Trial | Phase | Enrollment | Study Type | Start Date | Status |
Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar. [NCT02049346] | Phase 4 | 327 participants (Actual) | Interventional | 2012-03-31 | Completed |
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 3 | 673 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 4 | 37 participants (Actual) | Interventional | 2006-08-31 | Terminated(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 3 | 170 participants (Actual) | Interventional | 2002-09-30 | Completed |
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage [NCT03914690] | Phase 2 | 316 participants (Actual) | Interventional | 2014-07-31 | Completed |
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction [NCT00367991] | Phase 2 | 44 participants (Actual) | Interventional | 2006-11-30 | Completed |
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 2 | 65 participants (Actual) | Interventional | 2002-03-31 | Completed |
Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease [NCT01105494] | | 6,000 participants (Actual) | Observational | 2008-12-31 | Completed |
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 2 | 161 participants (Actual) | Interventional | 2010-05-17 | Completed |
A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy [NCT01586052] | Phase 1 | 11 participants (Actual) | Interventional | 2012-06-30 | Completed |
Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT [NCT03308448] | Phase 3 | 93 participants (Actual) | Interventional | 2018-01-06 | Completed |
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 1 | 107 participants (Actual) | Interventional | 2010-07-31 | Completed |
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 3 | 55 participants (Actual) | Interventional | 2011-07-31 | Completed |
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 3 | 656 participants (Actual) | Interventional | 2009-07-31 | Completed |
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 4 | 33 participants (Actual) | Interventional | 2009-10-31 | Terminated |
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 3 | 407 participants (Actual) | Interventional | 2018-09-05 | Completed |
Colorado-Oregon Altitude Study [NCT05734716] | Phase 4 | 121 participants (Actual) | Interventional | 2021-02-17 | Completed |
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 3 | 130 participants (Actual) | Interventional | 2011-10-31 | Completed |
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT) [NCT02802592] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2015-05-31 | Terminated(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 3 | 260 participants (Actual) | Interventional | 2007-03-31 | Terminated(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 4 | 30 participants (Actual) | Interventional | 2011-06-30 | Completed |
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) | Observational | 2009-09-30 | Completed |
Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes [NCT03700515] | | 72 participants (Anticipated) | Interventional | 2019-09-04 | Recruiting |
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 2 | 105 participants (Actual) | Interventional | 2017-07-27 | Completed |
Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population. [NCT01265680] | | 600 participants (Actual) | Interventional | 2012-02-29 | Completed |
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 2 | 150 participants (Anticipated) | Interventional | 2022-04-13 | Recruiting |
Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial [NCT01290328] | | 100 participants (Anticipated) | Interventional | 2011-02-28 | Terminated(stopped due to low enrollment, termination of funding) |
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease [NCT03842254] | Early Phase 1 | 6 participants (Actual) | Interventional | 2019-01-25 | Completed |
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 3 | 318 participants (Actual) | Interventional | 1997-08-31 | Completed |
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers [NCT03822884] | Phase 1 | 24 participants (Actual) | Interventional | 2016-09-30 | Completed |
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 1 | 23 participants (Actual) | Interventional | 2007-11-30 | Completed |
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) | Observational | 2021-06-01 | Recruiting |
Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot) [NCT01093820] | Phase 2 | 8 participants (Actual) | Interventional | 2010-04-30 | Completed |
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 3 | 1,228 participants (Actual) | Interventional | 2004-10-31 | Completed |
Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis [NCT01049711] | | 152 participants (Actual) | Observational | 2009-11-30 | Completed |
Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy [NCT03317210] | Phase 4 | 50 participants (Actual) | Interventional | 2002-09-01 | Completed |
Pre-operative Treatment With Erythropoietin and Iron Supplement for Prevention of Perioperative Blood Transfusion in Cardiac Surgery [NCT02210949] | Phase 4 | 7 participants (Actual) | Interventional | 2014-08-31 | Terminated(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) | Interventional | 2019-04-08 | Active, not recruiting |
Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA [NCT02547454] | | 393 participants (Actual) | Observational | 2008-12-31 | Completed |
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 3 | 60 participants (Anticipated) | Interventional | 2022-08-14 | Enrolling 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 3 | 117 participants (Actual) | Interventional | 2012-06-30 | Completed |
Optimized EPO Treatment of Neonatal Anemia [NCT02075970] | Phase 2 | 62 participants (Actual) | Interventional | 2014-06-30 | Completed |
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 3 | 71 participants (Actual) | Interventional | 2006-09-30 | Completed |
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 3 | 159 participants (Actual) | Interventional | 2022-03-16 | Completed |
A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa [NCT02817555] | Phase 4 | 50 participants (Actual) | Interventional | 2010-09-30 | Completed |
[NCT02036073] | Phase 4 | 490 participants (Actual) | Interventional | 2009-01-31 | Completed |
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study [NCT02251041] | Phase 2 | 72 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients [NCT00004914] | Phase 2 | 0 participants | Interventional | 2000-01-31 | Completed |
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 2 | 4 participants (Actual) | Interventional | 2019-07-01 | Terminated(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 4 | 60 participants (Anticipated) | Interventional | 2009-10-31 | Completed |
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 3 | 207 participants (Actual) | Interventional | 2015-12-31 | Completed |
A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients [NCT00258440] | | 7 participants (Actual) | Interventional | 2003-05-31 | Terminated(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 2 | 91 participants (Actual) | Interventional | 2002-03-31 | Completed |
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 2 | 175 participants (Actual) | Interventional | 2019-01-31 | Completed |
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 3 | 4 participants (Actual) | Interventional | 2009-04-30 | Terminated |
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 3 | 247 participants (Actual) | Interventional | 2009-01-29 | Active, 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 3 | 142 participants (Anticipated) | Interventional | 2011-08-31 | Recruiting |
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 2 | 56 participants (Anticipated) | Interventional | 2009-11-30 | Recruiting |
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 3 | 303 participants (Actual) | Interventional | 2010-06-30 | Completed |
Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) [NCT03715881] | Phase 2 | 99 participants (Anticipated) | Interventional | 2018-12-01 | Recruiting |
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) | Observational | 2010-02-28 | Completed |
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 3 | 156 participants (Actual) | Interventional | 2016-06-22 | Completed |
Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage [NCT03786289] | Phase 1 | 34 participants (Actual) | Interventional | 2018-12-03 | Completed |
Effect of Erythropoietin on Red Blood Cell Requirement in Children With Hemolytic Uremic Syndrome: a Randomized Controlled Trial [NCT03776851] | Phase 4 | 24 participants (Actual) | Interventional | 2019-01-01 | Completed |
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients [NCT03867071] | | 60 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 4 | 102 participants (Actual) | Interventional | 2010-08-13 | Completed |
Identification of New Serum Markers for Detection of Abuse With Erythropoietin [NCT01320449] | | 35 participants (Actual) | Interventional | 2011-08-31 | Completed |
A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury [NCT04588311] | Phase 3 | 2,500 participants (Anticipated) | Interventional | 2020-11-09 | Recruiting |
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) | Observational | 2017-08-01 | Completed |
A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury [NCT00987454] | Phase 3 | 606 participants (Actual) | Interventional | 2010-05-31 | Completed |
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) | Interventional | 1998-05-31 | Completed |
Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Recombinant Human Erythropoietin in Male Adults. [NCT04954989] | Phase 1 | 52 participants (Anticipated) | Interventional | 2023-01-31 | Not 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 2 | 83 participants (Actual) | Interventional | 2009-09-30 | Completed |
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 3 | 687 participants (Actual) | Interventional | 2009-12-07 | Completed |
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 3 | 160 participants (Anticipated) | Interventional | 2008-05-31 | Completed |
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 2 | 34 participants (Actual) | Interventional | 2009-11-30 | Terminated(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 1 | 24 participants (Actual) | Interventional | 2010-01-31 | Completed |
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 1 | 40 participants (Actual) | Interventional | 2006-01-31 | Completed |
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity [NCT00744445] | Phase 2 | 46 participants (Actual) | Interventional | 1993-10-31 | Completed |
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 4 | 132 participants (Actual) | Interventional | 2008-08-26 | Completed |
Single-Center, Open-Label, Sequential Trial to Test the Efficacy, Safety and Tolerability of Epoetin Alfa in Patients With Friedreich's Ataxia [NCT00631202] | Phase 2 | 10 participants (Anticipated) | Interventional | 2008-02-29 | Completed |
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 4 | 117 participants (Actual) | Interventional | 2007-01-31 | Completed |
