = 54)Iron at Week 32 (n = 47)Iron at Week 40 (n = 45)Iron at Week 48 (n = 46)
C.E.R.A0.09-0.210.340.152.24-2.02-1.930.310.550.681.640.80

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Mean Change From Baseline in Transferrin Saturation Over Time

Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

InterventionPercentage of Transferrin Saturation (Mean)
TSAT at Week 8 (n = 62)TSAT at Week 16 (n = 52)TSAT at Week 24 (n = 51)TSAT at Week 32 (n = 47)TSAT at Week 40 (n = 45)TSAT at Week 48 (n = 46)
C.E.R.A-5.911.691.422.523.525.32

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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time

Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48. (NCT00661388)
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48

Intervention10^9 cells/Liter (L) (Mean)
WBCs at Week 8 (n = 66)WBCs at Week 16 (n = 58)WBCs at Week 24 (n = 55)WBCs at Week 32 (n = 52)WBCs at Week 40 (n = 47)WBCs at Week 48 (n = 47)Platelets at Week 8 (n = 66)Platelets at Week 16 (n = 58)Platelets at Week 24 (n = 55)Platelets at Week 32 (n = 52)Platelets at Week 40 (n = 47)Platelets at Week 48 (n = 47)
C.E.R.A0.040.060.120.01-0.130.04-8.39-15.73-20.55-25.34-25.84-23.40

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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00661388)
Timeframe: Up to Week 52

InterventionParticipants (Number)
Any AEsAny SAEs
C.E.R.A5824

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Number of Participants Who Received Red Blood Cell Transfusions During the Study Period

Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented. (NCT00661388)
Timeframe: Up to Week 52

InterventionNumber of participants (Number)
DTP (n = 75)EEP (n = 57)LSTP (n = 54)
C.E.R.A211

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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP

Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. (NCT00661388)
Timeframe: Weeks 0 to Week 36

InterventionPercentage of participants (Number)
Any dose adjustment in DTPDose increased in DTPDose decreased in DTPDose increased and decreased in DTPAny dose adjustment in EEPDose increased in EEPDose decreased in EEPDose increased and decreased in EEP
C.E.R.A85.414.624.446.356.117.131.77.3

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Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period

Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement. (NCT00661388)
Timeframe: From Baseline (Week 0) to EEP (Week 29 to Week 36)

Interventiong/dL (Mean)
C.E.R.A1.99

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Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP

Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented. (NCT00661388)
Timeframe: From Week 29 to Week 36

InterventionDays (Mean)
C.E.R.A40.6

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Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24

Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

InterventionNumber of cells x 10^9/L (Mean)
Leucocytes, Change from BL to Week 16, n = 102Leucocytes, Change from BL to Week 24, n = 95Platelet, Change from BL to Week 16, n = 102Platelet, Change from BL to Week 24, n = 96
C.E.R.A. 120, 200, or 360 mcg0.27-0.032.560.17

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Number of Participants Taking Concomitant Medications

The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented. (NCT00661505)
Timeframe: Up to Week 28

InterventionNumber of participants (Number)
Antibacterials for systemic useVitaminsVaccinesAgents acting on the renin-angiotensin systemAnalgesicsAntianemic preparationsAntithrombotic agentsDrug for acid related disordersMineral supplementsOther
C.E.R.A. 120, 200, or 360 mcg131375444444

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Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24

Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventiongram/liter (Mean)
Transferrin, Change from BL to Week 16, n = 33Transferrin, Change from BL to Week 24, n = 29Albumin, Change from BL to Week 16, n = 98Albumin, Change from BL to Week 24, n = 93
C.E.R.A. 120, 200, or 360 mcg0.190.090.13-0.22

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Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period

The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. (NCT00661505)
Timeframe: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)

Interventiong/dL (Mean)
C.E.R.A. 120, 200, or 360 mcg0.29

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Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period

The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20. (NCT00661505)
Timeframe: EEP (Week 16 to Week 20)

Interventionmcg (Mean)
C.E.R.A. 120, 200, or 360 mcg103.5

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Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24

Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionmicromole/Liter (Mean)
Iron, Change from BL to Week 16, n = 98Iron, Change from BL to Week 24, n = 93TIBC, Change from BL to Week 16, n = 84TIBC, Change from BL to Week 24, n = 80Creatinine, Change from BL to Week 16, n = 2Creatinine, Change from BL to Week 24, n = 92
C.E.R.A. 120, 200, or 360 mcg2.081.150.240.05-20.3316.73

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Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24

Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionmillimole/liter (Mean)
Phosphate, Change from BL to Week 16, n = 97Phosphate, Change from BL to Week 24, n = 94Potassium, Change from BL to Week 16, n = 94Potassium, Change from BL to Week 24, n = 95
C.E.R.A. 120, 200, or 360 mcg0.040.06-0.04-0.02

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Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period

Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). (NCT00661505)
Timeframe: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)

InterventionPercentage of participants (Number)
DTP, n = 127EEP, n = 107
C.E.R.A. 120, 200, or 360 mcg75.636.4

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Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period

Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented. (NCT00661505)
Timeframe: Week 1 to Week 24

InterventionNumber of participants (Number)
During DTPDuring EEP
C.E.R.A. 120, 200, or 360 mcg10

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Mean Change From Baseline in Hemoglobin at Week 16 and Week 24

Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventiong/dL (Mean)
Change from BL to Week 16, n = 104Change from BL to Week 24, n = 98
C.E.R.A. 120, 200, or 360 mcg-0.000.22

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Mean Change From Baseline in Hematocrit at Week 16 and Week 24

The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionpercentage of red blood cells (Mean)
Change from BL to Week 16, n = 104Change from BL to Week 24, n = 99
C.E.R.A. 120, 200, or 360 mcg0.000.01

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Mean Change From Baseline in Ferritin at Week 16 and Week 24

Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionmicrogram/liter (Mean)
Change from BL to Week 16, n = 93Change from BL to Week 24, n = 75
C.E.R.A. 120, 200, or 360 mcg20.8031.51

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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24

Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

InterventionFemtoliter (Mean)
Change from BL to Week 16, n = 102Change from BL to Week 24, n = 95
C.E.R.A. 120, 200, or 360 mcg-2.02-1.26

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Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24

Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionmilligram/liter (Mean)
Change from BL to Week 16, n = 88Change from BL to Week 16, n = 81
C.E.R.A. 120, 200, or 360 mcg1.92-1.43

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Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period

The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion. (NCT00661505)
Timeframe: EEP (Week 16 to Week 24)

InterventionPercentage of participants (Number)
C.E.R.A. 120, 200, or 360 mcg46.43

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Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period

The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. (NCT00661505)
Timeframe: EEP (Week 16 to Week 24)

InterventionPercentage of participants (Number)
C.E.R.A. 120, 200, or 360 mcg51.18

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Number of Participants With Reports of Anti-erythropoietin Antibodies

The number of participants with Anti-epoetin antibodies is presented. (NCT00661505)
Timeframe: Up to Week 24

InterventionNumber of participants (Number)
C.E.R.A. 120, 200, or 360 mcg0

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Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period

The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24. (NCT00661505)
Timeframe: EEP (Week 16 to Week 24)

Interventiondays (Median)
C.E.R.A. 120, 200, or 360 mcg38.0

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Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24

Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

InterventionPercentage of TSAT (Mean)
Change from BL to Week 16, n = 89Change from BL to Week 24, n = 86
C.E.R.A. 120, 200, or 360 mcg4.112.41

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Mean Change From Baseline in Weight at Week 16 and Week 24

Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24

Interventionkilogram (Mean)
Change from BL to Week 16, n = 103Change from BL to Week 24, n = 100
C.E.R.A. 120, 200, or 360 mcg0.50.7

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Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0. (NCT00661505)
Timeframe: Baseline (Week -4 to Week 0), Week 16, and Week 24

InterventionMillimeters of Mercury (Mean)
SBP Before Dialysis,Change from BL to W 16,n = 105DBP Before Dialysis,Change from BL to W 16,n = 105SBP Before Dialysis,Change from BL to W 24,n = 101DBP Before Dialysis,Change from BL to W 24,n = 101SBP After Dialysis,Change from BL to W 16, n = 100DBP After Dialysis,Change from BL to W 16, n = 100SBP After Dialysis,Change from BL to W 24, n = 95DBP After Dialysis, Change from BL to W 24, n = 95
C.E.R.A. 120, 200, or 360 mcg2.12.43.02.2-0.31.71.01.8

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Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period

The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized. (NCT00661505)
Timeframe: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)

Interventionmcg (Mean)
During DTP, n = 127During EEP, n = 107
C.E.R.A. 120, 200, or 360 mcg121.6112.4

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Number of Participants With Any Adverse Events and Serious Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT00661505)
Timeframe: Up to Week 28

InterventionNumber of participants (Number)
Number of participants with any AENumber of participants with any SAE
C.E.R.A. 120, 200, or 360 mcg4413

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Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population

The mean absolute change in Hb levels between the screening/baseline period and the evaluation period was analyzed for the intent-to-treat (ITT) population in the same way as the primary efficacy endpoint. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between HX575 epoetin alfa Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL]. (NCT00666835)
Timeframe: 28 weeks

Interventiong/dL (Least Squares Mean)
HX575 Epoetin Alfa Hexal AG0.003
ERYPO®, Janssen-Cilag-0.187

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To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.

Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population. (NCT00666835)
Timeframe: 28 weeks

Interventiong/dL (Least Squares Mean)
HX575 Epoetin Alfa Hexal AG0.147
ERYPO®, Janssen-Cilag0.063

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Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods

A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks. (NCT00680043)
Timeframe: Weeks 1 to 28

Interventionpercentage of participants (Number)
Peginesatide 0.04 mg/kg0.923
Peginesatide 0.08 mg/kg0.973
Epoetin Alfa1.0

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Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods

(NCT00680043)
Timeframe: Weeks 1 to 28

Interventionpercentage of participants (Number)
Peginesatide 0.04 mg/kg0.026
Peginesatide 0.08 mg/kg0.0
Epoetin Alfa0.0

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Mean Change in Hemoglobin Between Baseline and the Evaluation Period

The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28. (NCT00680043)
Timeframe: Baseline and Weeks 21-28

,,
Interventiong/dL (Mean)
Baseline [N=39, 37, 38]Evaluation Period [N=37, 37, 36]Change from Baseline [N=37, 37, 36]
Epoetin Alfa9.0711.492.41
Peginesatide 0.04 mg/kg9.3411.452.15
Peginesatide 0.08 mg/kg9.2011.592.39

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RBC Transfusion From Day 29 Through the End of Study

incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks). (NCT00695396)
Timeframe: Day 29 through the end of study (approximately 48 weeks)

Interventionparticipants (Number)
Placebo4
Epoetin Alfa 40000 IU2
Epoetin Alfa 80000 IU1

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Red Blood Cell (RBC) Transfusion

Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study) (NCT00695396)
Timeframe: Approximately 48 weeks

Interventionparticipants (Number)
Placebo5
Epoetin Alfa 40000 IU3
Epoetin Alfa 80000 IU1

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Transfusion Dependent

Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period. (NCT00695396)
Timeframe: Approximately 48 weeks

Interventionparticipants (Number)
Placebo2
Epoetin Alfa 40000 IU2
Epoetin Alfa 80000 IU1

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Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average. (NCT00699348)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.60.00

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Percentage of Participants Requiring Any Dose Adjustment

Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. (NCT00699348)
Timeframe: Week 1 up to Week 16 and Week 17 up to Week 24

Interventionpercentage of participants (Number)
DTPEEP
C.E.R.A.70.350.9

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Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range

Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed. (NCT00699348)
Timeframe: Week 17 up to Week 24

Interventionpercentage of participants (Number)
C.E.R.A.73.94

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Change in Hemoglobin Concentration Between Reference SVP and EEP

The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed. (NCT00699348)
Timeframe: Week -4 up to Week 0 and Week 17 up to Week 24

Interventiong/dL (Mean)
C.E.R.A.-0.10

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Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. (NCT00699348)
Timeframe: Week 17 up to Week 24

Interventiondays (Median)
C.E.R.A.44.0

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Number of Participants With Red Blood Cell Transfusion During the Study

Number of participant who underwent red blood cell transfusion during the study was reported. (NCT00699348)
Timeframe: Week -4 up to Week 52

Interventionparticipants (Number)
C.E.R.A.38

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Weekly Epoetin Dose

Mean weekly epoetin dose [IU/kg] in study weeks 11-13 (NCT00701714)
Timeframe: weeks 11-13

InterventionIU/kg (Mean)
HX575, EPO HEXAL55.1
ERYPO57.9

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Immunogenicity

Number of participants with antibody formation against Epoetin during treatment period (safety set) (NCT00701714)
Timeframe: 13 weeks

Interventionparticipants (Number)
Treatmen HX575 EPO HEXAL5
Treatment ERYPO2

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Change in Hemoglobin Level

Mean absolute change in hemoglobin (baseline to end of study week 13) (NCT00701714)
Timeframe: 13 weeks

Interventiong/dL (Mean)
HX575, EPO HEXAL2.2
ERYPO2.1

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Change in Average Reticulocyte Count Between the Baseline and Evaluation Period

A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed. (NCT00717366)
Timeframe: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

,
Intervention10^3 cells/microliter (Mean)
Baseline (n=15,48)Change at Evaluation Period (n=11,36)
MIRCERA Group 1: Intermediate-Conversion-Factor Group46.0823.38
MIRCERA Group 2: High-Conversion-Factor Group43.7024.80

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Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL

The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21). (NCT00717366)
Timeframe: Evaluation Period (Week 17 to Week 21)

,
Interventionparticipants (Number)
Above 12 g/dLWithin 10-12 g/dLBelow 10 g/dL
MIRCERA Group 1: Intermediate-Conversion-Factor Group093
MIRCERA Group 2: High-Conversion-Factor Group3294

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Maximum Observed Serum Concentration (Cmax) of MIRCERA

Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported. (NCT00717366)
Timeframe: Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

Interventionpicograms per milliliter (pg/mL) (Geometric Mean)
MIRCERA Group 1: Intermediate-Conversion-Factor Group37700
MIRCERA Group 2: High-Conversion-Factor Group66100

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Change in Average Hb Concentration Between Baseline and Evaluation Period

A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration. (NCT00717366)
Timeframe: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

,
Interventiong/dL (Mean)
Baseline (n=16,48)Change at Evaluation Period (n=12,36)
MIRCERA Group 1: Intermediate-Conversion-Factor Group11.26-0.78
MIRCERA Group 2: High-Conversion-Factor Group11.08-0.15

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Time to Reach Cmax (Tmax) of MIRCERA

Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported. (NCT00717366)
Timeframe: Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

Interventionhours (Median)
MIRCERA Group 1: Intermediate-Conversion-Factor Group2.00
MIRCERA Group 2: High-Conversion-Factor Group2.00

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Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA

Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau). (NCT00717366)
Timeframe: Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

Interventionpicograms*hour/milliliter (pg*h/mL) (Geometric Mean)
MIRCERA Group 1: Intermediate-Conversion-Factor Group3630000
MIRCERA Group 2: High-Conversion-Factor Group7170000

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Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb

Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21). (NCT00717366)
Timeframe: Evaluation Period (Week 17 to Week 21)

Interventionparticipants (Number)
MIRCERA Group 1: Intermediate-Conversion-Factor Group7
MIRCERA Group 2: High-Conversion-Factor Group27

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Number of Participants With Blood Transfusions

(NCT00717366)
Timeframe: Baseline to Week 20

Interventionparticipants (Number)
MIRCERA Group 1: Intermediate-Conversion-Factor Group1
MIRCERA Group 2: High-Conversion-Factor Group2

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Apparent Terminal Phase Half-Life (t1/2) of MIRCERA

t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant. (NCT00717366)
Timeframe: Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

Interventionhours (Geometric Mean)
MIRCERA Group 1: Intermediate-Conversion-Factor Group147
MIRCERA Group 2: High-Conversion-Factor Group121

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Mean Values of Serum Ferritin Over Time

Mean values of serum ferritin were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionnanogram per mililiter (Mean)
Serum Ferritin, Week -2 (n = 126)Serum Ferritin, Week 4 (n = 117)Serum Ferritin, Week 8 (n = 109)Serum Ferritin, Week 12 (n = 105)
Mircera1806.301422.481109.071109.80

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Mean Values of Serum Sodium and Serum Potassium Over Time

Mean values of serum sodium and serum potassium were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionmillimole per liter (Mean)
Serum Potassium, Week -2 (n = 132)Serum Potassium, Week 4 (n = 123)Serum Potassium, Week 8 (n = 118)Serum Potassium, Week 12 (n = 115)Serum Sodium, Week -2 (n = 132)Serum Sodium, Week 4 (n = 122)Serum Sodium, Week 8 (n = 118)Serum Sodium, Week 12 (n = 115)
Mircera5.006.265.115.03137.1136.2137.0136.9

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Mean Values of Transferrin Over Time

Mean values of transferrin were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionmiligram per mililiter (Mean)
Transferrin, Week -2 (n = 25)Transferrin, Week 4 (n = 16)Transferrin, Week 8 (n = 18)Transferrin, Week 12 (n = 18)
Mircera168.24160.00165.72159.22

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Mean Values of Transferrin Saturation Over Time

Mean values of Transferrin Saturation (TSAT) were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

InterventionPercentage (Mean)
TSAT, Week -2 (n = 125)TSAT, Week 4 (n = 116)TSAT, Week 8 (n = 109)TSAT, Week 12 (n = 106)
Mircera45.5548.7046.0845.71

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Mean Values of White Blood Cells and Platelets Over Time

Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

InterventionPer cubic millimeter (Mean)
WBCs, Week -2 (n = 132)WBCs, Week 4 (n = 114)WBCs, Week 8 (n = 118)WBCs, Week 12 (n = 115)Platelets, Week -2 (n = 132)Platelets, Week 4 (n = 114)Platelets, Week 8 (n = 118)Platelets, Week 12 (n = 115)
Mircera7527.507369.747506.617484.35211772.73199508.77208745.76208566.37

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Number of Participants With Abnormal Electrocardiogram

Participants with abnormal electrocardiogram were reported. (NCT00737464)
Timeframe: At Week -2 and Week 12

InterventionNumber of participants (Number)
Week -2 (n=132)Week 12 (n=115)
Mircera6150

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Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths

Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT00737464)
Timeframe: Up to Week 14

InterventionNumber of participants (Number)
TEAEsSAEsDeaths
Mircera2793

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Mean Values of Hypochromic Red Blood Cells Over Time

Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

InterventionPercentage of RBCs (Mean)
Hypochromic RBCs, Week -2 (n = 41)Hypochromic RBCs, Week 4 (n = 34)Hypochromic RBCs, Week 8 (n = 42)Hypochromic RBCs, Week 12 (n = 42)
Mircera3.583.733.883.97

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Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time

Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionunits per litre (Mean)
AST, Week -2 (n = 128)AST, Week 4 (n = 123)AST, Week 8 (n = 117)AST, Week 12 (n = 115)ALT, Week -2 (n = 129)ALT, Week 4 (n = 121)ALT, Week 8 (n = 118)ALT, Week 12 (n = 115)Serum Alkaline Phosphatase, Week -2 (n = 131)Serum Alkaline Phosphatase, Week 4 (n = 123)Serum Alkaline Phosphatase, Week 8 (n = 118)Serum Alkaline Phosphatase, Week 12 (n = 115)
Mircera23.4823.2622.8623.1731.3430.1829.4431.07154.7163.3162.1159.3

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Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)

The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL. (NCT00737464)
Timeframe: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)

Interventiongm/dL (Mean)
Hb in SVPAvg of Hb in Last 4 Weeks TP
Mircera10.7611.28

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Mean Change From Baseline in Heart Rate Over Time

Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter. (NCT00737464)
Timeframe: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12

InterventionBeats per minute (bpm) (Mean)
Heart rate, Week -1, (n = 132)Heart rate, Week 0, (n = 131)Heart rate, Week 1, (n = 129)Heart rate, Week 2, (n = 124)Heart rate, Week 4, (n = 124)Heart rate, Week 6, (n = 121)Heart rate, Week 8, (n = 118)Heart rate, Week 10, (n = 115)Heart rate, Week 12, (n = 115)
Mircera78.7979.5478.6478.9878.6179.5579.8379.5679.80

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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time

Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter. (NCT00737464)
Timeframe: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12

InterventionmmHg (Mean)
SBP, Week-2, Before Dialysis (n = 132)SBP, Week-2, After Dialysis (n = 131)SBP, Week-1, Before Dialysis (n = 132)SBP, Week-1, After Dialysis (n =131)SBP, Week 0, Before Dialysis (n = 131)SBP, Week 0, After Dialysis (n = 130)SBP, Week 1, Before Dialysis (n = 129)SBP, Week 1, After Dialysis (n = 128)SBP, Week 2, Before Dialysis (n = 124)SBP, Week 2, After Dialysis (n = 123)SBP, Week 4, Before Dialysis (n = 124)SBP, Week 4, After Dialysis (n = 124)SBP, Week 6, Before Dialysis (n = 121)SBP, Week 6, After Dialysis (n = 121)SBP, Week 8, Before Dialysis (n = 118)SBP, Week 8, After Dialysis (n = 118)SBP, Week 10, Before Dialysis (n = 115)SBP, Week 10, After Dialysis (n = 115)SBP, Week 12, Before Dialysis (n = 115)SBP, Week 12, After Dialysis (n = 115)DBP, Week -2, Before Dialysis (n = 132)DBP, Week -2, After Dialysis (n = 131)DBP, Week -1, Before Dialysis (n = 132)DBP, Week -1, After Dialysis (n = 131)DBP, Week 0, Before Dialysis (n = 131)DBP, Week 0, After Dialysis (n = 130)DBP, Week 1, Before Dialysis (n = 129)DBP, Week 1, After Dialysis (n = 128)DBP, Week 2, Before Dialysis (n = 124)DBP, Week 2, After Dialysis (n = 123)DBP, Week 4, Before Dialysis (n = 124)DBP, Week 4, After Dialysis (n = 124)DBP, Week 6, Before Dialysis (n = 121)DBP, Week 6, After Dialysis (n = 121)DBP, Week 8, Before Dialysis (n = 118)DBP, Week 8, After Dialysis (n = 118)DBP, Week 10, Before Dialysis (n = 115)DBP, Week 10, After Dialysis (n = 115)DBP, Week 12, Before Dialysis (n = 115)DBP, Week 12, After Dialysis (n = 115)
Mircera145.04145.51146.72143.26145.05143.75147.02144.02146.85144.92146.68143.65145.16145.55144.77143.42144.14143.98144.55143.8082.9284.0583.9083.2284.0584.0484.6883.2783.7783.6984.1583.2983.3183.9783.2884.3583.9184.3384.1783.23

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Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)

Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL. (NCT00737464)
Timeframe: Weeks 8 to 12 (Last 4 weeks of treatment period)

InterventionPercentage of participants (Number)
Mircera57.89

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Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL

Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL. (NCT00737464)
Timeframe: Up to Week 12

InterventionWeeks (Mean)
Mircera3.15

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Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time

Mean values of serum iron and total iron binding capacity (TIBC) were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionmicrogram per deciliter (Mean)
Serum Iron, Week -2 (n = 131)Serum Iron, Week 4 (n = 122)Serum Iron, Week 8 (n = 118)Serum Iron, Week 12 (n = 112)TIBC, Week -2 (n = 131)TIBC, Week 4 (n = 122)TIBC, Week 8 (n = 115)TIBC, Week 12 (n = 112)
Mircera102.13108.56116.79110.53273.44266.98283.50276.43

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Mean Values of Serum Albumin and Serum Globulin Over Time

Mean values of serum albumin and serum globulin were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventiongram per deciliter (Mean)
Serum Albumin, Week -2 (n = 132)Serum Albumin, Week 4 (n = 123)Serum Albumin, Week 8 (n = 118)Serum Albumin, Week 12 (n = 115)Serum Globulin, Week -2 (n = 131)Serum Globulin, Week 4 (n = 123)Serum Globulin, Week 8 (n = 117)Serum Globulin, Week 12 (n = 113)
Mircera3.603.543.583.643.483.413.553.51

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Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time

Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionmiligram per deciliter (Mean)
Serum Creatinine, Week -2 (n = 132)Serum Creatinine, Week 4 (n = 123)Serum Creatinine, Week 8 (n = 116)Serum Creatinine, Week 12 (n = 115)BUN, Week -2 (n = 131)BUN, Week 4 (n = 122)BUN, Week 8 (n = 117)BUN, Week 12 (n = 113)Serum Phosphate, Week -2 (n = 124)Serum Phosphate, Week 4 (n = 114)Serum Phosphate, Week 8 (n = 112)Serum Phosphate, Week 12 (n = 107)Serum Bilirubin, Week -2 (n = 131)Serum Bilirubin, Week 4 (n = 123)Serum Bilirubin, Week 8 (n = 118)Serum Bilirubin, Week 12 (n = 115)
Mircera7.898.348.038.1957.7260.6760.1061.795.005.024.815.370.520.500.520.51

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Mean Corpuscular Volume Levels Over Time

Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported. (NCT00737464)
Timeframe: At Weeks -2, 4, 8, and 12

Interventionfemtoliters (Mean)
MCV, Week -2 (n = 125)MCV, Week 4 (n = 107)MCV, Week 8 (n = 112)MCV, Week 12 (n = 108)
Mircera90.3289.9989.4188.09

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Percentage of Participants Requiring Blood Transfusions

The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated. (NCT00737477)
Timeframe: Weeks 0 to 48

Interventionpercentage of participants (Number)
Mircera in CKD-Related Anemia3.2

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Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. (NCT00737477)
Timeframe: Weeks 16 to 24

Interventionpercentage of participants (Number)
Mircera in CKD-Related Anemia50.0

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Change in Hb Value From Baseline to the EEP

"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL." (NCT00737477)
Timeframe: Baseline and Weeks 16 to 24

Interventiong/dL (Mean)
Mircera in CKD-Related Anemia0.4

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Absolute Change in Dose of Mircera/CERA by Study Week

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants. (NCT00737477)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Interventionmcg (Mean)
Week 4, Dose Decrease (n=25)Week 4, Dose Increase (n=9)Week 8, Dose Decrease (n=32)Week 8, Dose Increase (n=14)Week 12, Dose Decrease (n=21)Week 12, Dose Increase (n=8)Week 16, Dose Decrease (n=20)Week 16, Dose Increase (n=8)Week 20, Dose Decrease (n=11)Week 20, Dose Increase (n=10)Week 24, Dose Decrease (n=18)Week 24, Dose Increase (n=10)Week 28, Dose Decrease (n=13)Week 28, Dose Increase (n=7)Week 32, Dose Decrease (n=10)Week 32, Dose Increase (n=8)Week 36, Dose Decrease (n=10)Week 36, Dose Increase (n=2)Week 40, Dose Decrease (n=11)Week 40, Dose Increase (n=4)Week 44, Dose Decrease (n=2)Week 44, Dose Increase (n=5)Week 48, Dose Decrease (n=0)Week 48, Dose Increase (n=2)
Mircera in CKD-Related Anemia25.837.828.442.924.552.524.047.529.134.529.050.538.535.027.037.528.575.037.322.518.532.0NA40.0

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Number of Dose Adjustments of Mircera/CERA

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. (NCT00737477)
Timeframe: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

Interventiondose adjustments (Mean)
Weeks 4 to 20 (n=95)Weeks 24 to 48 (n=76)Weeks 4 to 48 (n=95)
Mircera in CKD-Related Anemia2.05.63.3

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Percent Change in Dose of Mircera/CERA by Study Week

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants. (NCT00737477)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Interventionpercent change in dose (Mean)
Week 4, Dose Decrease (n=25)Week 4, Dose Increase (n=9)Week 8, Dose Decrease (n=32)Week 8, Dose Increase (n=14)Week 12, Dose Decrease (n=21)Week 12, Dose Increase (n=8)Week 16, Dose Decrease (n=20)Week 16, Dose Increase (n=8)Week 20, Dose Decrease (n=11)Week 20, Dose Increase (n=10)Week 24, Dose Decrease (n=18)Week 24, Dose Increase (n=10)Week 28, Dose Decrease (n=13)Week 28, Dose Increase (n=7)Week 32, Dose Decrease (n=10)Week 32, Dose Increase (n=8)Week 36, Dose Decrease (n=10)Week 36, Dose Increase (n=2)Week 40, Dose Decrease (n=11)Week 40, Dose Increase (n=4)Week 44, Dose Decrease (n=2)Week 44, Dose Increase (n=5)Week 48, Dose Decrease (n=0)Week 48, Dose Increase (n=2)
Mircera in CKD-Related Anemia23.722.233.321.430.322.041.125.657.621.545.029.638.529.736.524.643.722.551.626.735.824.0NA22.5

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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA

Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. (NCT00737477)
Timeframe: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

Interventionpercentage of participants (Number)
Any Dose Adjustment, Weeks 4 to 20 (n=95)Decreased Dose, Weeks 4 to 20 (n=75)Increased Dose, Weeks 4 to 20 (n=75)Dose Not Performed, Weeks 4 to 20 (n=95)Any Dose Adjustment, Weeks 24 to 48 (n=76)Decreased Dose, Weeks 24 to 48 (n=50)Increased Dose, Weeks 24 to 48 (n=50)Dose Not Performed, Weeks 24 to 48 (n=76)Any Dose Adjustment, Weeks 4 to 48 (n=95)Decreased Dose, Weeks 4 to 48 (n=94)Increased Dose, Weeks 4 to 48 (n=94)Dose Not Performed, Weeks 4 to 48 (n=95)
Mircera in CKD-Related Anemia84.269.343.334.710074.046.030.396.884.071.347.4

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Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period

Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks. (NCT00737477)
Timeframe: Weeks 16 to 24 and Weeks 0 to 48

Interventionweeks (Mean)
EEP (Weeks 16 to 24; n=80)Overall Study (Weeks 0 to 48; n=94)
Mircera in CKD-Related Anemia5.922.0

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Percentage of Participants With Down Excursions

"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44." (NCT00737477)
Timeframe: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

Interventionpercentage of participants (Number)
Weeks 4 to 16Weeks 16 to 24Weeks 24 to 44
Mircera in CKD-Related Anemia16.711.172.2

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Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit. (NCT00737477)
Timeframe: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48

Interventionpercentage of participants (Number)
Week 16 (n=80)Week 20 (n=76)Week 24 (n=75)Week 28 (n=73)Week 32 (n=72)Week 36 (n=68)Week 40 (n=65)Week 44 (n=63)Week 48 (n=62)
Mircera in CKD-Related Anemia37.535.544.039.744.451.544.644.438.7

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Percentage of Participants With Hb Values Within Target Range During the EEP

During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined. (NCT00737477)
Timeframe: Weeks 16 to 24

Interventionpercentage of participants (Number)
At Least One Hb Value (n=80)At Least Two Hb Values (n=77)All Three Hb Values (n=74)
Mircera in CKD-Related Anemia78.849.423.0

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Percentage of Participants With Up Excursions

"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44." (NCT00737477)
Timeframe: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

Interventionpercentage of participants (Number)
Weeks 4 to 16Weeks 16 to 24Weeks 24 to 44
Mircera in CKD-Related Anemia31.845.522.7

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Percentage of Participants With Cycles or Excursions

"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated." (NCT00737477)
Timeframe: Weeks 4 to 44

Interventionpercentage of participants (Number)
At Least One CycleAt Least One ExcursionAt Least One Up ExcursionAt Least One Down Excursion
Mircera in CKD-Related Anemia5.360.046.318.9

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Mean Serum Albumin Over Time

Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventiong/dL (Mean)
Week 0, n = 185Week 4, n = 172Week 10, n = 167Week 16, n = 155
MIRCERA3.513.483.573.61

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Mean Serum Alkaline Phosphatase Over Time

Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

InterventionU/L (Mean)
Week 0, n = 175Week 4, n = 159Week 10, n = 156Week 16, n = 145
MIRCERA176.2161.7161.7153.5

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Mean Serum Bilirubin Over Time

Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmg/dL (Mean)
Week 0, n = 142Week 4, n = 124Week 10, n = 123Week 16, n = 117
MIRCERA0.580.680.700.62

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Mean Serum Creatinine Over Time

Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmg/dL (Mean)
Week 0, n = 186Week 4, n = 171Week 10, n = 168Week 16, n = 158
MIRCERA8.258.659.489.05

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Mean Serum Ferritin Over Time

Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionnanogram /milliliter (ng/mL) (Mean)
Week 0, n = 188Week 4, n = 170Week 10, n = 161Week 16, n = 153
MIRCERA963.28702.37686.42641.26

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Mean Serum Iron Over Time

Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmicrogram/deciliter (mcg/dL) (Mean)
Week 0, n = 187Week 4, n = 171Week 10, n = 166Week 16, n = 157
MIRCERA91.7280.1787.6291.70

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Mean Serum Phosphate Over Time

Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmg/dL (Mean)
Week 0, n = 166Week 4, n = 156Week 10, n = 155Week 16, n = 146
MIRCERA6.206.328.716.17

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Mean Serum Potassium Over Time

Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmillimoles per liter (mmol/L) (Mean)
Week 0, n = 183Week 4, n = 168Week 10, n = 168Week 16, n = 157
MIRCERA5.765.237.538.30

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Mean Serum Sodium Over Time

Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmmol/L (Mean)
Week 0, n = 184Week 4, n = 168Week 10, n = 168Week 16, n = 156
MIRCERA136.4136.3133.9137.0

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Mean Total Iron-binding Capacity Over Time

Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmcg/dL (Mean)
Week 0, n = 185Week 4, n = 166Week 10, n = 160Week 16, n = 153
MIRCERA247.06243.25245.30245.30

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Mean Transferrin Over Time

Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmilligram per deciliter (mg/dL) (Mean)
Week 0, n = 73Week 4, n = 66Week 10, n = 55Week 16, n = 58
MIRCERA173.48176.97237.98181.50

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Mean Transferrin Saturation Over Time

Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

InterventionPercentage of transferrin saturation (Mean)
Week 0, n = 186Week 4, n=168Week 10, n=161Week 16, n = 153
MIRCERA40.3935.3136.9138.31

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Mean Value of Mean Corpuscular Volume Over Time

Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

InterventionFemtoliter (Mean)
Week 0, n = 183Week 4, n = 169Week 10, n = 167Week 16, n = 159
MIRCERA87.0589.1788.4688.03

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Mean White Blood Cell Count Over Time

The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventioncells per cubic millimeter (Mean)
Week 0, n = 187Week 4, n = 173Week 10, n = 167Week 16, n = 159
MIRCERA9382.899181.279361.389023.71

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Number of Participants With Abnormal Electrocardiogram

Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented. (NCT00737711)
Timeframe: Up to Week 16

InterventionParticipants (Number)
Participants with abnormal ECG, Week 0, n=189Participants with abnormal ECG, Week 16, n=164
MIRCERA5249

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Number of Participants With Adverse Events, Serious Adverse Events and Deaths

An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above (NCT00737711)
Timeframe: Up to Week 18

InterventionParticipants (Number)
Participants with any AEParticipants with SAEDeaths
MIRCERA53248

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Number of Participants With Reports of Blood Transfusions

Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons. (NCT00737711)
Timeframe: Up to Week 16