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 3 | 803 participants (Actual) | Interventional | 2007-09-30 | Completed |
Tracing Changed Production of Red Blood Cells [NCT05833477] | | 12 participants (Actual) | Interventional | 2022-10-28 | Completed |
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 4 | 1,695 participants (Actual) | Interventional | 2008-07-31 | Completed |
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 3 | 122 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 1 | 40 participants (Actual) | Interventional | 2012-11-30 | Completed |
Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects. A Randomized Controlled Clinical Study [NCT05360511] | Early Phase 1 | 24 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy [NCT03303573] | | 164 participants (Actual) | Observational | 2013-01-01 | Completed |
Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants - a Randomized, Double-blind, Placebo-controlled, Prospective, and Multicenter Clinical Study [NCT02076373] | Phase 3 | 120 participants (Actual) | Interventional | 2014-03-31 | Active, 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 4 | 50 participants (Actual) | Interventional | 2018-02-01 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2014-09-30 | Withdrawn(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 3 | 130 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
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 3 | 61 participants (Actual) | Interventional | 2003-06-30 | Completed |
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 3 | 74 participants (Actual) | Interventional | 2008-04-30 | Completed |
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome. [NCT02031289] | Phase 4 | 1,003 participants (Actual) | Interventional | 2013-12-31 | Completed |
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 2 | 0 participants (Actual) | Interventional | | Withdrawn |
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 3 | 421 participants (Actual) | Interventional | 2008-08-31 | Completed |
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 3 | 29 participants (Actual) | Interventional | 2007-06-30 | Terminated(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 3 | 163 participants (Actual) | Interventional | 2007-10-31 | Completed |
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) | Interventional | 2008-12-31 | Withdrawn(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 3 | 111 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Strategic decision unrelated to safety or efficacy) |
Effect of Erythropoietin on Renal Function After Kidney Transplantation [NCT00425698] | Phase 2/Phase 3 | 88 participants (Actual) | Interventional | 2007-02-28 | Completed |
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 3 | 572 participants (Actual) | Interventional | 2004-03-31 | Completed |
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 2 | 235 participants (Actual) | Interventional | 2006-11-30 | Terminated(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 3 | 124 participants (Actual) | Interventional | 2008-08-31 | Completed |
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 3 | 132 participants (Actual) | Interventional | 2008-05-14 | Completed |
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant [NCT00815867] | Phase 3 | 108 participants (Actual) | Interventional | 2007-10-31 | Completed |
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 3 | 407 participants (Actual) | Interventional | 2006-10-30 | Terminated(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 2 | 15 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Insufficient response rate) |
"Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion Op Maat (TOMaat) Study" [NCT00998088] | Phase 4 | 2,598 participants (Actual) | Interventional | 2004-05-31 | Completed |
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 3 | 101 participants (Actual) | Interventional | 2008-01-31 | Completed |
[NCT02745990] | | 440 participants (Anticipated) | Interventional | 2016-05-31 | Enrolling 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 3 | 282 participants (Anticipated) | Interventional | 2004-09-29 | Completed |
The Effect of Intravenous Erythropoietin Treatment on Cognition During Hypoglycemia in Patients With Type 1 Diabetes. [NCT00615368] | | 11 participants (Actual) | Interventional | 2008-05-31 | Completed |
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group [NCT00617474] | Phase 1 | 50 participants (Anticipated) | Interventional | 2008-03-31 | Not 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 3 | 80 participants (Actual) | Interventional | 2007-11-30 | Completed |
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 3 | 305 participants (Actual) | Interventional | 2015-12-31 | Completed |
Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD) [NCT01010802] | Phase 1 | 10 participants (Actual) | Interventional | 2008-08-31 | Completed |
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 3 | 120 participants (Anticipated) | Interventional | 2018-02-28 | Active, not recruiting |
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery [NCT00513240] | Phase 1/Phase 2 | 62 participants (Actual) | Interventional | 2006-09-30 | Completed |
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 2 | 98 participants (Actual) | Interventional | 2009-02-28 | Completed |
Augmentation of Medical Readiness and Physical Performance at High Altitude Using Pharmacological Countermeasures [NCT05300477] | Phase 4 | 18 participants (Anticipated) | Interventional | 2022-05-27 | Recruiting |
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 3 | 39 participants (Actual) | Interventional | 2008-02-29 | Terminated(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 3 | 80 participants (Actual) | Interventional | 2007-02-28 | Terminated(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 3 | 430 participants (Actual) | Interventional | 2007-07-31 | Completed |
A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants [NCT00334737] | Phase 2 | 102 participants (Actual) | Interventional | 2006-06-30 | Completed |
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 2 | 200 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 3 | 188 participants (Actual) | Interventional | 2007-11-30 | Completed |
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) | Interventional | 2001-10-31 | Completed |
An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients [NCT00922610] | Phase 4 | 28 participants (Actual) | Interventional | 2009-02-28 | Completed |
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial) [NCT02603406] | Phase 2 | 44 participants (Actual) | Interventional | 2016-07-15 | Completed |
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers [NCT00687518] | | 14 participants (Anticipated) | Interventional | 2008-03-31 | Recruiting |
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 3 | 208 participants (Actual) | Interventional | 2008-01-31 | Completed |
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) | Interventional | 2008-08-31 | Completed |
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 4 | 400 participants (Anticipated) | Interventional | 2022-10-20 | Not 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 3 | 133 participants (Actual) | Interventional | 2008-05-31 | Completed |
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 4 | 10 participants (Actual) | Interventional | 2006-04-30 | Terminated(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) | Interventional | 2010-07-31 | Not 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) | Observational | 2008-04-25 | Terminated(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 4 | 28 participants (Actual) | Interventional | 2004-06-30 | Completed |
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 2 | 11 participants (Actual) | Interventional | 2005-03-31 | Terminated(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 2 | 64 participants (Actual) | Interventional | 2008-07-31 | Completed |
''Erythropoietin Gel as an Adjunct to Split-Thickness Apically Positioned Flap in Augmentation of Attached Gingiva'' (A Randomized Controlled Clinical Study) [NCT05683782] | Phase 4 | 20 participants (Anticipated) | Interventional | 2022-10-01 | Recruiting |
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 2 | 60 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
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 4 | 58 participants (Actual) | Interventional | 2004-10-31 | Completed |
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 3 | 20 participants (Actual) | Interventional | 2008-03-27 | Completed |
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 3 | 200 participants (Actual) | Interventional | 2008-04-30 | Completed |
German Multicenter EPO Stroke Trial (Phase II/III) [NCT00604630] | Phase 2/Phase 3 | 522 participants (Actual) | Interventional | 2003-01-31 | Completed |
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 2 | 114 participants (Actual) | Interventional | 2008-06-30 | Completed |
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 3 | 281 participants (Actual) | Interventional | 2009-07-31 | Completed |
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 3 | 375 participants (Actual) | Interventional | 2006-09-30 | Completed |
Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation [NCT05907499] | Phase 3 | 76 participants (Anticipated) | Interventional | 2023-07-01 | Not 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 3 | 127 participants (Actual) | Interventional | 2008-06-30 | Completed |
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 4 | 2,825 participants (Actual) | Interventional | 2008-12-12 | Completed |
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes [NCT00910858] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2005-01-31 | Completed |
Erythropoietin Monotherapy for Brain Regeneration in Neonatal Encephalopathy in Low and Middle-Income Countries [NCT05395195] | Phase 3 | 504 participants (Anticipated) | Interventional | 2022-12-31 | Recruiting |
Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction [NCT04343170] | | 44 participants (Anticipated) | Interventional | 2023-11-01 | Active, not recruiting |
Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial [NCT00476619] | Phase 4 | 17 participants (Actual) | Interventional | 2004-09-30 | Terminated(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 3 | 351 participants (Actual) | Interventional | 2008-07-31 | Completed |
Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction [NCT00882466] | Phase 4 | 58 participants (Actual) | Interventional | 2008-05-31 | Completed |
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) | Interventional | 2010-05-31 | Completed |
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly [NCT02564094] | Phase 4 | 54 participants (Actual) | Interventional | 2005-02-28 | Completed |
Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone [NCT02731378] | Phase 4 | 603 participants (Anticipated) | Interventional | 2016-12-31 | Not yet recruiting |