InterventionParticipants (Number)
White blood cells transfusionsPack cell transfusionsPure red cell transfusions
MIRCERA160

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Mean Serum Globulin Over Time

Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventiong/dL (Mean)
Week 0, n = 179Week 4, n = 163Week 10, n = 159Week 16, n = 150
MIRCERA3.363.243.333.50

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Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16. (NCT00737711)
Timeframe: Baseline (Week 0) and Week 16

Interventiongram/deciliter (g/dL) (Mean)
MIRCERA2.11

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Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter

Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks. (NCT00737711)
Timeframe: Up to Week 16

InterventionWeeks (Mean)
MIRCERA6.10

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Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented. (NCT00737711)
Timeframe: Week 12 to Week 16

InterventionWeeks (Mean)
MIRCERA3.07

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Number of Participants With Reports of Anti-Epoetin Antibodies

Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA. (NCT00737711)
Timeframe: Up to Week 16

InterventionParticipants (Number)
MIRCERA0

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Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented. (NCT00737711)
Timeframe: Week 12 to Week 16

Interventionpercentage of participants (Number)
MIRCERA46.20

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Mean Alanine Aminotransferase Over Time

Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

InterventionU/L (Mean)
Week 0, n = 185Week 4, n = 171Week 10, n = 166Week 16, n = 157
MIRCERA27.8926.8028.1129.21

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Mean Aspartate Transaminase Over Time

Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

InterventionUnits/Liter (U/L) (Mean)
Week 0, n = 184Week 4, n = 171Week 10, n = 166Week 16, n = 157
MIRCERA22.3321.6924.6122.63

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Mean Blood Urea Nitrogen Over Time

Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventionmg/dL (Mean)
Week 0, n = 181Week 4, n = 170Week 10, n = 168Week 16, n = 157
MIRCERA68.9866.1967.2169.88

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Mean Hypochromic Red Blood Cells Over Time

Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventioncells per cubic millimeter (Mean)
Week 0, n = 39Week 4, n = 39Week 10, n = 36Week 16, n = 31
MIRCERA3.842.743.233.52

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Mean Platelet Count Over Time

Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. (NCT00737711)
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16

Interventioncells per cubic millimeter (Mean)
Week 0, n = 186Week 4, n = 177Week 10, n = 167Week 16, n = 158
MIRCERA214629.03203050.85204922.16194550.63

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Patient Score on the Overall IIEF Questionnaire

Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 12 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)53
Placebo60.5

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Hemoglobin Level at 2 Weeks After Surgery

Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl). (NCT00737893)
Timeframe: 2 weeks after surgery

Interventiong/dl (Median)
Erythropoietin (EPO)14.7
Placebo13.6

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Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain

Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 6 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)14
Placebo19

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Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 9 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)20
Placebo25

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Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 3 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)11
Placebo14

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Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain

Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 12 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)22
Placebo28

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Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain

Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. (NCT00737893)
Timeframe: At 6 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)47.8
Placebo53.2

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Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain

Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. (NCT00737893)
Timeframe: At 9 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)59.6
Placebo70.5

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Number of Participants Requiring Transfusion During Hospitalization

Assess the number of participants requiring transfusion during hospitalization. (NCT00737893)
Timeframe: During hospital stay, up to 1 week

InterventionParticipants (Count of Participants)
Erythropoietin (EPO)0
Placebo0

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Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain

Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. (NCT00737893)
Timeframe: At 12 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)62.2
Placebo73.7

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Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain

Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. (NCT00737893)
Timeframe: At 3 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)43.6
Placebo49.4

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Patient Score on the Overall IIEF Questionnaire

Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 3 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)33
Placebo40

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Patient Score on the Overall IIEF Questionnaire

Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 6 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)37.5
Placebo51

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Patient Score on the Overall IIEF Questionnaire

Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. (NCT00737893)
Timeframe: At 9 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)50
Placebo55

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Patient Score on the Quality of Erection Questionnaire (QEQ)

Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. (NCT00737893)
Timeframe: At 12 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)70.8
Placebo79.2

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Patient Score on the Quality of Erection Questionnaire (QEQ)

Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. (NCT00737893)
Timeframe: At 3 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)20.8
Placebo37.5

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Patient Score on the Quality of Erection Questionnaire (QEQ)

Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. (NCT00737893)
Timeframe: At 6 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)37.5
Placebo45.8

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Patient Score on the Quality of Erection Questionnaire (QEQ)

Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. (NCT00737893)
Timeframe: At 9 months post-surgery

Interventionscore on a scale (Median)
Erythropoietin (EPO)66.7
Placebo70.8

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Time to Non-Fatal and Fatal Stroke

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionyears (Median)
Erythropoiesis Stimulating AgentsNA
Methoxy Polyethylene Glycol-Epoetin BetaNA

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Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionyears (Median)
Erythropoiesis Stimulating AgentsNA
Methoxy Polyethylene Glycol-Epoetin BetaNA

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Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionpercentage of participants (Number)
Erythropoiesis Stimulating Agents0
Methoxy Polyethylene Glycol-Epoetin Beta0

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Percentage of Participants With Gastrointestinal Bleeding

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionpercentage of participants (Number)
Erythropoiesis Stimulating Agents11.1
Methoxy Polyethylene Glycol-Epoetin Beta11.7

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Percentage of Participants With Thromboembolic Events

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionpercentage of participants (Number)
Erythropoiesis Stimulating Agents34.5
Methoxy Polyethylene Glycol-Epoetin Beta32.8

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Time to All-Cause Mortality

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionyears (Median)
Erythropoiesis Stimulating Agents6.1
Methoxy Polyethylene Glycol-Epoetin Beta5.9

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Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionyears (Median)
Erythropoiesis Stimulating Agents5.1
Methoxy Polyethylene Glycol-Epoetin Beta5.1

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Time to Non-Fatal and Fatal Myocardial Infarction

(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years

Interventionyears (Median)
Erythropoiesis Stimulating AgentsNA
Methoxy Polyethylene Glycol-Epoetin BetaNA

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Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP

(NCT00773968)
Timeframe: EEP: Weeks 17 to 28

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta73.17

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Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)

Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated. (NCT00773968)
Timeframe: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28

Interventiong/dL (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta0.27

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Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP

(NCT00773968)
Timeframe: EEP: Weeks 17 to 28

Interventiondays (Median)
Methoxy Polyethylene Glycol-Epoetin Beta57.0

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Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)

The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration). (NCT00773968)
Timeframe: EEP: Weeks 17 to 28

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta65.85

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Percentage of Participants Who Required Red Blood Cell Transfusions

(NCT00773968)
Timeframe: Weeks 1 to 28

Interventionpercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta0.9

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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP

The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. (NCT00773968)
Timeframe: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28

Interventionpercentage of participants (Number)
DTP: Dose Increase OnlyDTP: Dose Decrease OnlyDTP: Both Dose Increase and DecreaseEEP: Dose Increase OnlyEEP: Dose Decrease OnlyEEP: Both Dose Increase and Decrease
Methoxy Polyethylene Glycol-Epoetin Beta17.139.022.031.79.89.8

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Duration of Major Erythroid Response (MER)

Duration of major erythroid response (MER) is defined as the time interval between the documented date of MER and the earliest date of resumption of red blood cell transfusions ≥ 2 units in an 8-week period, a reduction in hemoglobin concentration ≥ 2 g/dL in the absence of acute infection, gastrointestinal bleeding and hemolysis, or death. (NCT00843882)
Timeframe: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment

Interventionmonths (Median)
Arm A (Lenalidomide; Randomization)13
Arm B (Lenalidomide + Epoetin Alfa; Randomization)23.8

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Time to Major Erythroid Response (MER)

"Time to major erythroid response (MER) is defined in responders as the time from randomization to the documented date of MER.~For transfusion independent patients, the date of MER is the first date of the elevation in hemoglobin level of more than 2 g/dL that has been sustained for at least 8 weeks. For transfusion dependent patients, the date of MER is the beginning date of the time interval of transfusion independence that has been sustained for at least eight weeks." (NCT00843882)
Timeframe: Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment

Interventionmonths (Median)
Arm A (Lenalidomide; Randomization)3.6
Arm B (Lenalidomide + Epoetin Alfa; Randomization)3.7

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Proportion of Patients With Cytogenetic Response

"Evaluation of cytogenetic response requires 20 analyzable metaphases when using conventional techniques. Analysis of data will require 20 metaphases before and after treatment, which must be done on bone marrow only (peripheral blood is not a substitute). Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (>2 metaphases abnormal) chromosome abnormalities.~Partial response: > 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality." (NCT00843882)
Timeframe: Assessed at baseline and after completion of 16 weeks of treatment

Interventionproportion of participants (Number)
Arm A (Lenalidomide; Randomization)0.07
Arm B (Lenalidomide + Epoetin Alfa; Randomization)0.10

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Proportion of Patients With Bone Marrow Response

"Bone marrow response includes complete remission (CR) and partial remission (PR).~Complete remission (CR): Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. When erythroid precursors constitute < 50% of bone marrow nucleated cells, the percent of blasts is based on all nucleated cells; when there are ≥ 50% erythroid cells, the percent blasts should be based on the non-erythroid cells.~Partial remission (PR): All of the CR criteria (if abnormal prior to treatment), except blasts decreased by 50% over pre-treatment, or a less advanced Myelodysplastic Syndromes (MDS) World Health Organization (WHO) classification than pretreatment. Cellularity and morphology are not relevant." (NCT00843882)
Timeframe: Assessed at 16 weeks

Interventionproportion of participants (Number)
Arm A (Lenalidomide; Randomization)0.01
Arm B (Lenalidomide + Epoetin Alfa; Randomization)0.03

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Pretreatment Endogenous Erythropoietin Level

"Pretreatment endogenous erythropoietin level was assessed at baseline. The association between pretreatment endogenous erythropoietin level and major erythroid response was evaluated among patients who received lenalidomide alone.~Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients." (NCT00843882)
Timeframe: Assessed at baseline and after completion of 16 weeks of treatment

InterventionmU/mL (Median)
Arm A Patients With Major Erythroid Response514.5
Arm A Patients Without Major Erythroid Response150

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Proportion of Patients With Minor Erythroid Response

The definition of minor erythroid response: the mean hemoglobin is sustained 1.0 to 2.0 g/dL above the baseline value for a minimum of 8 weeks; or a 50% or greater decrease in 8-week red blood cell transfusion requirements compared to baseline. (NCT00843882)
Timeframe: Assessed every cycle during treatment and after completion of 16 weeks of treatment

Interventionproportion of participants (Number)
Arm A (Lenalidomide; Randomization)0.208
Arm B (Lenalidomide + Epoetin Alfa; Randomization)0.182

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Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. (NCT00843882)
Timeframe: Assessed after completion of 16 weeks of treatment

Interventionproportion of participants (Number)
Arm B (Lenalidomide + Epoetin Alfa; Crossover)0.25

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Proportion of Patients With Major Erythroid Response (MER) Among Those With Chromosome 5q31.1 Deletion

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. (NCT00843882)
Timeframe: Assessed after completion of 16 weeks of treatment

Interventionproportion of participants (Number)
Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)0.632

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Proportion of Patients With Major Erythroid Response (MER)

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a > 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. (NCT00843882)
Timeframe: Assessed after completion of 16 weeks of treatment

Interventionproportion of participants (Number)
Arm A (Lenalidomide; Randomization)0.115
Arm B (Lenalidomide + Epoetin Alfa; Randomization)0.283

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Mean Change From Baseline in Pulse Rate Over Time

Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionbeats per minute (Mean)
Week 8 (n = 175)Week 16 (n = 175)Week 24 (n = 173)Week 32 (n = 173)Week 40 (n = 174)Week 48 (n = 190)
C.E.R.A.0.370.020.300.400.520.76

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Mean Change From Baseline in Weight Over Time

Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48). (NCT00882713)
Timeframe: Week 16 and Week 48

Interventionkilogram (Mean)
Week 16 (n = 185)Week 48 (n = 191)
C.E.R.A.-0.200.06

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Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time

The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionmicromole/L (Mean)
Creatinine at Week 0 (n = 194)Creatinine at Week 8 (n = 139)Creatinine at Week 16 (n = 130)Creatinine at Week 24 (n = 130)Creatinine at Week 32 (n = 117)Creatinine at Week 40 (n = 110)Creatinine at Week 48 (n = 149)Iron at Week 0 (n = 194)Iron at Week 8 (n = 139)Iron at Week 16 (n = 129)Iron at Week 24 (n = 130)Iron at Week 32 (n = 116)Iron at Week 40 (n = 110)Iron at Week 48 (n = 148)TIBC at Week 0 (n = 194)TIBC at Week 8 (n = 137)TIBC at Week 16 (n = 126)TIBC at Week 24 (n = 123)TIBC at Week 32 (n = 116)TIBC at Week 40 (n = 110)TIBC at Week 48 (n = 147)
C.E.R.A.775.7692.5676.1683.7670.2674.8699.615.915.115.114.314.915.615.244.544.244.843.744.142.644.0

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Mean Hematocrit Levels Over Time

The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

InterventionProportion of red blood cells in blood (Mean)
HCT at Week 0 (n = 194)HCT at Week 8 (n = 184)HCT at Week 16 (n = 175)HCT at Week 24 (n = 180)HCT at Week 32 (n = 177)HCT at Week 40 (n = 163)HCT at Week 48 (n = 170)
C.E.R.A.0.340.360.360.360.360.360.35

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Mean Hemoglobin Levels Over Time

The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventiong/dL (Mean)
Hb at Week 0 (n = 194)Hb at Week 8 (n = 184)Hb at Week 16 (n = 175)Hb at Week 24 (n = 180)Hb at Week 32 (n = 177)Hb at Week 40 (n = 162)Hb at Week 48 (n = 168)
C.E.R.A.11.211.711.811.811.811.811.6

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Mean Phosphate and Potassium Levels Over Time

The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionmilimole/L (Mean)
Phosphate at Week 0 (n = 194)Phosphate at Week 8 (n = 139)Phosphate at Week 16 (n = 131)Phosphate at Week 24 (n = 130)Phosphate at Week 32 (n = 116)Phosphate at Week 40 (n = 110)Phosphate at Week 48 (n = 148)Potassium at Week 0 (n = 194)Potassium at Week 8 (n = 139)Potassium at Week 16 (n = 131)Potassium at Week 24 (n = 130)Potassium at Week 32 (n = 117)Potassium at Week 40 (n = 110)Potassium at Week 48 (n = 146)
C.E.R.A.1.71.71.71.71.61.41.65.35.45.45.55.55.55.3

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Mean Transferrin Saturation Levels Over Time

The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

InterventionPercentage of Transferrin Saturation (Mean)
TSAT at Week 0 (n = 194)TSAT at Week 8 (n = 136)TSAT at Week 16 (n = 125)TSAT at Week 24 (n = 123)TSAT at Week 32 (n = 115)TSAT at Week 40 (n = 110)TSAT at Week 48 (n = 147)
C.E.R.A.37.335.036.034.935.438.036.5

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Mean White Blood Cells and Thrombocytes Over Time

The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Intervention10^9 cells/L (Mean)
WBCs at Week 0 (n = 194)WBCs at Week 8 (n = 153)WBCs at Week 16 (n = 137)WBCs at Week 24 (n = 138)WBCs at Week 32 (n = 129)WBCs at Week 40 (n = 123)WBCs at Week 48 (n = 153)Thrombocytes at Week 0 (n = 194)Thrombocytes at Week 8 (n = 153)Thrombocytes at Week 16 (n = 137)Thrombocytes at Week 24 (n = 138)Thrombocytes at Week 32 (n = 129)Thrombocytes at Week 40 (n = 123)Thrombocytes at Week 48 (n = 153)
C.E.R.A.6.56.56.36.46.36.36.5213.9207.5202.5200.5208.6206.1204.7

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Number of Participants With Any Adverse Events or Serious Adverse Events

An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly. (NCT00882713)
Timeframe: Up to Week 52

InterventionParticipants (Number)
Any AEsAny SAEs
C.E.R.A.3919

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Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period

Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP. (NCT00882713)
Timeframe: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)

Interventiong/dL (Mean)
C.E.R.A.0.48

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Mean Ferritin Levels Over Time

The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionmcg/L (Mean)
Ferritin at Week 0 (n = 194)Ferritin at Week 8 (n = 138)Ferritin at Week 16 (n = 129)Ferritin at Week 24 (n = 128)Ferritin at Week 32 (n = 116)Ferritin at Week 40 (n = 110)Ferritin at Week 48 (n = 148)
C.E.R.A.547.6522.2517.6508.6522.6562.8505.6

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Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP

Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24. (NCT00882713)
Timeframe: EEP (Week 17 to Week 24)

InterventionDays (Mean)
C.E.R.A.35.1

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Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP

Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24. (NCT00882713)
Timeframe: EEP (Week 17 to Week 24)

InterventionPercentage of participants (Number)
C.E.R.A.60.6

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Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period

The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0. (NCT00882713)
Timeframe: EEP (Week 17 to Week 24)

InterventionPercentage of participants (Number)
C.E.R.A.52.0

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Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase

Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported. (NCT00882713)
Timeframe: Up to Week 52

InterventionNumber of RBCs transfusion (Number)
During DTPDuring EEPDuring LTSP
C.E.R.A.312

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Mean Albumin Levels Over Time

The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventiong/L (Mean)
Albumin at Week 0 (n = 193)Albumin at Week 8 (n = 139)Albumin at Week 16 (n = 130)Albumin at Week 24 (n = 128)Albumin at Week 32 (n = 116)Albumin at Week 40 (n = 108)Albumin at Week 48 (n = 147)
C.E.R.A.43.141.041.340.239.940.439.9

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Mean C-Reactive Protein Levels Over Time

The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48. (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionmiligrams/L (Mean)
CRP at Week 0 (n = 190)CRP at Week 8 (n = 139)CRP at Week 16 (n = 130)CRP at Week 24 (n = 127)CRP at Week 32 (n = 112)CRP at Week 40 (n = 109)CRP at Week 48 (n = 140)
C.E.R.A.6.97.98.69.37.17.27.4

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Mean Change From Baseline in Blood Pressure Over Time

Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48). (NCT00882713)
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

Interventionmillimeter of mercury (Mean)
SBP before dialysis at Week 8 (n = 189)SBP before dialysis at Week 16 (n = 185)SBP before dialysis at Week 24 (n = 182)SBP before dialysis at Week 32 (n = 181)SBP before dialysis at Week 40 (n = 175)SBP before dialysis at Week 48 (n = 191)SBP after dialysis at Week 8 (n = 185)SBP after dialysis at Week 16 (n = 181)SBP after dialysis at Week 24 (n = 178)SBP after dialysis at Week 32 (n = 177)SBP after dialysis at Week 40 (n = 171)SBP after dialysis at Week 48 (n = 187)DBP before dialysis at Week 8 (n = 189)DBP before dialysis at Week 16 (n = 185)DBP before dialysis at Week 24 (n = 182)DBP before dialysis at Week 32 (n = 181)DBP before dialysis at Week 40 (n = 175)DBP before dialysis at Week 48 (n = 191)DBP after dialysis at Week 8 (n = 185)DBP after dialysis at Week 16 (n = 181)DBP after dialysis at Week 24 (n = 178)DBP after dialysis at Week 32 (n = 177)DBP after dialysis at Week 40 (n = 171)DBP after dialysis at Week 48 (n = 187)
C.E.R.A.1.15-0.78-0.58-1.280.27-0.521.680.480.600.401.221.63-0.77-1.87-1.58-2.08-1.35-0.90-0.40-0.11-0.90-1.07-1.50-1.21

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Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP

Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. (NCT00882713)
Timeframe: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)

InterventionPercentage of participants (Number)
Dose adjustment during DTP (n = 193)Dose adjustment during EEP (n = 185)
C.E.R.A.5634.6

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Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)

The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days. (NCT00910858)
Timeframe: On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.

Interventionng/mL (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide18510480.7

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Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide

Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method. (NCT00910858)
Timeframe: On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.

Interventionng*h/mL (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide563315248

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Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose

"Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:~(amount excreted unchanged in urine over the first 5 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers." (NCT00910858)
Timeframe: On Day 14, at predose and over the interval of 0-5 hours postdose.

Interventionpercent of administered dose (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide34.035.432.5

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Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level

To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus > 500 mIU/mL). Response includes participants with either a major or minor response. (NCT00910858)
Timeframe: Assessed every 28 days until study discontinuation (up to 1218 days)

,,
Interventionpercentage of participants (Number)
Baseline EPO ≤ 500 mIU/mLBaseline EPO > 500 mIU/mL
Non-responders47.839.1
Overall53.838.5
Responders62.537.5

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Percentage of Participants With a Erythroid Response Across All Phases

Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment). (NCT00910858)
Timeframe: Assessed every 28 days until study discontinuation (up to 1218 days).

,,
Interventionpercentage of participants (Number)
Major responseMinor response
10 mg Del 5q85.70
10 mg Non-del 5q17.65.9
15 mg Non-del 5q40.00

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PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)

The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7. (NCT00910858)
Timeframe: On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.

Interventionng/mL (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide17910178.3

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PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose

"Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:~(amount excreted unchanged in urine over 24 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers." (NCT00910858)
Timeframe: On Day -7 at predose and over the intervals of 0-5, 5-8, 8-12, and 12-24 hours postdose.

Interventionpercent of administered dose (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide65.167.962.2

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PK Phase: Terminal Half-life (t1/2)

The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz). (NCT00910858)
Timeframe: On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.

Interventionhours (Geometric Mean)
Total LenalidomideS-LenalidomideR-Lenalidomide
10 mg Lenalidomide3.724.143.58

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Time to Grade 4 Neutropenia or Thrombocytopenia

Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1. (NCT00910858)
Timeframe: From the date of first dose until 30 days after the last dose (up to 1218 days)

,
Interventiondays (Median)
Grade 4 NeutropeniaGrade 4 Thrombocytopenia
Del 5q28.029.0
Non-del 5q69.053.0

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PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide

Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method. (NCT00910858)
Timeframe: On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

Interventionng*h/mL (Geometric Mean)
10 mg Lenalidomide817

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Change in Hemoglobin Concentration Between SVP and the EEP

Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24. (NCT00922116)
Timeframe: SVP (Baseline), and EEP (Weeks 17 to 24)

Interventiongrams per deciliter (g/dL) (Mean)
Mircera0.55

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Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP

DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. (NCT00922116)
Timeframe: Weeks 1 to 24

Interventionpercentage of participants (Number)
Mircera87.2

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Average Dose of Mircera Per Month

(NCT00922116)
Timeframe: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24

Interventionmicrogram (mcg) (Mean)
Week 0-4Week 4-8Week 8-12Week 12-16Week 16-20Week 20-24
Mircera121.2100.878.872.766.966.2

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Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP

DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. (NCT00922116)
Timeframe: Weeks 1 to 24

Interventiondays (Mean)
Mircera103.6

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Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP

EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson. (NCT00922116)
Timeframe: EEP (Weeks 17 to 24)

Interventionpercentage of participants (Number)
Mircera73.0

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Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)

The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson. (NCT00922116)
Timeframe: EEP (Weeks 17 to 24)

Interventionpercentage of participants (Number)
Mircera53.9

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Number of Participants With Composite Events of Infusion Reactions

(NCT00924781)
Timeframe: 12 weeks

InterventionParticipants (Number)
MK2578 1mcg/600U QW0
MK2578 1mcg/600 QM0
MK2578 1mcg/350U QW0
MK2578 1mcg/350U QM0

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Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

(NCT00924781)
Timeframe: 12 weeks

InterventionParticipants (Number)
MK2578 1mcg/600U QW0
MK2578 1mcg/600U QM1
MK2578 1mcg/350U QW0
MK2578 1mcg/350U QM0

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Change From Baseline in Hg Level at Week 12

(NCT00924781)
Timeframe: 12 weeks

Interventiong/dL (Mean)
MK2578 1mcg/600U QW-0.1
MK2578 1mcg/600U QM-0.5

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Change From Baseline in Hemoglobin (Hg) Level at Week 4

(NCT00924781)
Timeframe: 4 weeks

Interventiong/dL (Mean)
MK2578 1mcg/600U QW-0.6
MK2578 1mcg/600U QM-0.7
MK2578 1mcg/350U QW-1.0
MK2578 1mcg/350U QM-1.0

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Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia

(NCT00924781)
Timeframe: 12 weeks

,,,
InterventionParticipants (Number)
DeathMICVAPeripheral vascular thrombosesVascular access thrombosisCHFHypertensionSeizurePure red cell aplasia
MK2578 1mcg/350U QM000000000
MK2578 1mcg/350U QW000010000
MK2578 1mcg/600U QM010000100
MK2578 1mcg/600U QW000000100

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NIHSS Change From Baseline at Day 30

The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). (NCT00938314)
Timeframe: Baseline and Day 30

Interventionscores on a scale (Mean)
NTx®-265 Low Dose4.67
NTx®-265 Medium Dose4.29
NTx®-265 High Dose5.00
Saline Placebo5.33

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Trails A Test Change From Baseline at Day 90

The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…) (NCT00938314)
Timeframe: Baseline and Day 90

Interventionseconds (Mean)
NTx®-265 Low Dose-11.33
NTx®-265 Medium Dose-21.89
NTx®-265 High Dose-13.29
Saline Placebo-23.44

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Trails B Test Change From Baseline at Day 90

The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D) (NCT00938314)
Timeframe: Baseline and Day 90

Interventionseconds (Mean)
NTx®-265 Low Dose-44.33
NTx®-265 Medium Dose-41.33
NTx®-265 High Dose-55.14
Saline Placebo-22.78

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Action Research Arm Test (ARAT) Change From Baseline at Day 90

The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0. (NCT00938314)
Timeframe: Baseline and Day 90

Interventionscores on a scale (Mean)
NTx®-265 Low Dose10.67
NTx®-265 Medium Dose33.50
NTx®-265 High Dose30.33
Saline Placebo23.75

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Barthel Index at Day 90

The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst. (NCT00938314)
Timeframe: Day 90

InterventionScores on a scale (Mean)
NTx®-265 Low Dose68.18
NTx®-265 Medium Dose80.17
NTx®-265 High Dose85.25
Saline Placebo90.89

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National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90

The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). (NCT00938314)
Timeframe: Baseline and Day 90

Interventionscores on a scale (Mean)
NTx®-265 Low Dose6.79
NTx®-265 Medium Dose6.50
NTx®-265 High Dose6.08
Saline Placebo7.17

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NIHSS Response >=4 at Day 90

The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90. (NCT00938314)
Timeframe: Baseline and Day 90

,,,
Interventionparticipants (Number)
No Response (<4)Response (>=4)
NTx®-265 High Dose519
NTx®-265 Low Dose618
NTx®-265 Medium Dose717
Saline Placebo519

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Modified Rankin Scale (mRS) Response <=2 at Day 90

The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90. (NCT00938314)
Timeframe: Day 90

,,,
Interventionparticipants (Number)
response (mRS <=2)No response (mRS > 2)
NTx®-265 High Dose159
NTx®-265 Low Dose1113
NTx®-265 Medium Dose1113
Saline Placebo186

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Boston Naming Test (BNT) Change From Baseline at Day 90

The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst. (NCT00938314)
Timeframe: Baseline and Day 90

InterventionScores on a scale (Mean)
NTx®-265 Low Dose3.93
NTx®-265 Medium Dose4.17
NTx®-265 High Dose0.20
Saline Placebo3.69

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Gait Velocity Test Change From Baseline at Day 90

The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters. (NCT00938314)
Timeframe: Baseline and Day 90

Interventionseconds (Mean)
NTx®-265 Low Dose-22.75
NTx®-265 Medium Dose-50.33
NTx®-265 High Dose-6.40
Saline Placebo-53.80

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Geriatric Depression Scale at Day 90

The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 - 5 is normal, whereas a score of 6 -15 suggests depression. (NCT00938314)
Timeframe: Day 90

Interventionscores on a scale (Mean)
NTx®-265 Low Dose7.25
NTx®-265 Medium Dose3.88
NTx®-265 High Dose3.56
Saline Placebo4.74

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Line Cancellation Test Change From Baseline at Day 90

The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side. (NCT00938314)
Timeframe: Baseline and Day 90

Interventionscores on a scale (Mean)
NTx®-265 Low Dose-0.03
NTx®-265 Medium Dose-0.07
NTx®-265 High Dose-0.04
Saline Placebo-0.00

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Percentage of Participants Who Discontinued Treatment

Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up). (NCT01023035)
Timeframe: From Study Day 1 up to Study Treatment Week 48

Interventionpercentage of participants (Number)
Ribavirin Dose Reduction Arm29
Erythropoietin Use Arm34
Treated/Not Randomized63

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Percentage of Participants With Sustained Virologic Response (SVR)

SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24 (NCT01023035)
Timeframe: At Follow-up Week 24

Interventionpercentage of participants (Number)
Ribavirin Dose Reduction Arm71.5
Erythropoietin Use Arm70.9

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Mean Single Scoring Values of the IPSS - Randomized Phase

The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival). (NCT01034657)
Timeframe: 52 weeks

Interventionunits on a scale (Mean)
LBH5891.0
LBH589 + Epoetin Alfa1.0
Not Randomized0.0

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Percentage of Participants With Objective Response During the Randomized Phase

Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L. (NCT01034657)
Timeframe: 32 weeks, 48 weeks

,,
InterventionPercentage of participants (Number)
Week 32 ( n=5,1,1)Week 48 (n=6,5,1)
LBH5890.00.0
LBH589 + Epoetin Alfa0.00.0
Not Randomized0.00.0

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Mean Single Scoring Values of the IPSS - Core Phase

The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival). (NCT01034657)
Timeframe: baseline

Interventionunits on a scale (Mean)
LBH5890.43

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Frequency Distribution of IPSS Score Status - Randomized Phase

The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival). (NCT01034657)
Timeframe: 52 weeks

,,
InterventionPercentage of participants (Number)
Week 52 (randomized phase), LowWeek 52 (randomized phase), , INT-1Week 52 (randomized phase), INT-2Week 52 (randomized phase), HIgh
LBH5890.016.70.00.0
LBH589 + Epoetin Alfa0.016.70.00.0
Not Randomized100.00.00.00.0

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Frequency Distribution of IPSS Score Status - Core Phase

The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival). (NCT01034657)
Timeframe: baseline

InterventionPercentage of participants (Number)
Baseline (core phase), LowBaseline (core phase),, INT-1Baseline (core phase),, INT-2Baseline (core phase), High
LBH58932.467.60.00.0

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Percentage of Participants With Objective Response During Core Phase

Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L. (NCT01034657)
Timeframe: 16 weeks

InterventionPercentage of participants (Number)
LBH5890.0

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Percentage of Participants With HI-E - Randomized Phase

HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence. (NCT01034657)
Timeframe: 32 weeks, 52 weeks

,,
InterventionPercentage of participants (Number)
32 weeks (n=5,1,1)52 weeks (n=4,3,1)
LBH5890.00.0
LBH589 + Epoetin Alfa0.00.0
Not Randomized0.00.0

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Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase

HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence. (NCT01034657)
Timeframe: 16 weeks

InterventionPercentage of participants (Number)
LBH5890.0

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Overall Survival (OS) - Overall Period

OS was defined as the time from start of treatment to death from any cause. (NCT01034657)
Timeframe: 48 weeks

Interventionmonths (Median)
LBH589NA

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Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period

Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported. (NCT01066000)
Timeframe: Up to Week 24

InterventionWeeks (Mean)
Mircera3.92

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Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period

The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported. (NCT01066000)
Timeframe: Up to Week 24

Interventiong/dL (Mean)
At baselineMean change at EEP
Mircera10.890.04

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Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods

Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported. (NCT01066000)
Timeframe: Up to Week 24

InterventionMonths (Mean)
Mircera1

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Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)

The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL. (NCT01066000)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Mircera45.8

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Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period

The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported. (NCT01066000)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Participants maintaining Hb >10 g/dlParticipants maintaining Hb within 10-12 g/dl
Mircera62.516.7

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Number of Participants With Adverse Events and Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period. (NCT01066000)
Timeframe: Up to Week 28

InterventionParticipants (Number)
Number of participants serious AETotal number of participants with at least one AE
Mircera415

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Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods

Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported. (NCT01066000)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20

Interventionμg/month (Mean)
At BaselineAt Week 4At Week 8At Week 12At Week 16At Week 20
Mircera97.9103.1107.3119114.6120.8

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Number of Participants With Marked Laboratory Abnormalities

A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL). (NCT01066000)
Timeframe: Up to Week 28

InterventionParticipants (Number)
At Baseline, Hb-LowAt Baseline, Hct-LowAt Baseline, WBC-LowAt Baseline, WBC-HighAt Baseline, MCV-LowAt Baseline, MCV- HighAt Baseline, RBC-LowAt Baseline, RBC -HighAt Baseline, Platelets-LowAt Baseline, Iron-LowAt Baseline, Iron-HighAt Baseline, Feritin-HighAt Baseline, Transferin-LowAt Baseline, TIBC-LowAt Baseline, TSAT-LowAt Baseline, TSAT-HighAt Baseline, Albumin-LowAt Baseline, hs-CRP-HighAt Baseline, Potassium-HighAt Baseline, Phosphorus-HighAt Week 8, Hb-LowAt Week 8, Hct-LowAt Week 8, WBC-HighAt Week 8, MCV-LowAt Week 8, RBC -HighAt Week 8, Platelets-LowAt Week 8, Platelets-HighAt Week 8, Iron-LowAt Week 8, Iron-HighAt Week 8, Feritin-HighAt Week 8, Transferin-LowAt Week 8, TIBC-LowAt Week 24, Hb-LowAt Week 24, Hct-LowAt Week 24, WBC-HighAt Week 24, RBC -HighAt Week 24, Platelets-LowAt Week 24, Platelets-HighAt Week 24, Iron-LowAt Week 24, Iron-HighAt Week 24, Feritin-HighAt Week 24, Transferin-LowAt Week 24, Transferin-HighAt Week 24, TIBC-LowAt Week 24, TSAT-LowAt Week 24, TSAT-HighAt Week 24, Albumin-HighAt Week 24, hs-CRP-HighAt Week 24,Potassium-LowAt Week 24, Potassium-HighAt Week 24, Phosphorus-High
Mircera3028123412710125924883291922223525121122662418142441418611213122311

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Mean Number of RBC Units Transfused During Initial 5 Months of Treatment

Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets. (NCT01099202)
Timeframe: 5 weeks to 5 Months

InterventionPRBC Units (Mean)
Procrit10.63
No Procrit13.11

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Number of PRBC Transfusions During Initial 5 Months of Treatment

Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months. (NCT01099202)
Timeframe: 5 weeks to 5 Months

Interventiontransfusions (Mean)
Procrit6.22
No Procrit7.44

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Change in Erythropoietin Dose

Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL. (NCT01102218)
Timeframe: Baseline and 6 months

InterventionUnits EPO (Mean)
Erythropoietin Plus Pentoxifylline-8700
Erythropoietin Alone-2988

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Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks

(NCT01147666)
Timeframe: Week 7

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)3
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)3
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)6
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)6
Cohort A-9 (Roxadustat 2.0 mg/kg)0
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)1
Cohorts A (Epoetin Alfa)13
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)2
Cohort B (Epoetin Alfa)3
Cohort B (Placebo)0

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Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks

(NCT01147666)
Timeframe: Week 7

InterventionParticipants (Count of Participants)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)3
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)3
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)5
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)5
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)3
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)6
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)6
Cohort A-9 (Roxadustat 2.0 mg/kg)0
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)1
Cohort A (Epoetin Alfa)19
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)0
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)2
Cohort B (Epoetin Alfa)3
Cohort B (Placebo)0

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Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)

The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Weeks 17, 18, 19, and 20

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)5
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)2
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)10
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)10
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)7
Cohort A-9 (Roxadustat 2.0 mg/kg)2
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)6
Cohorts A (Epoetin Alfa)19

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Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)

The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Weeks 17, 18, 19, and 20

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)1
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)6
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)5
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)6
Cohort A-9 (Roxadustat 2.0 mg/kg)2
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)3
Cohorts A (Epoetin Alfa)8
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)0
Cohort B (Epoetin Alfa)0
Cohort B (Placebo)0

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Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Week 7

InterventionParticipants (Count of Participants)
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)0
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)1
Cohort B (Epoetin Alfa)2
Cohort B (Placebo)0

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Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. (NCT01147666)
Timeframe: Weeks 8, 10, 12, 14, 17, 19, and 20

,,,,,,,
InterventionParticipants (Count of Participants)
Week 8Week 10Week 12Week 14Week 17Week 19Week 20
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)6656665
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)3333223
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)6666543
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)4466555
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)4444422
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)4531445
Cohort A-9 (Roxadustat 2.0 mg/kg)1011112
Cohorts A (Epoetin Alfa)9796687

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Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks

(NCT01147666)
Timeframe: Baseline up to Week 6

InterventionParticipants (Count of Participants)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)0
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)0
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)0
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)1
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)0
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)2
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)1
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)2
Cohort A-9 (Roxadustat 2.0 mg/kg)1
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)4
Cohort A (Epoetin Alfa)6
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)0
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)0
Cohort B (Epoetin Alfa)1
Cohort B (Placebo)0

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Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only

Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. (NCT01147666)
Timeframe: Baseline up to Week 6

,,,,
InterventionParticipants (Count of Participants)
Dose IncreasedDose ReducedDose InterruptedDose Resume
Cohort A (Epoetin Alfa)9630
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)0040
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)3076
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)0044
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)0200

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Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks

Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. (NCT01147666)
Timeframe: Baseline up to Week 19

,,,,,,,
InterventionParticipants (Count of Participants)
Dose IncreasedDose ReducedDose InterruptedDose Resume
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)8631
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)2310
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)5353
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)5521
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)4400
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)7411
Cohort A-9 (Roxadustat 2.0 mg/kg)1100
Cohorts A (Epoetin Alfa)121198

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Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Baseline, Week 7

Interventiong/dL (Mean)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)-0.40
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)0.91
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)0.71
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)0.25
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)-0.15
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)-0.18
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)-0.32
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)-0.47
Cohort A-9 (Roxadustat 2.0 mg/kg)-0.00
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)0.24
Cohorts A (Epoetin Alfa)-0.51
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)-2.63
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)-0.89
Cohort B (Epoetin Alfa)-0.28
Cohort B (Placebo)-2.50

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Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks

(NCT01147666)
Timeframe: Baseline up to Week 19

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)0
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)0
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)2
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)1
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)2
Cohort A-9 (Roxadustat 2.0 mg/kg)1
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)4
Cohorts A (Epoetin Alfa)6
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)0
Cohort B (Epoetin Alfa)1
Cohort B (Placebo)0

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Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20

,,,,,,,,,,
Interventiong/dL (Mean)
Change at Week 8Change at Week 10Change at Week 12Change at Week 14Change at Week 17Change at Week 19Change at Week 20
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)0.200.260.380.330.02-0.10-0.57
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)0.490.560.260.53-0.09-0.11-0.39
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)0.080.170.04-0.03-0.09-0.32-0.55
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)0.01-0.17-0.10-0.27-0.27-0.28-0.55
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)-0.49-0.56-0.56-0.41-0.48-0.82-0.82
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)-0.29-0.27-0.35-0.24-0.27-0.35-0.33
Cohort A-9 (Roxadustat 2.0 mg/kg)0.05-0.15-0.15-0.15-0.300.050.15
Cohort B (Epoetin Alfa)-0.410.19-0.080.420.160.120.12
Cohort B (Placebo)-2.37-2.37-2.37-2.37-2.37-2.37-2.47
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)-0.89-1.46-2.02-2.29-2.69-3.02-2.82
Cohorts A (Epoetin Alfa)-0.21-0.34-0.48-0.50-0.45-0.30-0.36

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Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. (NCT01147666)
Timeframe: Week 7

InterventionParticipants (Count of Participants)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)3
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)7
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)6
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)3
Cohort A (Epoetin Alfa)2

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Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks

Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron. (NCT01147666)
Timeframe: Baseline up to Week 19

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)2
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)3
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)2
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)3
Cohort A-9 (Roxadustat 2.0 mg/kg)0
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)4
Cohorts A (Epoetin Alfa)4
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)3
Cohort B (Epoetin Alfa)0
Cohort B (Placebo)1

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Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks

The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values. (NCT01147666)
Timeframe: Weeks 17, 18, 19, and 20

InterventionParticipants (Count of Participants)
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)6
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)5
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)6
Cohort A-9 (Roxadustat 2.0 mg/kg)2
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)4
Cohorts A (Epoetin Alfa)8
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)0
Cohort B (Epoetin Alfa)0
Cohort B (Placebo)0

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Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6

The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. (NCT01147666)
Timeframe: Baseline up to Week 6

Interventiong/dL/week (Number)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)-0.0135
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)0.1926
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)0.1682
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)-0.0220
Cohort A (Epoetin Alfa)-0.1267

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Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only

Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values. (NCT01147666)
Timeframe: Week 7

InterventionParticipants (Count of Participants)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)4
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)8
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)7
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)4
Cohort A (Epoetin Alfa)3

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Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks

Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron. (NCT01147666)
Timeframe: Baseline up to Week 6

InterventionParticipants (Count of Participants)
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)2
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)2
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)3
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)4
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)2
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)3
Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg)2
Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg)3
Cohort A-9 (Roxadustat 2.0 mg/kg)0
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg)4
Cohort A (Epoetin Alfa)6
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)1
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)3
Cohort B (Epoetin Alfa)0
Cohort B (Placebo)1

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Mean Time Participants Spent Having Hb Concentration Within Target Range

Target Hb concentration was between 10.0 and 12.0 g/dL. (NCT01156363)
Timeframe: Weeks 1 to 32

Interventiondays (Mean)
Mircera - CMUH112.6
Mircera - KMUH105.0
Mircera - BTCH107.6
Mircera108.9

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Percentage of Participants Requiring Dose Adjustments

Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm. (NCT01156363)
Timeframe: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8

Interventionpercentage of participants (Number)
Baseline to Month 1: Increase (n=81)Baseline to Month 1: No Change (n=81)Baseline to Month 1: Decrease (n=81)Baseline to Month 1: Not Done (n=81)Month 1 to Month 2: Increase (n=75)Month 1 to Month 2: No Change (n=75)Month 1 to Month 2: Decrease (n=75)Month 1 to Month 2: Not Done (n=75)Months 2 to 3: Increase (n=72)Months 2 to 3: No Change (n=72)Months 2 to 3: Decrease (n=72)Months 2 to 3: Not Done (n=72)Months 3 to 4: Increase (n=68)Months 3 to 4: No Change (n=68)Months 3 to 4: Decrease (n=68)Months 3 to 4: Not Done (n=68)Months 4 to 5: Increase (n=67)Months 4 to 5: No Change (n=67)Months 4 to 5: Decrease (n=67)Months 4 to 5: Not Done (n=67)Months 5 to 6: Increase (n=66)Months 5 to 6: No Change (n=66)Months 5 to 6: Decrease (n=66)Months 5 to 6: Not Done (n=66)Months 6 to 7: Increase (n=64)Months 6 to 7: No Change (n=64)Months 6 to 7: Decrease (n=64)Months 6 to 7: Not Done (n=64)Months 7 to 8: Increase (n=64)Months 7 to 8: No Change (n=64)Months 7 to 8: Decrease (n=64)Months 7 to 8: Not Done (n=64)
Mircera7.461.721.09.94.069.316.010.76.959.719.413.94.464.716.214.711.961.211.914.96.159.121.213.612.565.69.412.53.184.40.012.5

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Mean Monthly Hb Values

The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). (NCT01156363)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

,,,
Interventiong/dL (Mean)
Baseline (n=35,26,22,83)Month 1 (n=35,26,22,83)Month 2 (n=34,26,21,81)Month 3 (n=33,22,20,75)Month 4 (n=31,22,19,72)Month 5 (n=28,21,19,68)Month 6 (n=28,20,19,67)Month 7 (n=27,20,19,66)Month 8 (n=26,19,19,64)
Mircera10.810.910.911.110.911.010.911.111.2
Mircera - BTCH10.810.911.211.811.411.511.411.011.1
Mircera - CMUH10.710.710.810.810.911.010.911.311.5
Mircera - KMUH11.111.310.910.910.510.510.410.910.8

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Change in Hb Concentration Between Reference and Treatment Period

The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). (NCT01156363)
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

,,,
Interventiong/dL (Mean)
Change at Month 1 (n=35,26,22,83)Change at Month 2 (n=34,26,21,81)Change at Month 3 (n=33,22,20,75)Change at Month 4 (n=31,22,19,72)Change at Month 5 (n=28,21,19,68)Change at Month 6 (n=28,20,19,67)Change at Month 7 (n=27,20,19,66)Change at Month 8 (n=26,19,19,64)
Mircera0.10.00.20.00.10.00.20.4
Mircera - BTCH0.10.41.00.60.70.60.20.4
Mircera - CMUH-0.00.10.20.20.40.30.70.9
Mircera - KMUH0.1-0.3-0.3-0.7-0.7-0.8-0.4-0.4

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Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range

Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported. (NCT01156363)
Timeframe: Weeks 1 to 32

Interventionpercentage of participants (Number)
Mircera - CMUH77.1
Mircera - KMUH88.5
Mircera - BTCH90.9
Mircera84.3

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Relative Percent Change in Hb Concentration From Baseline Over the Study Period

(NCT01168349)
Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28

,,
Interventionpercent change (Mean)
Change at Week 4-6 (n=519,262,781)Change at Week 12-16 (n=501,257,758)Change at Week 24-28 (n=357,195,552)
Anemic Cancer Participants (Total Participants)11.916.619.5
Hematological Malignancy Participants13.018.624.7
Solid Tumor Participants11.315.616.6

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Percentage of Participants With Vitamins Prescription

(NCT01168349)
Timeframe: Week 4 to 6, Week 12 to 16, Week 24 to 48

,,,,,,,,
Interventionpercentage of participants (Number)
Week 4-6 (n=217,129,142,74,63,143,23,29,820)Week 12-16 (n=230,132,153,86,72,158,23,30,884)Week 24-28 (n=165,114,111,72,57,127,17,21,684)
Anemic Cancer Participants (Total Participants)6.85.43.4
Breast Cancer Participants1.60.80.9
Chronic Lymphocytic Leukemia Participants10.310.09.5
Colon/Rectum Cancer Participants0.73.91.8
Hodgkin's Lymphoma Participants17.417.45.9
Lung Cancer Participants12.46.56.1
Multiple Myeloma Participants3.24.20.0
Non-Hodgkin's Lymphoma Participants9.88.23.9
Ovary Cancer Participants4.13.52.8

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Percentage of Participants With Subcutaneous (SC) Route of Administration

(NCT01168349)
Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

,,
Interventionpercentage of participants (Number)
Baseline (n=668,300,968)Week 4-6 (n=494,262,756)Week 12-16 (n=238,163,401)Week 24-28 (n=116,76,192)
Anemic Cancer Participants (Total Participants)99.199.299.099.0
Hematological Malignancy Participants100.0100.0100.0100.0
Solid Tumor Participants98.798.898.398.3

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Percentage of Participants With Early Treatment Response: Day 21 to 42

Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. (NCT01168349)
Timeframe: Day 21 to 42

Interventionpercentage of participants (Number)
Solid Tumor Participants52.4
Hematological Malignancy Participants55.7
Anemic Cancer Participants (Total Participants)53.5

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Karnofsky Performance Status (KPS): Baseline

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. (NCT01168349)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Responders78.5
Non-responders78.6
Anemic Cancer Participants (Total Participants)78.6

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Percentage of Participants With At Least 1 Sick Leave

Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants). (NCT01168349)
Timeframe: Week 4 Up to Week 28

Interventionpercentage of participants (Number)
Responders59.2
Non-responders74.4
Anemic Cancer Participants (Total Participants)66.3

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Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion

Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. (NCT01168349)
Timeframe: Baseline up to Week 28

Interventionpercentage of participants (Number)
Responders17.2
Non-responders31.4
Anemic Cancer Participants (Total Participants)23.8

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Mean Starting Dose of NeoRecormon® Injection

Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks). (NCT01168349)
Timeframe: Baseline

InterventionIU/kg/weeks (Mean)
Solid Tumor Participants471.2
Hematological Malignancy Participants447.3
Anemic Cancer Participants (Total Participants)463.9

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Percentage of Participants With Professional Activity: Baseline

Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment. (NCT01168349)
Timeframe: Baseline

,,
Interventionpercentage of participants (Number)
ActiveDisabilityNo occupationRetiredSick leaveStudent, trainingUnemployment
Anemic Cancer Participants (Total Participants)3.62.96.365.719.50.41.7
Non-responders3.03.36.36520.10.61.7
Responders4.12.66.266.318.90.21.7

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Percentage of Participants With Pre-specified Dose and Frequency of Injections

Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported. (NCT01168349)
Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

,,
Interventionpercentage of participants (Number)
Baseline: 30000 IU/weeks-qw (n=669,300,969)Baseline: 20000 IU/weeks-qw (n=669,300,969)Baseline: 40000 IU/weeks-qw (n=669,300,969)Baseline: Other (n=669,300,969)Week 4-6: 30000 IU/weeks-qw (n=494,262,756)Week 4-6: 20000 IU/weeks-qw (n=494,262,756)Week 4-6: 30000 IU/weeks-tw (n=494,262,756)Week 4-6: 60000 IU/weeks-qw (n=494,262,756)Week 4-6: 30000 IU/weeks-q2w (n=494,262,756)Week 4-6: 40000 IU/weeks-qw (n=494,262,756)Week 4-6: Other (n=494,262,756)Week 12-16: 30000 IU/weeks-qw (n=244,163,407)Week 12-16: 20000 IU/weeks-qw (n=244,163,407)Week 12-16: 30000 IU/weeks-tw (n=244,163,407)Week 12-16: 60000 IU/weeks-qw (n=244,163,407)Week 12-16: 30000 IU/weeks-q2w (n=244,163,407)Week 12-16: Other (n=244,163,407)Week 24-28: 30000 IU/weeks-qw (n=119,76,195)Week 24-28: 20000 IU/weeks-qw (n=119,76,195)Week 24-28: 60000 IU/weeks-qw (n=119,76,195)Week 24-28: 40000 IU/weeks-qw (n=119,76,195)Week 24-28: Other (n=119,76,195)
Anemic Cancer Participants (Total Participants)96.52.01.10.493.11.71.20.91.11.20.888.72.51.51.22.73.489.72.12.12.14.1
Hematological Malignancy Participants93.73.72.30.389.73.11.50.81.52.70.884.72.53.71.23.14.989.51.32.63.92.6
Solid Tumor Participants97.81.20.60.494.91.01.01.00.80.40.891.42.50.01.22.52.589.92.51.70.85.0

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Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment

(NCT01168349)
Timeframe: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28

,,
Interventionpercentage of participants (Number)
Baseline up to Week 4-6 (n=639,294,933)Baseline up to Week 12-16 (n=582,275,857)Baseline up to Week 24-28 (n=457,227,684)
Anemic Cancer Participants (Total Participants)16.349.071.3
Hematological Malignancy Participants8.537.165.6
Solid Tumor Participants19.954.674.2

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Mean Number of RBC Units

Mean number of units was based on the number of participants with at least 1 RBC transfusion. (NCT01168349)
Timeframe: Baseline up to Week 28

InterventionRBC units (Mean)
Responders3.4
Non-responders4.3
Anemic Cancer Participants (Total Participants)4.0

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Percentage of Participants With Adequate Iron Status

Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%. (NCT01168349)
Timeframe: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

,,
Interventionpercentage of participants (Number)
Baseline (n=58,65,123)Week 4-6 (n=31,18,49)Week 12-16 (n=24,18,42)Week 24-28 (n=13,17,30)
Anemic Cancer Participants (Total Participants)43.120.431.063.3
Hematological Malignancy Participants47.716.738.970.6
Solid Tumor Participants37.922.625.053.8

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Time to First RBC Transfusions

Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used. (NCT01168349)
Timeframe: Baseline up to Week 28

Interventionweeks (Median)
RespondersNA
Non-respondersNA

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Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed. (NCT01168349)
Timeframe: Week 4 to 6

Interventionpercentage of participants (Number)
Responders5.8
Non-responders6.2
Anemic Cancer Participants (Total Participants)6.0

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Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed. (NCT01168349)
Timeframe: Week 24 to 28

Interventionpercentage of participants (Number)
Responders4.9
Non-responders4.1
Anemic Cancer Participants (Total Participants)4.5

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Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed. (NCT01168349)
Timeframe: Week 12 to 16

Interventionpercentage of participants (Number)
Responders4.3
Non-responders4.3
Anemic Cancer Participants (Total Participants)4.3

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Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline

Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed. (NCT01168349)
Timeframe: Baseline

Interventionpercentage of participants (Number)
Responders6.8
Non-responders8.1
Anemic Cancer Participants (Total Participants)7.4

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Mean Number of RBC Transfusions

Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion. (NCT01168349)
Timeframe: Baseline up to Week 28

InterventionRBC transfusions (Mean)
Responders1.7
Non-responders2.1
Anemic Cancer Participants (Total Participants)2.0

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Mean Number of Days of Sick Leave

Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants). (NCT01168349)
Timeframe: Week 4 Up to Week 28

Interventiondays (Mean)
Responders89.4
Non-responders93.3
Anemic Cancer Participants (Total Participants)91.5

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KPS: Week 4 to 6

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. (NCT01168349)
Timeframe: Week 4 to 6

Interventionunits on a scale (Mean)
Responders81.2
Non-responders76.7
Anemic Cancer Participants (Total Participants)79.2

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KPS: Week 24 to 28

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. (NCT01168349)
Timeframe: Week 24 to 28

Interventionunits on a scale (Mean)
Responders79.7
Non-responders75.6
Anemic Cancer Participants (Total Participants)77.8

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KPS: Week 12 to 16

KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. (NCT01168349)
Timeframe: Week 12 to 16

Interventionunits on a scale (Mean)
Responders78.4
Non-responders74.7
Anemic Cancer Participants (Total Participants)76.7

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Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities). (NCT01168349)
Timeframe: Baseline, Week 4 to 6

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 4 to 6
Anemic Cancer Participants (Total Participants)6.2-0.9
Non-responders6.2-0.8
Responders6.2-1.1

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Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities). (NCT01168349)
Timeframe: Baseline, Week 24 to 28

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 24 to 28
Anemic Cancer Participants (Total Participants)5.8-1.5
Non-responders5.7-1.4
Responders5.9-1.5

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Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16

Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities). (NCT01168349)
Timeframe: Baseline, Week 12 to 16

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 12 to 16
Anemic Cancer Participants (Total Participants)6.0-1.4
Non-responders5.9-1.3
Responders6.1-1.5

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Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment

Percentage of participants with at least 1 temporary discontinuation was reported. (NCT01168349)
Timeframe: Baseline up to Week 28

Interventionpercentage of participants (Number)
Solid Tumor Participants8.1
Hematological Malignancy Participants10.3
Anemic Cancer Participants (Total Participants)8.8

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Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks

(NCT01168349)
Timeframe: Baseline

Interventionpercentage of participants (Number)
Solid Tumor Participants69.9
Hematological Malignancy Participants67.6
Anemic Cancer Participants (Total Participants)69.2

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Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU

(NCT01168349)
Timeframe: Baseline up to Week 28

Interventionpercentage of participants (Number)
Solid Tumor Participants86.2
Hematological Malignancy Participants82.7
Anemic Cancer Participants (Total Participants)85.1

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Percentage of Participants With Modifications of NeoRecormon® Regimen

All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported. (NCT01168349)
Timeframe: Baseline up to Week 28

Interventionpercentage of participants (Number)
Solid Tumor Participants7.2
Hematological Malignancy Participants12.0
Anemic Cancer Participants (Total Participants)8.7

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Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL

(NCT01168349)
Timeframe: Baseline up to Week 28

Interventionpercentage of participants (Number)
Solid Tumor Participants36.0
Hematological Malignancy Participants18.5
Anemic Cancer Participants (Total Participants)30.3

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Percentage of Participants With Early Treatment Response: Day 28 to 42

Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation. (NCT01168349)
Timeframe: Day 28 to 42

Interventionpercentage of participants (Number)
Solid Tumor Participants52.4
Hematological Malignancy Participants56.5
Anemic Cancer Participants (Total Participants)53.8

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Changes in Functional Performance in Daily Activities

Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point. (NCT01193660)
Timeframe: Baseline -1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Self care of FSS: BaselineSelf care of FSS: 1 monthSelf care of FSS: 3 monthsSelf care of FSS: 6 monthsMobility of FSS: BaselineMobility of FSS: 1 monthMobility of FSS: 3 monthsMobility of FSS: 6 monthsSocial function of FSS: BaselineSocial function of FSS: 1 monthSocial function of FSS: 3 monthsSocial function of FSS: 6 monthsSelf care of CAS: BaselineSelf care of CAS: 1 monthSelf care of CAS: 3 monthsSelf care of CAS: 6 monthsMobility of CAS: BaselineMobility of CAS: 1 monthMoblity of CAS: 3 monthsMobility of CAS: 6 monthsSocial function of CAS: BaselineSocial function of CAS: 1 monthSocial function of CAS: 3 monthsSocial function of CAS: 6 months
Erythropoietin & Rehabilitation38.240.443.545.029.232.434.636.640.142.545.847.817.921.124.226.019.722.626.029.224.730.034.236.2
Only Rehabilitation37.440.041.742.824.927.929.331.434.837.540.042.315.319.021.523.113.515.619.324.018.221.124.227.6
Umbilical Cord Blood & Erythropoietin & Rehabilitation39.142.244.746.524.828.131.734.640.042.846.449.118.020.127.029.414.619.622.524.923.028.534.838.4

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Changes in Functional Independence in Daily Activities

WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point. (NCT01193660)
Timeframe: Baseline - 1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Baseline1 month3 months6 months
Erythropoietin & Rehabilitation36.637.538.540.3
Only Rehabilitation31.433.237.137.7
Umbilical Cord Blood & Erythropoietin & Rehabilitation34.135.638.741.1

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Changes in Cognitive Neurodevelopmental Outcome

Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones. (NCT01193660)
Timeframe: Baseline -1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
BSID-II Mental Scale: BaselineBSID-II Mental Scale: 1 month - BaselineBSID-II Mental Scale: 3 months - BaselineBSID-II Mental Scale: 6 months - BaselineBSID-II Mental Scale: 3 months - 1 monthBSID-II Mental Scale: 6 months - 1 monthBSID-II Mental Scale: 6 months - 3 months
Erythropoietin & Rehabilitation105.93.47.411.54.08.14.1
Only Rehabilitation86.63.35.89.92.56.64.1
Umbilical Cord Blood & Erythropoietin & Rehabilitation94.18.212.017.63.89.45.6

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Changes in Motor Performance

GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. (NCT01193660)
Timeframe: Baseline -1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Baseline1 month - Baseline3 months - Baseline6 months - Baseline3 months - 1 month6 months - 1 month6 months - 3 months
Erythropoietin & Rehabilitation38.24.57.59.22.94.71.7
Only Rehabilitation35.56.08.19.62.13.61.5
Umbilical Cord Blood & Erythropoietin & Rehabilitation34.57.0011.514.54.57.53.1

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Changes in Brain MRI

Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter. (NCT01193660)
Timeframe: Baseline - 6 months

,,
Interventionunits on a scale (Mean)
Anterior portion of Rt. posterior Internal CapsulePosterior portion of Rt posterior Internal CapsuleAnterior portion of Lt. posterior Internal CapsulePosterior portion of Lt posterior Internal Capsule
Erythropoietin & Rehabilitation0.010.020.020.04
Only Rehabilitation0.010.020.040.05
Umbilical Cord Blood & Erythropoietin & Rehabilitation0.030.040.030.05

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Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism

"18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE." (NCT01193660)
Timeframe: Baseline - 2 weeks

,,
Interventionunits on a scale (Number)
Rt. Lentiform Nucleus, Gray Matter, PutamenLt. Frontal Lobe, Medial Frontal GyrusLt. Sub-lobar, InsulaLt. Lentiform Nucleus, Gray Matter, PutamenLt.Lentiform Nucleus, Gray Matter, Globus PallidusLt. Midbrain (Thalamus)Rt. Parietal Lobe, PrecuneusLt. Temporal Lobe, Middle Temporal GyrusRt. Parietal Lobe, Pre- and Post-central GyrusRt. Frontal Lobe, Paracentral LobuleRt. Limbic Lobe, Anterior CingulateLt. Frontal Lobe, Precentral GyrusLt. Lentiform Nucleus, PutamenRt. Cerebellar Anterior Lobe, CulmenLt. Cerebellar Posterior Lobe, Cerebellar TonsilRt. Frontal Lobe, Orbital GyrusRt. Occipital Lobe, Middle Occipital GyrusLt. Limbic Lobe, Parahippocampal GyrusRt. Limbic Lobe, Parahippocampal GyrusRt Cerebellum, Posterior Lobe, DecliveRt Cerebellum, Anterior Lobe, Culmen, OccipitalLt Cerebellum, Posterior Lobe, Declive, OccipitalLt. Frontal Lobe, Middle Frontal GyrusRt. Frontal Lobe, Middle Frontal GyrusRt. Frontal Lobe, Sub-gyralLt. Temporal Lobe, Fusiform GyrusLt. Temporal Lobe, Inferior Temporal GyrusRt. Temporal Lobe, Middle Temporal Gyrus
Erythropoietin & Rehabilitation0000000001111111000-1-1-1000000
Only Rehabilitation00-10000-10000011100-1000-1-1-1-1-1-1
Umbilical Cord Blood & Erythropoietin & Rehabilitation1111111110000000-1-1-1000000000

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Changes in Standardized Gross Motor Function

GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. (NCT01193660)
Timeframe: Baseline - 1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Baseline1 month - Baseline3 months - Baseline6 months - Baseline3 months - 1 month6 months - 1 month6 months - 3 months
Erythropoietin & Rehabilitation42.64.36.89.02.54.72.2
Only Rehabilitation36.84.66.47.81.83.11.3
Umbilical Cord Blood & Erythropoietin & Rehabilitation36.03.76.59.12.95.42.6

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Changes in Muscle Strength

Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point. (NCT01193660)
Timeframe: Baseline - 1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Baseline1 month3 months6 months
Erythropoietin & Rehabilitation104.8106.8107.7109.3
Only Rehabilitation100.3101.8103.6104.3
Umbilical Cord Blood & Erythropoietin & Rehabilitation100.7105.0107.8109.9

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Changes in Motor Neurodevelopmental Outcome

Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones. (NCT01193660)
Timeframe: Baseline - 1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
BSID-II Motor Scale: BaselineBSID-II Motor Scale: 1 month - BaselineBSID-II Motor Scale: 3 months - BaselineBSID-II Motor Scale: 6 months - BaselineBSID-II Motor Scale: 3 months - 1 monthBSID-II Motor Scale: 6 months - 1 monthBSID-II Motor Scale: 6 months - 3 months
Erythropoietin & Rehabilitation53.35.26.87.61.62.50.9
Only Rehabilitation45.52.74.35.21.52.51.0
Umbilical Cord Blood & Erythropoietin & Rehabilitation45.25.09.511.74.56.72.2

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Changes in Hand Function

QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times. (NCT01193660)
Timeframe: Baseline - 1 month - 3 months - 6 months

,,
Interventionunits on a scale (Mean)
Baseline1 month - Baseline3 months - Baseline6 months - Baseline3 months - 1 month6 months - 1 month6 months - 3 months
Erythropoietin & Rehabilitation52.85.78.810.73.15.12.4
Only Rehabilitation43.06.610.513.03.56.43.1
Umbilical Cord Blood & Erythropoietin & Rehabilitation36.05.011.113.95.78.42.8

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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs. (NCT01194154)
Timeframe: 24 months

,
Interventionpercentage of participants (Number)
SAEsAEs
Mircera35.684.7
Placebo41.086.3

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Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24

UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. (NCT01194154)
Timeframe: Baseline, Month 24

,
Interventionmg/g (Mean)
Baseline (n=110, 107)Change at Month 24 (n=43, 53)
Mircera261.1173.8
Placebo237.370.59

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Change From Baseline in Serum Creatinine Concentration at Month 24

Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. (NCT01194154)
Timeframe: Baseline, Month 24

,
Interventionmcmol/L (Mean)
Baseline (n=115, 120)Change at Month 24 (n=68, 91)
Mircera147.87.04
Placebo149.34.04

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Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24

Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. (NCT01194154)
Timeframe: Baseline, Month 24

,
InterventionmL/min (Mean)
Baseline (n=115, 120)Change at Month 24 (n=67, 91)
Mircera53.18-2.97
Placebo52.48-2.08

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Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)

The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m^2) = 175 x Serum Cr^-1.154 x age^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m^2 / Year) is defined as -365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement. (NCT01194154)
Timeframe: 24 months

InterventionmL/min/1.73m^2/year (Least Squares Mean)
Mircera3.04
Placebo0.82

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Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as -365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement. (NCT01194154)
Timeframe: 24 months

InterventionmL/min/1.73m^2/year (Least Squares Mean)
Mircera3.02
Placebo0.78

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Change From Baseline in Serum Cystatin C Concentration at Month 24

Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise. (NCT01194154)
Timeframe: Baseline, Month 24

,
Interventionmg/L (Mean)
Baseline (n=115, 120)Change at Month 24 (n=67, 91)
Mircera1.790.10
Placebo1.760.02

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Baseline Retic Count

retic count measured at study entry (NCT01235923)
Timeframe: baseline

Interventionx1000 cells/microliter (Mean)
Weekly Epo122
Three Times a Week Epo140

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Reticulocyte Count

reticulocyte count at 4 weeks (end of study) (NCT01235923)
Timeframe: 4 weeks

Interventioncells x 1000/microliter (Mean)
Weekly Epo275
Three Times a Week Epo268

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Change From Baseline in Mean Hb Concentration at Week 20

Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]). (NCT01342640)
Timeframe: Baseline (Week 0), Week 20

InterventionGrams per deciliter (gm/dL) (Mean)
Baseline (n=53)Change at Week 20 (n=35)
Methoxy Polyethylene Glycol-Epoetin Beta8.8201.440

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Change From Baseline in Mean Hb Concentration at Week 28

PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). (NCT01342640)
Timeframe: Baseline (Week 0), Week 28

Interventiongm/dL (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta1.680

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Change From Baseline in Mean Hb Concentration at Week 24

PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]). (NCT01342640)
Timeframe: Baseline (Week 0), Week 24

Interventiongm/dL (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta1.470

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Incidence of Acute Kidney Injury Based on RIFLE Criteria

(NCT01369732)
Timeframe: upto 7 days after surgery

Interventionparticipants (Number)
Saline Group18
Erythropoietin Group18

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Number of Participants With a Serious Adverse Events (SAE)

Serious adverse events were prespecified. These included any symptomatic thrombosis involving a major vessel, unrelated to an infusion catheter requiring anticoagulation therapy, hematocrit level >65% or an increase of ≥15% in hematocrit in the absence of a preceding blood transfusion, hypertension (defined by receipt of antihypertensive therapy for more than 1 month, discharge with medication, or both), severe pulmonary hemorrhage, severe necrotizing enterocolitis (defined as Bell's stage 2b or 3), severe retinopathy of prematurity resulting in laser surgery or bevacizumab therapy, severe sepsis (defined as culture-proven bacterial or fungal sepsis resulting in blood-pressure support or substantive new respiratory support), grade 3 or 4 intracranial hemorrhage, cardiac arrest that did not result in death, and death. (NCT01378273)
Timeframe: From birth to hospital discharge (average 12-16 weeks depending on gestational age at birth)

InterventionParticipants (Count of Participants)
Control284
Epo 1000 U/kg Followed by 400 U/kg282

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Number of Participants With Death or Severe Neurodevelopmental Impairment (NDI) at 22-26 Months Corrected Age

"Severe NDI was defined as Bayley Scales of infant Development, 3rd edition composite motor score or composite cognitive score <70. This instrument is normed at 100 with standard deviation of 15.~Cerebral palsy was classified as hemiplegia, diplegia, or quadriplegia, and severity was determined according to the Gross Motor Function Classification System (GMFCS) (levels range from 0 [no impairment] to 5 [most severe impairment]). Severe cerebral palsy was defined as a GMFCS level higher than 2." (NCT01378273)
Timeframe: 22-26 months corrected age

InterventionParticipants (Count of Participants)
Control94
Epo 1000 U/kg Followed by 400 U/kg97

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Biomarkers

Plasma Epo concentrations were measured in both groups within the first 24 h after birth before study drug administration (baseline), 30 minutes after study drug administration on day 7 (peak Epo concentration) and 30 minutes before study drug on day 9 (trough Epo) and a random level on day 14 after transition to subcutaneous dosing. (NCT01378273)
Timeframe: Baseline (first 24 hours after birth), days 7, 9 and 14 after birth

,
InterventionmU/mL (Median)
BaselinePeak EpoTrough EpoRandom (day 14)
Control7.62.25.14.6
Epo 1000 U/kg Followed by 400 U/kg72,90715.325

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Imaging

Brain MRI at 36 weeks PMA. Injury scoring was done using a modified scoring system of Kidokoro, with higher scores indicating greater brain injury. Scoring Range: 0-39 (NCT01378273)
Timeframe: 36 weeks postmenstrual age

Interventionscore on a scale (Mean)
Control4.1
Epo 1000 U/kg Followed by 400 U/kg3.8

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Red Blood Cell Transfusions

The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW38
Epoetin Alfa TIW42

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Mortality

Number of participants who died during the study. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW25
Epoetin Alfa TIW26

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Number of Hemoglobin Responders

Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW179
Epoetin Alfa TIW187

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Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16

Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests. (NCT01394991)
Timeframe: from randomization through Week 16

Interventionparticpants (Number)
Epoetin Alfa QW5
Epoetin Alfa TIW10

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Number of Positively Adjudicated Thrombovascular Events

The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW5
Epoetin Alfa TIW13

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Number of Suspected Thrombovascular Events

Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW9
Epoetin Alfa TIW20

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Time to First Positively Adjudicated Thrombovascular Event

Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW5
Epoetin Alfa TIW13

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Time to First Suspected Thrombovascular Event

Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead. (NCT01394991)
Timeframe: during the study (randomization through week 26)

Interventionparticipants (Number)
Epoetin Alfa QW9
Epoetin Alfa TIW20

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Mean Weekly Hemoglobin Level From Week 21 to Week 24