Early Treatment With Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants: Comparison of High and Low Dose [NCT00910234] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2009-08-31 | Not 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 3 | 233 participants (Actual) | Interventional | 2008-04-30 | Completed |
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 3 | 0 participants (Actual) | Interventional | 2007-10-31 | Withdrawn(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 3 | 25 participants (Actual) | Interventional | 2008-06-30 | Terminated(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) | Interventional | 2001-02-28 | Completed |
The Effect of Erythropoietin on Platelet Activation Markers: a Prospective Study in Healthy Volunteers [NCT01392612] | Phase 4 | 12 participants (Actual) | Interventional | 2006-11-30 | Completed |
Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients [NCT04013646] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2019-05-02 | Recruiting |
Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration [NCT04073849] | Early Phase 1 | 24 participants (Actual) | Interventional | 2019-07-15 | Completed |
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 4 | 191 participants (Actual) | Interventional | 2009-04-30 | Completed |
Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study [NCT06178835] | Phase 4 | 76 participants (Actual) | Interventional | 2017-09-12 | Completed |
Human Recombinant Erythropoietin (HrEPO) in Asphyxia Neonatorum: A Pilot Trial [NCT00945789] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2007-10-31 | Completed |
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 3 | 605 participants (Actual) | Interventional | 2000-07-31 | Completed |
Effect of Erythropoietin on Neonatal Hypoxic Ischemic Encephalopathy [NCT00808704] | Phase 1/Phase 2 | 167 participants (Actual) | Interventional | 2003-08-31 | Completed |
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery [NCT01066351] | Phase 3 | 200 participants (Anticipated) | Interventional | 2010-01-31 | Enrolling by invitation |
Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI) [NCT00423020] | Phase 4 | 72 participants | Interventional | | Recruiting |
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 2 | 32 participants (Actual) | Interventional | 2006-06-30 | Terminated(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 2 | 57 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 3 | 120 participants (Actual) | Interventional | 2007-10-31 | Completed |
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 3 | 75 participants (Actual) | Interventional | 2008-08-31 | Completed |
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 4 | 273 participants (Actual) | Interventional | 1996-07-31 | Completed |
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 4 | 189 participants (Actual) | Interventional | 2008-07-31 | Completed |
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 3 | 96 participants (Actual) | Interventional | 2008-09-30 | Completed |
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 4 | 35 participants (Actual) | Interventional | 2008-06-30 | Completed |
Generation of Positive Biological Samples to Epoetin for Doping Control. [NCT02920372] | Phase 1 | 2 participants (Actual) | Interventional | 2016-11-30 | Completed |
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 3 | 850 participants (Anticipated) | Interventional | 2005-04-30 | Terminated(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 2 | 157 participants (Actual) | Interventional | 2006-07-31 | Completed |
RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa [NCT00416624] | Phase 2 | 239 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 3 | 424 participants (Actual) | Interventional | 2007-03-31 | Completed |
Treatment Program for Anemia in AIDS Patients [NCT00002022] | | 0 participants | Interventional | | Completed |
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 2 | 30 participants (Actual) | Interventional | 2010-01-31 | Completed |
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 2 | 137 participants (Actual) | Interventional | 2001-10-31 | Completed |
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 1 | 46 participants (Actual) | Interventional | 2019-05-28 | Completed |
Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital [NCT00511901] | Phase 4 | 22 participants (Actual) | Interventional | 2005-11-30 | Terminated(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 3 | 2,098 participants (Actual) | Interventional | 2006-03-02 | Completed |
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury [NCT00313716] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 3 | 680 participants (Actual) | Interventional | 1998-04-30 | Completed |
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study [NCT01886443] | Phase 1 | 10 participants (Actual) | Interventional | 2013-08-31 | Completed |
[NCT01889056] | Phase 1/Phase 2 | 32 participants (Anticipated) | Interventional | 2013-02-28 | Active, not recruiting |
[NCT01902511] | | 60 participants (Actual) | Interventional | 2013-07-31 | Completed |
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy [NCT00266617] | Phase 2 | 86 participants (Actual) | Interventional | | Completed |
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 4 | 316 participants (Actual) | Interventional | 1999-11-30 | Completed |
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 2 | 120 participants (Anticipated) | Interventional | 2023-05-03 | Recruiting |
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 3 | 51 participants (Actual) | Interventional | 2005-02-28 | Completed |
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 2 | 67 participants (Actual) | Interventional | 2004-05-31 | Completed |
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 2 | 40 participants (Anticipated) | Interventional | 2005-11-30 | Completed |
"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 3 | 360 participants (Anticipated) | Interventional | 2023-10-24 | Recruiting |
Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial [NCT01962571] | Phase 3 | 108 participants (Actual) | Interventional | 2014-11-25 | Completed |
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) | Interventional | 2013-11-26 | Completed |
Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia. [NCT00364455] | Phase 3 | 56 participants (Actual) | Interventional | 2002-12-31 | Completed |
Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial [NCT02002039] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2012-06-30 | Completed |
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 3 | 50 participants (Actual) | Interventional | 2001-10-31 | Terminated |
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 3 | 478 participants (Actual) | Interventional | 2004-04-30 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2008-02-29 | Withdrawn |
[NCT00006136] | Phase 2 | 15 participants | Interventional | 1999-03-31 | Completed |
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 3 | 138 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 4 | 86 participants (Actual) | Interventional | 2010-10-31 | Completed |
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 4 | 28 participants (Actual) | Interventional | 2006-05-31 | Completed |
Prognostic Value of Serum Erythropoietin Level,Ferritin Level and Fibrinogen in Adult Low Risk MDS [NCT04573686] | | 50 participants (Anticipated) | Observational | 2021-01-01 | Not 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 2 | 22 participants (Actual) | Interventional | 2007-07-31 | Terminated |
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 4 | 1 participants (Actual) | Interventional | 2007-12-31 | Terminated(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 2 | 241 participants (Actual) | Interventional | 2010-09-30 | Completed |
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 3 | 202 participants (Actual) | Interventional | 2009-02-28 | Completed |
Impact of Erythropoietin on Hematological Adaptations and Physical Performance [NCT05078138] | Phase 4 | 8 participants (Actual) | Interventional | 2021-09-01 | Completed |
Erythropoietin as an add-on Treatment for Cognitive Side-effects of Electroconvulsive Therapy [NCT03339596] | Phase 2 | 60 participants (Actual) | Interventional | 2017-06-26 | Completed |
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 4 | 70 participants (Actual) | Interventional | 2011-07-18 | Completed |
Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit [NCT00622934] | Phase 2 | 20 participants (Anticipated) | Interventional | 2007-07-31 | Recruiting |
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 1 | 42 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting |
Insulin Resistance and Substrate Metabolism After Acute EPO Administration in Healthy Young Men [NCT00793767] | | 10 participants (Anticipated) | Interventional | 2009-01-31 | Completed |
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial [NCT06135259] | Phase 3 | 18 participants (Anticipated) | Interventional | 2023-12-20 | Not 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 3 | 0 participants (Actual) | Interventional | 2009-04-30 | Withdrawn(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 3 | 120 participants (Anticipated) | Interventional | 2007-10-31 | Recruiting |
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 3 | 823 participants (Actual) | Interventional | 2007-10-31 | Completed |
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) | Observational | 2010-01-31 | Completed |
EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study. [NCT01423955] | Phase 2 | 75 participants (Actual) | Interventional | 2011-10-31 | Completed |
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 4 | 4 participants (Actual) | Interventional | 2006-09-30 | Terminated(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 3 | 140 participants (Actual) | Interventional | 2008-09-30 | Completed |
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067] | Phase 3 | 10 participants (Actual) | Interventional | 2008-04-30 | Terminated(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 2 | 32 participants | Interventional | 2004-09-30 | Completed |
Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa. [NCT00337441] | Phase 2 | 62 participants | Interventional | 2003-01-31 | Active, 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 2 | 129 participants (Actual) | Interventional | 2003-02-28 | Completed |
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 2 | 51 participants (Actual) | Interventional | 2003-08-31 | Completed |
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 2 | 115 participants (Actual) | Interventional | 2003-03-31 | Completed |
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 | Observational | 2006-04-30 | Recruiting |
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 2 | 60 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 2 | 12 participants (Actual) | Interventional | 2004-06-30 | Terminated(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 3 | 300 participants | Interventional | 2004-02-29 | Terminated |
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 4 | 50 participants (Actual) | Interventional | | Completed |
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 2 | 201 participants (Actual) | Interventional | 2013-10-28 | Completed |