(NCT01473407)
Timeframe: Week 21 up to Week 24

Interventiong/dL (Mean)
Epoetin Hospira10.17
Epogen10.28

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Mean Weekly Hemoglobin Level Through 24 Weeks

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventiong/dL (Mean)
Epoetin Hospira10.25
Epogen10.26

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Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event

In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported. (NCT01473407)
Timeframe: Week 1 up to Week 28

InterventionParticipants (Count of Participants)
Epoetin Hospira9
Epogen11

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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)

ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator. (NCT01473407)
Timeframe: Baseline up to Week 28

InterventionParticipants (Count of Participants)
Epoetin Hospira0
Epogen0

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Number of Participants With Clinically Significant Change From Baseline in Physical Examination

Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator. (NCT01473407)
Timeframe: Baseline up to Week 28

InterventionParticipants (Count of Participants)
Epoetin Hospira0
Epogen0

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Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator. (NCT01473407)
Timeframe: Baseline up to Week 28

InterventionParticipants (Count of Participants)
Epoetin Hospira0
Epogen0

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Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira13.1
Epogen14.5

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Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies

Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. (NCT01473407)
Timeframe: Week 1 up to Week 28

Interventionpercentage of participants (Number)
Epoetin Hospira0.4
Epogen0.0

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Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range

Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported. (NCT01473407)
Timeframe: Week 12, 24

,
Interventionpercentage of participants (Number)
Week 12Week 24
Epoetin Hospira81.073.2
Epogen73.271.4

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator. (NCT01473407)
Timeframe: Baseline up to Week 28

InterventionParticipants (Count of Participants)
Epoetin Hospira0
Epogen0

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Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira5.3
Epogen10.9

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Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira21.6
Epogen23.0

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Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira44.1
Epogen43.2

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Percentage of Participants Who Received Blood Transfusions

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira6.3
Epogen5.9

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Percentage of Participants Who Required Permanent Dose Changes of Study Medication

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira86.3
Epogen93.2

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Percentage of Participants Who Required Temporary Dose Changes of Study Medication

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionpercentage of participants (Number)
Epoetin Hospira7.4
Epogen4.2

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Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level

In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL (NCT01473407)
Timeframe: Week 1 up to Week 24

,
InterventionParticipants (Count of Participants)
Dose Decrease: Hb <9.0 g/dLDose Decrease: Hb (9 to 11 g/dL)Dose Decrease: Hb >11.0 g/dLDose Increase: Hb <9.0 g/dLDose Increase: Hb (9 to 11 g/dL)Dose Increase: Hb >11.0 g/dL
Epoetin Hospira4949147502736
Epogen3746150672654

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Mean Weekly Dosage of Study Medication From Week 21 to Week 24

(NCT01473407)
Timeframe: Week 21 up to Week 24

Interventionunit per kilogram per week (U/kg/week) (Mean)
Epoetin Hospira89.61
Epogen90.37

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Mean Weekly Dosage of Study Medication Through 24 Weeks

(NCT01473407)
Timeframe: Week 1 up to Week 24

InterventionU/kg/week (Mean)
Epoetin Hospira87.51
Epogen90.95

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Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range

Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. (NCT01473407)
Timeframe: Week 12, 24

,
Interventionpercentage of participants (Number)
Week 12Week 24
Epoetin Hospira19.026.8
Epogen26.828.6

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Number of Participants With Treatment-Emergent Adverse Events by Severity

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). (NCT01473407)
Timeframe: Week 1 up to Week 28

,
InterventionParticipants (Count of Participants)
MildModerateSevere
Epoetin Hospira1167442
Epogen1116949

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. (NCT01473407)
Timeframe: Week 1 up to Week 28

,
InterventionParticipants (Count of Participants)
AEsSAEs
Epoetin Hospira23275
Epogen22982

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Total Dose of Study Medication Administered

(NCT01473407)
Timeframe: Week 1 up to Week 24

Interventionunits of study medication (Mean)
Epoetin Hospira146752.6
Epogen147145.2

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Number of Participants With Clinically Significant Change From Baseline in Physical Examination

Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator. (NCT01473420)
Timeframe: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38

InterventionParticipants (Count of Participants)
Epoetin Hospira: Titration Period0
Epogen: Titration Period0
Epoetin Hospira: Maintenance Period0
Epogen: Maintenance Period0

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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)

ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator. (NCT01473420)
Timeframe: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38

InterventionParticipants (Count of Participants)
Epoetin Hospira: Titration Period0
Epogen: Titration Period0
Epoetin Hospira: Maintenance Period0
Epogen: Maintenance Period0

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Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event

In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported. (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

InterventionParticipants (Count of Participants)
Epoetin Hospira: Titration Period4
Epogen: Titration Period6
Epoetin Hospira: Maintenance Period4
Epogen: Maintenance Period4

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Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period

(NCT01473420)
Timeframe: Week 30 up to Week 34

Interventiong/dL (Mean)
Epoetin Hospira: Maintenance Period10.17
Epogen: Maintenance Period10.11

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Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventiong/dL (Mean)
Epoetin Hospira: Maintenance Period10.20
Epogen: Maintenance Period10.22

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Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period

(NCT01473420)
Timeframe: Week 30 up to Week 34

Interventionunit per kilogram per week (U/kg/week) (Mean)
Epoetin Hospira: Maintenance Period82.07
Epogen: Maintenance Period79.14

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Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

InterventionU/kg/week (Mean)
Epoetin Hospira: Maintenance Period81.93
Epogen: Maintenance Period75.08

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator. (NCT01473420)
Timeframe: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38

InterventionParticipants (Count of Participants)
Epoetin Hospira: Titration Period0
Epogen: Titration Period0
Epoetin Hospira: Maintenance Period0
Epogen: Maintenance Period0

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Percentage of Participants With General Tolerability

General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability. (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

,,,
Interventionpercentage of participants (Number)
Excellent TolerabilityGood TolerabilityMild IntolerabilityModerate IntolerabilitySevere Intolerability
Epoetin Hospira: Maintenance Period63.927.04.90.01.6
Epoetin Hospira: Titration Period68.828.82.50.00.0
Epogen: Maintenance Period50.827.916.42.51.6
Epogen: Titration Period67.425.62.32.30.0

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Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period

Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported. (NCT01473420)
Timeframe: Week 26, 34

,
Interventionpercentage of participants (Number)
Week 26Week 34
Epoetin Hospira: Maintenance Period73.579.8
Epogen: Maintenance Period60.974.0

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Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period

Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. (NCT01473420)
Timeframe: Week 26, 34

,
Interventionpercentage of participants (Number)
Week 26Week 34
Epoetin Hospira: Maintenance Period13.510.1
Epogen: Maintenance Period19.313.0

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Percentage of Participants With Local Tolerability

Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability. (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

,,,
Interventionpercentage of participants (Number)
Excellent TolerabilityGood TolerabilityMild IntolerabilityModerate IntolerabilitySevere Intolerability
Epoetin Hospira: Maintenance Period67.224.64.11.60.0
Epoetin Hospira: Titration Period70.025.03.81.30.0
Epogen: Maintenance Period54.130.39.03.32.5
Epogen: Titration Period66.325.65.81.20.0

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Number of Participants With Treatment-Emergent Adverse Events by Severity

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

,,,
InterventionParticipants (Count of Participants)
MildModerateSevere
Epoetin Hospira: Maintenance Period422419
Epoetin Hospira: Titration Period21159
Epogen: Maintenance Period412718
Epogen: Titration Period231615

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Epoetin Hospira: Maintenance Period8523
Epoetin Hospira: Titration Period4512
Epogen: Maintenance Period8633
Epogen: Titration Period5422

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Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period

In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL (NCT01473420)
Timeframe: Week 19 up to Week 34

,
InterventionParticipants (Count of Participants)
Dose Decrease: Hb <9.0 g/dLDose Decrease: Hb (9.0 to 11.0 g/dL)Dose Decrease: Hb >11.0 g/dLDose Increase: Hb <9.0 g/dLDose Increase: Hb (9.0 to 11.0 g/dL)Dose Increase: Hb >11.0 g/dL
Epoetin Hospira: Maintenance Period9203524117
Epogen: Maintenance Period10144023313

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Total Dose of Study Medication Administered: Maintenance Period

In this outcome measure mean of total dose of study medication administered in maintenance period was reported. (NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionunits of study medication (Mean)
Epoetin Hospira: Maintenance Period102003.2
Epogen: Maintenance Period86478.5

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Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period4.1
Epogen: Maintenance Period9.0

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Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period9.8
Epogen: Maintenance Period19.7

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Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period6.6
Epogen: Maintenance Period10.7

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Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period29.1
Epogen: Maintenance Period52.2

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Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies

Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. (NCT01473420)
Timeframe: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38

Interventionpercentage of participants (Number)
Epoetin Hospira: Titration Period0.0
Epogen: Titration Period0.0
Epoetin Hospira: Maintenance Period0.0
Epogen: Maintenance Period0.0

[back to top]

Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period55.8
Epogen: Maintenance Period62.0

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Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period30.2
Epogen: Maintenance Period25.0

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Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period

(NCT01473420)
Timeframe: Week 1 up to Week 18

Interventionpercentage of participants (Number)
Epoetin Hospira: Titration Period47.5
Epogen: Titration Period47.7

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Percentage of Participants Who Received Blood Transfusions: Maintenance Period

(NCT01473420)
Timeframe: Week 19 up to Week 34

Interventionpercentage of participants (Number)
Epoetin Hospira: Maintenance Period4.0
Epogen: Maintenance Period4.1

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Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator. (NCT01473420)
Timeframe: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38

InterventionParticipants (Count of Participants)
Epoetin Hospira: Titration Period0
Epogen: Titration Period0
Epoetin Hospira: Maintenance Period0
Epogen: Maintenance Period0

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Percentage of Participants Undergoing Conversion to Peginesatide Injection

(NCT01478971)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Peginesatide Injection88

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Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion

(NCT01478971)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Epoetin Standard of Care10.7
Peginesatide Treatment Period8.3

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Peginesatide Dosing

The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide. (NCT01478971)
Timeframe: Month 6 - 12

Interventionmg (Mean)
Starting DoseAverage Dose During Treatment PeriodLast Weekly Average Dose
Peginesatide Injection5.14.95.2

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Percentage of Participants Who Received at Least One Intravenous Iron Dose

Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores. (NCT01478971)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Epoetin Standard of Care85.4
Peginesatide Treatment Period73.2

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Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL

Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL. (NCT01478971)
Timeframe: Months 1, 2, 3, 4, 5 and 6 of each treatment period

,
Interventionpercentage of participants (Number)
Month 1 (n=156, 155)Month 2 (n=157, 155)Month 3 (n=156, 155)Month 4 (n=156, 151)Month 5 (n=157, 147)Month6 (n=157, 146)
Epoetin Standard of Care39.140.841.044.942.758.0
Peginesatide Treatment Period44.546.545.249.044.939.0

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Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL

(NCT01519947)
Timeframe: Up to approximately 20 months

Interventionmicrograms (mcg) (Mean)
Pre-dialysis, Sea Level150.3
Dialysis, Sea Level194.7
Pre-dialysis, >1800 Meters98.7
Dialysis, >1800 Meters66.6

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Change in Hemoglobin Concentration

(NCT01519947)
Timeframe: From baseline to 6 months

Interventiongrams per deciliter (g/dL) (Mean)
Pre-dialysis, Sea Level1.4
Dialysis, Sea Level2.5
Pre-dialysis, >1800 Meters2.0
Dialysis, >1800 Meters2.4

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Percentage of Participants With Adverse Events

An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. (NCT01519947)
Timeframe: Up to approximately 20 months

Interventionpercentage of participants (Number)
Pre-dialysis, Sea Level84.2
Dialysis, Sea Level90.0
Pre-dialysis, >1800 Meters66.7
Dialysis, >1800 Meters85.7

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Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment

(NCT01519947)
Timeframe: 3 and 6 months

,,,
Interventionpercentage of participants (Number)
3 months6 months
Dialysis, >1800 Meters28.619.0
Dialysis, Sea Level10.00.0
Pre-dialysis, >1800 Meters0.013.3
Pre-dialysis, Sea Level36.852.6

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Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)

Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1) (NCT01576341)
Timeframe: 52 weeks

,,
Interventiong/dL (Mean)
Actual ValueChange from Baseline Period
HX57510.831.02
HX575 - ESA Maintenance10.860.22
HX575 - ESA Naive10.811.61

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Anti-Erythropoietin (EPO) Antibodies

The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay (NCT01576341)
Timeframe: 52 weeks

Interventionpercentage of participants (Number)
HX5751.7

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Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels

Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. (NCT01628107)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)

ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion. (NCT01628107)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira2

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Number of Participants Who Received Concomitant Medication

(NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionParticipants (Number)
Epoetin Hospira406

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Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48

(NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionUnit per kilogram per week (U/kg/week) (Mean)
Epoetin Hospira95.30

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Mean Hemoglobin Levels: Over Week 1 to 48

(NCT01628107)
Timeframe: Week 1 up to Week 48

Interventiong/dL (Mean)
Epoetin Hospira10.21

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Mean Hematocrit Levels: Over Week 1 to 48

Hematocrit is defined as the percentage of red blood cells in the blood. (NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of red blood cells (Mean)
Epoetin Hospira32.17

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests

Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion. (NCT01628107)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)

(NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira20.9

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Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)

(NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira13.9

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Percentage of Participants With Hemoglobin Level Outside the Target Range

Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. (NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira90.1

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Week 1 up to Week 12

InterventionPercentage of participants (Number)
Epoetin Hospira59.4

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Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks

(NCT01628107)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

InterventionU/kg/week (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira94.9394.8494.0199.55

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Week 13 up to Week 24

InterventionPercentage of participants (Number)
Epoetin Hospira57.5

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Week 25 up to Week 36

InterventionPercentage of participants (Number)
Epoetin Hospira54.3

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Week 37 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira51.7

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Up through 7 days after first dose of study drug (Week 1)

InterventionPercentage of participants (Number)
Epoetin Hospira13.0

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Mean Hematocrit Levels for Interval of 12 Weeks

Hematocrit is defined as the percentage of red blood cells in the blood. (NCT01628107)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

InterventionPercentage of red blood cells (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira32.2632.2132.0332.17

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Mean Hemoglobin Levels for Interval of 12 Weeks

(NCT01628107)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

Interventiong/dL (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira10.2610.2510.1810.21

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Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies

Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies. (NCT01628107)
Timeframe: Baseline, Week 48

InterventionPercentage of participants (Number)
BaselineWeek 48
Epoetin Hospira00.6

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira85.7

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Number of Participants With Clinically Significant Change From Baseline in Physical Examinations

Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion. (NCT01628107)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Percentage of Participants Who Received Blood Transfusions

(NCT01628107)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira9.7

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Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies

Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. (NCT01628120)
Timeframe: Baseline, Week 48

InterventionPercentage of participants (Number)
BaselineWeek 48
Epoetin Hospira0.60.7

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Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks

(NCT01628120)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

InterventionU/kg/week (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira80.4983.1485.9888.86

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Mean Hemoglobin Levels: Over Week 1 to 48

(NCT01628120)
Timeframe: Week 1 up to Week 48

Interventiong/dL (Mean)
Epoetin Hospira10.24

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Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48

(NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionUnit per kilogram per week (U/kg/week) (Mean)
Epoetin Hospira83.74

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Number of Participants Who Received Concomitant Medication

(NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionParticipants (Number)
Epoetin Hospira170

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Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)

ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion. (NCT01628120)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels

Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. (NCT01628120)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests

Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion. (NCT01628120)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Week 1 up to Week 12

InterventionPercentage of participants (Number)
Epoetin Hospira67.1

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira87.6

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Week 13 up to Week 24

InterventionPercentage of participants (Number)
Epoetin Hospira60.5

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Week 25 up to Week 36

InterventionPercentage of participants (Number)
Epoetin Hospira57.9

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Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)

(NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira20.7

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Percentage of Participants Who Received Blood Transfusions

(NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira8.3

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Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)

(NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira13.0

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Number of Participants With Clinically Significant Change From Baseline in Physical Examinations

Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator. (NCT01628120)
Timeframe: Baseline up to Week 48

InterventionParticipants (Number)
Epoetin Hospira0

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Week 37 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira48.5

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Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. (NCT01628120)
Timeframe: Up through 7 days after first dose of study drug (Week 1)

InterventionPercentage of participants (Number)
Epoetin Hospira17.4

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Percentage of Participants With Hemoglobin Level Outside Target Range

Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. (NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of participants (Number)
Epoetin Hospira86.4

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Mean Hematocrit Levels for Interval of 12 Weeks

Hematocrit is defined as the percentage of red blood cells in the blood. (NCT01628120)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

InterventionPercentage of red blood cells (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira31.9032.3232.4032.31

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Mean Hematocrit Levels: Over Week 1 to 48

Hematocrit is defined as the percentage of red blood cells in the blood. (NCT01628120)
Timeframe: Week 1 up to Week 48

InterventionPercentage of red blood cells (Mean)
Epoetin Hospira32.22

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Mean Hemoglobin Levels for Interval of 12 Weeks

(NCT01628120)
Timeframe: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

Interventiong/dL (Mean)
Week 1 to Week 12Week 13 to Week 24Week 25 to Week 36Week 37 to Week 48
Epoetin Hospira10.1610.2810.3010.25

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Mean Weekly Dose During Evaluation Period (Week 21-28)

Mean weekly study drug dose during evaluation period (Week 21-28) (NCT01693029)
Timeframe: Week 21-28

Interventioninternational units (Mean)
HX575 Epoetin Alfa5876.5
US-licensed Epoetin Alfa5804.0

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Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)

Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study . (NCT01693029)
Timeframe: Week -4 to Day1 and Week 21-28

Interventiong/dL (Least Squares Mean)
HX575 Epoetin Alfa-0.0960
US-licensed Epoetin Alfa-0.0035

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Incidence of Antibody Formation Against Epoetin

Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies. (NCT01693029)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
HX575 Epoetin Alfa7
US-licensed Epoetin Alfa2

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Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)

Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study . (NCT01693029)
Timeframe: Week -4 to Day1 and Week 21-28

,
Interventiong/dL (Mean)
Baseline periodEvaluation periodChange from baseline period to evaluation period
HX575 Epoetin Alfa10.5310.42-0.11
US-licensed Epoetin Alfa10.5010.510.01

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Reticulocyte Count

Reticulocytes are immature red blood cells. (NCT01736215)
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8

InterventionNanogram per liter (Mean)
Baseline (n=18)Week 1 (n=17)Week 2 (n=16)Week 4 (n=17)Week 8 (n=7)
Participants With Cancer Related Anemia92.3364.81200.74120.68111.74

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Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)

EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed. (NCT01736215)
Timeframe: Baseline

InterventionParticipants (Number)
EPO level less than or equal to 45.2EPO level greater than 45.3
Participants With Cancer Related Anemia1213

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Percentage of Participants With Response to Erythropoietin Treatment

Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria. (NCT01736215)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Participants With Cancer Related Anemia52.63

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Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4

CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed. (NCT01736215)
Timeframe: Baseline

InterventionParticipants (Number)
CRP less than or equal to 10.3CRP greater than 10.4
Participants With Cancer Related Anemia1312

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Serum Hematocrit Level

Hematocrit is the amount of red blood cells in the blood. (NCT01736215)
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8

InterventionPercentage of red blood cells (Mean)
Baseline (n=19)Week 1 (n=18)Week 2 (n=18)Week 4 (n=18)Week 8 (n=7)
Participants With Cancer Related Anemia30.7530.5930.7633.1933.01

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Transferring Iron Binding Capacity (TIBC)

TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. (NCT01736215)
Timeframe: Baseline, Week 1 and Week 2

InterventionMcg per dl (Mean)
Baseline (n=19)Week 1 (n=18)Week 2 (n=18)
Participants With Cancer Related Anemia275.26281.39288.17

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Serum Iron Level

Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin. (NCT01736215)
Timeframe: Baseline, Week 1 and Week 2

InterventionMicrogram per deciliter (Mcg per dl) (Mean)
BaselineWeek 1Week 2
Participants With Cancer Related Anemia66.0689.2253.06

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Serum Hemoglobin Level

Hemoglobin is defined as a substance that carries oxygen and gives blood its red color. (NCT01736215)
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8

InterventionGram per deciliter (g per dl) (Mean)
Baseline (n=19)Week 1 (n=18)Week 2 (n=18)Week 4 (n=18)Week 8 (n=7)
Participants With Cancer Related Anemia9.969.9410.0010.6410.43

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Serum Ferritin Level

Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron. (NCT01736215)
Timeframe: Baseline, Week 1 and Week 2

InterventionMicrogram per liter (Mean)
Baseline (n=19)Week 1 (n=18)Week 2 (n=18)
Participants With Cancer Related Anemia807.28870.28685.11

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Peginesatide Dose by Visit

(NCT01737879)
Timeframe: Baseline and Weeks 5, 9, 13, and 17

Interventionmg (Mean)
Baseline (n=30)Week 5 (n=16)Week 9 (n=15)Week 13 (n=9)Week 17 (n=9)
Peginesatide5.425.044.984.005.12

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Hemoglobin Concentration by Visit

(NCT01737879)
Timeframe: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21

Interventiong/dL (Mean)
Baseline (n=34)Week 3 (n=34)Week 5 (n=29)Week 7 (n=21)Week 9 (n=20)Week 11 (n=19)Week 13 (n=14)Week 15 (n=10)Week 17 (n=10)Week 19 (n=10)Week 21 (n=1)End of study visit (n=32)
Peginesatide10.5111.0910.8611.0310.5910.8010.5010.7010.3510.9310.1010.55

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Number of Participants With Change/Improvement Visual Acuity From the Beseline

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)28
Methylprednisolone3
Observation5

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Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)26
Methylprednisolone7
Observation8

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Percentage of Participants Who Required Blood Transfusions During the Study

The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit. (NCT01809314)
Timeframe: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4

Interventionpercentage of participants (Number)
Baseline to Month 1 (n=1073)Month 1 to 2 (n=853)Month 2 to 3 (n=650)Month 3 to 4 (n=281)
NeoRecormon in Symptomatic Anemia4.14.13.83.9

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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT

"ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as Baseline 0, EOT 2. Transition to a lower performance status indicates improved/increased independence." (NCT01809314)
Timeframe: Baseline, Month 4

Interventionpercentage of participants (Number)
Baseline 0, EOT 0 (n=71)Baseline 0, EOT 1 (n=71)Baseline 0, EOT 2 (n=71)Baseline 1, EOT 0 (n=168)Baseline 1, EOT 1 (n=168)Baseline 1, EOT 2 (n=168)Baseline 2, EOT 0 (n=33)Baseline 2, EOT 1 (n=33)Baseline 2, EOT 2 (n=33)
NeoRecormon in Symptomatic Anemia77.519.72.823.867.38.921.248.530.3

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Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)

The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L). (NCT01809314)
Timeframe: Baseline, Month 4

Interventiong/L (Mean)
NeoRecormon in Symptomatic Anemia14.58

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Summary of Erythroid Response Within 24 Weeks in Participants Randomized to EPO at Baseline and Not Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)

Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL). Percentages are based on N. Confidence intervals are calculated using Clopper-Pearson method. Hemoglobin value is at time of first response (NCT01868477)
Timeframe: baseline up to 24 weeks

Interventionpercentage of participants (Number)
EPO (24 Weeks)71.4

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Absolute Change in Hemoglobin (Hb) From Baseline for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)

This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventiong/dL (Median)
Responders - Week 5Responders - Week 9Responders - Week 13Responders - Week 17Responders - Week 21Non-responders - Week 5Non-responders - Week 9Non-responders - Week 13Non-responders - Week 17Non-responders - Week 21
Deferasirox + Erythropoietin Alpha0.71.62.92.41.7-0.10.00.2-0.5-0.6

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Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)

This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. The time-course of Hb and its absolute changes from baseline was summarized by descriptive statistics by visit and erythroid response. Patients randomized to EPO and not switching after 12 weeks to EPO+DFX would consist of only responders. (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventiong/dL (Median)
Responders - Week 5Non-responders - Week 5Non-responders - Week 13Non-responders - Week 21
EPO+DFX at 12 Weeks1.20.30.40.0

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Absolute Change in Hemoglobin (Hb) From Baseline for Erythropoietin Alpha Arm (Full Analysis Set)

This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventiong/dL (Median)
Responders - Week 5Responders - Week 9Responders - Week 13Responders - Week 17Responders - Week 21Non-responders - Week 5Non-responders - Week 9Non-responders - Week 13
Erythropoietin Alpha1.51.91.71.60.8-0.9-1.7-2.5

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Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventionng/mL (Median)
Responders - Week 5Responders - Week 9Responders - Week 17Responders - Week 21Non-responders - Week 5Non-responders - Week 17Non-responders - Week 21
Deferasirox + Erythropoietin Alpha-82.5-13916.5-95.5-38.0-123-291

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Absolute Change in Serum Ferritin up to 24 Weeks for Erythropoietin Alpha Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventionng/mL (Median)
Responders - Week 5Responders - Week 9Responders - Week 13Responders - Week 17Responders - Week 21Non-responders - Week 5Non-responders - Week 9Non-responders - Week 13
Erythropoietin Alpha-98.5-79.024.8-57.8-39.8-352-189-44.5

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Absolute Change in Platelets and Neutrophil Levels up to 24 Weeks

Absolute change in platelets and neutrophil levels for participants showing improvement: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L) (NCT01868477)
Timeframe: Baseline up to 24 weeks

,
Intervention10^9 cells/L (Mean)
PlateletsNeutrophils
Deferasirox + Erythropoietin Alpha66.32.4
Erythropoietin Alpha58.71.2

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Summary of Hematologic Improvement in Patients Randomized to EPO+DFX and EPO Alone, Within 24 Weeks of Treatment (Full Analysis Set)

Percentage of participants achieving an hematologic improvement defined as: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L), hemoglobin improvement: Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL) (NCT01868477)
Timeframe: Baseline up to 24 weeks

,
Interventionpercentage of participants (Number)
Hematologic improvementNeutropil improvementPlatelet improvementHemoglobin improvement
Deferasirox + Erythropoietin Alpha45.580.080.060.0
Erythropoietin Alpha10066.750.066.7

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Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)

Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set) (NCT01868477)
Timeframe: Baseline up to 24 weeks

InterventionAbsolute change in serum ferritin from baseline (ng/mL)
"Responders - Week 1372023740"Non-responders - Week 972023740"Non-responders - Week 1372023740
"
Deferasirox + Erythropoietin AlphaMedian

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Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)

Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set) (NCT01868477)
Timeframe: Baseline up to 24 weeks

InterventionThis analysis included patients randomized either (g/dL)
"Responders - Week 972023742"Responders - Week 1372023742"Responders - Week 1772023742"Non-responders - Week 972023742"Non-responders - Week 1772023742
"
EPO+DFX at 12 WeeksMedian

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Absolute Change in Serum Ferritin up to 24 Weeks for EPO+DFX at 12 Weeks Arm (Full Analysis Set)

Absolute change in serum ferritin from baseline (NCT01868477)
Timeframe: Baseline up 24 weeks

Interventionng/mL (Median)
Responders - Week 5Responders - Week 9Responders - Week 13Responders - Week 17Non-responders - Week 5Non-responders - Week 9Non-responders - Week 13Non-responders - Week 17Non-responders - Week 21
EPO+DFX at 12-116-13659.574.5-68.3-148220.4-16.6-10.5

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Summary of Erythroid Response in Participants Randomized to EPO Alone at Baseline and Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)

Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL) (NCT01868477)
Timeframe: Week 13 up to 24 weeks

Interventionparticipants (Number)
EPO+DFX (12 Weeks)0

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Absolute Change in Hemoglobin Values up to 24 Weeks

Absolute change in hemoglobin values for patients showing improvement: Hemoglobin improvement Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL) (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventiong/dL (Mean)
Erythropoietin Alpha1.3
Deferasirox + Erythropoietin Alpha1.4

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Absolute Change From Baseline to Post-baseline Value for Hemoglobin(g/dL)(Full Analysis Set)

Hematological response criteria defined as: Erythroid response: hemoglobin (Hb) increase from baseline >= 1.5 g/dL (baseline < 11 g/dL), neutrophil response: increase from baseline >= 100% and increase > 0.5 × 10^9/L (baseline <1 × 10^9/L), platelet response: increase from baseline >= 30 × 10^9/L (baseline <100 × 10^9/L) according to modified IWG 2006 criteria (NCT01868477)
Timeframe: Baseline up to 24 weeks

Interventiong/dL (Mean)
Erythropoietin Alpha1.8
Deferasirox + Erythropoietin Alpha2.1

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Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)

Difference in percentage of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria increase in hemoglobin (Hb) ≥ 1.5 g/dL. Erythroid response is defined as the increase in Hb from baseline ≥ 1.5 g/dL. Patients achieving erythroid response at least once within 12 weeks were considered responders (NCT01868477)
Timeframe: Baseline up to 12 weeks

Interventionpercentage of participants (Number)
Erythropoietin Alpha41.7
Deferasirox + Erythropoietin Alpha27.3

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Number of Subjects Requiring at Least One Blood Transfusion During Surgery.

The number of subjects who had blood transfusions (at least 1) during surgery (NCT01888003)
Timeframe: During surgery (less than 1 day)

InterventionParticipants (Number)
Anemia Treatment Group (AMG)0
Conventional Treatment Group (CTG)0
Non Anemia Group (NAG)0

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Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital

Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital (NCT01888003)
Timeframe: post surgery through discharge, an average of 2 days

Interventionparticipants (Number)
Anemia Treatment Group (AMG)0
Conventional Treatment Group (CTG)1
Non Anemia Group (NAG)0

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Alberta Infant Motor Scale (AIMS)

The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items), & standing (16 items). Each item is scored as 'observed' or 'not observed'. Total score range is 0-58, scored as percentile ranks after a raw score is obtained and plotted against age at testing, based on validated norms. (NCT01913340)
Timeframe: 12 months

Interventionpercentile (Mean)
Erythropoietin53.5
Normal Saline42.8

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Growth Parameters: Head Circumference

(NCT01913340)
Timeframe: 12-months

Interventioncm (Mean)
Erythropoietin45.7
Normal Saline45.5

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Warner Initial Developmental Evaluation (WIDEA) at 6 Months of Age

A 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care score range 7-28. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Higher the score means higher functioning. Lower scores means lower functioning. (NCT01913340)
Timeframe: 6 months

,
Interventionunits on a scale (Mean)
Total score (50-200)Self-care (7-28)Mobility (9-36)Communication (13-52)Social Cognition (11-44)
Erythropoietin75.328.114.116.416.7
Normal Saline68.826.112.415.314.9

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Growth Parameters: Weight

(NCT01913340)
Timeframe: 12-months

Interventionkg (Mean)
Erythropoietin9.9
Normal Saline9.7

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Moderate to Severe Neurodevelopmental Impairment

Moderate to severe neurodevelopmental impairment at 12 months was defined as AIMS less than 5th percentile for age, or WIDEA more than 2 standard deviations below the mean based on normative data from typically developing infants at 12.9 months of age. (NCT01913340)
Timeframe: 12-months

InterventionParticipants (Count of Participants)
Erythropoietin2
Normal Saline5

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Brain Injury, as Determined by Neonatal Brain MRI

(NCT01913340)
Timeframe: neonatal hospitalization

,
Interventionparticipants (Number)
Global brain injury score: None (0)Global brain injury score: Mild (1-11)Global brain injury score: Moderate (12-31)Global brain injury score: Severe (>=32)Presence of brain injury: SubcorticalPresence of brain injury: CorticalPresence of brain injury: White matterPresence of brain injury: BrainstemPresence of brain injury: CerebellarPresence of brain injury: >=2 regions injured
Erythropoietin814017412107
Normal Saline31165179154514

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Markers of Organ Function

The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit (NCT01913340)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

,
Interventionparticipants (Number)
Liver dysfunction (ALT >100 IU/L)Hypotension (requiring inotrope or vasopressor)Thrombocytopenia (platelet < 100,000 per uL)Persistent pulmonary hypertensionDisseminated intravascular coagulationSepsis (positive blood culture and antibiotics >=7Renal dysfunction (creatinine > 1.5)Hypertension (requiring anti-hypertensive)Polycythemia (requiring intervention)Death during birth hospitalizationCardiopulmonary collapse within 2 hours of drugThrombosis of major vesselUnexpected event related to study drug
Erythropoietin10965304102110
Normal Saline612104555005010

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Warner Initial Developmental Evaluation (WIDEA)

A 43-item questionnaire developed and standardized to assess the functional domains of self-care, motor function, communication and social cognition in young children. Self care sub-scale score range 17-68. Mobility score range is 9-36. Communication score range is 13-52. Social Cognition score range is 11-44. Total scale range is 50-200. Higher scores mean higher functioning. Lower scores mean lower functioning. (NCT01913340)
Timeframe: 12 months

,
Interventionunits on a scale (Mean)
Total score (50-200)Self-care (17-68)Mobility (9-36)Communication (13-52)Social Cognition (11-44)
Erythropoietin12236.728.628.228.8
Normal Saline11033.823.825.526.9

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Growth Parameters: Height

(NCT01913340)
Timeframe: 12-months

Interventioncm (Mean)
Erythropoietin74.3
Normal Saline71.7

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Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study

(NCT01940484)
Timeframe: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)

Interventionmcg (Mean)
Visit 2 (n=91)Visit 3 (n=87)Visit 4 (n=90)Visit 5 (n=89)Visit 6 (n=85)Visit 7 (n=83)
Chronic Renal Anemia Participants106.59108.91117.38122.47127.35133.73

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Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta

Dose adjustment included dose increase or dose decrease with respect to previous visit's dose. (NCT01940484)
Timeframe: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)

Interventionparticipants (Number)
Visit 2-Decreased (n=97)Visit 2-Increased (n=97)Visit 3-Decreased (n=91)Visit 3-Increased (n=91)Visit 4-Decreased (n=86)Visit 4-Increased (n=86)Visit 5-Decreased (n=90)Visit 5-Increased (n=90)Visit 6-Decreased (n=88)Visit 6-Increased (n=88)Visit 7-Decreased (n=85)Visit 7-Increased (n=85)Visit 8-Decreased (n=81)Visit 8-Increased (n=81)
Chronic Renal Anemia Participants006417418316211411

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)

(NCT01940484)
Timeframe: Visit 7 (Month 6)

Interventionparticipants (Number)
Chronic Renal Anemia Participants24

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Mean Hemoglobin Value at Visit 3 (Month 2)

(NCT01940484)
Timeframe: Visit 3 (Month 2)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants10.81

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Mean Hemoglobin Value at Visit 7 (Month 6)

(NCT01940484)
Timeframe: Visit 7 (Month 6)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants10.94

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)

(NCT01940484)
Timeframe: Visit 4 (Month 3)

Interventionparticipants (Number)
Chronic Renal Anemia Participants22

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)

(NCT01940484)
Timeframe: Visit 6 (Month 5)

Interventionparticipants (Number)
Chronic Renal Anemia Participants24

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)

(NCT01940484)
Timeframe: Visit 5 (Month 4)

Interventionparticipants (Number)
Chronic Renal Anemia Participants17

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)

(NCT01940484)
Timeframe: Visit 3 (Month 2)

Interventionparticipants (Number)
Chronic Renal Anemia Participants26

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Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)

(NCT01940484)
Timeframe: Visit 2 (Month 1)

Interventionparticipants (Number)
Chronic Renal Anemia Participants23

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Mean Hemoglobin Value at Visit 6 (Month 5)

(NCT01940484)
Timeframe: Visit 6 (Month 5)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants10.82

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Mean Hemoglobin Value at Visit 5 (Month 4)

(NCT01940484)
Timeframe: Visit 5 (Month 4)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants10.80

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Mean Hemoglobin Value at Visit 4 (Month 3)

(NCT01940484)
Timeframe: Visit 4 (Month 3)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants10.61

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Mean Hemoglobin Value at Visit 2 (Month 1)

(NCT01940484)
Timeframe: Visit 2 (Month 1)

Interventiong/dL (Mean)
Chronic Renal Anemia Participants11.31

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Percentage of Participants With Exacerbation of Hypertension During Weeks 28 to 52

Percentage of participants with exacerbation of hypertension, meeting at least one of the following criteria are reported: i) Increase in BP: An increase from baseline of ≥ 20 mmHg in sBP and sBP >170 mmHg, or an increase from baseline of ≥15 mmHg dBP and dBP >100 mmHg. (NCT02052310)
Timeframe: Weeks 28 to 52

Interventionpercentage of participants (Number)
Roxadustat14.0
Epoetin Alfa15.2

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Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)

Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0) up to Week 24

Interventionpercentage of participants (Number)
Roxadustat88.2
Epoetin Alfa84.4

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Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 36), Censoring for Rescue Therapy

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 36

Interventiong/dL (Mean)
Roxadustat2.70
Epoetin Alfa2.46

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Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52

Monthly iron use for each participant = Total IV iron in mg / [(last dose date - first dose date of study medication in the period)+1]/ 28. (NCT02052310)
Timeframe: Weeks 28 to 52

Interventionmg/PEM (Median)
Roxadustat0.00
Epoetin Alfa26.86

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Time to Achieve the First Hb Response up to Week 24 Censoring for Rescue Therapy

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Median time to event was calculated using Kaplan Meier Survival Estimates. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0) up to Week 24

Interventionweeks (Median)
Roxadustat7.1
Epoetin Alfa8.1

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Time to First Exacerbation of Hypertension During Weeks 28 to 52

An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mm Hg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. (NCT02052310)
Timeframe: Weeks 28 to 52

Interventionweeks (Median)
RoxadustatNA
Epoetin AlfaNA

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Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Week 18 to 24

,
Interventiong/dL (Mean)
BaselineChange at Week 18 to 24
Epoetin Alfa8.382.48
Roxadustat8.542.34

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Time to First RBC Transfusion

Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa)

Interventionweeks (Median)
RoxadustatNA
Epoetin AlfaNA

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US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population)

Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0) up to Week 24

Interventionpercentage of participants (Number)
Roxadustat84.3
Epoetin Alfa79.5

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Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population)

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 52

,
Interventiong/dL (Mean)
BaselineChange at Week 28 to 52
Epoetin Alfa8.432.44
Roxadustat8.432.62

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US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)

Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 52

,
Interventiong/dL (Mean)
BaselineChange at Week 28 to 52
Epoetin Alfa8.462.36
Roxadustat8.432.57

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Percentage of Participants With Hb ≥10.0 g/dL Averaged Over Weeks 28 to 36 and 28 to 52, Regardless of Rescue Therapy

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. (NCT02052310)
Timeframe: Weeks 28 to 36 and 28 to 52

,
Interventionpercentage of participants (Number)
Weeks 28 to 36Weeks 28 to 52
Epoetin Alfa70.872.5
Roxadustat73.473.6

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Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12

Baseline MAP was defined as the last MAP value prior to the first dose of study treatment. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Weeks 8 to 12

,
Interventionmillimeters of mercury (mmHg) (Mean)
BaselineChange at Weeks 8 to 12
Epoetin Alfa99.041.15
Roxadustat99.33-0.12

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Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24

Baseline LDL Cholesterol was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment. (NCT02052310)
Timeframe: Baseline (Day 1, Week 0), Week 12 to 24

,
Interventionmg/dL (Mean)
BaselineChange at Weeks 12 to 24
Epoetin Alfa109.22-5.39
Roxadustat109.12-23.80

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Percentage of Participants With Platelet Response (in Participants With Pre-Treatment Platelets <100*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria

Platelet response according to IWG 2006 criteria was defined as an absolute increase of >/= 30x10^9/L for participants starting with >20x10^9/L platelets. (NCT02145026)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Epoetin Beta16

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Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria

Erythroid response at Week 12 according to IWG 2006 criteria was defined as a hemoglobin (Hb) increase of >/= 1.5 grams/deciliter (g/dL), and a reduction of units of red blood cell (RBC) transfusions by at least 4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only RBC transfusions given for an Hb of NCT02145026)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Epoetin Beta60

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Percentage of Participants With Adverse Events

(NCT02145026)
Timeframe: From signing of informed consent up to 4 weeks after last dose (up to 18 weeks)

InterventionPercentage of Participants (Number)
Epoetin Beta48.48

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Percentage of Participants With Neutrophil Response (in Participants With Pre-Treatment Neutrophil <1.0*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria

Neutrophil response according to IWG 2006 criteria was defined as at least 100% increase and an absolute increase of >0.5x10^9/L. (NCT02145026)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Epoetin Beta33.3

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Time-To-First Administration of RBC Transfusion as Rescue Therapy

Time-to-first RBC transfusion as rescue therapy was calculated as (date of first occurrence of any RBC transfusion as rescue therapy, or date of censoring if no event had occurred) - (date of first dose of IP) + 1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events. (NCT02174731)
Timeframe: Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period)

Interventionevents per 100 participant years (Number)
Roxadustat6.0
Epoetin Alfa7.2

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Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52

Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented. (NCT02174731)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 52

Interventiong/dL (Least Squares Mean)
Roxadustat0.77
Epoetin Alfa0.68

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Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)

Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb is defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Changes in Hb from baseline to mean value during Weeks 28 to 52 in participants with baseline hsCRP >ULN was analyzed using a MAR based multiple imputation ANCOVA. Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 52 are presented. (NCT02174731)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 52

Interventiong/dL (Least Squares Mean)
Roxadustat0.80
Epoetin Alfa0.59

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Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24

Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analysed using ANCOVA. Baseline Hb and baseline LDL were used as covariates and treatment groups, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented. (NCT02174731)
Timeframe: Baseline (Day 1, Week 0) to Week 24

Interventionmillimole per liter (Least Squares Mean)
Roxadustat-0.38
Epoetin Alfa-0.05

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Mean Monthly IV Iron Use From Week 36 to End of Study (EOS)

Oral iron supplementation was allowed for both treatment groups without restriction. Oral iron was recommended for dietary supplementation to support erythropoiesis and as the first line treatment for prevention and treatment of iron deficiency, unless the participant was intolerant to this route of treatment. In participants receiving roxadustat, the Investigator was allowed to initiate the use of an approved IV iron supplement if a participant's Hb value had not sufficiently responded to 2 or more dose increases of the IP, and ferritin <100 nanogram per milliliter (ng/mL) or transferrin saturation (TSAT) <20%. IP treatment was allowed to continue during IV iron administration. Discontinuation of IV iron supplementation was recommended once the participant was no longer considered to be iron deficient (ferritin >100 ng/mL and TSAT >20%). (NCT02174731)
Timeframe: Week 36 to EOS (4 weeks after the treatment period)

Interventionmilligram per month (Mean)
Roxadustat58.71
Epoetin Alfa91.37

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Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52

The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was >=10 g/dL was computed and subsequently divided by the time between the measurements from Week 28 to Week 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects. (NCT02174731)
Timeframe: Week 28 to 52

Interventionproportion of total time (Least Squares Mean)
Roxadustat0.79
Epoetin Alfa0.76

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Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52

The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was within 10-12 g/dL was computed and subsequently divided by the time between the measurement from Week 28 to 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects. (NCT02174731)
Timeframe: Week 28 to 52

Interventionproportion of total time (Least Squares Mean)
Roxadustat0.65
Epoetin Alfa0.63

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Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period

Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 36,without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period was analysed using Mixed Model of Repeated Measures (MMRM). Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 36 are presented for participants that did not receive rescue therapy within 6 weeks prior to and during this 8-week evaluation period. (NCT02174731)
Timeframe: Baseline (Day 1, Week 0), Week 28 to 36

Interventiong/dL (Least Squares Mean)
Roxadustat0.88
Epoetin Alfa0.74

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Serum IL-6 Level

(NCT02238080)
Timeframe: Baseline, Month 6

Interventionpicograms per milliliter (pg/mL) (Mean)
BaselineMonth 6
Methoxy Polyethylene Glycol-Epoetin Beta15.816.7

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Serum Hemoglobin Level

(NCT02238080)
Timeframe: Baseline, Month 6

Interventiongrams per deciliter (g/dL) (Mean)
BaselineMonth 6
Methoxy Polyethylene Glycol-Epoetin Beta11.211.2

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Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). (NCT02238080)
Timeframe: Month 6

Interventioncorrelation coefficient (Number)
Methoxy Polyethylene Glycol-Epoetin Beta0.19473

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Serum CRP Level

(NCT02238080)
Timeframe: Baseline, Month 6

Interventionmilligrams per liter (mg/L) (Mean)
BaselineMonth 6
Methoxy Polyethylene Glycol-Epoetin Beta13.716.3

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Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg). (NCT02238080)
Timeframe: Month 6

Interventionpercentage of participants (Number)
No changeDose increaseDose decrease
Methoxy Polyethylene Glycol-Epoetin Beta46.529.923.5

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Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

(NCT02238080)
Timeframe: Baseline, Month 6

Interventionmcg/kg (Mean)
BaselineChange at Month 6
Methoxy Polyethylene Glycol-Epoetin Beta175.213.6

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Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). (NCT02238080)
Timeframe: Day 1

Interventioncorrelation coefficient (Number)
Methoxy Polyethylene Glycol-Epoetin Beta0.05557

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Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). (NCT02238080)
Timeframe: Month 6

Interventioncorrelation coefficient (Number)
Methoxy Polyethylene Glycol-Epoetin Beta0.12684

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Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). (NCT02238080)
Timeframe: Day 1

Interventioncorrelation coefficient (Number)
Methoxy Polyethylene Glycol-Epoetin Beta0.1485

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Hemoglobin Intra-subject Variability

Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated. (NCT02253654)
Timeframe: The evaluation period (weeks 13 to 37)

Interventiong/dL (Mean)
Epoetin Alfa Alternative Titration0.74
Epoetin Alfa USPI Titration0.70

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Number of RBC Units Transfused Overall and During Each Study Period

The number of red blood cell (RBC) units transfused during the study and during each study period. (NCT02253654)
Timeframe: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

,
Interventionparticipants (Number)
Overall Study: 1 RBC Unit (n = 89, 100)Overall Study: 2 RBC Units (n = 89, 100)Overall Study: 3 RBC Units (n = 89, 100)Overall Study: > 3 RBC Units (n = 89, 100)Titration Period: 1 RBC Unit (n = 89, 100)Titration Period: 2 RBC Units (n = 89, 100)Titration Period: 3 RBC Units (n = 89, 100)Titration Period: > 3 RBC Units (n = 89, 100)Evaluation Period: 1 RBC Unit (n = 89, 100)Evaluation Period: 2 RBC Units (n = 89, 100)Evaluation Period: 3 RBC Units (n = 89, 100)Evaluation Period: > 3 RBC Units (n = 89, 100)Safety Follow-up Period: 1 RBC Unit (n = 83, 90)Safety Follow-up Period: 2 RBC Units (n = 83, 90)Safety Follow-up Period: 3 RBC Units (n = 83, 90)Safety Follow-up Period: >3 RBC Units (n = 83, 90)
Epoetin Alfa Alternative Titration1212011013100100
Epoetin Alfa USPI Titration4521100034210100

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Percentage of Participants With Hemoglobin Excursions at Each Visit

An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported. (NCT02253654)
Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

,
Interventionpercentage of participants (Number)
Overall Excursions (n = 89, 100)Overall Excursions < 9.0 (n = 89, 100)Overall Excursions > 11.0 (n = 89, 100)Overall Excursions > 12.0 (n = 89, 100)Baseline Excursions (n = 89, 100)Baseline Excursions < 9.0 (n = 89, 100)Baseline Excursions > 11.0 (n = 89, 100)Baseline Excursions > 12.0 (n = 89, 100)Week 3 Excursions (n = 89, 100)Week 3 Excursions < 9.0 (n = 89, 100)Week 3 Excursions > 11.0 (n = 89, 100)Week 3 Excursions > 12.0 (n = 89, 100)Week 5 Excursions (n = 89, 99)Week 5 Excursions < 9.0 (n = 89, 99)Week 5 Excursions > 11.0 (n = 89, 99)Week 5 Excursions > 12.0 (n = 89, 99)Week 7 Excursions (n = 88, 97)Week 7 Excursions < 9.0 (n = 88, 97)Week 7 Excursions > 11.0 (n = 88, 97)Week 7 Excursions > 12.0 (n = 88, 97)Week 9 Excursions (n = 89, 100)Week 9 Excursions < 9.0 (n = 89, 100)Week 9 Excursions > 11.0 (n = 89, 100)Week 9 Excursions > 12.0 (n = 89, 100)Week 11 Excursions (n = 88, 99)Week 11 Excursions < 9.0 (n = 88, 99)Week 11 Excursions > 11.0 (n = 88, 99)Week 11 Excursions > 12.0 (n = 88, 99)Week 13 Excursions (n = 89, 100)Week 13 Excursions < 9.0 (n = 89, 100)Week 13 Excursions > 11.0 (n = 89, 100)Week 13 Excursions > 12.0 (n = 89, 100)Week 15 Excursions (n = 89, 100)Week 15 Excursions < 9.0 (n = 89, 100)Week 15 Excursions > 11.0 (n = 89, 100)Week 15 Excursions > 12.0 (n = 89, 100)Week 17 Excursions (n = 89, 100)Week 17 Excursions < 9.0 (n = 89, 100)Week 17 Excursions > 11.0 (n = 89, 100)Week 17 Excursions > 12.0 (n = 89, 100)Week 19 Excursions (n = 89, 100)Week 19 Excursions < 9.0 (n = 89, 100)Week 19 Excursions > 11.0 (n = 89, 100)Week 19 Excursions > 12.0 (n = 89, 100)Week 21 Excursions (n = 87, 99)Week 21 Excursions < 9.0 (n = 87, 99)Week 21 Excursions > 11.0 (n = 87, 99)Week 21 Excursions > 12.0 (n = 87, 99)Week 23 Excursions (n = 88, 98)Week 23 Excursions < 9.0 (n = 88, 98)Week 23 Excursions > 11.0 (n = 88, 98)Week 23 Excursions > 12.0 (n = 88, 98)Week 25 Excursions (n = 87, 98)Week 25 Excursions < 9.0 (n = 87, 98)Week 25 Excursions > 11.0 (n = 87, 98)Week 25 Excursions > 12.0 (n = 87, 98)Week 27 Excursions (n = 88, 94)Week 27 Excursions < 9.0 (n = 88, 94)Week 27 Excursions > 11.0 (n = 88, 94)Week 27 Excursions > 12.0 (n = 88, 94)Week 29 Excursions (n = 89, 92)Week 29 Excursions < 9.0 (n = 89, 92)Week 29 Excursions > 11.0 (n = 89, 92)Week 29 Excursions > 12.0 (n = 89, 92)Week 31 Excursions (n = 85, 89)Week 31 Excursions < 9.0 (n = 85, 89)Week 31 Excursions > 11.0 (n = 85, 89)Week 31 Excursions > 12.0 (n = 85, 89)Week 33 Excursions (n = 86, 90)Week 33 Excursions < 9.0 (n = 86, 90)Week 33 Excursions > 11.0 (n = 86, 90)Week 33 Excursions > 12.0 (n = 86, 90)Week 35 Excursions (n = 87, 88)Week 35 Excursions < 9.0 (n = 87, 88)Week 35 Excursions > 11.0 (n = 87, 88)Week 35 Excursions > 12.0 (n = 87, 88)Week 37 Excursions (n = 87, 93)Week 37 Excursions < 9.0 (n = 87, 93)Week 37 Excursions > 11.0 (n = 87, 93)Week 37 Excursions > 12.0 (n = 87, 93)
Epoetin Alfa Alternative Titration91.048.380.925.83.43.40.00.029.22.227.05.636.01.134.85.627.36.820.53.429.29.020.23.422.74.518.22.325.87.918.04.527.05.621.36.723.69.014.64.528.19.019.19.027.68.019.53.429.56.822.75.728.72.326.45.729.510.219.33.425.85.620.24.520.04.715.35.922.17.015.13.526.411.514.94.620.78.012.63.4
Epoetin Alfa USPI Titration93.061.083.019.011.011.00.00.027.06.021.05.029.34.025.37.128.98.220.64.117.010.07.00.023.27.116.21.021.09.012.01.024.013.011.00.021.012.09.03.019.013.06.00.017.212.15.10.020.410.210.20.020.413.37.12.021.316.05.30.029.316.313.02.228.116.911.21.122.211.111.12.221.613.68.00.017.212.94.30.0

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Percentage of Participants With Transfusion Events Overall and During Each Study Period

The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period. (NCT02253654)
Timeframe: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

,
Interventionpercentage of participants (Number)
Overall (n = 89, 100)Titration Period (n = 89, 100)Evaluation Period (n = 89, 100)Safety Follow-up Period (n = 83, 90)
Epoetin Alfa Alternative Titration6.72.25.61.2
Epoetin Alfa USPI Titration12.01.010.01.1

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Weekly Epoetin Alfa Dose at Each Visit

(NCT02253654)
Timeframe: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

,
Interventionunits (Mean)
Week 1 (n = 89, 100)Week 3 (n = 89, 100)Week 5 (n = 89, 100)Week 7 (n = 89, 100)Week 9 (n = 89, 100)Week 11 (n = 89, 100)Week 13 (n = 89, 100)Week 15 (n = 89, 100)Week 17 (n = 89, 100)Week 19 (n = 89, 100)Week 21 (n = 89, 99)Week 23 (n = 89, 98)Week 25 (n = 89, 98)Week 27 (n = 89, 96)Week 29 (n =89, 94)Week 31 (n = 88, 91)Week 33 (n = 87, 90)Week 35 (n = 87, 90)
Epoetin Alfa Alternative Titration13139.99683.78324.29319.19253.410039.310358.48889.310251.710475.89605.18905.17543.89765.79088.88543.29019.08709.2
Epoetin Alfa USPI Titration104006912.56874.06411.08003.06483.07387.56874.56924.57112.56909.66830.17486.76662.56083.06673.16235.65950.6

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Hemoglobin Rate of Change at Each Visit

Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline. (NCT02253654)
Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

,
Interventiong/dL/2 weeks (Mean)
Week 3 (n = 89, 100)Week 5 (n = 89, 99)Week 7 (n = 88, 97)Week 9 (n = 89, 100)Week 11 (n = 88, 99)Week 13 (n = 89, 100)Week 15 (n = 89, 100)Week 17 (n = 89, 100)Week 19 (n = 89, 100)Week 21 (n = 87, 99)Week 23 (n = 88, 98)Week 25 (n = 87, 98)Week 27 (n = 88, 94)Week 29 (n =89, 92)Week 31 (n = 85, 89)Week 33 (n = 86, 90)Week 35 (n = 87, 88)Week 37 (n = 87, 93)
Epoetin Alfa Alternative Titration0.360.10-0.22-0.120.02-0.050.19-0.220.18-0.020.160.07-0.180.04-0.02-0.16-0.05-0.04
Epoetin Alfa USPI Titration0.270.13-0.19-0.280.19-0.19-0.010.02-0.06-0.060.09-0.060.010.05-0.030.06-0.13-0.03

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Hemoglobin Concentration at Each Visit

(NCT02253654)
Timeframe: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

,
Interventiong/dL (Mean)
Baseline (n = 89, 100)Week 3 (n = 89, 100)Week 5 (n = 89, 99)Week 7 (n = 88, 97)Week 9 (n = 89, 100)Week 11 (n = 88, 99)Week 13 (n = 89, 100)Week 15 (n = 89, 100)Week 17 (n = 89, 100)Week 19 (n = 89, 100)Week 21 (n = 87, 99)Week 23 (n = 88, 98)Week 25 (n = 87, 98)Week 27 (n = 88, 94)Week 29 (n =89, 92)Week 31 (n = 85, 89)Week 33 (n = 86, 90)Week 35 (n = 87, 88)Week 37 (n = 87, 93)
Epoetin Alfa Alternative Titration10.1510.5410.6610.4510.3210.3310.2810.4610.2010.3710.3310.4610.5610.3210.3410.3410.1810.1210.10
Epoetin Alfa USPI Titration10.0410.3410.5110.289.9710.159.999.9810.019.949.9210.039.949.9710.029.9610.059.949.86

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Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant. (NCT02253654)
Timeframe: The evaluation period (weeks 13-37)

Interventionpercentage of hemoglobin measurements (Mean)
Epoetin Alfa Alternative Titration46.41
Epoetin Alfa USPI Titration46.02

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Average Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52

Monthly iron use for each participant= Total IV iron in mg / [(last dose date - first dose date of study medication in the period)+1]/ 28. (NCT02273726)
Timeframe: Weeks 28 to 52

Interventionmg/PEM (Mean)
Roxadustat17.07
Epoetin Alfa37.02

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Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants With Mean Hb 10.0 to 12.0 g/dL Averaged Over Weeks 28 to 36, Censoring for Rescue Therapy

Hb values under the influence of a rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. (NCT02273726)
Timeframe: Weeks 28 to 36

Interventionpercentage of participants (Number)
Roxadustat64.1
Epoetin Alfa60.8

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Time to First Exacerbation of Hypertension During Weeks 28 to 52

An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. (NCT02273726)
Timeframe: Weeks 28 to 52

Interventionweeks (Median)
RoxadustatNA
Epoetin AlfaNA

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Time to First RBC Transfusion

Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 183.7 weeks for roxadustat and 180.4 weeks for epoetin alfa)

Interventionweeks (Median)
RoxadustatNA
Epoetin AlfaNA

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US (FDA Submission): Hb Responder Rate- Percentage of Participants With Mean Hb Level ≥10.0 g/dL Averaged Over Weeks 28 to 52, Regardless of Rescue Therapy

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. (NCT02273726)
Timeframe: Weeks 28 to 52

Interventionpercentage of participants (Number)
Roxadustat66.1
Epoetin Alfa58.6

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Change From Baseline in Hb Levels Averaged Over Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN)

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 18 to 24

,
Interventiong/dL (Mean)
BaselineChange at Weeks 18-24
Epoetin Alfa10.24-0.03
Roxadustat10.300.61

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Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28

Baseline LDL Cholesterol was defined as the last available value prior to the first dose of study treatment. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 12 to 28

,
Interventionmg/dL (Mean)
BaselineChange at Weeks 12 to 28
Epoetin Alfa84.451.23
Roxadustat84.53-13.70

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Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28

Baseline MAP was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 20 to 28

,
Interventionmillimeters of mercury (mmHg) (Mean)
BaselineChange at Weeks 20 to 28
Epoetin Alfa100.340.04
Roxadustat101.410.46

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Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28

The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), general health perceptions (5 items), mental health (5 items), social function (2 items), and vitality (4 items). The physical functioning subscore and vitality subscore are reported. Each scale was transformed into 0-100 score, with higher scores indicating better health status. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 12 to 28

,
Interventionscore on a scale (Mean)
Physical functioning subscore: BaselinePhysical functioning subscore: Change at Weeks 12 to 28Vitality subscore: BaselineVitality subscore: Change at Weeks 12 to 28
Epoetin Alfa39.63-0.2051.270.30
Roxadustat38.55-0.1551.65-0.92

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Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol

Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 28 to 36

,
Interventiong/dL (Mean)
BaselineChange at Weeks 28 to 36
Epoetin Alfa10.35-0.03
Roxadustat10.330.54

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US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy

Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. (NCT02273726)
Timeframe: Baseline (Day 1, Week 0), Weeks 28 to 52

,
Interventiong/dL (Mean)
BaselineChange at Weeks 28 to 52
Epoetin Alfa10.31-0.09
Roxadustat10.300.39

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Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104

Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. (NCT02278341)
Timeframe: Weeks 37-52 and weeks 53-104

,
Interventionmg per month (Least Squares Mean)
Weeks 37-52Weeks 53-104
ESA (Erythropoiesis-Stimulating Agent)70.098.1
Roxadustat34.949.5

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Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal

Achieved antihypertensive treatment goal was defined as SBP < 140 mmHg and DBP < 90 mmHg over an evaluation period based on the average of available values in weeks 12-28 (pre-dialysis). (NCT02278341)
Timeframe: Weeks 12 to 28

,
InterventionNumber of participants (Number)
Antihypertensive Treatment Achievement - YesAntihypertensive Treatment Achievement - NoAntihypertensive Treatment Achievement-Missing
ESA (Erythropoiesis-Stimulating Agent)26114910
Roxadustat26413019

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Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28

Missing category for Fasting Only includes non-fasting participants and the participants with missing values. (NCT02278341)
Timeframe: Weeks 12 to 28

,
InterventionNumber of participants (Number)
Yes [Regardless of Fasting Status]No [Regardless of Fasting Status]Missing [Regardless of Fasting Status]Yes [Fasting Only]No [Fasting Only]Missing [Fasting Only]
ESA (Erythropoiesis-Stimulating Agent)23118188580255
Roxadustat2751191911161241

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Safety was assessed by evaluation of the following variables: (TEAEs; frequency, severity, seriousness, and relationship to study drug), Vital signs (systolic and diastolic blood pressure, pulse, respiratory rate and weight), Clinical laboratory variables (hematology, biochemistry including liver enzymes and total bilirubin, and urinalysis), Physical examination, 12-lead electrocardiogram (ECG) and Vascular Access Thrombosis. All AEs collected during the Safety Emergent Period were counted as TEAE. The TEAE was defined as an adverse event (AE) if it was observed after starting administration of the roxadustat or ESA. Any clinically significant abnormalities were reported as an AEs. All reported deaths after the first study drug administration and up to 28 days after the Analysis Date of Last Dose and considering last dosing frequency. (NCT02278341)
Timeframe: Baseline up to EOS (Up to week 108)

,
InterventionParticipants (Count of Participants)
TEAEDrug-Related TEAESerious TEAEDrug-Related Serious TEAETEAE Leading to DeathDrug-Related TEAE Leading to DeathTEAE Leading to Withdrawal of TreatmentDrug-Related TEAE Leading to Withdraw of TreatmentTEAE NCI CTC Grades 3 or HigherDeath During the Safety Emergent PeriodDeath
ESA (Erythropoiesis-Stimulating Agent)36135189105521611495159
Roxadustat35977210336753591816478

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Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Percentage for each participant was calculated as Number of Hb values >= 10.0 g/dL / Total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period. (NCT02278341)
Timeframe: Weeks 28-36, 44-52 and 96-104

,
Interventionpercentage of Hb values (Mean)
Weeks 28-36Weeks 44-52Weeks 96-104
ESA (Erythropoiesis-Stimulating Agent)87.28686.91483.543
Roxadustat93.00289.42188.858

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Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Percentage for each participant was calculated as Number of Hb values within 10.0-12.0 g/dL / Total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period. (NCT02278341)
Timeframe: Weeks 28-36, 44-52 and 96-104

,
Interventionpercentage of Hb values (Mean)
Weeks 28-36Weeks 44-52Weeks 96-104
ESA (Erythropoiesis-Stimulating Agent)76.09874.63473.690
Roxadustat76.32675.89176.522

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Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)

The PGIC is a patient-rated instrument that measures change in participant's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), when compared to the start of treatment. The percentage of participants presented includes very much improved, much improved and minimally improved. (NCT02278341)
Timeframe: Baseline and weeks 8, 12, 28, 36, 52, 76, 104

,
InterventionPercentage of participants (Number)
Week 8Week 12Week 28Week 36Week 52Week 76Week 104
ESA (Erythropoiesis-Stimulating Agent)49.549.557.156.355.351.951.3
Roxadustat59.665.562.360.457.161.261.6

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Time to First Hospitalization

Time to first hospitalization in years was defined in years as: (First event date during the Efficacy Emergent Period - Analysis date of First dose intake +1)/365.25, and the 'First event date' was defined as 'Date of first Admission and 'Analysis Date of first dose intake. For participants without hospitalization, the time to censoring was calculated as: (Date of End of Efficacy Emergent Period - Analysis Date of first dose intake + 1) / 365.25. Date of End of Efficacy Emergent Period was defined as as the treatment period up to the EOT visit. For participants who have experienced more than one hospitalization, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

,
InterventionPercentage of participants (Number)
Year 0.5Year 1Year 1.5Year 2
ESA (Erythropoiesis-Stimulating Agent)18.332.741.948.3
Roxadustat19.432.043.552.6

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Time to First Occurrence of an Increase in Blood Pressure

Increase in Blood Pressure was defined as either: SBP ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: DBP ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Weeks 1 to 36

,
InterventionPercentage of participants (Number)
Week 12Week 24Week 36
ESA (Erythropoiesis-Stimulating Agent)12.016.224.1
Roxadustat11.616.121.2

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Time to First Occurrence of an Increase in Blood Pressure

Increase in Blood Pressure was defined as either: Systolic Blood Pressure (SBP) ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: Diastolic Blood Pressure (DBP) ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. For participants who have experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Weeks 1 to 36

,
InterventionPercentage of participants (Number)
Week 12Week 24Week 36
ESA (Erythropoiesis-Stimulating Agent)11.115.423.5
Roxadustat11.715.921.1

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Time to First RBC Transfusion

For participants who have experienced more than one RBC transfusion, only their first event following study treatment was used. For RBC transfusions, when the number of units was not given but the volume transfused was, the number of units were estimated by volume transfused/250 mL (for transfusion of packed cell units) or volume transfused/500 mL (for transfusion of full blood). Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

,
InterventionPercentage of participants (Number)
Year 0.5Year 1Year 1.5Year 2
ESA (Erythropoiesis-Stimulating Agent)3.28.410.914.4
Roxadustat3.67.410.011.4

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Time to First Use of IV Iron Supplementation

For participants who have received more than one IV iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

,
InterventionPercentage of participants (Number)
Year 0.5Year 1Year 1.5Year 2
ESA (Erythropoiesis-Stimulating Agent)33.544.155.059.3
Roxadustat11.217.423.633.3

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Time to First Use of Rescue Therapy

Rescue therapy was defined as red blood cell (RBC) transfusion for both treatment groups and ESA for roxadustat participants. Only rescue medication that was started during the study treatment and up to end of efficacy emergent period was taken into account and considered as use of rescue medication. For participants who have experienced more than one use of rescue therapy, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

,
InterventionPercentage of participants (Number)
Year 0.5Year 1Year 1.5Year 2
ESA (Erythropoiesis-Stimulating Agent)3.28.410.914.4
Roxadustat3.98.211.412.8

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"Change From BL to the Average of Weeks 12 to 28 in Anemia Subscale (AnS) (Additional Concerns) of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score"

Baseline FACT-An AnS was defined as the FACT-An AnS value on Day 1. Together with the Functional Assessment of Cancer Therapy - General (FACT-G), the Anemia Subscale (AnS) is referred to as the FACT-An Total. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The Anemia AnS score range is 0 to 80. For the above score, a higher score indicates better QoL. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Least Squares Mean)
Roxadustat0.400
ESA (Erythropoiesis-Stimulating Agent)0.274

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Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]

Baseline Hb was defined as the mean of four central laboratory Hb values; four latest Hb values prior or on the same date as the first study drug intake. For participants who did not have an available Hb value during the week 28-36 period, imputation rules were applied. For analyses without rescue therapy, participants who used rescue therapy after the initiation of rescue therapy were set to missing for 6 weeks from the start date of rescue therapy. If no Hb value was available, an imputation technique was used, with the mean of all available values from Day 1 to minimum (End of Efficacy Emergent Period) carried forward. (NCT02278341)
Timeframe: Baseline and weeks 28 to 36

Interventiong/dL (Least Squares Mean)
Roxadustat0.428
ESA (Erythropoiesis-Stimulating Agent)0.193

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Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28

Baseline LDL was defined as the LDL value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

Interventionmmol/L (Least Squares Mean)
Roxadustat-0.459
ESA (Erythropoiesis-Stimulating Agent)-0.082

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Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28

Baseline MAP was defined as the MAP value on day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)*DBP + (1/3)*SBP. (NCT02278341)
Timeframe: Baseline and weeks 20 to 28

InterventionmmHg (Least Squares Mean)
Roxadustat-0.739
ESA (Erythropoiesis-Stimulating Agent)-0.160

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Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28

Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)*DBP + (1/3)*SBP. (NCT02278341)
Timeframe: Baseline and weeks 20 to 28

InterventionmmHg (Least Squares Mean)
Roxadustat-0.969
ESA (Erythropoiesis-Stimulating Agent)-0.120

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Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28

Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Least Squares Mean)
Roxadustat0.460
ESA (Erythropoiesis-Stimulating Agent)-0.396

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Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28

Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measure eight scales: (1) physical functioning (PF); (2) role limitations due to physical health problems (RP); (3) bodily pain (BP); (4) social functioning (SF); (5) general health perceptions (GH); (6) role limitations due to emotional problems (RE); (7) vitality, energy or fatigue (VT); and (8) mental health(MH). Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consists of 11 questions focused on health and ability to do usual activities, with higher scores indicating better health status. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Least Squares Mean)
Roxadustat0.050
ESA (Erythropoiesis-Stimulating Agent)-0.155

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Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)]

Baseline Hb was defined as the mean of four central laboratory Hb values: four latest Hb values prior or on the same date as first study drug intake. Change from baseline to the average Hb are observed values. Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model with treatment, baseline hemoglobin, randomization stratification factors and the available non missing hemoglobin for each scheduled week. (NCT02278341)
Timeframe: Baseline and weeks 28 to 52

Interventiong/dL (Least Squares Mean)
Roxadustat0.363
ESA (Erythropoiesis-Stimulating Agent)0.192

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Change From BL to the Average of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score

Baseline assessment was defined as the value on Day 1. The EuroQol Questionnaire -5 Dimensions -5 Levels (EQ-5D-5L) is a self-reported questionnaire, used as a measure of respondents' Health Related Quality of Life (HRQoL) and utility values. The EQ-5D consists of the descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The VAS records the respondent's self rated health status on a graduated (0-100) scale, where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state' with higher scores for higher HRQoL. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Mean)
Roxadustat3.041
ESA (Erythropoiesis-Stimulating Agent)2.735

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Change From BL to the Average of Weeks 12 to 28 in SF-36 Physical Component Score (PCS)

Baseline SF-36 PCS was defined as the SF-36 PCS value on Day 1. SF-36 contains 36-item that measures 8 scales with scores ranging from 0-100: physical functioning (PF); role limitations due to physical health problems (RP); bodily pain (BP); social functioning (SF); general health perceptions (GH); role limitations due to emotional problems (RE); vitality, energy or fatigue (VT); and mental health (MH). These scores are normed to the US population (norm-based scoring had very little impact on results when data was collected in Western European countries) to have a mean of 50 and standard deviation of 10. The PCS was calculated based on all 8 scales and ranges from 5.02-79.78. For each of these above scales, higher scores always indicating better health status. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Least Squares Mean)
Roxadustat0.560
ESA (Erythropoiesis-Stimulating Agent)0.039