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects [NCT00368238] | Phase 2 | 96 participants | Interventional | 2005-10-31 | Completed |
A Double-blind, Randomized, Placebo-controlled, Clinical Trial to Test the Efficacy of Epoetin Alfa on Physical Performance of Friedreich Ataxia Patients. [NCT01493973] | Phase 2 | 56 participants (Actual) | Interventional | 2013-01-31 | Completed |
An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure [NCT00338000] | Phase 4 | 292 participants (Actual) | Interventional | 2001-06-30 | Completed |
An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT (Epoetin Alfa) [NCT00338468] | Phase 4 | 13 participants (Actual) | Interventional | 2003-11-30 | Terminated(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 3 | 98 participants (Actual) | Interventional | 2002-09-30 | Terminated(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 2 | 99 participants | Interventional | 2004-10-31 | Active, 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 4 | 0 participants | Interventional | | Terminated |
Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta). [NCT00491868] | Phase 3 | 134 participants (Actual) | Interventional | 2007-06-30 | Completed |
Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2 [NCT00478517] | Phase 1 | 20 participants | Interventional | 2007-05-31 | Withdrawn |
High-dose Erythropoietin for Asphyxia and Encephalopathy [NCT02811263] | Phase 3 | 500 participants (Actual) | Interventional | 2017-01-31 | Completed |
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 4 | 8 participants (Actual) | Interventional | 2003-06-30 | Terminated(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 2 | 10 participants (Actual) | Interventional | 2007-09-30 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2007-11-30 | Withdrawn(stopped due to lack of pharmaceutical support) |
Systemic Erythropoietin Injection in Patients Having Optic Atrophy [NCT04680143] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2020-09-01 | Completed |
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump [NCT00542568] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2008-08-31 | Completed |
"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 3 | 176 participants (Actual) | Interventional | 1999-11-30 | Completed |
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 2 | 88 participants (Actual) | Interventional | 2014-03-13 | Completed |
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 3 | 392 participants (Actual) | Interventional | 2020-01-04 | Completed |
Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit. [NCT05018364] | | 80 participants (Actual) | Observational | 2020-08-01 | Completed |
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 3 | 175 participants (Actual) | Interventional | 2019-06-20 | Active, not recruiting |
A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy [NCT00003600] | Phase 3 | 344 participants (Actual) | Interventional | 1998-12-31 | Completed |
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 3 | 172 participants (Actual) | Interventional | 1997-12-31 | Completed |
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 2 | 31 participants (Actual) | Interventional | 2005-10-31 | Terminated(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 2 | 0 participants (Actual) | Interventional | 2004-08-31 | Terminated(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 3 | 14 participants (Actual) | Interventional | 2003-08-31 | Completed |
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 2 | 0 participants | Interventional | 2003-07-31 | Completed |
Erythropoietin Protect the Cerebral Blood Flow and Oxygenation During Simulated Dive? [NCT00265486] | | 12 participants (Anticipated) | Observational | 2005-08-31 | Recruiting |
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 3 | 0 participants (Actual) | Interventional | 1996-05-31 | Withdrawn |
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 2 | 72 participants (Actual) | Interventional | | Completed |
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia [NCT00270049] | Phase 2 | 195 participants (Actual) | Interventional | 1990-11-30 | Completed |
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 3 | 316 participants (Actual) | Interventional | 1993-04-30 | Completed |
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 3 | 375 participants (Actual) | Interventional | 1996-08-31 | Completed |
A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy [NCT00270166] | Phase 3 | 201 participants (Actual) | Interventional | 1995-02-28 | Completed |
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 2 | 102 participants (Actual) | Interventional | 1988-07-31 | Completed |
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 1 | 7 participants (Actual) | Interventional | 2005-12-21 | Completed |
Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure. [NCT00399269] | Phase 3 | 100 participants (Actual) | Interventional | 2006-12-31 | Completed |
A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease [NCT00077597] | Phase 3 | 182 participants (Actual) | Interventional | 2004-02-29 | Completed |
Influence of G-CSF and EPO on Associative Learning and Motor Skills [NCT00298597] | Phase 2 | 180 participants (Anticipated) | Interventional | 2006-03-31 | Completed |
[NCT00083486] | Phase 3 | 0 participants | Interventional | 2004-02-29 | Terminated |
Effect of Early Correction of Anemia on the Progression of Chronic Renal Insufficiency (ECAP) [NCT00312871] | Phase 4 | 217 participants (Actual) | Interventional | 2001-02-28 | Terminated(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 2 | 153 participants (Actual) | Interventional | 2006-05-31 | Completed |
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 4 | 292 participants (Actual) | Interventional | 2002-10-31 | Completed |
Resistance to ErythroPoietin Effectiveness Algorithm Trial [NCT00319150] | Phase 3 | 6 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to New evidence and trouble recruiting) |
The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial [NCT05167734] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-11-30 | Recruiting |
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects [NCT00091910] | Phase 3 | 1,460 participants (Actual) | Interventional | 2003-09-30 | Completed |
Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ). [NCT00433615] | Phase 3 | 124 participants (Actual) | Interventional | 2007-02-28 | Completed |
Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn [NCT01732146] | Phase 3 | 120 participants (Actual) | Interventional | 2013-03-28 | Completed |
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 2 | 0 participants (Actual) | Interventional | | Withdrawn(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 2 | 529 participants (Actual) | Interventional | 2007-01-31 | Completed |
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 2 | 0 participants (Actual) | Interventional | 2007-05-31 | Withdrawn(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 3 | 80 participants (Anticipated) | Interventional | 2007-01-31 | Active, 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 2 | 0 participants | Interventional | 2002-10-31 | Completed |
High Dose Erythropoietin for Neonates With Asphyxia [NCT00491413] | Phase 1 | 15 participants (Anticipated) | Interventional | | Not 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 3 | 187 participants (Actual) | Interventional | 2007-06-30 | Completed |
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 2 | 16 participants (Actual) | Interventional | 2009-02-28 | Terminated |
Effects of Systemic Erythropoietin Therapy on Cerebral Autoregulation and Incidence of Delayed Ischemic Deficits in Patients With Aneurysmal Subarachnoid Hemorrhage [NCT00140010] | Phase 2 | 80 participants (Actual) | Interventional | 2005-04-30 | Completed |
A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy [NCT00144495] | Phase 3 | 104 participants (Actual) | Interventional | 2004-02-29 | Completed |
A Randomized, Double-Blind Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy [NCT00144482] | Phase 3 | 122 participants (Actual) | Interventional | 2003-12-31 | Completed |
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 2 | 124 participants | Interventional | 2005-10-31 | Not 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) | Interventional | 2003-09-30 | Completed |
Erythropoietin and Pediatric Cardiac Surgery [NCT00451698] | | 9 participants (Actual) | Interventional | 2007-10-31 | Terminated(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 4 | 3 participants (Actual) | Interventional | 2007-07-31 | Terminated(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 3 | 51 participants (Actual) | Interventional | 2008-03-31 | Completed |
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 2 | 48 participants (Actual) | Interventional | 2010-08-31 | Terminated(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 3 | 0 participants | Interventional | | Completed |
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 4 | 358 participants (Actual) | Interventional | 2003-02-28 | Completed |
A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants [NCT01235923] | Phase 2 | 20 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 2 | 186 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 2 | 310 participants (Actual) | Interventional | 2004-05-31 | Completed |
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 3 | 939 participants (Actual) | Interventional | 2000-06-30 | Completed |
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 3 | 37 participants (Actual) | Interventional | 2002-12-31 | Terminated(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 2 | 39 participants (Actual) | Interventional | 2009-06-30 | Terminated |
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 4 | 90 participants (Actual) | Interventional | | Completed |
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 3 | 265 participants (Actual) | Interventional | 2007-05-31 | Completed |
Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia [NCT00495378] | Phase 4 | 25 participants (Actual) | Interventional | 2002-11-30 | Terminated(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 2 | 0 participants | Interventional | 2003-10-13 | Completed |
Frequent, Low-Dose Erythropoietin: A Mechanistic Approach to Mitigate Adverse Cardiovascular Effects of Erythropoietin Therapy in Patients With Chronic Kidney Disease [NCT03277183] | Phase 4 | 5 participants (Actual) | Interventional | 2017-11-02 | Terminated(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 4 | 289 participants (Actual) | Interventional | 1999-02-28 | Completed |
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 2 | 0 participants | Interventional | 2002-10-31 | Completed |
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 2 | 0 participants | Interventional | 2002-10-31 | Completed |
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 2 | 40 participants (Actual) | Interventional | 2006-08-31 | Completed |
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 3 | 60 participants (Actual) | Interventional | 2001-12-31 | Completed |