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Change From BL to the Average Value of Weeks 12 to 28 in Total FACT-An Score

Baseline FACT-An Total Score was defined on Day 1. Total Fact-An score is composed of FACT-G and Ans scales. FACT-G contains 27 items that cover four dimensions of well-being: physical (PWB) - 7 items, functional (FWB) - 7 items, social/family (SWB) - 7 items, and emotional (EWB) - 6 items. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The total score is obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. The FACT-An Total Score scale range is 0-188. A higher score indicates better QoL. (NCT02278341)
Timeframe: Baseline and weeks 12 to 28

InterventionUnits on a scale (Least Squares Mean)
Roxadustat-0.501
ESA (Erythropoiesis-Stimulating Agent)-0.373

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Mean Monthly Intravenous (IV) Iron Use

Participants with no or missing medication records of IV Iron have their monthly IV Iron use set to 0 mg. For participants who took IV Iron, but without a dosing frequency, the average values were set to missing. (NCT02278341)
Timeframe: Day 1 to week 36

Interventionmg per month (Least Squares Mean)
Roxadustat21.6
ESA (Erythropoiesis-Stimulating Agent)53.5

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Mean Monthly Number of RBC Packs Per Participant

During efficacy emergent period, the mean monthly number of RBC packs was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. Participants without medication records of RBC have their number of RBC packs and volume set to 0. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

InterventionRBC packs per month (Least Squares Mean)
Roxadustat0.026
ESA (Erythropoiesis-Stimulating Agent)0.032

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Mean Monthly Volume of RBC Transfusion Per Participant

During Efficacy Emergent Period, the mean monthly volume of blood transfused was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

InterventionmL per month (Least Squares Mean)
Roxadustat6.061
ESA (Erythropoiesis-Stimulating Agent)5.929

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Number of Days of Hospitalization Per Year

The number of days of hospitalizations per year was calculated as the sum of the durations of all non-HD hospitalizations in days (Date of discharge - Date of admission + 1)] / (duration of efficacy emergent period in days / 365.25). In case of missing dates, the hospitalization duration was imputed by the average duration per stay derived from the participants with non-missing duration within the same treatment group. (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

InterventionDays per year (Mean)
Roxadustat12.186
ESA (Erythropoiesis-Stimulating Agent)7.868

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Number of Hospitalizations

The number of hospitalizations per participant were calculated during the Efficacy Emergent Period. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). It included all Non-Hemodialysis (HD) hospitalizations. The HD days were not counted as hospitalizations, even when performed overnight. (NCT02278341)
Timeframe: Baseline to End of Treatment (EOT) (Up to week 104)

InterventionHospitalizations (Mean)
Roxadustat0.9
ESA (Erythropoiesis-Stimulating Agent)0.9

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Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy

Hb response was defined as mean Hb during weeks 28 to 36 within the target range of 10.0 to 12.0 g/dL. The percentages and 95% CI are unadjusted, the exact method of Clopper-Pearson was used for 95% CI. (NCT02278341)
Timeframe: Weeks 28 to 36

InterventionPercentage of participants (Number)
Roxadustat83.1
ESA (Erythropoiesis-Stimulating Agent)82.1

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Percentage of Participants With Hb Response During Weeks 28 to 36

Hb response during weeks 28-36, was defined as mean Hb from 10-12 g/dL without receiving rescue therapy in the 6 weeks prior to, or during, the evaluation period. The percentages and 95% CI were unadjusted, the exact method of Clopper-Pearson was used for 95% CI. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period). (NCT02278341)
Timeframe: Weeks 28 to 36

InterventionPercentage of participants (Number)
Roxadustat84.2
ESA (Erythropoiesis-Stimulating Agent)82.4

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Percentage of Participants With Oral Iron Use Only

Percentage of participants with/without IV iron only was calculated based on total number of participants within the Efficacy Emergent Period. The Efficacy Emergent Period is defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). (NCT02278341)
Timeframe: Baseline to EOT (Up to week 104)

InterventionPercentage of participants (Number)
Roxadustat31.0
ESA (Erythropoiesis-Stimulating Agent)11.7

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Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)

Percentage of change from baseline to each study visit were calculated for HbA1c. Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. (NCT02278341)
Timeframe: Baseline and weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to 108 weeks)

,
Interventionpercentage of Glycated Hemoglobin (Mean)
Week 12Week 28Week 36Week 44Week 52Week 60Week 84Week 104EOS
ESA (Erythropoiesis-Stimulating Agent)-0.0005-0.0006-0.0004-0.0006-0.0007-0.00040.0001-0.00030.0001
Roxadustat0.0009-0.0004-0.0001-0.0001-0.00010.00000.00030.00000.0011

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Change From BL in Hb to Each Postdosing Time Point

Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose). (NCT02278341)
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 18,20, 22, 24, 26, 28, 30, 32, 34, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72,76, 80, 84, 88, 92, 96, 100, and 104

,
Interventiong/dL (Least Squares Mean)
Hb Change From BL to Week 1Hb Change From BL to Week 2Hb Change From BL to Week 3Hb Change From BL to Week 4Hb Change From BL to Week 5Hb Change From BL to Week 6Hb Change From BL to Week 7Hb Change From BL to Week 8Hb Change From BL to Week 10Hb Change From BL to Week 12Hb Change From BL to Week 14Hb Change From BL to Week 16Hb Change From BL to Week 18Hb Change From BL to Week 20Hb Change From BL to Week 22Hb Change From BL to Week 24Hb Change From BL to Week 26Hb Change From BL to Week 28Hb Change From BL to Week 30Hb Change From BL to Week 32Hb Change From BL to Week 34Hb Change From BL to Week 36Hb Change From BL to Week 40Hb Change From BL to Week 44Hb Change From BL to Week 48Hb Change From BL to Week 52Hb Change From BL to Week 56Hb Change From BL to Week 60Hb Change From BL to Week 64Hb Change From BL to Week 68Hb Change From BL to Week 72Hb Change From BL to Week 76Hb Change From BL to Week 80Hb Change From BL to Week 84Hb Change From BL to Week 88Hb Change From BL to Week 92Hb Change From BL to Week 96Hb Change From BL to Week 100Hb Change From BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)0.0680.0540.0710.095-0.0450.138-0.0310.116-0.0190.1390.0050.2440.0170.2170.0690.0750.0730.3420.1060.1110.0840.2250.0640.2520.1310.1860.0690.171-0.0930.100-0.0090.189-0.0150.126-0.0180.154-0.0580.1380.133
Roxadustat0.2320.4960.6330.8030.7230.8680.6980.8160.6400.7320.5080.6130.3800.5010.2660.2620.3160.5490.3330.3100.3640.4820.1990.3350.1580.3850.2170.3680.1810.3060.1090.4010.0870.3180.0260.3570.1260.3020.232

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Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy

Change from baseline to the average Hb are observed values. Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose). (NCT02278341)
Timeframe: Baseline and weeks 28 to 36, 44 to 52, and 96 to 104

,
Interventiong/dL (Least Squares Mean)
Hb Change From BL to Weeks 28-36Hb Change From BL to Weeks 44-52Hb Change From BL to Weeks 96-104
ESA (Erythropoiesis-Stimulating Agent)0.1730.1940.076
Roxadustat0.4080.2980.225

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Change From BL in Serum Ferritin

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. (NCT02278341)
Timeframe: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, and EOS (up to 108 weeks)

,
Interventionpmol/L (Mean)
Week 4Week 8Week 12Week 20Week 28Week 36Week 44Week 52Week 60Week 68Week 76Week 84Week 92Week 100Week 104EOS
ESA (Erythropoiesis-Stimulating Agent)-141.78-160.75-179.47-246.89-265.21-269.26-323.30-347.58-394.40-456.16-447.70-454.44-371.64-364.78-348.70-166.94
Roxadustat-214.64-245.37-269.76-337.94-427.46-507.34-545.14-615.19-622.55-604.47-646.76-629.31-749.58-746.86-753.82-554.53

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Change From BL in Serum Hepcidin

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. (NCT02278341)
Timeframe: Baseline and weeks 4, 12, 20, 36, 52, 104, and End of Study (EOS - up to 108 weeks)

,
Interventionµg/L (Mean)
Week 4Week 12Week 20Week 36Week 52Week 104EOS
ESA (Erythropoiesis-Stimulating Agent)-4.265-6.741-11.818-14.530-17.522-18.735-17.664
Roxadustat-14.265-12.298-15.149-23.405-32.709-40.101-27.192

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Change From BL in Transferrin Saturation (TSAT)

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied. (NCT02278341)
Timeframe: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks)

,
InterventionPercentage of saturation (Mean)
Week 4Week 8Week 12Week 20Week 28Week 36Week 44Week 52Week 60Week 68Week 76Week 84Week 92Week 100Week 104EOS
ESA (Erythropoiesis-Stimulating Agent)-2.331-3.128-3.189-4.398-3.829-4.022-5.254-5.788-5.187-6.237-6.623-5.378-6.259-6.354-5.054-3.763
Roxadustat-4.151-3.681-2.643-3.782-5.463-5.351-6.069-7.278-6.997-7.279-7.156-7.867-6.996-8.379-7.650-5.466

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Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
InterventionRatio (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)-0.060-0.057-0.078-0.013
Roxadustat-0.245-0.155-0.345-0.261

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Change From BL to Each Post-dosing Study Visit in Total Cholesterol

Baseline assessment was the assessment from Day 1 visit. If baseline value was missing, then the latest screening period value was used as the baseline regardless of fasting status. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
Interventionmmol/L (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)-0.105-0.135-0.241-0.277
Roxadustat-0.608-0.641-0.803-0.904

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Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
InterventionRatio (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)0.0130.0020.0070.007
Roxadustat-0.037-0.034-0.051-0.062

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Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
Interventiong/L (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)-0.006-0.012-0.013-0.012
Roxadustat-0.114-0.113-0.097-0.097

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Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
Interventionmg/dL (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)1.00-0.12-0.01-0.01
Roxadustat-11.03-11.18-13.18-13.50

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Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting. (NCT02278341)
Timeframe: Baseline and weeks 8, 28, 52, 104

,
Interventionmmol/L (Mean)
Change from BL to Week 8Change from BL to Week 28Change from BL to Week 52Change from BL to Week 104
ESA (Erythropoiesis-Stimulating Agent)-0.107-0.127-0.229-0.240
Roxadustat-0.518-0.540-0.700-0.788

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Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose). Averaged Hb values over weeks 28-36, weeks 44-52 and weeks 96-104 are observed values. (NCT02278341)
Timeframe: Weeks 28 to 36, 44 to 52, and 96 to 104

,
Interventiong/dL (Least Squares Mean)
Average Hb Over Weeks 28-36Average Hb Over Weeks 44-52Average Hb Over Weeks 96-104
ESA (Erythropoiesis-Stimulating Agent)10.94610.99410.858
Roxadustat11.18311.09911.007

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Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment

(NCT02504294)
Timeframe: Baseline (8 Weeks prior to randomization), Week 17 up to Week 24

InterventionUnits per week (Least Squares Mean)
Epoetin Hospira-1861.8
Epogen-799.8

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Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)

(NCT02504294)
Timeframe: Week 17 up to Week 24

InterventionPercentage of Weeks (Number)
Epoetin Hospira61.9330
Epogen63.3305

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Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study

Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes. (NCT02538107)
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)

Interventiong/dL (Mean)
Visit 1 (Month 1) (n=135, 0)Visit 2 (Month 2) (n=142, 0)Visit 3 (Month 3) (n=155, 0)Visit 4 (Month 4) (n=150, 0)Visit 5 (Month 5) (n=147, 0)Visit 6 (Month 6) (n=132, 0)Visit 7 (Month 7) (n=141, 0)Visit 8 (Month 8) (n=137, 0)Visit 9 (Month 9) (n=141, 0)Visit 10 (Month 10) (n=128, 0)Visit 11 (Month 11) (n=116, 0)Visit 12 (Month 12) (n=132, 0)Visit 13 (Month 13) (n=122, 0)Visit 14 (Month 14) (n=118, 0)Visit 15 (Month 15) (n=104, 0)Entire study (Month 1 to Month 15) (n=192, 0)
Absence of Acute Bleeding-Kidney Transplant Participants11.2311.4011.6511.5111.7511.5711.5311.5011.5711.5311.5911.3711.2411.3211.4011.45

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Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)

(NCT02538107)
Timeframe: From Month 7 to Month 9

Interventionpercentage of participants (Number)
Kidney Transplant Participants40.4

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Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)

(NCT02538107)
Timeframe: From Month 7 to Month 15

Interventionpercentage of participants (Number)
Kidney Transplant Participants12.2

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Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)

(NCT02538107)
Timeframe: From Month 7 to Month 12

Interventionpercentage of participants (Number)
Kidney Transplant Participants21.2

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Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)

(NCT02538107)
Timeframe: From Month 7 to Month 9

Interventionpercentage of participants (Number)
Kidney Transplant Participants20.7

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Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)

(NCT02538107)
Timeframe: From Month 7 to Month 15

Interventionpercentage of participants (Number)
Kidney Transplant Participants41.2

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Hemoglobin Level Based on the Type of Kidney Transplantation Performed

Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. (NCT02538107)
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)

,
Interventiong/dL (Mean)
Visit 1 (Month 1) (n=22, 113)Visit 2 (Month 2) (n=25, 118)Visit 3 (Month 3) (n=27, 128)Visit 4 (Month 4) (n=23, 128)Visit 5 (Month 5) (n=25, 122)Visit 6 (Month 6) (n=20, 113)Visit 7 (Month 7) (n=21, 121)Visit 8 (Month 8) (n=24, 113)Visit 9 (Month 9) (n=17, 125)Visit 10 (Month 10) (n=21, 107)Visit 11 (Month 11) (n=18, 99)Visit 12 (Month 12) (n=22, 110)Visit 13 (Month 13) (n=23, 100)Visit 14 (Month 14) (n=18, 101)Visit 15 (Month 15) (n=21, 84)Entire study (Month 1 to Month 15) (n=34, 159)
Cadaveric Donation-Kidney Transplant Participants11.2611.4111.7111.5611.7511.6611.5911.5711.6011.5911.6211.4111.3211.3511.5011.49
Living Donation-Kidney Transplant Participants11.0811.3711.3411.3011.7411.0811.2311.1811.3611.2611.4611.1210.8611.2111.0511.25

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Hemoglobin Level Based on the Presence of Inflammatory Diseases

Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. (NCT02538107)
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)

,
Interventiong/dL (Mean)
Visit 1 (Month 1) (n=41, 94)Visit 2 (Month 2) (n=43, 100)Visit 3 (Month 3) (n=45, 110)Visit 4 (Month 4) (n=47, 104)Visit 5 (Month 5) (n=43, 104)Visit 6 (Month 6) (n=42, 91)Visit 7 (Month 7) (n=40, 102)Visit 8 (Month 8) (n=40, 97)Visit 9 (Month 9) (n=42, 100)Visit 10 (Month 10) (n=34, 94)Visit 11 (Month 11) (n=34, 83)Visit 12 (Month 12) (n=33, 99)Visit 13 (Month 13) (n=36, 87)Visit 14 (Month 14) (n=31, 88)Visit 15 (Month 15) (n=27, 78)Entire study (Month 1 to Month 15) (n=56, 137)
Inflammatory Diseases Absent-Kidney Transplant Participants11.2011.4411.6111.5111.7611.6811.5611.4611.5511.5011.5311.4111.2611.4211.5511.48
Inflammatory Diseases Present-Kidney Transplant Participants11.3011.3311.7511.5411.7111.3411.4611.5811.6111.6311.7511.2311.1711.0711.0311.38

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Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)

GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented. (NCT02538107)
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)

,
Interventiong/dL (Mean)
Visit 1 (Month 1) (n=35, 41)Visit 2 (Month 2) (n=35, 45)Visit 3 (Month 3) (n=40, 48)Visit 4 (Month 4) (n=37, 52)Visit 5 (Month 5) (n=37, 47)Visit 6 (Month 6) (n=34, 41)Visit 7 (Month 7) (n=36, 46)Visit 8 (Month 8) (n=28, 48)Visit 9 (Month 9) (n=38, 46)Visit 10 (Month 10) (n=30, 41)Visit 11 (Month 11) (n=30, 38)Visit 12 (Month 12) (n=27, 45)Visit 13 (Month 13) (n=31, 39)Visit 14 (Month 14) (n=27, 41)Visit 15 (Month 15) (n=24, 35)Entire study (Month 1 to Month 15) (n=46, 60)
GFR (<30 mL/Min)-Kidney Transplant Participants11.1511.1711.6011.2611.4011.3211.4611.4611.5011.2211.5511.4111.4411.2911.2011.26
GFR (30-60 mL/Min)-Kidney Transplant Participants11.4411.4211.6511.7511.8711.9011.6211.6611.8511.8811.6911.6711.4111.4011.8111.62

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Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)

(NCT02538107)
Timeframe: From Month 7 to Month 12

Interventionpercentage of participants (Number)
Kidney Transplant Participants52.6

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Hemoglobin Level Based on the Etiology of Chronic Kidney Disease

Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. (NCT02538107)
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)

,
Interventiong/dL (Mean)
Visit 1 (Month 1) (n=43, 37)Visit 2 (Month 2) (n=43, 40)Visit 3 (Month 3) (n=49, 46)Visit 4 (Month 4) (n=49, 41)Visit 5 (Month 5) (n=46, 40)Visit 6 (Month 6) (n=40, 36)Visit 7 (Month 7) (n=46, 44)Visit 8 (Month 8) (n=39, 35)Visit 9 (Month 9) (n=45, 40)Visit 10 (Month 10) (n=44, 31)Visit 11 (Month 11) (n=33, 38)Visit 12 (Month 12) (n=36, 41)Visit 13 (Month 13) (n=41, 36)Visit 14 (Month 14) (n=40, 33)Visit 15 (Month 15) (n=35, 31)Entire study (Month 1 to Month 15) (n=60, 55)
Glomerulonephritis-Kidney Transplant Participants11.2711.4211.7911.3711.8811.6211.7111.7111.8811.6011.9611.3311.3211.5911.4011.52
Other Reason-Kidney Transplant Participants11.4411.4811.7511.7611.7211.6811.5211.6011.4611.6711.4711.3711.2011.2611.4711.52

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 19-21

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta75

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Number of Dose Adaptations

Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified). (NCT02547454)
Timeframe: Up to 36 Months

InterventionEvents (Number)
Total dose adaptationsInflammation or infectionKidney function declineOver responseIron deficiencyInsufficient responseAdverse effectStart of maintenance phaseKidney function improvementRe-introduction of treatmentOther
Methoxy Polyethylene Glycol-Epoetin Beta72911323141421327144127

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Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta

Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months. (NCT02547454)
Timeframe: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months

Interventionmicrogram (Median)
Month 1 (n=393)Month 3 (n=263)Month 6 (n=300)Month 9 (n=239)Month 12 (n=206)Month 15 (n=175)Month 18 (n=177)Month 21 (n=93)After 21 Months up to 36 Months (n=30)
Methoxy Polyethylene Glycol-Epoetin Beta1007575675050505050

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Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Baseline

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta71.3

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 7-9

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta32.3

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 4-6

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta35.1

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: After 21 Months up to 36 Months

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta31.4

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 4-6

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta73.6

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Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta

Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline (NCT02547454)
Timeframe: Baseline

Interventionmicrogram (Mean)
Methoxy Polyethylene Glycol-Epoetin Beta88

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 16-18

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta79.7

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 13-15

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta78.2

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 10-12

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta75.9

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 1-3

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta77.2

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: After 21 Months up to 36 Months

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta68.6

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Percentage of Participants With Dose 0

Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period. (NCT02547454)
Timeframe: Up to 36 Months

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta32.6

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Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L

(NCT02547454)
Timeframe: Up to 36 Months

InterventionMonths (Median)
Methoxy Polyethylene Glycol-Epoetin BetaNA

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Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L

(NCT02547454)
Timeframe: Up to 36 Months

InterventionMonths (Median)
Methoxy Polyethylene Glycol-Epoetin BetaNA

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 19-21

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta26

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 16-18

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta31.4

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Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 7-9

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta74.1

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 13-15

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta33.5

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 10-12

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta35.2

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Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: At Months 1-3

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta34

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Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline

If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. (NCT02547454)
Timeframe: Baseline

InterventionPercentage of participants (Number)
Methoxy Polyethylene Glycol-Epoetin Beta22.8

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Percentage of Participants With Iron Replacement

Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both. (NCT02547454)
Timeframe: Up to 36 Months

InterventionPercentage of participants (Number)
Oral Iron ReplacementIntravenous Iron ReplacmentOral and Intravenous Iron ReplacmentNo Iron Replacment
Methoxy Polyethylene Glycol-Epoetin Beta37.731.610.919.8

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Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

(NCT02596945)
Timeframe: Month 7 to Month 9

Interventionpercentage of participants (Number)
Peritoneal Dialysis Participants14.8

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Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

(NCT02596945)
Timeframe: Month 7 to Month 9

Interventionpercentage of participants (Number)
Peritoneal Dialysis Participants38.9

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Average Duration in Days Mircera Was Administered at a Stable Dose

(NCT02596945)
Timeframe: Up to 9 months

Interventiondays (Mean)
Peritoneal Dialysis Participants182.1

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Percentage of Participants With Response to Treatment Based on Hemoglobin Levels

Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion. (NCT02761642)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Epoetin Beta46.2

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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline

Participants were distributed into 3 subgroups. First subgroup contained participants who received adjuvant chemotherapy. Second subgroup contained participants who received metastatic 1st or 2nd line chemotherapy. Third subgroup contained participants who received metastatic 3rd line chemotherapy. (NCT02761642)
Timeframe: Baseline, Week 12

Interventiong/dL (Mean)
Baseline; Adjuvant ChemotherapyBaseline; Metastatic 1st or 2nd LineBaseline; Metastatic 3rd LineChange at Week 12; Adjuvant ChemotherapyChange at Week 12; Metastatic 1st or 2nd LineChange at Week 12; Metastatic 3rd Line
Epoetin Beta10.29.810.21.71.61.2

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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline

Participants were distributed into 2 subgroups. One subgroup contained participants who had hemoglobin (Hb) level less than (<) 10 g/dL and other subgroup contained participants who had hemoglobin level greater than or equal to (≥) 10 g/dL but <11 g/dL (10≤ Hb <11 g/dL). (NCT02761642)
Timeframe: Baseline, Week 12

Interventiong/dL (Mean)
Baseline; Hb <10 g/dLBaseline; 10≤ Hb <11 g/dLChange at Week 12; Hb <10 g/dLChange at Week 12; 10≤ Hb <11 g/dL
Epoetin Beta9.410.52.11.1

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Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline

Participants were distributed into 2 subgroups. One subgroup contained participants who had spent <6 months on chemotherapy and other subgroup contained participants who had spent 6 months or more on chemotherapy. (NCT02761642)
Timeframe: Baseline, Week 12

Interventiong/dL (Mean)
Baseline; <6 Months on ChemotherapyBaseline; ≥6 Months on ChemotherapyChange at Week 12; <6 Months on ChemotherapyChange at Week 12; ≥6 Months on Chemotherapy
Epoetin Beta10.010.01.61.4

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Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment

(NCT02761642)
Timeframe: Baseline, Week 12

Interventiong/dL (Mean)
BaselineChange at Week 12
Epoetin Beta10.01.6

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Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL

Time to increase in hemoglobin level by at least 1 g/dL was defined as the time between the start of treatment and an increase in hemoglobin level by at least 1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method. (NCT02761642)
Timeframe: Baseline up to Week 12

Interventiondays (Mean)
Epoetin Beta34.2

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Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks

(NCT02761642)
Timeframe: Baseline, Week 4

Interventionpercentage of participants (Number)
Epoetin Beta45.4

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Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores

FACT-An comprised of 2 subscales ('Fatigue' and 'Non-fatigue') of 20-items. All questions were rated on a scale from 0 to 4, where higher scores indicate improved quality of life. The 'Fatigue' subscale consists of 13 questions with score range from 0-52; 'Non-fatigue' subscale consists of 7 questions with score range from 0-28. Total FACT-An score was transformed to a 0-100 scale (instead of 0-80 scale) to get better perception of the participant's quality of life indicator. (NCT02761642)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Mean)
BaselineWeek 12
Epoetin Beta65.671.9

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Percentage of Participants With Response to Treatment

Response to treatment was defined as an increase of greater than (>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4. (NCT02767765)
Timeframe: Week 4

Interventionpercentage of participants (Number)
r-HuEPO50.8

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Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment

"No Response to treatment after 4 weeks was defined as meeting any of the following criteria: <1 g/dL increase in hemoglobin level or hemoglobin level <8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of >1 g/dL but required transfusion then the participant is considered as Non- Responder." (NCT02767765)
Timeframe: Week 4

Interventionpercentage of participants (Number)
r-HuEPO50.8

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Percentage of Participants Who Required Transfusion

(NCT02767765)
Timeframe: Baseline, Week 2, Week 4

Interventionpercentage of participants (Number)
BaselineWeek 2Week 4
r-HuEPO8.24.91.7

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Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4

FACT-An comprises of 4 subscales of 27-item (FACT-General scale [FACT-G]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188. (NCT02767765)
Timeframe: Baseline, Week 4

Interventionunits on a scale (Mean)
Baseline (n=56)Change at Week 4 (n=35)
r-HuEPO23.59-6.23

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Time to Response

Time to response was defined as the time between the start of treatment and the increase in hemoglobin level >1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method. (NCT02767765)
Timeframe: Baseline up to Week 4

Interventiondays (Median)
r-HuEPO19

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Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment

Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes >40000 per microliter or >25% increase in soluble transferrin receptor or >0.5 g/dL increase in hemoglobin level. (NCT02767765)
Timeframe: Week 2

Interventionpercentage of participants (Number)
r-HuEPO78.7

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Number of Participants With Epilepsy

≥ 2 afebrile, unprovoked seizures (NCT02811263)
Timeframe: Prior to 22-26 months

InterventionParticipants (Count of Participants)
Erythropoietin5
Placebo4

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Number of Participants With Death or Neurodevelopmental Impairment

Neurodevelopmental impairment defined as any of the following: a) Gross Motor Function Scale (GMFCS) level ≥ 1, or b) GMFCS = 0 or 0.5 and cerebral palsy (CP) (any type), or c) Bayley III Cognitive Score < 90 (NCT02811263)
Timeframe: Prior to final outcome assessment at 22-26 months of age; For extenuating circumstances, for example, COVID-19 restrictions, may be performed up to 36 months of age

InterventionParticipants (Count of Participants)
Erythropoietin126
Placebo110

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MR Evidence of Brain Injury - Brain Injury Score

Global brain injury scores were calculated using a validated scoring system for HIE. The extent of injury was recorded (i.e., none = 0, <25% = 1, 25-50% = 2; >50% = 3) as seen on T1, T2, and apparent diffusion coefficient (ADC) images in 8 regions of the brain: caudate, putamen/globus pallidus, thalamus, posterior limb of t he internal capsule (PLIC), cortex, white matter, brainstem, and cerebellum. The severity of brain injury was determined from the global injury score as follows: none (global injury score = 0), mild (1-11), moderate (12-32), or severe (33-138). (NCT02811263)
Timeframe: During first week of life

Interventionscore on a scale (Median)
Erythropoietin8
Placebo7

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Bayley III Language Score

The Bayley III language score is a population normed score. 100 indicates the population mean with a standard deviation of 15; higher scores indicate a higher level of development. (NCT02811263)
Timeframe: 22-26 months; For extenuating circumstances, for example, COVID-19 restrictions, may be performed up to 36 months of age

Interventionscore on a scale (Mean)
Erythropoietin87.9
Placebo86.7

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Number of Participants With Behavioral Abnormalities Determined by the Externalizing Score of the Child Behavior Checklist

Score for externalizing problems on Childhood Behavior Checklist of >= 65 (NCT02811263)
Timeframe: 22-26 months

InterventionParticipants (Count of Participants)
Erythropoietin15
Placebo3

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Number of Participants Experiencing Cortical Visual Impairment, Per Parent/Caregiver Report, Compared Between the Epo and Placebo Groups.

(NCT02811263)
Timeframe: Through 22-26 months

InterventionParticipants (Count of Participants)
Erythropoietin19
Placebo20

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Number of Participants Experiencing Hearing Impairment Requiring Hearing Aids, Per Parent/Caregiver Report, Compared Between the Epo and Placebo Groups.

(NCT02811263)
Timeframe: Through 22-26 months

InterventionParticipants (Count of Participants)
Erythropoietin10
Placebo13

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Serial Circulating Biomarkers of Inflammation/Brain Injury

Epo level at baseline, day 2, and day 4. (NCT02811263)
Timeframe: During first week of life

,
InterventionmU/ml (Median)
BaselineDay 2Day 4
Erythropoietin32.715302682
Placebo36.034.420.5

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Bayley III Cognitive Score

The Bayley III cognitive score is a population normed score. 100 indicates the population mean with a standard deviation of 15; higher scores indicate a higher level of development. (NCT02811263)
Timeframe: 22-26 months; For extenuating circumstances, for example, COVID-19 restrictions, may be performed up to 36 months of age

Interventionscore on a scale (Mean)
Erythropoietin89.1
Placebo89.5

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Cost of Erythropoiesis Stimulating Agent

total cost over 12 months in Canadian dollars (NCT02817555)
Timeframe: 12 months

Interventiondollars Canadian (Median)
Epoetin Alfa4178.70
Darbepoetin Alfa2302.92

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Iron Cost

total iron cost over 12 months in Canadian dollars (NCT02817555)
Timeframe: 12 months

Interventioncanadian dollars (Median)
Epoetin Alfa726.56
Darbepoetin Alfa750

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Hemoglobin

median hemoglobin (g/L) over 12 months (NCT02817555)
Timeframe: 12 months

Interventiong/L (Median)
Epoetin Alfa108
Darbepoetin Alfa109.8

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Iron Dose

median weekly iron dose (mg) over 12 months (NCT02817555)
Timeframe: 12 months

Interventionmg/week (Median)
Epoetin Alfa40.36
Darbepoetin Alfa41.67

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Transferrin Saturation (TSAT)

median TSAT (%) over 12 months (NCT02817555)
Timeframe: 12 months

Interventionpercentage saturation (Median)
Epoetin Alfa26.71
Darbepoetin Alfa28.58

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Ferritin

mean ferritin (ug/L) over 12 months (NCT02817555)
Timeframe: 12 months

Interventionug/L (Mean)
Epoetin Alfa847.58
Darbepoetin Alfa726.29

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Number of Participants With Renal Replacement Therapy

suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours. (NCT03007537)
Timeframe: 3 months

Interventionparticipants (Number)
Control Group0
Erythropoietin Group0

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Number of Participants With Acute Kidney Injury

Occurrence of acute kidney injury according to KDIGO guideline (NCT03007537)
Timeframe: 7 days

Interventionparticipants (Number)
Control Group15
Erythropoietin Group9

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AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57

The effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 24 hours post dose on Day 57

,
InterventionmmHg*Hours (Least Squares Mean)
AUEC of SBPAUEC of DBPAUEC of MAP
Daprodustat3288.431736.112299.42
Recombinant Human Erythropoietin3433.401853.602431.36

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Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1

The initial effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 1. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 24 hours post dose on Day 1

,
InterventionmmHg*Hours (Least Squares Mean)
AUEC of SBPAUEC of DBPAUEC of MAP
Daprodustat3337.911763.112324.69
Recombinant Human Erythropoietin3351.331834.822378.93

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Area Under Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionHour*nanograms per milliliter (Geometric Mean)
Daprodustat, Day 1, n=42Daprodustat, Day 57, n=28GSK2391220, Day 1, n=42GSK2391220, Day 57, n=31GSK2487818, Day 1, n=41GSK2487818, Day 57, n=28GSK2506102, Day 1, n=42GSK2506102, Day 57, n=31GSK2506104, Day 1, n=42GSK2506104, Day 57, n=31GSK2531398, Day 1, n=42GSK2531398, Day 57, n=31GSK2531401, Day 1, n=42GSK2531401, Day 57, n=31
Daprodustat767.95616.12483.12516.59177.39171.09166.89199.85662.23756.39204.02212.04334.86430.10

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Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionMillimeters of mercury (Mean)
SBP, Baseline (Day1, predose), n=45, 43SBP, Day 1: 3 hours, n=44, 43SBP, Day1: 12 hours, n=44, 43SBP, Day 1: 24 hours, n=41, 40SBP, Day 29: pre-dialysis, n=38, 40SBP, Day 29: post dialysis, n=38, 40SBP, Day 57: pre-dialysis, n=32, 36SBP, Day 57: post dialysis, n=32, 36SBP, Day 57: 3 hours, n=32, 36SBP, Day 57: 12 hours, n=32, 36SBP, Day 57: 24 hours, n=32, 36SBP, Week 10: pre-dialysis, n=42, 42SBP, Week 10: post dialysis, n=41, 42DBP, Baseline (Day1, predose), n=45, 43DBP, Day 1: 3 hours, n=44, 43DBP, Day1: 12 hours, n=44, 43DBP, Day 1: 24 hours, n=41, 40DBP, Day 29: pre-dialysis, n=38, 40DBP, Day 29: post dialysis, n=38, 40DBP, Day 57: pre-dialysis, n=32, 36DBP, Day 57: post dialysis, n=32, 36DBP, Day 57: 3 hours, n=32, 36DBP, Day 57: 12 hours, n=32, 36DBP, Day 57: 24 hours, n=32, 36DBP, Week 10: pre-dialysis, n=42, 42DBP, Week 10: post dialysis, n=41, 42
Daprodustat135.87140.64142.05140.24143.05130.97142.75135.66140.94130.47143.78142.71138.7370.0074.9177.1174.2271.9269.4772.6971.4772.4467.3876.4473.8671.05
Recombinant Human Erythropoietin137.00144.05143.56142.05148.10141.93151.53141.64148.06145.47144.83147.12136.7472.0575.5377.1976.1877.9573.3076.6972.5675.7275.9474.8175.8369.52

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Absolute Values for Temperature

Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionDegrees celsius (Mean)
Baseline (Day1, predose), n=45, 43Day 1: 3 hours, n=44, 43Day1: 12 hours, n=44, 43Day 1: 24 hours, n=41, 40Day 29: pre-dialysis, n=38, 40Day 29: post dialysis, n=38, 40Day 57: pre-dialysis, n=32, 36Day 57: post dialysis, n=32, 36Day 57: 3 hours, n=32, 36Day 57: 12 hours, n=32, 36Day 57: 24 hours, n=32, 36Week 10: pre-dialysis, n=42, 42Week 10: post dialysis, n=41, 42
Daprodustat36.45636.42736.47036.45936.38936.31636.41936.38436.42236.52536.44736.41436.461
Recombinant Human Erythropoietin36.44236.37436.50736.38036.41836.38036.40336.37836.49736.41436.50636.38336.450

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Absolute Values for Pulse Rate

Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1:3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionBeats per minute (Mean)
Baseline (Day1, predose), n=45, 43Day 1: 3 hours, n=44, 43Day1: 12 hours, n=44, 43Day 1: 24 hours, n=41, 40Day 29: pre-dialysis, n=38, 40Day 29: post dialysis, n=38, 40Day 57: pre-dialysis, n=32, 36Day 57: post dialysis, n=32, 36Day 57: 3 hours, n=32, 36Day 57: 12 hours, n=32, 36Day 57: 24 hours, n=32, 36Week 10: pre-dialysis, n=42, 42Week 10: post dialysis, n=41, 42
Daprodustat72.0972.4871.9573.3772.9274.0074.5972.6370.9170.5071.1673.0771.76
Recombinant Human Erythropoietin76.1976.2172.6576.4376.0576.1877.1775.7575.2575.1175.3675.8174.55

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Absolute Values for Hematology Parameters: Hemoglobin and Erythrocyte Mean Corpusclar Hemoglobin Concentration ( Ery. MCHC)

Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionGrams per liter (Mean)
Hemoglobin, Baseline (Day 1), n=45, 42Hemoglobin, Day 29, n=37, 39Hemoglobin, Day 57, n=31, 35Hemoglobin, Week 10, n=39, 38ery.MCHC, Baseline (Day 1), n=45, 42ery.MCHC, Day 29, n=37, 39ery.MCHC, Day 57, n=31, 35ery.MCHC, Week 10, n=39, 38
Daprodustat102.2100.2105.299.6326.7327.1329.0326.7
Recombinant Human Erythropoietin104.599.7107.9102.9322.6320.8318.3320.6

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Absolute Values for Hematology Parameters: Erythrocytes and Reticulocytes

Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
Intervention10^12 cells per liter (Mean)
Erythrocytes, Baseline (Day 1), n=45, 42Erythrocytes, Day 29, n=37, 39Erythrocytes, Day 57, n=31, 35Erythrocytes, Week 10, n=39, 38Reticulocytes, Baseline (Day 1), n=45, 42Reticulocytes, Day 29, n=37, 39Reticulocytes, Day 57, n=31, 35Reticulocytes, Week 10, n=39, 38
Daprodustat3.313.203.343.130.03020.04860.04890.0613
Recombinant Human Erythropoietin3.453.273.533.380.04010.07330.06270.0566

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Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
Intervention10^9 cells per liter (Mean)
Basophils, Baseline (Day 1), n=45, 41Basophils, Day 29, n=37, 39Basophils, Day 57, n=30, 35Basophils, Week 10, n=39, 38Eosinophils, Baseline (Day 1), n=45, 41Eosinophils, Day 29, n=37, 39Eosinophils, Day 57, n=30, 35Eosinophils, Week 10, n=39, 38Lymphocytes, Baseline (Day 1), n=45, 41Lymphocytes, Day 29, n=37, 39Lymphocytes, Day 57, n=30, 35Lymphocytes, Week 10, n=39, 38Monocytes, Baseline (Day 1), n=45, 41Monocytes, Day 29, n=37, 39Monocytes, Day 57, n=30, 35Monocytes, Week 10, n=39, 38Neutrophils, Baseline (Day 1), n=45, 41Neutrophils, Day 29, n=37, 39Neutrophils, Day 57, n=30, 35Neutrophils, Week 10, n=39, 38Platelets, Baseline (Day 1), n=45, 42Platelets, Day 29, n=37, 38Platelets, Day 57, n=30, 34Platelets, Week 10, n=39, 38Leukocytes, Baseline (Day 1), n=45, 41Leukocytes, Day 29, n=37, 39Leukocytes, Day 57, n=30, 35Leukocytes, Week 10, n=39, 38
Daprodustat0.0500.0450.0490.0440.1960.2380.2180.2311.2571.3851.2091.3670.3980.4420.4320.4694.0914.3194.3814.250188.5195.2207.8209.36.006.436.296.35
Recombinant Human Erythropoietin0.0440.0540.0450.0540.2290.1910.1600.1841.3071.4361.2251.4080.4080.4600.4480.4434.0534.2424.3774.369193.8222.1213.5229.56.046.386.256.45

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Absolute Values for Hematology Parameter: Hematocrit

Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionProportion of red blood cells in blood (Mean)
Baseline (Day 1), n=45, 42Day 29, n=37, 39Day 57, n=31, 35Week 10, n=39, 38
Daprodustat0.31330.30660.31960.3050
Recombinant Human Erythropoietin0.32420.31130.33970.3209

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Absolute Values for Hematology Parameter: Erythrocyte Distribution Width

Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionPercentage of width (Mean)
Baseline (Day 1), n=45, 42Day 29, n=37, 39Day 57, n=31, 35Week 10, n=39, 38
Daprodustat16.0616.5216.1116.42
Recombinant Human Erythropoietin15.7116.7516.6716.45

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Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Volume (MCV)

Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionFemtoliters (Mean)
Baseline (Day 1), n=45, 42Day 29, n=37, 39Day 57, n=31, 35Week 10, n=39, 38
Daprodustat95.096.596.597.9
Recombinant Human Erythropoietin94.896.297.195.7

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Absolute Values for Hematology Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) and Reticulocyte Corpuscular Hemoglobin Content (CHr)

Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionPicograms (Mean)
ery. MCH, Baseline (Day 1), n=45, 42ery. MCH, Day 29, n=37, 39ery. MCH, Day 57, n=31, 35ery. MCH, Week 10, n=39, 38CHr, Baseline (Day 1), n=45, 43CHr, Day 29, n=36, 40CHr, Day 57, n=32, 36CHr, Week 10, n=39, 39
Daprodustat31.0331.5631.7531.9630.7030.5530.7130.55
Recombinant Human Erythropoietin30.5730.8330.8830.6629.9730.1929.8529.76

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Absolute Values for Electrocardiogram (ECG) Mean Heart Rate

Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10

,
InterventionBeats per minute (Mean)
Baseline (Day 1-predose), n=45, 43Day 1: 24 hours, n=40, 38Day 57: predose, n=32, 36Day 57: 24 hours, n=32, 36Week 10, n=39, 40
Daprodustat72.271.671.271.272.3
Recombinant Human Erythropoietin73.674.872.775.174.3

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Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval Corrected for Heart Rate (QTc) and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB)

Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10

,
InterventionMilliseconds (Mean)
PR interval, Baseline (Day 1-predose), n=45, 43PR interval, Day 1: 24 hours, n=39, 38PR interval, Day 57: predose, n=32, 35PR interval, Day 57: 24 hours, n=32, 36PR interval, Week 10, n=39, 40QRS duration, Baseline (Day 1-predose), n=45, 43QRS duration, Day 1: 24 hours, n=40, 38QRS duration, Day 57: predose, n=32, 36QRS duration, Day 57: 24 hours, n=32, 36QRS duration, Week 10, n=39, 40QTc interval, Baseline (Day 1-predose), n=9, 17QTc interval, Day 1: 24 hours, n=7, 11QTc interval, Day 57: predose, n=5, 8QTc interval, Day 57: 24 hours, n=5, 8QTc interval, Week 10, n=6, 10QTcB, Baseline (Day 1-predose), n=45, 43QTcB, Day 1: 24 hours, n=40, 38QTcB, Day 57: predose, n=32, 36QTcB, Day 57: 24 hours, n=32, 36QTcB, Week 10, n=39, 39
Daprodustat156.5158.1155.8156.4162.5106.2106.0106.7106.4108.5440.6446.1452.8430.6438.8448.0438.9442.3437.4442.0
Recombinant Human Erythropoietin160.5163.3152.1160.3159.9107.4107.4112.4111.0109.1429.4424.7436.1431.8428.3445.6439.3449.1442.0441.6

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Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indirect (Indrt) Bilirubin

Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and Indrt bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionMicromoles per liter (Mean)
Direct bilirubin,Baseline(Day1),n=45,43Direct bilirubin, Day 29, n=37, 39Direct bilirubin, Day 57, n=31, 35Direct bilirubin, Week 10, n=39, 38Total bilirubin, Baseline (Day 1),n=45,43Total bilirubin, Day 29, n=37, 39Total bilirubin, Day 57, n=31, 35Total bilirubin, Week 10, n=42, 41Indrt bilirubin, Baseline (Day 1), n=45,43Indrt bilirubin, Day 29, n=37, 39Indrt bilirubin, Day 57, n=31, 35Indrt bilirubin, Week 10, n=39, 38
Daprodustat2.01.91.91.88.67.19.07.76.65.27.05.9
Recombinant Human Erythropoietin1.81.71.81.77.77.28.67.06.05.46.95.3

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Absolute Values for Clinical Chemistry Parameters: Calcium Corrected for Albumin (CCA), Glucose, Potassium, Phosphate and Sodium

Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionMillimoles per liter (Mean)
CCA, Baseline (Day 1),n=45,43CCA, Day 29, n=37, 40CCA, Day 57, n=31, 35CCA, Week 10, n=39, 38Glucose, Baseline (Day 1), n=45,43Glucose, Day 29, n=37, 40Glucose, Day 57, n=31, 35Glucose, Week 10, n=39, 38Potassium, Baseline (Day 1), n=45,43Potassium, Day 29, n=37, 40Potassium, Day 57, n=31, 35Potassium, Week 10, n=39, 38Phosphate, Baseline (Day 1), n=45,43Phosphate, Day 29, n=37, 40Phosphate, Day 57, n=31, 35Phosphate, Week 10, n=39, 38Sodium, Baseline (Day 1), n=45,43Sodium, Day 29, n=37, 40Sodium, Day 57, n=31, 35Sodium, Week 10, n=39, 38
Daprodustat2.2542.2422.2402.2277.408.287.277.983.994.393.814.661.1291.4550.9531.629137.9137.8137.7137.9
Recombinant Human Erythropoietin2.2662.2422.2652.2327.677.357.017.364.064.604.014.651.2421.7611.2741.849138.0138.4138.6138.6

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Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionInternational units per liter (Mean)
ALP, Baseline (Day1), n=45, 43ALP, Day 29, n=37, 40ALP, Day 57, n=31, 35ALP, Week 10, n=42, 41ALT, Baseline (Day 1), n=45, 43ALT, Day 29, n=37, 40ALT, Day 57, n=31, 35ALT, Week 10, n=42, 41AST, Baseline (Day 1), n=45, 43AST, Day 29, n=37, 40AST, Day 57, n=31, 35AST, Week 10, n=42, 41
Daprodustat100.9104.4109.098.313.810.411.010.616.813.214.914.0
Recombinant Human Erythropoietin100.095.7101.798.815.012.012.912.317.013.715.215.2

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Absolute Values for Clinical Chemistry Parameters: Albumin and Protein

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionGrams per liter (Mean)
Albumin, Baseline (Day1), n=45, 43Albumin, Day 29, n=37, 40Albumin, Day 57, n=31, 35Albumin, Week 10, n=39, 38Protein, Baseline (Day 1), n=45, 43Protein, Day 29, n=37, 40Protein, Day 57, n=31, 35Protein, Week 10, n=39, 38
Daprodustat41.239.141.438.772.369.474.067.5
Recombinant Human Erythropoietin40.538.340.938.072.668.073.167.8

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Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs)

An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Number of participants with treatment emergent common (>=2% non-SAEs in each arm) non-SAEs has been presented. (NCT03029247)
Timeframe: Up to Week 8

InterventionParticipants (Count of Participants)
Daprodustat10
Recombinant Human Erythropoietin4

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Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57

"The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction. Least square (LS) mean of 6 hour average SBP post AC2 on Day 57 and its corresponding standard error has been presented." (NCT03029247)
Timeframe: Up to 6 hours post dose on Day 57

InterventionMillimeters of mercury (mmHg) (Least Squares Mean)
Daprodustat142.87
Recombinant Human Erythropoietin143.03

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Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57

The effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR, difference between post-HD/pre-AC2 HR and post-HD/pre-AC1 HR and treatment by difference in post-HD HR between AC1 and 2 interaction. LS mean of 6 hour average HR post AC2 on Day 57 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 6 hours post dose on Day 57

InterventionBeats per minute (Least Squares Mean)
Daprodustat70.49
Recombinant Human Erythropoietin70.62

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Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1

The initial effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR. LS mean of 6 hour average HR post AC1 on Day 1 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 6 hours post dose on Day 1

InterventionBeats per minute (Least Squares Mean)
Daprodustat70.77
Recombinant Human Erythropoietin73.72

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AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57

The effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 24 hours post dose on Day 57

InterventionBeats per minute*Hours (Least Squares Mean)
Daprodustat1579.38
Recombinant Human Erythropoietin1677.06

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AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1

The initial effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 24 hours post dose on Day 1

InterventionBeats per minute*Hours (Least Squares Mean)
Daprodustat1652.63
Recombinant Human Erythropoietin1727.03

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Number of Participants Who Discontinued the Study Treatment

Number of participants who discontinued the study treatment due to any reason are presented. The reasons for discontinuation included adverse events, protocol specified withdrawal criteria met, physician decision and withdrawal by participant. (NCT03029247)
Timeframe: Up to Week 10

,
InterventionParticipants (Count of Participants)
Adverse eventProtocol-specified withdrawal criteria metPhysician decisionWithdrawal by participant
Daprodustat2713
Recombinant Human Erythropoietin2410

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Time of Occurrence of Cmax (Tmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionHours (Median)
Daprodustat, Day 1, n=44Daprodustat, Day 57, n=32GSK2391220, Day 1, n=44GSK2391220, Day 57, n=32GSK2487818, Day 1, n=44GSK2487818, Day 57, n=32GSK2506102, Day 1, n=44GSK2506102, Day 57, n=32GSK2506104, Day 1, n=44GSK2506104, Day 57, n=32GSK2531398, Day 1, n=44GSK2531398, Day 57, n=32GSK2531401, Day 1, n=44GSK2531401, Day 57, n=32
Daprodustat2.0002.0004.1604.0003.0904.0006.0006.0006.0005.9904.1604.0008.0158.000

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Terminal Phase Half-life (t1/2) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionHours (Geometric Mean)
Daprodustat, Day 1, n=22Daprodustat, Day 57, n=10GSK2391220, Day 1, n=9GSK2391220, Day 57, n=4GSK2487818, Day 1, n=20GSK2487818, Day 57, n=13GSK2506102, Day 1, n=1GSK2506102, Day 57, n=32GSK2506104, Day 1, n=1GSK2506104, Day 57, n=32GSK2531398, Day 1, n=11GSK2531398, Day 57, n=9GSK2531401, Day 1, n=44GSK2531401, Day 57, n=32
Daprodustat3.0313.6356.8207.4473.3883.5248.530NA6.150NA5.5826.182NANA

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Number of Participants With Any Serious Adverse Events (SAEs)

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. (NCT03029247)
Timeframe: Up to Week 10

InterventionParticipants (Count of Participants)
Daprodustat10
Recombinant Human Erythropoietin5

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Plasma Concentrations of Metabolite GSK2531398

Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531398. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=44Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=40Day 1, 16 hours, n=42Day 1, 24 hours, n=42Day 57, Predose, n=31Day 57, 0.5 hours, n=30Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=30Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=31Day 57, 24 hours, n=32
Daprodustat0.0004.4096.13913.77915.08714.88114.90713.9309.7847.7514.6871.2464.4825.40610.58015.19117.90419.82715.03810.2928.3485.334

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Plasma Concentrations of Metabolite GSK2506104

Blood samples were collected at indicated time points for the concentrations of metabolite GSK2506104. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=43Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=40Day 1, 16 hours, n=42Day 1, 24 hours, n=42Day 57, Predose, n=31Day 57, 0.5 hours, n=31Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=31Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=31Day 57, 24 hours, n=32
Daprodustat0.0009.33713.26328.98632.62334.26637.25039.46333.82231.22424.2684.13310.75912.90223.39133.56141.08947.51143.64639.68536.23427.808

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Plasma Concentrations of Metabolite GSK2506102

Blood samples were collected at indicated time points for the concentrations of metabolite GSK25206102. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=44Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=40Day 1, 16 hours, n=42Day 1, 24 hours, n=42Day 57, Predose, n=31Day 57, 0.5 hours, n=30Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=30Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=31Day 57, 24 hours, n=32
Daprodustat0.0001.8622.5755.9997.0477.5548.5649.3798.6588.2257.0241.1262.4722.8905.0827.6889.47411.50710.94510.2869.7358.449

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Plasma Concentrations of Metabolite GSK2487818

Blood samples were collected at indicated time points for the concentrations of metabolite GSK2487818. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=43Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=39Day 1, 16 hours, n=43Day 1, 24 hours, n=43Day 57, Predose, n=31Day 57, 0.5 hours, n=31Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=30Day 57, 4 hours, n=32Day 57, 6 hours, n=31Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=30Day 57, 24 hours, n=31
Daprodustat0.0008.62413.18125.20423.63220.72615.50911.6545.6733.2981.3791.5037.76010.50720.25425.09224.86521.74911.4195.5373.6131.693

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Plasma Concentrations of Metabolite GSK2391220

Blood samples were collected at indicated time points for the concentrations of metabolite GSK2391220. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=43Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=40Day 1, 16 hours, n=42Day 1, 24 hours, n=42Day 57, Predose, n=31Day 57, 0.5 hours, n=31Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=31Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=31Day 57, 24 hours, n=32
Daprodustat0.0009.84714.36130.03632.35932.89233.10532.26723.92119.77112.6933.01910.04312.41023.43332.86138.44341.43233.68925.77121.48114.836

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Plasma Concentrations of Daprodustat

Blood samples were collected at indicated time points for the concentrations of daprodustat. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=43Day 1, 2 hours, n=43Day 1, 3 hours, n=43Day 1, 4 hours, n=44Day 1, 6 hours, n=44Day 1, 8 hours, n=43Day 1, 12 hours, n=41Day 1, 16 hours, n=43Day 1, 24 hours, n=43Day 57, Predose, n=31Day 57, 0.5 hours, n=31Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=31Day 57, 8 hours, n=31Day 57, 12 hours, n=30Day 57, 16 hours, n=30Day 57, 24 hours, n=31
Daprodustat0.000197.118265.828156.103114.485105.37571.99550.06914.1655.3502.8998.657175.616260.817245.277142.36682.69643.75116.4848.6617.2791.371

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Maximum Plasma Concentration (Cmax) of Daprodustat, GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat and its metabolites GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401. PK parameters were analyzed using standard non-compartmental analysis. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Geometric Mean)
Daprodustat, Day 1, n=44Daprodustat, Day 57, n=32GSK2391220, Day 1, n=44GSK2391220, Day 57, n=32GSK2487818, Day 1, n=44GSK2487818, Day 57, n=32GSK2506102, Day 1, n=44GSK2506102, Day 57, n=32GSK2506104, Day 1, n=44GSK2506104, Day 57, n=32GSK2531398, Day 1, n=44GSK2531398, Day 57, n=32GSK2531401, Day 1, n=44GSK2531401, Day 57, n=32
Daprodustat218.841163.79539.50644.70326.67824.8469.93312.11443.16951.64318.45420.36218.33523.337

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Change From Pre-dose in SBP, DBP and MAP at Day 1

The change from pre-dose in SBP, DBP and MAP was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. (NCT03029247)
Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose

,
InterventionmmHg (Mean)
SBP, Hour 1, n=34, 31SBP, Hour 2, n=35, 31SBP, Hour 3, n=35, 31SBP, Hour 4, n=35, 31SBP, Hour 5, n=35, 31SBP, Hour 6, n=35, 31SBP, Hour 7, n=34, 26SBP, Hour 8, n=33, 29SBP, Hour 9, n=33, 30SBP, Hour 10, n=31, 28SBP, Hour 11, n=33, 27SBP, Hour 12, n=35, 28SBP, Hour 13, n=34, 28SBP, Hour 14, n=34, 31SBP, Hour 15, n=32, 26SBP, Hour 16, n=34, 31SBP, Hour 17, n=32, 30SBP, Hour 18, n=32, 27SBP, Hour 19, n=34, 27SBP, Hour 20, n=33, 27SBP, Hour 21, n=30, 27SBP, Hour 22, n=29, 27SBP, Hour 23, n=31, 26SBP, Hour 24, n=31, 27DBP, Hour 1, n=34, 31DBP, Hour 2, n=35, 31DBP, Hour 3, n=35, 31DBP, Hour 4, n=35, 31DBP, Hour 5, n=35, 31DBP, Hour 6, n=35, 31DBP, Hour 7, n=34, 26DBP, Hour 8, n=33, 29DBP, Hour 9, n=33, 30DBP, Hour 10, n=31, 28DBP, Hour 11, n=33, 27DBP, Hour 12, n=35, 28DBP, Hour 13, n=34, 28DBP, Hour 14, n=34, 31DBP, Hour 15, n=32, 26DBP, Hour 16, n=34, 31DBP, Hour 17, n=32, 30DBP, Hour 18, n=32, 27DBP, Hour 19, n=34, 27DBP, Hour 20, n=33, 27DBP, Hour 21, n=30, 27DBP, Hour 22, n=29, 27DBP, Hour 23, n=31, 26DBP, Hour 24, n=31, 27MAP, Hour 1, n=34, 31MAP, Hour 2, n=35, 31MAP, Hour 3, n=35, 31MAP, Hour 4, n=35, 31MAP, Hour 5, n=35, 31MAP, Hour 6, n=35, 31MAP, Hour 7, n=34, 26MAP, Hour 8, n=33, 29MAP, Hour 9, n=33, 30MAP, Hour 10, n=31, 28MAP, Hour 11, n=33, 27MAP, Hour 12, n=35, 28MAP, Hour 13, n=34, 28MAP, Hour 14, n=34, 31MAP, Hour 15, n=32, 26MAP, Hour 16, n=34, 31MAP, Hour 17, n=32, 30MAP, Hour 18, n=32, 27MAP, Hour 19, n=34, 27MAP, Hour 20, n=33, 27MAP, Hour 21, n=30, 27MAP, Hour 22, n=29, 27MAP, Hour 23, n=31, 26MAP, Hour 24, n=31, 27
Daprodustat1.00-4.99-5.85-1.68-1.860.292.300.43-5.81-5.70-7.00-6.05-2.49-5.30-1.47-4.40-5.05-5.23-3.01-13.27-8.32-3.932.732.630.01-0.82-1.30-1.06-0.69-0.06-0.121.35-2.14-3.52-4.88-4.79-2.15-3.99-0.54-3.56-3.65-2.08-0.36-2.96-2.54-0.254.054.48-1.87-4.79-5.13-4.78-3.48-1.270.450.08-7.02-8.18-8.74-6.49-5.72-6.99-4.06-4.79-5.10-6.98-4.44-9.47-7.39-2.770.882.02
Recombinant Human Erythropoietin5.274.725.090.93-2.10-2.540.633.830.251.481.96-1.67-1.374.57-0.138.591.765.481.526.891.723.508.725.020.991.970.88-1.17-1.49-1.49-1.271.79-0.68-0.82-2.45-3.95-2.65-1.00-4.121.15-2.980.30-0.430.401.90-1.96-0.442.162.834.203.46-1.05-1.18-2.170.872.200.610.76-3.60-6.15-3.32-0.75-5.103.84-2.091.52-1.024.233.870.754.102.20

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Change From Pre-dose in HR at Day 1

The change from pre-dose in HR was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. (NCT03029247)
Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose

,
InterventionBeats per minute (Mean)
Hour 1, n=34, 31Hour 2, n=35, 31Hour 3, n=35, 31Hour 4, n=35, 31Hour 5, n=35, 31Hour 6, n=35, 31Hour 7, n=34, 26Hour 8, n=33, 29Hour 9, n=33, 30Hour 10, n=31, 28Hour 11, n=33, 27Hour 12, n=35, 28Hour 13, n=34, 28Hour 14, n=34, 31Hour 15, n=32, 26Hour 16, n=34, 31Hour 17, n=32, 30Hour 18, n=32, 27Hour 19, n=34, 27Hour 20, n=33, 27Hour 21, n=30, 27Hour 22, n=29, 27Hour 23, n=31, 26Hour 24, n=31, 27
Daprodustat-1.16-1.050.763.180.910.972.140.620.202.542.070.77-0.25-1.54-0.92-1.02-0.850.60-0.56-1.91-1.820.82-1.01-0.89
Recombinant Human Erythropoietin0.13-2.06-0.16-1.13-0.66-1.66-1.01-1.110.671.601.57-2.01-2.450.25-3.06-2.87-4.340.98-2.65-4.77-3.00-2.610.24-0.96

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Change From Baseline Values for Vital Signs: SBP and DBP

Vital signs including SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionMillimeters of mercury (Mean)
SBP, Day 1: 3 hours, n=44, 43SBP, Day1: 12 hours, n=44, 43SBP, Day 1: 24 hours, n=41, 40SBP, Day 29: pre-dialysis, n=38, 40SBP, Day 29: post dialysis, n=38, 40SBP, Day 57: pre-dialysis, n=32, 36SBP, Day 57: post dialysis, n=32, 36SBP, Day 57: 3 hours, n=32, 36SBP, Day 57: 12 hours, n=32, 36SBP, Day 57: 24 hours, n=32, 36SBP, Week 10: pre-dialysis, n=42, 42SBP, Week 10: post dialysis, n=41, 42DBP, Day 1: 3 hours, n=44, 43DBP, Day1: 12 hours, n=44, 43DBP, Day 1: 24 hours, n=41, 40DBP, Day 29: pre-dialysis, n=38, 40DBP, Day 29: post dialysis, n=38, 40DBP, Day 57: pre-dialysis, n=32, 36DBP, Day 57: post dialysis, n=32, 36DBP, Day 57: 3 hours, n=32, 36DBP, Day 57: 12 hours, n=32, 36DBP, Day 57: 24 hours, n=32, 36DBP, Week 10: pre-dialysis, n=42, 42DBP, Week 10: post dialysis, n=41, 42
Daprodustat5.346.753.908.24-3.846.63-0.474.81-5.667.667.362.735.077.274.072.630.182.941.722.69-2.386.693.711.00
Recombinant Human Erythropoietin7.056.566.2312.005.8316.036.1412.569.979.3310.480.103.495.144.185.881.235.861.724.895.113.973.50-2.81

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Change From Baseline Values for Temperature

Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionDegrees celsius (Mean)
Day 1: 3 hours, n=44, 43Day1: 12 hours, n=44, 43Day 1: 24 hours, n=41, 40Day 29: pre-dialysis, n=38, 40Day 29: post dialysis, n=38, 40Day 57: pre-dialysis, n=32, 36Day 57: post dialysis, n=32, 36Day 57: 3 hours, n=32, 36Day 57: 12 hours, n=32, 36Day 57: 24 hours, n=32, 36Week 10: pre-dialysis, n=42, 42Week 10: post dialysis, n=41, 42
Daprodustat-0.0270.0160.015-0.089-0.163-0.003-0.0380.0000.1030.025-0.055-0.002
Recombinant Human Erythropoietin-0.0670.065-0.050-0.033-0.070-0.028-0.0530.067-0.0170.075-0.0620.005

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Change From Baseline Values for Pulse Rate

Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1, predose) and at Day 1: 3, 12, 24 hours; Day 29: pre- and post-dialysis; Day 57: pre- and post-dialysis, 3, 12, 24 hours and Week 10: pre- and post-dialysis

,
InterventionBeats per minute (Mean)
Day 1: 3 hours, n=44, 43Day1: 12 hours, n=44, 43Day 1: 24 hours, n=41, 40Day 29: pre-dialysis, n=38, 40Day 29: post dialysis, n=38, 40Day 57: pre-dialysis, n=32, 36Day 57: post dialysis, n=32, 36Day 57: 3 hours, n=32, 36Day 57: 12 hours, n=32, 36Day 57: 24 hours, n=32, 36Week 10: pre-dialysis, n=42, 42Week 10: post dialysis, n=41, 42
Daprodustat0.610.091.390.871.952.500.53-1.19-1.59-0.941.33-0.54
Recombinant Human Erythropoietin0.02-3.53-0.350.030.152.140.720.220.080.33-0.48-1.74

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Change From Baseline Values for Hematology Parameters: Hemoglobin and Ery. MCHC

Blood samples were collected for the analysis of hematology parameters: hemoglobin and ery.MCHC. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionGrams per liter (Mean)
Hemoglobin, Day 29, n=37, 38Hemoglobin, Day 57, n=31, 34Hemoglobin, Week 10, n=39, 37ery.MCHC, Day 29, n=37, 38ery.MCHC, Day 57, n=31, 34ery.MCHC, Week 10, n=39, 37
Daprodustat-4.10.5-3.20.32.3-0.6
Recombinant Human Erythropoietin-5.12.5-1.8-2.0-4.4-0.8

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Change From Baseline Values for Hematology Parameters: Erythrocytes and Reticulocytes

Blood samples were collected for the analysis of hematology parameters: erythrocytes and reticulocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
Intervention10^12 cells per liter (Mean)
Erythrocytes, Day 29, n=37, 38Erythrocytes, Day 57, n=31, 34Erythrocytes, Week 10, n=39, 37Reticulocytes, Day 29, n=37, 38Reticulocytes, Day 57, n=31, 34Reticulocytes, Week 10, n=39, 37
Daprodustat-0.17-0.06-0.180.01560.01690.0314
Recombinant Human Erythropoietin-0.200.04-0.110.03150.02040.0159

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Change From Baseline Values for Hematology Parameters: Ery. MCH and CHr

Blood samples were collected for the analysis of hematology parameter: ery.MCH and CHr. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionPicograms (Mean)
ery. MCH, Day 29, n=37, 38ery. MCH, Day 57, n=31, 34ery. MCH, Week 10, n=39, 37CHr, Day 29, n=36, 40CHr, Day 57, n=32, 36CHr, Week 10, n=39, 39
Daprodustat0.390.700.78-0.23-0.12-0.29
Recombinant Human Erythropoietin0.400.490.380.20-0.09-0.03

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Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
Intervention10^9 cells per liter (Mean)
Basophils, Day 29, n=37, 37Basophils, Day 57, n=30, 33Basophils, Week 10, n=39, 36Eosinophils, Day 29, n=37, 37Eosinophils, Day 57, n=30, 33Eosinophils, Week 10, n=39, 36Lymphocytes, Day 29, n=37, 37Lymphocytes, Day 57, n=30, 33Lymphocytes, Week 10, n=39, 36Monocytes, Day 29, n=37, 37Monocytes, Day 57, n=30, 33Monocytes, Week 10, n=39, 36Neutrophils, Day 29, n=37, 37Neutrophils, Day 57, n=30, 33Neutrophils, Week 10, n=39, 36Platelets, Day 29, n=37, 37Platelets, Day 57, n=30, 33Platelets, Week 10, n=39, 37Leukocytes, Day 29, n=37, 37Leukocytes, Day 57, n=30, 33Leukocytes, Week 10, n=39, 36
Daprodustat-0.007-0.002-0.0040.0400.0160.0420.095-0.0900.1030.0330.0240.0700.0710.0810.2180.613.920.60.230.020.42
Recombinant Human Erythropoietin0.0100.0040.009-0.039-0.038-0.0360.102-0.0990.0780.0350.0250.0530.0610.3250.18122.716.426.30.170.210.28

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Change From Baseline Values for Hematology Parameter: Hematocrit

Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionProportion of red blood cells in blood (Mean)
Day 29, n=37, 38Day 57, n=31, 34Week 10, n=39, 37
Daprodustat-0.0131-0.0016-0.0096
Recombinant Human Erythropoietin-0.01360.0131-0.0054

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Change From Baseline Values for Hematology Parameter: Erythrocyte Distribution Width

Blood samples were collected for the analysis of hematology parameter: erythrocyte distribution width. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionPercentage of width (Mean)
Day 29, n=37, 38Day 57, n=31, 34Week 10, n=39, 37
Daprodustat0.380.120.35
Recombinant Human Erythropoietin1.090.850.59

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Change From Baseline Values for Hematology Parameter: Ery. MCV

Blood samples were collected for the analysis of hematology parameter: ery.MCV. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionFemtoliters (Mean)
Day 29, n=37, 38Day 57, n=31, 34Week 10, n=39, 37
Daprodustat1.21.52.7
Recombinant Human Erythropoietin1.82.91.4

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Change From Baseline Values for ECG Parameters: PR Interval, QRS Duration, QTc and QTcB

Full 12-lead ECGs were obtained in supine position using an ECG machine to measure ECG parameters: PR interval, QRS duration, QTc interval and QTcB. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10

,
InterventionMilliseconds (Mean)
PR interval, Day 1: 24 hours, n=39, 38PR interval, Day 57: predose, n=32, 35PR interval, Day 57: 24 hours, n=32, 36PR interval, Week 10, n=39, 40QRS duration, Day 1: 24 hours, n=40, 38QRS duration, Day 57: predose, n=32, 36QRS duration, Day 57: 24 hours, n=32, 36QRS duration, Week 10, n=39, 40QTc interval, Day 1: 24 hours, n=7, 11QTc interval, Day 57: predose, n=4, 8QTc interval, Day 57: 24 hours, n=4, 8QTc interval, Week 10, n=6, 9QTcB, Day 1: 24 hours, n=40, 38QTcB, Day 57: predose, n=32, 36QTcB, Day 57: 24 hours, n=32, 36QTcB, Week 10, n=39, 39
Daprodustat3.00.20.84.9-0.50.30.00.82.1-6.3-29.0-6.7-7.0-7.0-12.0-7.2
Recombinant Human Erythropoietin1.9-3.91.81.20.02.81.40.7-9.41.0-3.4-10.3-3.14.9-2.2-3.0

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Change From Baseline Values for ECG Mean Heart Rate

Full 12-lead ECGs were obtained in supine position using an ECG machine to measure mean heart rate. Baseline (Day 1-predose) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1-predose) and at Day 1: 24 hours; Day 57: pre-dose; Day 57: 24 hours and Week 10

,
InterventionBeats per minute (Mean)
Day 1: 24 hours, n=40, 38Day 57: predose, n=32, 36Day 57: 24 hours, n=32, 36Week 10, n=39, 40
Daprodustat-0.6-1.6-1.7-0.1
Recombinant Human Erythropoietin0.80.12.50.4

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Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Indrt. Bilirubin

Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and indrt. bilirubin. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionMicromoles per liter (Mean)
Direct bilirubin, Day 29, n=37, 39Direct bilirubin, Day 57, n=31, 35Direct bilirubin, Week 10, n=39, 38Total bilirubin, Day 29, n=37, 39Total bilirubin, Day 57, n=31, 35Total bilirubin, Week 10, n=42, 41Indrt bilirubin, Day 29, n=37, 39Indrt bilirubin, Day 57, n=31, 35Indrt bilirubin, Week 10, n=39, 38
Daprodustat-0.1-0.1-0.3-1.50.6-1.0-1.40.6-0.8
Recombinant Human Erythropoietin-0.1-0.1-0.1-0.80.7-0.8-0.70.9-0.5

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Change From Baseline Values for Clinical Chemistry Parameters: CCA, Glucose, Potassium, Phosphate and Sodium