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 3 | 114 participants (Actual) | Interventional | 2001-08-31 | Completed |
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 3 | 47 participants (Actual) | Interventional | 2001-03-31 | Terminated(stopped due to low accrual) |
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 [NCT00398749] | | 1,927 participants (Actual) | Observational | 2005-10-31 | Completed |
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 3 | 336 participants (Actual) | Interventional | 2004-06-30 | Completed |
Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia [NCT00003681] | Phase 2 | 50 participants (Anticipated) | Interventional | 1998-08-31 | Active, not recruiting |
[NCT00083434] | Phase 3 | 0 participants | Interventional | 2004-02-29 | Terminated(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) | Interventional | 2023-05-20 | Recruiting |
An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer [NCT00022386] | Phase 4 | 0 participants | Interventional | | Completed |
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 3 | 42 participants (Actual) | Interventional | 2022-01-28 | Active, 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) | Interventional | 2016-01-31 | Completed |
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 3 | 1 participants (Actual) | Interventional | 2002-01-01 | Completed |
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 2 | 103 participants (Actual) | Interventional | 2017-07-05 | Completed |
A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue [NCT00052221] | | 0 participants (Actual) | Interventional | 2003-05-20 | Withdrawn |
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 2 | 0 participants | Interventional | 2001-06-30 | Completed |
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 3 | 2 participants (Actual) | Interventional | 2004-06-30 | Terminated(stopped due to This study was stopped early due to slow enrollment.) |
Correction of Hemoglobin and Outcomes In Renal Insufficiency [NCT00211120] | Phase 4 | 1,432 participants (Actual) | Interventional | 2002-03-31 | Terminated(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 2 | 267 participants (Actual) | Interventional | 2005-09-30 | Completed |
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 4 | 110 participants (Actual) | Interventional | 2003-08-31 | Completed |
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 3 | 7 participants (Actual) | Interventional | 2005-08-31 | Terminated(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 3 | 420 participants (Anticipated) | Interventional | 2005-09-30 | Completed |
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 3 | 580 participants (Actual) | Interventional | 2005-04-30 | Completed |
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation [NCT00157300] | Phase 4 | 92 participants (Actual) | Interventional | 2005-07-31 | Completed |
A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer [NCT00058331] | Phase 3 | 365 participants (Actual) | Interventional | 2003-06-30 | Completed |
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 4 | 0 participants | Interventional | 2002-02-28 | Terminated |
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events. [NCT00535925] | Phase 4 | 850 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 2 | 192 participants (Actual) | Interventional | 2005-08-31 | Terminated |
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy [NCT00875004] | | 27 participants (Actual) | Interventional | 2007-12-07 | Terminated(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 1 | 50 participants (Anticipated) | Interventional | 2019-01-14 | Recruiting |
Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT) [NCT00737893] | Phase 2 | 56 participants (Actual) | Interventional | 2017-07-01 | Completed |
Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome [NCT00356733] | Phase 3 | 62 participants (Actual) | Interventional | 2007-01-31 | Completed |
Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis [NCT03835507] | Phase 1/Phase 2 | 64 participants (Anticipated) | Interventional | 2016-06-20 | Recruiting |
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 2 | 42 participants (Actual) | Interventional | 2021-10-16 | Completed |
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 2 | 9 participants (Actual) | Interventional | 2004-06-30 | Terminated(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 2 | 420 participants (Actual) | Interventional | 2006-01-31 | Completed |
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis [NCT00236964] | Phase 3 | 78 participants | Interventional | 2001-02-28 | Completed |
Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients [NCT00260052] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2003-07-31 | Withdrawn(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 2 | 6 participants (Actual) | Interventional | 2005-03-31 | Terminated(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 2 | 29 participants (Actual) | Interventional | 2004-07-31 | Terminated(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 2 | 208 participants (Actual) | Interventional | | Completed |
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy [NCT00269997] | Phase 2 | 72 participants (Actual) | Interventional | | Completed |
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 2 | 1 participants (Actual) | Interventional | 1991-04-30 | Completed |
[NCT00238043] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 2005-08-31 | Active, not recruiting |
Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation [NCT05669079] | Phase 3 | 100 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
EPREX (Epoetin Alfa) Versus ARANESP (Darbepoetin Alfa): Looking at Outcome of Anemia Treatment and Comparing Cost-effectiveness (EVALUATE). [NCT00264108] | | 492 participants (Actual) | Observational | 2005-06-30 | Completed |
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 1 | 80 participants (Actual) | Interventional | 2013-02-28 | Completed |
[NCT00284271] | Phase 2 | 65 participants (Actual) | Interventional | 2004-01-31 | Completed |
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 3 | 150 participants (Actual) | Interventional | 2002-05-31 | Completed |
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 | Interventional | 2004-01-31 | Active, 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 3 | 80 participants (Actual) | Interventional | 1990-01-31 | Completed |
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 3 | 55 participants (Actual) | Interventional | | Completed |
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 2 | 63 participants (Actual) | Interventional | | Completed |
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 2 | 89 participants (Actual) | Interventional | 2005-08-31 | Completed |
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 3 | 596 participants (Actual) | Interventional | 2000-02-29 | Completed |
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 3 | 224 participants (Actual) | Interventional | 2000-08-31 | Completed |
Phase 4 Study on the Efficacy of Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function [NCT00418119] | Phase 4 | 10 participants | Interventional | 2007-01-31 | Not 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 3 | 229 participants (Actual) | Interventional | 2005-12-31 | Completed |
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 2 | 60 participants (Actual) | Interventional | | Completed |
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 2 | 56 participants (Actual) | Interventional | | Completed |
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 3 | 112 participants (Actual) | Interventional | | Completed |
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 3 | 77 participants (Actual) | Interventional | 1989-05-31 | Completed |
A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension [NCT00270101] | Phase 3 | 156 participants (Actual) | Interventional | 1995-01-31 | Completed |
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 3 | 17 participants (Actual) | Interventional | 1989-09-30 | Completed |
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 3 | 17 participants (Actual) | Interventional | | Completed |
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 2 | 50 participants (Actual) | Interventional | 2006-01-31 | Completed |
Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa [NCT00322413] | Phase 3 | 80 participants | Interventional | 1997-01-31 | Completed |
Erythropoietin Role in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial [NCT03401710] | | 134 participants (Actual) | Interventional | 2018-04-16 | Terminated(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 1 | 40 participants (Actual) | Interventional | 2006-02-28 | Completed |
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 2 | 61 participants (Actual) | Interventional | 2006-03-31 | Terminated(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) | Interventional | 2019-11-07 | Completed |
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 2 | 519 participants (Actual) | Interventional | 2002-01-31 | Completed |
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 3 | 69 participants (Actual) | Interventional | 2003-06-30 | Completed |
Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20) [NCT00310232] | Phase 3 | 70 participants (Actual) | Interventional | 2001-02-28 | Terminated(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 4 | 76 participants (Actual) | Interventional | 2007-02-28 | Completed |
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 3 | 300 participants (Anticipated) | Interventional | 2000-07-31 | Active, 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 2 | 11 participants (Actual) | Interventional | 2014-09-30 | Completed |
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 | Interventional | | Completed |
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 1 | 28 participants (Anticipated) | Interventional | 2013-02-28 | Not 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 1 | 80 participants (Anticipated) | Interventional | 2013-02-28 | Not yet recruiting |
Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness [NCT01665781] | Phase 4 | 39 participants (Actual) | Interventional | 2012-08-31 | Completed |
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 3 | 92 participants (Actual) | Interventional | 2013-12-31 | Terminated |
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) | Observational | 2012-11-21 | Completed |
[NCT01823029] | | 387 participants (Actual) | Interventional | 2012-11-30 | Completed |
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847] | Phase 1/Phase 2 | 117 participants (Actual) | Interventional | 2015-02-28 | Completed |
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 3 | 184 participants (Actual) | Interventional | 2008-01-31 | Completed |
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 2 | 10 participants (Actual) | Interventional | 2007-08-31 | Completed |
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 | Interventional | | Completed |
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 2 | 1 participants (Actual) | Interventional | 2010-03-31 | Completed |
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 2 | 2 participants (Actual) | Interventional | 2017-05-02 | Terminated(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 1 | 40 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
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 3 | 214 participants (Anticipated) | Interventional | 2016-03-01 | Recruiting |
The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema [NCT03821168] | Phase 2/Phase 3 | 58 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial [NCT02564796] | Phase 2 | 4 participants (Actual) | Interventional | 2016-11-30 | Terminated(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 2 | 20 participants (Actual) | Interventional | 2019-04-01 | Completed |
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 | Interventional | | Completed |
Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation [NCT03010579] | Phase 4 | 70 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
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 3 | 2,104 participants (Actual) | Interventional | 2000-12-04 | Completed |
Preterm Erythropoietin Neuroprotection Trial (PENUT Trial) [NCT01378273] | Phase 3 | 941 participants (Actual) | Interventional | 2013-12-31 | Completed |
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients [NCT05325073] | Phase 4 | 20 participants (Anticipated) | Interventional | 2022-02-18 | Recruiting |
Proliferative Effects of Erythropoietin on Human Endometrium [NCT03060603] | | 14 participants (Actual) | Observational | 2017-02-23 | Completed |
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients [NCT03004209] | Phase 4 | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn |
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 3 | 224 participants (Actual) | Interventional | 2003-02-28 | Completed |
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561] | Phase 2/Phase 3 | 18 participants (Anticipated) | Interventional | 2022-04-05 | Recruiting |
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 2 | 96 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to Slow Enrollment) |
The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury [NCT03007537] | | 101 participants (Actual) | Interventional | 2015-10-01 | Terminated(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) | Observational | 2009-07-31 | Completed |
Non-interventional, Observational Study to Investigate the Efficiency and Safety of Mircera in Patients With a Kidney Transplant [NCT02538107] | | 290 participants (Actual) | Observational | 2007-09-30 | Completed |
Assessing Combination Hydroxyurea and Exogenous Erythropoietin in Sickle Cell Disease [NCT05451940] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2023-05-25 | Recruiting |
Renal Effects of Erythropoietin in Humans [NCT01584921] | Phase 1 | 16 participants (Actual) | Interventional | 2012-03-31 | Completed |
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 2 | 96 participants (Actual) | Interventional | 2011-09-30 | Completed |
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 3 | 320 participants (Anticipated) | Interventional | 2023-05-31 | Not 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 2 | 56 participants (Actual) | Interventional | 2007-07-31 | Completed |
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 3 | 363 participants (Actual) | Interventional | 2019-01-02 | Active, not recruiting |
Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest [NCT01369732] | Phase 4 | 66 participants (Actual) | Interventional | 2011-05-31 | Completed |
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 2 | 28 participants (Actual) | Interventional | 2014-01-28 | Completed |
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 | Interventional | | Completed |
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 3 | 838 participants (Actual) | Interventional | 2014-11-21 | Completed |
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 | Interventional | | Completed |
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 1 | 28 participants (Actual) | Interventional | 2013-02-28 | Completed |
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 | Interventional | | Completed |
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 1 | 0 participants | Interventional | | Completed |
Preventing Adverse Outcomes of Neonatal Hypoxic Ischaemic Encephalopathy With Erythropoietin: A Phase III Randomised Placebo Controlled Multicentre Clinical Trial [NCT03079167] | Phase 3 | 313 participants (Actual) | Interventional | 2016-05-14 | Active, not recruiting |
Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes [NCT00003138] | Phase 3 | 118 participants (Actual) | Interventional | 1998-03-04 | Completed |
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 3 | 0 participants | Interventional | 2000-06-30 | Completed |
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy [NCT00005787] | Phase 1 | 3 participants (Actual) | Interventional | 1999-09-30 | Terminated(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 4 | 216 participants (Actual) | Interventional | 2015-04-01 | Completed |
Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya [NCT03162588] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2010-05-01 | Completed |
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 3 | 612 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis [NCT01478971] | Phase 3 | 184 participants (Actual) | Interventional | 2011-10-31 | Completed |
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 3 | 124 participants (Anticipated) | Interventional | 2018-03-26 | Recruiting |
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 | Interventional | | Completed |
Effect of Erythropoietin and Hypothermia on Management of Neonatal Hypoxic Ischemic Encephalopathy [NCT03163589] | Phase 3 | 40 participants (Anticipated) | Interventional | 2017-12-01 | Not yet recruiting |
Erythropoietin in Methanol Associated Optic Neuropathy [NCT02376881] | Phase 3 | 24 participants (Anticipated) | Interventional | 2015-03-31 | Active, 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 3 | 1,043 participants (Actual) | Interventional | 2014-02-11 | Completed |
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) | Observational | 2015-02-28 | Not 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) | Observational | 2009-08-31 | Completed |
[NCT00000587] | Phase 2 | 0 participants | Interventional | 1988-09-30 | Completed |
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 2 | 20 participants (Actual) | Interventional | 2016-03-21 | Completed |
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) | Interventional | 2023-07-31 | Not yet recruiting |
Effect of Early Application of Recombinant Human Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome [NCT03110341] | Phase 3 | 400 participants (Anticipated) | Interventional | 2017-04-10 | Recruiting |
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) | Interventional | 2003-03-31 | Completed |
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis [NCT01737879] | Phase 4 | 41 participants (Actual) | Interventional | 2012-10-31 | Terminated(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 4 | 70 participants (Actual) | Interventional | 2013-01-01 | Completed |
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 3 | 435 participants (Actual) | Interventional | 2012-09-30 | Completed |
Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy [NCT01809314] | | 1,167 participants (Actual) | Observational | 2008-03-31 | Completed |
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 3 | 417 participants (Actual) | Interventional | 2012-04-30 | Completed |
The Benefits of a Preoperative Anemia Management Program [NCT01888003] | | 51 participants (Actual) | Interventional | 2013-04-30 | Terminated |
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) | Interventional | 2023-02-15 | Recruiting |
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis [NCT00236938] | Phase 3 | 121 participants (Actual) | Interventional | 2002-07-31 | Completed |
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 4 | 87 participants (Actual) | Interventional | 2012-05-30 | Completed |
Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions [NCT00378352] | Phase 2 | 223 participants (Actual) | Interventional | 2005-09-30 | Completed |
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS [NCT00520468] | Phase 2 | 15 participants (Actual) | Interventional | 2004-06-30 | Completed |
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 4 | 504 participants (Actual) | Interventional | 2006-01-31 | Completed |
Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy [NCT01736215] | | 33 participants (Actual) | Observational | 2010-11-30 | Terminated(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 3 | 275 participants (Anticipated) | Interventional | 1997-12-31 | Completed |
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study [NCT01913340] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2013-09-30 | Completed |
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 3 | 337 participants (Actual) | Interventional | 2007-09-30 | Terminated(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 3 | 320 participants (Actual) | Interventional | 2012-01-17 | Completed |
Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients [NCT02335593] | Phase 2 | 64 participants (Actual) | Interventional | 2014-12-31 | Completed |
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 3 | 432 participants (Actual) | Interventional | 2015-07-13 | Completed |
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 4 | 16 participants (Actual) | Interventional | 2015-08-31 | Terminated |
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 1 | 68 participants (Actual) | Interventional | 2018-01-25 | Completed |
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) | Interventional | 2023-08-30 | Recruiting |
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 4 | 100 participants (Actual) | Interventional | 2014-08-06 | Completed |
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 3 | 170 participants (Actual) | Interventional | 2012-05-31 | Completed |
The Effect of High Dose Erythropoietin in Acute Renal Failure [NCT03102021] | Phase 2 | 25 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease [NCT04502537] | | 200 participants (Anticipated) | Observational | 2021-02-01 | Recruiting |
Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation [NCT02496377] | | 100 participants (Actual) | Interventional | 2014-08-29 | Completed |
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) | Observational | 2009-12-31 | Completed |
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 2 | 50 participants (Actual) | Interventional | 2010-06-30 | Completed |
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 3 | 741 participants (Actual) | Interventional | 2015-01-15 | Completed |
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 3 | 2,133 participants (Actual) | Interventional | 2014-07-01 | Completed |
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 3 | 406 participants (Actual) | Interventional | 2012-07-16 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