Blood samples were collected for the analysis of clinical chemistry parameters including CCA, glucose, potassium, phosphate and sodium. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionMillimoles per liter (Mean)
CCA, Day 29, n=37, 40CCA, Day 57, n=31, 35CCA, Week 10, n=39, 38Glucose, Day 29, n=37, 40Glucose, Day 57, n=31, 35Glucose, Week 10, n=39, 38Potassium, Day 29, n=37, 40Potassium, Day 57, n=31, 35Potassium, Week 10, n=39, 38Phosphate, Day 29, n=37, 40Phosphate, Day 57, n=31, 35Phosphate, Week 10, n=39, 38Sodium, Day 29, n=37, 40Sodium, Day 57, n=31, 35Sodium, Week 10, n=39, 38
Daprodustat0.0000.004-0.0100.75-0.450.620.45-0.140.670.389-0.1230.505-0.10.2-0.2
Recombinant Human Erythropoietin-0.021-0.000-0.033-0.48-0.83-0.180.53-0.040.580.5130.0040.5990.30.60.5

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Plasma Concentrations of Metabolite GSK2531401

Blood samples were collected at indicated time points for the concentrations of metabolite GSK2531401. (NCT03029247)
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours on Days 1 and 57

InterventionNanograms per milliliter (Mean)
Day 1, Predose, n=45Day 1, 0.5 hours, n=43Day 1, 1 hour, n=44Day 1, 2 hours, n=43Day 1, 3 hours, n=44Day 1, 4 hours, n=43Day 1, 6 hours, n=43Day 1, 8 hours, n=42Day 1, 12 hours, n=40Day 1, 16 hours, n=42Day 1, 24 hours, n=42Day 57, Predose, n=31Day 57, 0.5 hours, n=31Day 57, 1 hour, n=31Day 57, 2 hours, n=30Day 57, 3 hours, n=31Day 57, 4 hours, n=32Day 57, 6 hours, n=30Day 57, 8 hours, n=31Day 57, 12 hours, n=31Day 57, 16 hours, n=31Day 57, 24 hours, n=32
Daprodustat0.0002.9274.13411.01313.75215.49718.30221.13920.17420.12718.1432.4484.4865.4809.01514.02717.72224.28525.55725.28824.88121.914

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Change From Baseline Values for Clinical Chemistry Parameters: ALP, ALT and AST

Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT and AST. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionInternational units per liter (Mean)
ALP, Day 29, n=37, 40ALP, Day 57, n=31, 35ALP, Week 10, n=42, 41ALT, Day 29, n=37, 40ALT, Day 57, n=31, 35ALT, Week 10, n=42, 41AST, Day 29, n=37, 40AST, Day 57, n=31, 35AST, Week 10, n=42, 41
Daprodustat-3.40.5-4.5-3.2-3.1-3.3-3.2-2.1-3.3
Recombinant Human Erythropoietin-5.33.4-1.9-2.6-1.9-2.8-3.0-1.9-2.0

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Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein

Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Baseline value (Day1) is the latest non-missing pre-dose assessment. Change from Baseline is defined as Post-dose visit value minus Baseline value. (NCT03029247)
Timeframe: Baseline (Day 1) and at Days 29, 57 and Week 10

,
InterventionGrams per liter (Mean)
Albumin, Day 29, n=37, 40Albumin, Day 57, n=31, 35Albumin, Week 10, n=39, 38Protein, Day 29, n=37, 40Protein, Day 57, n=31, 35Protein, Week 10, n=39, 38
Daprodustat-2.20.4-2.9-3.71.2-5.2
Recombinant Human Erythropoietin-2.40.5-2.4-4.70.7-4.9

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Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1

The initial effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 SBP, DBP and MAP. LS mean of 6 hour average SBP, DBP and MAP post AC1 on Day 1 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 6 hours post dose on Day 1

,
InterventionmmHg (Least Squares Mean)
SBPDBPMAP
Daprodustat141.3675.9799.18
Recombinant Human Erythropoietin142.6877.92101.58

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Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57

The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing after AC2 on Day 57. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 DBP and MAP, difference between post-HD/pre-AC2 DBP and MAP and post-HD/pre-AC1 DBP and MAP and treatment by difference in post-HD DBP and MAP between AC1 and 2 interaction. LS mean of 6 hour average DBP and MAP post AC2 on Day 57 and its corresponding standard error has been presented. (NCT03029247)
Timeframe: Up to 6 hours post dose on Day 57

,
InterventionmmHg (Least Squares Mean)
DBPMAP
Daprodustat75.5898.98
Recombinant Human Erythropoietin77.64101.49

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Number of Participants With Treatment-emergent Adverse Events

Treatment-emergent adverse events were collected in all participants enrolled in the study. (NCT03140722)
Timeframe: up to 24 weeks

InterventionParticipants (Count of Participants)
Vadadustat0
Epoetin Alfa0

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Change From Baseline in SBP, DBP and MAP at End of Treatment

Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented. (NCT03400033)
Timeframe: Baseline (Week -4) and end of treatment (last on-treatment value until Week 52)

,
InterventionMillimeter of mercury (mmHg) (Mean)
SBPDBPMAP
Daprodustat-1.4-1.8-1.7
Epoetin Alfa-0.9-0.8-0.8

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Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S)

The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity of their anemia of Chronic kidney disease (CKD). It is measured on a 5-point disease severity scale ranging from 0 (absent) to 4 (very severe), higher score indicates more disease severity. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline in on-treatment PGI-S scores was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model fitted from Baseline up to Week 52 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions. (NCT03400033)
Timeframe: Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52

,
InterventionScores on a scale (Least Squares Mean)
Week 8; n=248, 126Week 12; n=243, 120Week 28; n=211, 106Week 52; n=170, 85
Daprodustat-0.10-0.13-0.07-0.11
Epoetin Alfa0.05-0.010.030.04

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Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)

Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented. (NCT03400033)
Timeframe: Week 28 to Week 52

InterventionPercentage of days (Median)
Daprodustat70.83
Epoetin Alfa61.76

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Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria

Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented. (NCT03400033)
Timeframe: Up to Week 52

InterventionPercentage of participants (Number)
Daprodustat2.2
Epoetin Alfa2.2

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Number of Participants With at Least One BP Exacerbation Event During the Study

BP exacerbation (based on post-dialysis BP) is defined as: SBP >= 25 mmHg increased from Baseline or SBP >=180mmHg; or DBP >=15 mmHg increase from Baseline or DBP >=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported. (NCT03400033)
Timeframe: Up to 52 weeks

InterventionParticipants (Count of Participants)
Daprodustat151
Epoetin Alfa91

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Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years

BP exacerbation event is defined (based on post-dialysis BP) as SBP >=25 mmHg increased from Baseline or SBP >=180 mmHg; or DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model. (NCT03400033)
Timeframe: Up to 52 weeks

InterventionEvents per 100 participant years (Number)
Daprodustat250.45
Epoetin Alfa356.91

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Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)

Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter. (NCT03400033)
Timeframe: Week 28 to Week 52

InterventionParticipants (Count of Participants)
Daprodustat172
Epoetin Alfa68

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Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13). (NCT03400033)
Timeframe: Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52

,,,,,,,,
InterventionNanograms per milliliter (Geometric Mean)
Daprodustat; n=1, 2, 10, 18, 14, 9, 6, 3, 2GSK2391220; n=4, 17,42, 57, 40, 25, 16, 3, 3GSK2487818; n=1, 4, 5, 20, 14, 7, 4, 3, 2GSK2506102; n=4, 17, 45, 59, 43, 27, 16, 3, 3GSK2506104; n=6, 17, 45, 59, 43, 27, 16, 3, 3GSK2531398; n=2, 7, 22, 41, 33, 20, 15, 3, 3GSK2531401; n=6, 17, 45, 59, 44, 27, 16, 3, 3
Daprodustat 12 mg0.37271.15720.29961.51003.51410.44446.8137
Daprodustat 16 mg0.34431.16540.30271.54803.38720.39175.6037
Daprodustat 2 mg6.24000.86230.36200.99510.97501.17781.4466
Daprodustat 20 mg0.38711.17920.28681.65553.60000.37288.4611
Daprodustat 24 mg0.16211.49870.25853.20996.57300.399211.7372
Daprodustat 32 mg0.27681.69740.24141.68924.20680.39636.0453
Daprodustat 4 mg1.12070.58930.28670.83721.95880.60693.5579
Daprodustat 48 mg0.34861.35310.21111.85954.18940.228016.2584
Daprodustat 8 mg0.17860.63410.15940.96342.03810.23624.0910

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Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)

Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13). (NCT03400033)
Timeframe: Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52

,,,,,,,,
InterventionNanograms per milliliter (Geometric Mean)
Daprodustat; n=8, 20, 49, 57, 45, 28, 16, 3, 3GSK2391220; n=8, 19, 50, 59, 45, 28, 16, 3, 3GSK2487818; n=7, 18, 47, 56, 45, 28, 16, 3, 3GSK2506102; n=8, 19, 51, 59, 45, 28, 16, 3, 3GSK2506104; n=8, 19, 51, 59, 45, 28, 16, 3, 3GSK2531398; n=8, 17, 46, 59, 45, 27, 16, 3, 3GSK2531401; n=7, 19, 51, 59, 45, 28, 16, 3, 3
Daprodustat 12 mg143.87908.95358.01342.835710.81863.80178.8488
Daprodustat 16 mg126.68249.51316.42763.200711.57834.08508.4814
Daprodustat 2 mg44.58322.62982.03200.83283.20201.27312.0473
Daprodustat 20 mg212.508711.89959.66173.571213.85096.102910.7368
Daprodustat 24 mg290.316322.337819.96936.455524.492610.753214.7926
Daprodustat 32 mg197.70719.35828.43272.49819.54574.62967.1458
Daprodustat 4 mg51.92614.02243.27031.40185.20392.36764.0012
Daprodustat 48 mg310.193831.669829.30427.124530.403414.784420.1044
Daprodustat 8 mg113.40496.38266.34742.03857.52203.73485.4631

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Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52

Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value*time, treatment group*time as variables. (NCT03400033)
Timeframe: Baseline (Week -4 ) and Week 52

,
InterventionMillimeter of mercury (mmHg) (Least Squares Mean)
SBPDBPMAP
Daprodustat-3.18-2.52-2.72
Epoetin Alfa0.55-0.29-0.12

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Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)

Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region. (NCT03400033)
Timeframe: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)

InterventionGrams per deciliter (g/dL) (Least Squares Mean)
Daprodustat-0.04
Epoetin Alfa0.02

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Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant

Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region. (NCT03400033)
Timeframe: Day 1 to Week 52

InterventionMilligrams (Least Squares Mean)
Daprodustat98.11
Epoetin Alfa106.23

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Change From Baseline in Hemoglobin Levels at Week 52

Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms. (NCT03400033)
Timeframe: Baseline (Pre-dose on Day 1) and Week 52

InterventionGrams per deciliter (Least Squares Mean)
Daprodustat-0.03
Epoetin Alfa0.11

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The Proportion of Patients With Treatment Success

Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months (NCT03408639)
Timeframe: Week 12 to week 26

Interventionproportion of patients (Number)
CinnaPoietin®0.41
Eprex®0.44

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The Proportion of Patients With Maintenance Success

Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks (NCT03408639)
Timeframe: 26 weeks

Interventionproportion of patients (Number)
CinnaPoietin®0.71
Eprex®0.43

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The Proportion of Patients With Any Permanent or Transient Dose Change

The proportion of patients with any permanent or transient dose change during 26 weeks. (NCT03408639)
Timeframe: 26 weeks

Interventionproportion of patients (Number)
CinnaPoietin®0.9
Eprex®0.95

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The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)

The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks. (NCT03408639)
Timeframe: 26 weeks

Interventionproportion of patients (Number)
CinnaPoietin®0.92
Eprex®1

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The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks

The proportion of patients with an increase in Hb concentration of > 1.0 g/dl for four consecutive weeks during 26 weeks. (NCT03408639)
Timeframe: 26 weeks

InterventionParticipants (Count of Participants)
CinnaPoietin®44
Eprex®41

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The Proportion of Patients Needed Blood Transfusions

The proportion of patients needed blood transfusions during 26 weeks. (NCT03408639)
Timeframe: 26 weeks

Interventionproportion of patients (Number)
CinnaPoietin®0.04
Eprex®0.04

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The Percentage of Patients With Hematocrit Measurements More Than 30%

The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26. (NCT03408639)
Timeframe: Week 22 to week 26

Interventionpercentage of patients (Number)
CinnaPoietin®86.76
Eprex®92.86

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The Percentage of Patients With Hb Measurements More Than 10.0 g/dl

The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26. (NCT03408639)
Timeframe: Week 22 to week 26

InterventionParticipants (Count of Participants)
CinnaPoietin®55
Eprex®48

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The Incidence of Hb Levels Above 13 g/dl

The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL. (NCT03408639)
Timeframe: 26 weeks

InterventionParticipants (Count of Participants)
CinnaPoietin®31
Eprex®42

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The Incidence of Adverse Events

The incidence of adverse events during 26 weeks. (NCT03408639)
Timeframe: 26 weeks

InterventionParticipants (Count of Participants)
CinnaPoietin®23
Eprex®18

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Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment

The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint. (NCT03408639)
Timeframe: Week 22 to week 26

InterventionIU/Kg/week (Mean)
CinnaPoietin®117.02
Eprex®110.01

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Mean Hb Change Level During the Last Four Weeks of Treatment

The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment. (NCT03408639)
Timeframe: Week 22 to week 26

Interventiong/dL (Mean)
CinnaPoietin®0.4
Eprex®0.74

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Mean Change From Baseline in Ferritin Concentration

Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20

,,,,,,,,
Interventionmicrograms per liter (µg/L) (Mean)
BaselineWeek 4Week 8Week 12Week 16Week 20
ESA Hyporesponder: Epoetin Alfa449.6-61.5397.8-35.062.3607.0
ESA Hyporesponder: Vadadustat 600 mg1182.234.8111.3-0.580.0249.0
High Dose of Epoetin Alfa: Epoetin Alfa723.6-145.6-78.3-195.3-81.8-104.8
High Dose of Epoetin Alfa: Vadadustat 300 mg910.241.429.4-68.0-144.0-199.4
High Dose of Epoetin Alfa: Vadadustat 450 mg745.2152.9-5.6-23.827.84.8
High Dose of Epoetin Alfa: Vadadustat 600 mg739.545.5-87.8-30.1-97.2-51.6
Low Dose of Epoetin Alfa: Epoetin Alfa919.3-23.724.9-42.499.526.5
Low Dose of Epoetin Alfa: Vadadustat 300 mg939.3-30.1-120.8-118.5-92.0-113.6
Low Dose of Epoetin Alfa: Vadadustat 450 mg1043.6-101.9-185.4-194.8-70.9-166.6

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Mean Change From Baseline in Hepcidin Concentration

Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 12 and Week 20

,,,,,,,,
Interventionnanograms per milliliter (ng/mL) (Mean)
BaselineWeek 12Week 20
ESA Hyporesponder: Epoetin Alfa74.748-1.062-9.023
ESA Hyporesponder: Vadadustat 600 mg239.958-128.587-152.243
High Dose of Epoetin Alfa: Epoetin Alfa143.519-62.787-80.680
High Dose of Epoetin Alfa: Vadadustat 300 mg185.852-55.283-93.412
High Dose of Epoetin Alfa: Vadadustat 450 mg215.608-34.868-83.012
High Dose of Epoetin Alfa: Vadadustat 600 mg160.760-74.797-43.701
Low Dose of Epoetin Alfa: Epoetin Alfa259.161-66.646-83.685
Low Dose of Epoetin Alfa: Vadadustat 300 mg194.870-50.565-86.025
Low Dose of Epoetin Alfa: Vadadustat 450 mg208.816-53.675-38.627

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Mean Change From Baseline in Iron Concentration

Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20

,,,,,,,,
Interventionmicrograms per deciliter (µg/dL) (Mean)
BaselineWeek 4Week 8Week 12Week 16Week 20
ESA Hyporesponder: Epoetin Alfa58.43.82.0-12.6-12.0-10.3
ESA Hyporesponder: Vadadustat 600 mg81.68.60.3-2.519.5-15.3
High Dose of Epoetin Alfa: Epoetin Alfa65.7-6.6-12.6-16.1-13.9-8.4
High Dose of Epoetin Alfa: Vadadustat 300 mg57.73.34.5-2.8-0.728.7
High Dose of Epoetin Alfa: Vadadustat 450 mg80.99.6-5.9-0.45.2-3.1
High Dose of Epoetin Alfa: Vadadustat 600 mg73.11.711.7-5.1-4.613.4
Low Dose of Epoetin Alfa: Epoetin Alfa90.1-18.3-8.6-26.0-17.9-16.6
Low Dose of Epoetin Alfa: Vadadustat 300 mg87.4-8.0-5.5-2.7-22.8-14.2
Low Dose of Epoetin Alfa: Vadadustat 450 mg93.9-11.2-15.0-22.2-18.3-9.5

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Mean Change From Baseline in Reticulocyte Count

Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20

,,,,,,,,
Intervention10^3 cells/microliter (µL) (Mean)
BaselineWeek 1Week 4Week 8Week 11Week 12Week 13Week 16Week 20
ESA Hyporesponder: Epoetin Alfa83.0-25.217.5-21.8-27.2-17.316.34.040.0
ESA Hyporesponder: Vadadustat 600 mg77.6-35.8-26.8-3.3-6.73.82.0-31.5-3.3
High Dose of Epoetin Alfa: Epoetin Alfa62.620.422.514.03.94.60.126.638.5
High Dose of Epoetin Alfa: Vadadustat 300 mg59.3-18.1-5.69.126.247.746.3-2.210.3
High Dose of Epoetin Alfa: Vadadustat 450 mg48.4-3.92.920.432.520.315.99.716.4
High Dose of Epoetin Alfa: Vadadustat 600 mg51.5-6.66.123.19.226.910.50.210.9
Low Dose of Epoetin Alfa: Epoetin Alfa48.81.00.823.121.022.216.48.323.8
Low Dose of Epoetin Alfa: Vadadustat 300 mg51.93.114.614.011.716.116.713.914.5
Low Dose of Epoetin Alfa: Vadadustat 450 mg47.26.914.923.920.216.312.119.613.2

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Mean Change From Baseline in Total Iron Binding Capacity

Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20

,,,,,,,,
Interventionµg/dL (Mean)
BaselineWeek 4Week 8Week 12Week 16Week 20
ESA Hyporesponder: Epoetin Alfa225.67.8-24.8-0.6-2.5-6.0
ESA Hyporesponder: Vadadustat 600 mg211.044.256.058.042.566.7
High Dose of Epoetin Alfa: Epoetin Alfa218.2-0.5-7.4-3.8-13.7-5.4
High Dose of Epoetin Alfa: Vadadustat 300 mg210.127.626.325.155.351.7
High Dose of Epoetin Alfa: Vadadustat 450 mg235.741.049.441.053.168.4
High Dose of Epoetin Alfa: Vadadustat 600 mg223.648.258.854.560.967.9
Low Dose of Epoetin Alfa: Epoetin Alfa234.8-13.4-1.1-9.9-3.0-9.5
Low Dose of Epoetin Alfa: Vadadustat 300 mg237.835.930.342.435.038.0
Low Dose of Epoetin Alfa: Vadadustat 450 mg230.727.737.037.227.844.9

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Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)

Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. (NCT03799627)
Timeframe: Baseline; Week 10 to Week 12

,,,,,,,,
Interventiongrams per deciliter (g/dL) (Mean)
BaselineChange from Baseline at PEP
ESA Hyporesponder: Epoetin Alfa9.620-0.290
ESA Hyporesponder: Vadadustat 600 mg9.530-0.671
High Dose of Epoetin Alfa: Epoetin Alfa9.9500.268
High Dose of Epoetin Alfa: Vadadustat 300 mg9.778-0.911
High Dose of Epoetin Alfa: Vadadustat 450 mg10.288-0.284
High Dose of Epoetin Alfa: Vadadustat 600 mg10.095-0.418
Low Dose of Epoetin Alfa: Epoetin Alfa10.1650.160
Low Dose of Epoetin Alfa: Vadadustat 300 mg10.223-0.371
Low Dose of Epoetin Alfa: Vadadustat 450 mg10.0590.072

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Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group

Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)

InterventionMilliunits per milliliter (Geometric Mean)
BaselineWeek 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg8.0312.99.49

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Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group

Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)

,,
InterventionMilliunits per milliliter (Geometric Mean)
BaselineWeek 1Week 1 +1 (Day 8)Week 11Week 13
High Dose of Epoetin Alfa: Vadadustat 300 mg9.9315.316.119.439.2
High Dose of Epoetin Alfa: Vadadustat 600 mg6.9820.217.417.310.5
Low Dose of Epoetin Alfa: Vadadustat 450 mg9.5317.518.914.915.7

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Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

InterventionHours (Median)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg9.0111.7

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Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,
InterventionHours (Median)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 300 mg12.510.16.49
High Dose of Epoetin Alfa: Vadadustat 450 mg10.312.43.95
Low Dose of Epoetin Alfa: Vadadustat 300 mg8.538.826.73

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Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,
InterventionHours (Median)
Week 1Week 1 +1 (Day 8)Week 11Week 13
High Dose of Epoetin Alfa: Vadadustat 600 mg11.014.65.655.01
Low Dose of Epoetin Alfa: Vadadustat 450 mg10.58.8310.411.0

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Number of Participants With Hb Values Within the Target Range at the SEP

The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. (NCT03799627)
Timeframe: Week 18 to Week 20

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg6
Low Dose of Epoetin Alfa: Vadadustat 450 mg7
Low Dose of Epoetin Alfa: Epoetin Alfa9
High Dose of Epoetin Alfa: Vadadustat 300 mg2
High Dose of Epoetin Alfa: Vadadustat 450 mg3
High Dose of Epoetin Alfa: Vadadustat 600 mg2
High Dose of Epoetin Alfa: Epoetin Alfa6
ESA Hyporesponder: Vadadustat 600 mg1
ESA Hyporesponder: Epoetin Alfa1

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Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing

"The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for Vadadustat Total (TIW dosing regimen). For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing." (NCT03799627)
Timeframe: Week 18 to Week 20

InterventionParticipants (Count of Participants)
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)0
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)2
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)2
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)3
Vadadustat Total (TIW Dosing Regimen)7

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Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. (NCT03799627)
Timeframe: Up to Week 24

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg18
Low Dose of Epoetin Alfa: Vadadustat 450 mg27
Low Dose of Epoetin Alfa: Epoetin Alfa13
High Dose of Epoetin Alfa: Vadadustat 300 mg12
High Dose of Epoetin Alfa: Vadadustat 450 mg14
High Dose of Epoetin Alfa: Vadadustat 600 mg13
High Dose of Epoetin Alfa: Epoetin Alfa9
ESA Hyporesponder: Vadadustat 600 mg5
ESA Hyporesponder: Epoetin Alfa3

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Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group

Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT03799627)
Timeframe: Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)

,
InterventionMilliunits per milliliter (Geometric Mean)
BaselineWeek 1Week 1 +1 (Day 8)Week 11
Low Dose of Epoetin Alfa: Vadadustat 300 mg7.3312.115.614.2
High Dose of Epoetin Alfa: Vadadustat 450 mg8.7714.118.020.6

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Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

Interventionliters per hour (Geometric Mean)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg1.291.55

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Number of Participants With Hb Values Within the Target Range at the PEP

The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. (NCT03799627)
Timeframe: Week 10 to Week 12

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg12
Low Dose of Epoetin Alfa: Vadadustat 450 mg13
Low Dose of Epoetin Alfa: Epoetin Alfa15
High Dose of Epoetin Alfa: Vadadustat 300 mg1
High Dose of Epoetin Alfa: Vadadustat 450 mg4
High Dose of Epoetin Alfa: Vadadustat 600 mg4
High Dose of Epoetin Alfa: Epoetin Alfa6
ESA Hyporesponder: Vadadustat 600 mg0
ESA Hyporesponder: Epoetin Alfa0

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Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,,,
Interventionliters per hour (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 300 mg0.8770.9680.747
High Dose of Epoetin Alfa: Vadadustat 450 mg0.7440.7951.00
High Dose of Epoetin Alfa: Vadadustat 600 mg0.7630.7081.02
Low Dose of Epoetin Alfa: Vadadustat 300 mg0.8881.040.872
Low Dose of Epoetin Alfa: Vadadustat 450 mg0.8690.9671.33

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Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

InterventionLiters (Geometric Mean)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg15.812.4

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Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,,,
InterventionLiters (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 300 mg13.717.410.1
High Dose of Epoetin Alfa: Vadadustat 450 mg12.115.38.24
High Dose of Epoetin Alfa: Vadadustat 600 mg13.815.68.76
Low Dose of Epoetin Alfa: Vadadustat 300 mg10.912.510.2
Low Dose of Epoetin Alfa: Vadadustat 450 mg14.313.710.7

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Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

Interventionhours*µg/mL (Geometric Mean)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg464388

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Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,,,
Interventionhours*µg/mL (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 300 mg342310402
High Dose of Epoetin Alfa: Vadadustat 450 mg605566450
High Dose of Epoetin Alfa: Vadadustat 600 mg786847588
Low Dose of Epoetin Alfa: Vadadustat 300 mg338289344
Low Dose of Epoetin Alfa: Vadadustat 450 mg518465338

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Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

Intervention1/hour (Geometric Mean)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg0.07710.0594

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Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,
Intervention1/hour (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 300 mg0.05600.07140.124
High Dose of Epoetin Alfa: Vadadustat 450 mg0.06810.04690.175
Low Dose of Epoetin Alfa: Vadadustat 300 mg0.07970.07200.0925

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Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,
Intervention1/hour (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11Week 13
High Dose of Epoetin Alfa: Vadadustat 600 mg0.06080.04690.1160.138
Low Dose of Epoetin Alfa: Vadadustat 450 mg0.06650.06150.06870.0632

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Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

InterventionMicrograms per milliliter (μg/mL) (Geometric Mean)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg44.231.6

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Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,
InterventionMicrograms per milliliter (μg/mL) (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 450 mg47.044.238.1
Low Dose of Epoetin Alfa: Vadadustat 300 mg26.020.128.6

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Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,
InterventionMicrograms per milliliter (μg/mL) (Geometric Mean)
Week 1Week 1 +1 (Day 8)Week 11Week 13
High Dose of Epoetin Alfa: Vadadustat 300 mg26.523.832.411.5
High Dose of Epoetin Alfa: Vadadustat 600 mg56.560.141.260.2
Low Dose of Epoetin Alfa: Vadadustat 450 mg40.837.624.430.6

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Number of Participants Classified as Hb Outliers

The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. (NCT03799627)
Timeframe: Weeks 13 - 20

,,,,,,,,
InterventionParticipants (Count of Participants)
Hb >12.0 g/dLHb >13.0 g/dLHb >14.0 g/dLHb <8.0 g/dL and decline in Hb ≥0.5 g/dL from BaselineHb increase >1.0 g/dL within any 2-week interval
ESA Hyporesponder: Epoetin Alfa00012
ESA Hyporesponder: Vadadustat 600 mg00010
High Dose of Epoetin Alfa: Epoetin Alfa10016
High Dose of Epoetin Alfa: Vadadustat 300 mg00014
High Dose of Epoetin Alfa: Vadadustat 450 mg10012
High Dose of Epoetin Alfa: Vadadustat 600 mg00033
Low Dose of Epoetin Alfa: Epoetin Alfa31104
Low Dose of Epoetin Alfa: Vadadustat 300 mg21124
Low Dose of Epoetin Alfa: Vadadustat 450 mg20028

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Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,,
InterventionHours (Median)
Week 1Week 1 +1 (Day 8)Week 11Week 13
High Dose of Epoetin Alfa: Vadadustat 300 mg3.483.333.504.25
High Dose of Epoetin Alfa: Vadadustat 600 mg2.002.172.112.04
Low Dose of Epoetin Alfa: Vadadustat 450 mg2.722.113.501.98

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Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

,
InterventionHours (Median)
Week 1Week 1 +1 (Day 8)Week 11
High Dose of Epoetin Alfa: Vadadustat 450 mg3.503.302.03
Low Dose of Epoetin Alfa: Vadadustat 300 mg2.083.283.23

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Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose

Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. (NCT03799627)
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose

InterventionHours (Median)
Week 1Week 1 +1 (Day 8)
ESA Hyporesponder: Vadadustat 600 mg3.283.42

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Mean Change in Hb Between Baseline and the SEP

Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. (NCT03799627)
Timeframe: Baseline; Week 18 to Week 20

Interventiong/dL (Mean)
Low Dose of Epoetin Alfa: Vadadustat 300 mg-0.197
Low Dose of Epoetin Alfa: Vadadustat 450 mg-0.186
Low Dose of Epoetin Alfa: Epoetin Alfa0.070
High Dose of Epoetin Alfa: Vadadustat 300 mg0.114
High Dose of Epoetin Alfa: Vadadustat 450 mg-0.421
High Dose of Epoetin Alfa: Vadadustat 600 mg-0.545
High Dose of Epoetin Alfa: Epoetin Alfa0.343
ESA Hyporesponder: Vadadustat 600 mg-0.283
ESA Hyporesponder: Epoetin Alfa-0.400

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Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12

"Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for Vadadustat Total (TIW dosing regimen). For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing." (NCT03799627)
Timeframe: Week 10 to Week 12; Week 18 to Week 20

Interventiong/dL (Mean)
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)-0.050
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)-1.021
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)-0.360
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)-0.103
Vadadustat Total (TIW Dosing Regimen)-0.422

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Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation

Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. (NCT03799627)
Timeframe: Up to Week 20

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg23
Low Dose of Epoetin Alfa: Vadadustat 450 mg21
Low Dose of Epoetin Alfa: Epoetin Alfa16
High Dose of Epoetin Alfa: Vadadustat 300 mg10
High Dose of Epoetin Alfa: Vadadustat 450 mg14
High Dose of Epoetin Alfa: Vadadustat 600 mg18
High Dose of Epoetin Alfa: Epoetin Alfa10
ESA Hyporesponder: Vadadustat 600 mg4
ESA Hyporesponder: Epoetin Alfa5

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Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue

ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. (NCT03799627)
Timeframe: Up to Week 20

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg2
Low Dose of Epoetin Alfa: Vadadustat 450 mg8
Low Dose of Epoetin Alfa: Epoetin Alfa3
High Dose of Epoetin Alfa: Vadadustat 300 mg5
High Dose of Epoetin Alfa: Vadadustat 450 mg5
High Dose of Epoetin Alfa: Vadadustat 600 mg3
High Dose of Epoetin Alfa: Epoetin Alfa1
ESA Hyporesponder: Vadadustat 600 mg3
ESA Hyporesponder: Epoetin Alfa1

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Number of Participants Requiring Red Blood Cell (RBC) Transfusion

RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. (NCT03799627)
Timeframe: Up to Week 20

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg0
Low Dose of Epoetin Alfa: Vadadustat 450 mg1
Low Dose of Epoetin Alfa: Epoetin Alfa0
High Dose of Epoetin Alfa: Vadadustat 300 mg3
High Dose of Epoetin Alfa: Vadadustat 450 mg1
High Dose of Epoetin Alfa: Vadadustat 600 mg2
High Dose of Epoetin Alfa: Epoetin Alfa0
ESA Hyporesponder: Vadadustat 600 mg1
ESA Hyporesponder: Epoetin Alfa1

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Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP

The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. (NCT03799627)
Timeframe: Week 10 to Week 12

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg14
Low Dose of Epoetin Alfa: Vadadustat 450 mg19
Low Dose of Epoetin Alfa: Epoetin Alfa18
High Dose of Epoetin Alfa: Vadadustat 300 mg1
High Dose of Epoetin Alfa: Vadadustat 450 mg6
High Dose of Epoetin Alfa: Vadadustat 600 mg6
High Dose of Epoetin Alfa: Epoetin Alfa8
ESA Hyporesponder: Vadadustat 600 mg0
ESA Hyporesponder: Epoetin Alfa1

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Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP

The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. (NCT03799627)
Timeframe: Week 18 to Week 20

InterventionParticipants (Count of Participants)
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg10
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg11
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa14
High Dose of Epoetin Alfa: Vadadustat 300 mg3
High Dose of Epoetin Alfa: Vadadustat 450 mg5
High Dose of Epoetin Alfa: Vadadustat 600 mg2
High Dose of Epoetin Alfa: Epoetin Alfa8
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg1
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa2

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Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values

Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. (NCT03799627)
Timeframe: Up to Week 24

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg0
Low Dose of Epoetin Alfa: Vadadustat 450 mg0
Low Dose of Epoetin Alfa: Epoetin Alfa0
High Dose of Epoetin Alfa: Vadadustat 300 mg0
High Dose of Epoetin Alfa: Vadadustat 450 mg0
High Dose of Epoetin Alfa: Vadadustat 600 mg0
High Dose of Epoetin Alfa: Epoetin Alfa0
ESA Hyporesponder: Vadadustat 600 mg0
ESA Hyporesponder: Epoetin Alfa0

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Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values

Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. (NCT03799627)
Timeframe: Up to Week 24

InterventionParticipants (Count of Participants)
Low Dose of Epoetin Alfa: Vadadustat 300 mg0
Low Dose of Epoetin Alfa: Vadadustat 450 mg0
Low Dose of Epoetin Alfa: Epoetin Alfa0
High Dose of Epoetin Alfa: Vadadustat 300 mg0
High Dose of Epoetin Alfa: Vadadustat 450 mg0
High Dose of Epoetin Alfa: Vadadustat 600 mg0
High Dose of Epoetin Alfa: Epoetin Alfa0
ESA Hyporesponder: Vadadustat 600 mg0
ESA Hyporesponder: Epoetin Alfa0

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Reticulocyte Response: AUC 0-120h

(NCT03822884)
Timeframe: 120hr

InterventionmUI*h/mL (Mean)
Hemax® PFS 40,000 UI341.65
Hemax® 40,000 UI344.49
Erypo ® 40,000 UI345.58

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Reticulocyte Response: Cmax

Reticulocyte count by flow cytometry, as a surrogate marker of the pharmacodynamics of erythropoietin. Maximum reticulocyte concentration achieved. (NCT03822884)
Timeframe: 120hr

InterventionmUI / ml (Mean)
Hemax® PFS 40,000 UI1.23
Hemax® 40,000 UI1.33
Erypo ® 40,000 UI1.31

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AUC0-∞

AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞. (NCT03822884)
Timeframe: 120hr

InterventionmUI*h/mL (Mean)
Hemax® PFS 40,000 UI42487.04
Hemax® 40,000 UI36907.41
Erypo ® 40,000 UI43978.39

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Tmax

Tmax: time to the maximum serum concentration of epoetin alfa (NCT03822884)
Timeframe: 120hr

Interventionh (Mean)
Hemax® PFS 40,000 UI14.17
Hemax® 40,000 UI15.04
Erypo ® 40,000 UI14.96

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AUC0-t

AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours). (NCT03822884)
Timeframe: 120 h

InterventionmUI*h/mL (Mean)
Hemax® PFS 40,000 UI37440.71
Hemax® 40,000 UI34483.73
Erypo ® 40,000 UI41150.49

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Cmax

Cmax: maximum serum concentration of epoetin alfa. (NCT03822884)
Timeframe: 120hr

InterventionmUI / ml (Mean)
Hemax® PFS 40,000 UI853.11
Hemax® 40,000 UI808.29
Erypo ® 40,000 UI913.07

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