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
Intervention | Months (Median) |
---|
Supportive Care | 31 |
Erythropoietin | 37 |
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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
Intervention | Proportion of patients (Number) |
---|
Supportive Care | 0.459 |
Erythropoietin | 0.714 |
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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
Intervention | Scores on a scale (Mean) |
---|
Supportive Care | 84.1 |
Erythropoietin | 84.33 |
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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
Intervention | Participants (Count of Participants) |
---|
| Disease Recurrence | No recurrence |
---|
Arm 1: CEF | 141 | 560 |
,Arm 2: EC/T | 135 | 566 |
,Arm 3: AC/T | 191 | 511 |
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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
Intervention | Participants (Count of Participants) |
---|
| Death | Alive |
---|
Arm 1: CEF | 123 | 578 |
,Arm 2: EC/T | 107 | 594 |
,Arm 3: AC/T | 146 | 556 |
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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
Intervention | Participants (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]) | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
,Cohort 2 (RO0503821 [0.25/150 1x/2week]) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 3 (RO0503821 [0.4/150 1x/Week]) | 3 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
,Cohort 4 (RO0503821 [0.4/150 1x/2week]) | 4 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 5 (RO0503821 [0.6/150 1x/Week]) | 4 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 6 (RO0503821 [0.6/150 1x/2week]) | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
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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
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs | Deaths |
---|
RO0503821 (1x/2Week) | 37 | 20 | 2 |
,RO0503821 (1x/Week) | 42 | 20 | 3 |
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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
Intervention | mm HG (Mean) |
---|
| DBP- before dialysis | DBP - After dialysis | SBP - before dialysis | SBP - After dialysis |
---|
Cohort 1 (RO0503821 [0.25/150 1x/Week]) | -2 | 4 | -1 | 6 |
,Cohort 2 (RO0503821 [0.25/150 1x/2week]) | -1 | 0 | 5 | 3 |
,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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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
Intervention | BpM (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
Intervention | participants (Number) |
---|
| Platelets - High, n = 16, 15, 19 | Platelets - Low, n = 16, 15, 19 | WBC - High, n = 16, 15, 19 | Eosinophils - High, n = 15, 15, 19 | Lymphocytes - Low, n = 15, 15, 19 | Monocytes - High, n = 15, 15, 19 | Neutrophils - High, n = 15, 15, 19 | Neutrophils - Low, n = 15, 15, 19 | ALT - High, n = 22, 21, 22 | ALP - High, n = 22, 21, 22 | AST - High, n = 22, 21, 22 | Total bilirubin - High, n = 22, 21, 22 | Albumin - Low, n = 22, 21, 22 | Phosphate - High , n = 12, 13, 14 | Phosphate - Low, n = 12, 13, 14 | Potassium - High, n = 22, 21, 22 | Potassium - Low, n = 22, 21, 22 |
---|
RO0503821 (1x/2week) | 1 | 0 | 0 | 1 | 2 | 0 | 3 | 2 | 1 | 0 | 1 | 0 | 0 | 6 | 1 | 2 | 0 |
,RO0503821 (1x/3week) | 0 | 3 | 1 | 2 | 1 | 1 | 3 | 0 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 2 | 0 |
,RO0503821 (1x/Week) | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 2 | 7 | 2 | 3 | 1 |
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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
Intervention | bpm (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
Intervention | participants (Number) |
---|
| Participants with SAEs | Participants with AEs |
---|
RO0503821 (1x/2Week) | 9 | 21 |
,RO0503821 (1x/3week) | 12 | 22 |
,RO0503821 (1x/Week) | 11 | 22 |
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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)
Intervention | g/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)
Intervention | Cells 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)
Intervention | gram/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
Intervention | mmHg (Mean) |
---|
| DBP | SBP |
---|
Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | 2 | 12 |
,Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week) | 5 | 2 |
,Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | 6 | 5 |
,Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | 6 | 2 |
,Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | 2 | 8 |
,Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | -3 | -11 |
,Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | 6 | 6 |
,Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | -2 | 3 |
,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
Intervention | participants (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
Intervention | participants (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
Intervention | participants (Number) |
---|
| Number of participants with adverse events | Number of participants with serious adverse events | Number of deaths |
---|
Epoetin (1-3x/Weeks) | 214 | 99 | 17 |
,RO0503821 (1x/2 Weeks) | 203 | 101 | 19 |
,RO0503821 (1x/4 Weeks) | 202 | 87 | 15 |
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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
Intervention | millimeter 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) | 3 | 1 | 1 | -1 | -0 | 1 | -2 | -3 |
,RO0503821 (1x/2 Weeks) | 1 | -0 | 0 | 1 | 3 | 2 | -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
Intervention | beats 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) | 1 | 1 |
,RO0503821 (1x/4 Weeks) | 2 | 1 |
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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
Intervention | participants (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) | 3 | 6 | 3 | 5 | 0 | 0 |
,RO0503821 (1x/2 Weeks) | 0 | 14 | 0 | 8 | 1 | 1 |
,RO0503821 (1x/4 Weeks) | 1 | 10 | 2 | 6 | 2 | 2 |
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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
Intervention | gram 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
Intervention | participants (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) | 5 | 16 | 18 | 94 | 17 | 36 | 3 | 4 | 1 | 0 |
,RO0503821 (1x/2 Weeks) | 4 | 15 | 14 | 106 | 21 | 33 | 10 | 6 | 0 | 0 |
,RO0503821 (1x/4 Weeks) | 2 | 14 | 13 | 95 | 21 | 35 | 3 | 3 | 3 | 1 |
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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
Intervention | participants (Number) |
---|
| Any AE's | Any SAE's | Deaths |
---|
Epoetin Reference | 167 | 85 | 12 |
,RO0503821 (1x/2 Weeks) | 171 | 70 | 13 |
,RO0503821 (1x/4 Weeks) | 177 | 73 | 18 |
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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
Intervention | mm 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 Reference | 2 | 2 | 7 | 12 |
,RO0503821 (1x/2 Weeks) | 2 | 1 | 3 | 4 |
,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
Intervention | mmHG (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 Reference | 1 | 2 | -1 | 2 | -1 | 1 | -2 | 2 |
,RO0503821 (1x/2 Weeks) | 0 | -1 | 1 | 0 | 1 | -1 | -1 | 1 |
,RO0503821 (1x/4 Weeks) | 0 | -1 | -0 | 0 | 4 | 3 | -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)
Intervention | g/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)
Intervention | participants (Number) |
---|
RO0503821 (1x/2 Weeks) | 124 |
RO0503821 (1x/4 Weeks) | 111 |
Epoetin Reference | 127 |
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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
Intervention | participants (Number) |
---|
RO0503821 (1x/2 Weeks) | 12 |
RO0503821 (1x/4 Weeks) | 20 |
Epoetin Reference | 19 |
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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
Intervention | participants (Number) |
---|
| Platelets, high; n=189,189, 188 | Platelets, low; n=189,189, 188 | RBC, high; n = 118, 112, 115 | RBC, low; n = 118, 112, 115 | WBC, high; n=189,189, 188 | WBC, low; n=189,189, 188 | ALAT, high; n=189,189, 188 | ALP, high; n=189,189, 188 | ASAT, high; n=185,189, 186 | Albumin, low; n=182,186, 185 | Phosphate, high; n=189,189, 188 | Phosphate, low; n=189,189, 188 | Potassium, high; n=189,189, 188 | Potassium, low; n=189,189, 188 | Glucose fasting, high; n=126,137, 124 | Glucose fasting, low; n=126,137, 124 |
---|
Epoetin Reference | 1 | 1 | 1 | 73 | 5 | 4 | 6 | 11 | 2 | 17 | 82 | 18 | 38 | 1 | 2 | 0 |
,RO0503821 (1x/2 Weeks) | 0 | 8 | 0 | 48 | 1 | 3 | 6 | 5 | 4 | 16 | 84 | 14 | 32 | 1 | 1 | 0 |
,RO0503821 (1x/4 Weeks) | 1 | 11 | 2 | 48 | 2 | 4 | 11 | 8 | 5 | 20 | 78 | 17 | 38 | 4 | 2 | 0 |
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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
Intervention | BpM (Mean) |
---|
| Pulse rate (Week 36, n=147,149, 156) | Pulse rate (Week 52, n= 140, 135, 142) |
---|
Epoetin Reference | 6 | 2 |
,RO0503821 (1x/2 Weeks) | 1 | -3 |
,RO0503821 (1x/4 Weeks) | 4 | 1 |
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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
Intervention | BpM (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) | 1 | 1 |
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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)
Intervention | g/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)
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 94.3 |
Comparator ESA | 93.3 |
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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
Intervention | Participants (Number) |
---|
PROCRIT | 9 |
Placebo | 11 |
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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
Intervention | Units on a scale. (Mean) |
---|
PROCRIT | 27.30 |
Placebo | 30.88 |
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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
Intervention | percentage of change (Mean) |
---|
Group A: Venofer and Erythropoietin EPO Fixed Dose | 0.7226 |
Group B: Erythropoietin EPO Fixed Dose Only | 0.4630 |
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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
Intervention | ng/mL (Mean) |
---|
Group A: Venofer and Erythropoietin EPO Fixed Dose | 545.05 |
Group B: Erythropoietin EPO Fixed Dose Only | 70.523 |
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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
Intervention | g/dL (Mean) |
---|
Group A: Venofer and Erythropoietin EPO Fixed Dose | 1.3 |
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
Intervention | percentage of change (Mean) |
---|
Group A: Venofer and Erythropoietin EPO Fixed Dose | 18.176 |
Group B: Erythropoietin EPO Fixed Dose Only | 10.383 |
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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)
Intervention | g/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.
Intervention | events (Number) |
---|
Weekly Procrit (Epoetin Alfa) Dosing | 38 |
Interval Dosing (Epoetin Alfa) Non PK Group | 130 |
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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
Intervention | participants (Number) |
---|
Weekly Procrit (Epoetin Alfa) Dosing | 0 |
Interval Dosing (Epoetin Alfa) Non PK Group | 5 |
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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
Intervention | participants (Number) |
---|
PROCRIT 40,000 IU QW | 5 |
Placebo | 6 |
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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
Intervention | participants (Number) |
---|
PROCRIT 40,000 IU QW | 3 |
Placebo | 0 |
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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
Intervention | mL (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
Intervention | participants (Number) |
---|
| Favorable outcome | Unfavorable outcome |
---|
Epo1 Group | 17 | 18 |
,Epo2 Group | 17 | 40 |
,Placebo Group | 34 | 55 |
,TT10 Group | 31 | 63 |
,TT7 Group | 37 | 50 |
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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
Intervention | units on a scale (Median) |
---|
TT7 Group | 5 |
TT10 Group | 8 |
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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
Intervention | participants (Number) |
---|
| Developed ARDS | Did not develop ARDS |
---|
TT10 Group | 25 | 76 |
,TT7 Group | 16 | 83 |
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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
Intervention | participants (Number) |
---|
| Developed one or more infections | Did not develop infection |
---|
TT10 Group | 36 | 65 |
,TT7 Group | 27 | 72 |
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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
Intervention | participants (Number) |
---|
| Died | Survived |
---|
Epo1 Group | 6 | 32 |
,Epo2 Group | 7 | 57 |
,Placebo Group | 18 | 80 |
,TT10 Group | 17 | 84 |
,TT7 Group | 14 | 85 |
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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
Intervention | participants (Number) |
---|
| No. of participants with at least one Tt | Calcium Channel Blocking Agents | Loop Diuretics | Angiotensin-Converting Enzyme Inhibitors | Beta-Adrenoceptor Blocking Agents | Angiotensin-II Receptor Antagonists | Alpha-Adrenoreceptor Antagonists | Antihypertensive Agents | Thiazide And Related Diuretics | Antianginal Agents | Potassium Sparing Diuretics | Aldosterone Antagonists | Cardiac Glycosides | Diuretics | Supplements | Calcium Compounds And Regulators | Miscellaneous Drugs | Tricyclic Antidepressants |
---|
Early Epoetin Beta Therapy | 287 | 201 | 183 | 158 | 169 | 89 | 87 | 55 | 44 | 6 | 4 | 2 | 1 | 2 | 1 | 0 | 0 | 1 |
,Late Epoetin Beta Therapy | 282 | 204 | 180 | 153 | 136 | 96 | 73 | 52 | 40 | 5 | 7 | 5 | 1 | 0 | 1 | 1 | 1 | 0 |
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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
Intervention | participants (Number) |
---|
| From CL 0 (BL) to CL 0; n = 167, 149 | From CL 0 (BL) to CL I; n = 167, 149 | From CL 0 (BL) to CL II; n = 167, 149 | From CL 0 (BL) to CL III; n = 167, 149 | From CL 0 (BL) to CL IV; n = 167, 149 | From CL I (BL) to CL 0; n = 37, 43 | From CL I (BL) to CL I; n = 37, 43 | From CL I (BL) to CL II; n = 37, 43 | From CL I (BL) to CL III; n = 37, 43 | From CL I (BL) to CL IV; n = 37, 43 | From CL II (BL) to CL 0; n = 53, 44 | From CL II (BL) to CL I; n = 53, 44 | From CL II (BL) to CL II; n = 53, 44 | From CL II (BL) to CL III; n = 53, 44 | From CL II (BL) to CL IV; n = 53, 44 | From CL III (BL) to CL 0; n = 0, 0 | From CL III (BL)to CL I; n = 0, 0 | From CL III (BL)to CL II; n = 0, 0 | From CL III (BL)to CL III; n = 0, 0 | From CL III (BL)to CL IV; n = 0, 0 | From CL IV (BL)to CL 0; n = 0, 0 | From CL IV (BL)to CL I; n = 0, 0 | From CL IV (BL)to CL II; n = 0, 0 | From CL IV (BL)to CL III; n = 0, 0 | From CL IV (BL)to CL IV; n = 0, 0 |
---|
Early Epoetin Beta Therapy | 49 | 7 | 7 | 2 | 0 | 1 | 28 | 5 | 0 | 0 | 0 | 5 | 39 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Late Epoetin Beta Therapy | 42 | 4 | 7 | 1 | 0 | 0 | 34 | 4 | 0 | 0 | 0 | 1 | 37 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | centimeters (Mean) |
---|
| LVEDD, Baseline, n = 219, 233 | LVEDD, Year 1, n = 170, 186 | LVEDD, Year 2, n = 135, 147 | LVEDD, Year 3, n = 74, 81 | LVEDD, Year 4, n = 2,11 | LVPWT, Baseline, n = 219, 233 | LVPWT, Year 1, n = 170, 186 | LVPWT, Year 2, n= 135, 147 | LVPWT, Year 3, n = 74, 81 | LVPWT, Year 4, n = 2,11 | IVSWT, Baseline, n = 219, 233 | IVSWT, Year 1, n = 170, 186 | IVSWT, Year 2, n = 135, 147 | IVSWT, Year 3, n = 74, 81 | IVSWT, Year 4, n = 2, 11 | LVESD, Baseline, n = 219, 233 | LVESD, Year 1, n = 170, 186 | LVESD, Year 2, n = 135, 147 | LVESD, Year 3, n = 74, 81 | LVESD, Year 4, n = 2, 11 | LVRWT, Baseline, n = 219, 233 | LVRWT, Year 1, n = 170, 186 | LVRWT, Year 2, n = 135, 147 | LVRWT, Year 3, n = 74, 81 | LVRWT, Year 4, n = 2, 11 |
---|
Early Epoetin Beta Therapy | 5.05 | 4.93 | 4.95 | 5.09 | 5.21 | 1.05 | 1.02 | 1.01 | 1.01 | 1.08 | 1.18 | 1.17 | 1.12 | 1.14 | 1.30 | 2.85 | 2.76 | 2.78 | 2.88 | 2.93 | 0.42 | 0.42 | 0.41 | 0.41 | 0.41 |
,Late Epoetin Beta Therapy | 4.91 | 4.94 | 4.93 | 4.88 | 5.08 | 1.05 | 1.01 | 0.99 | 1.00 | 0.92 | 1.20 | 1.13 | 1.11 | 1.12 | 1.04 | 2.74 | 2.73 | 2.75 | 2.67 | 2.84 | 0.43 | 0.41 | 0.41 | 0.42 | 0.37 |
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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.
Intervention | Square meter (Mean) |
---|
| BSA, Baseline, n = 287, 290 | BSA, Year 1, n = 257, 261 | BSA, Year 2, n = 224, 234 | BSA, Year 3, n = 116, 121 | BSA, Year 4, n = 4, 11 |
---|
Early Epoetin Beta Therapy | 1.83 | 1.83 | 1.82 | 1.82 | 1.96 |
,Late Epoetin Beta Therapy | 1.79 | 1.77 | 1.77 | 1.72 | 1.76 |
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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
Intervention | milliliters per meter square (Mean) |
---|
| LV Volume, Baseline; n = 218, 232 | LV Volume, Week 12; n = 170, 186 | LV Volume, Week 24; n = 134, 146 | LV Volume, Week 36; n = 72, 80 | LV Volume, Week 48; n = 2, 11 |
---|
Early Epoetin Beta Therapy | 67.73 | -2.83 | -0.69 | 3.34 | 14.48 |
,Late Epoetin Beta Therapy | 65.11 | 3.15 | 2.62 | 4.05 | 7.91 |
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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
Intervention | gram/square meter (Mean) |
---|
| LVMI, Baseline; n = 219, 232 | LVMI, Week 12; n = 171, 186 | LVMI, Week 24; n = 136, 146 | LVMI, Week 36; n = 74, 81 | LVMI, Week 48; n = 2, 11 |
---|
Early Epoetin Beta Therapy | 120.32 | -5.06 | -6.58 | -1.30 | 2.00 |
,Late Epoetin Beta Therapy | 117.97 | -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
Intervention | percentage (Mean) |
---|
| LVEF, Baseline; n = 219, 233 | LVEF, Week 12; n = 170, 186 | LVEF, Week 24; n = 135, 147 | LVEF, Week 36; n = 74, 81 | LVEF, Week 48; n = 2,11 | FS, Baseline; n = 219, 232 | FS, Week 12; n = 196, 212 | FS, Week 24; n = 174, 192 | FS, Week 36; n = 98, 105 | FS, Week 48; n = 4,12 |
---|
Early Epoetin Beta Therapy | 81.31 | -0.08 | -0.47 | -0.61 | -0.46 | 43.67 | 0.13 | 0.11 | 0.05 | 1.00 |
,Late Epoetin Beta Therapy | 81.95 | 0.08 | -0.23 | 0.24 | 2.80 | 44.67 | 0.08 | -0.19 | 0.70 | 3.00 |
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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
Intervention | number of cardiovascular intervention (Number) |
---|
Early Epoetin Beta Therapy | 21 |
Late Epoetin Beta Therapy | 18 |
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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
Intervention | days (Mean) |
---|
Early Epoetin Beta Therapy | 33.0 |
Late Epoetin Beta Therapy | 28.2 |
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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
Intervention | participants (Number) |
---|
| Total Death Events for All-cause | Sudden Death | Cerebrovascular Accident | Cardiac Failure | Cardiac Failure Acute | Sepsis | Acute Myocardial Infarction | Bronchopneumonia | Respiratory Failure | Septic Shock | Acute Heart Failure | Acute Respiratory Failure | Angina Pectoris | Arrhythmia | Cardiac Arrest | Cardio-Respiratory Arrest | Cardiopulmonary Failure | Cerebral Infarction | Clostridial Infection | Colon Cancer Metastatic | Embolic Stroke | Intestinal Infarction | Intestinal Ischaemia | Laryngeal Cancer | Lung Neoplasm Malignant | Metastases To Lung | Metastatic Neoplasm | Myocardial Infarction | Oesophageal Carcinoma | Peripheral Vascular Disorder | Pneumonia | Pulmonary Embolism | Renal Failure | Unevaluable Event | Uraemic Encephalopathy |
---|
Early Epoetin Beta Therapy | 31 | 4 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 |
,Late Epoetin Beta Therapy | 21 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| Platelets - High; n = 206, 208 | Platelets - Low; n = 206, 208 | Creatinine - High; n = 206, 208 | Albumin - Low; n = 201, 205 | Phosphate - High; n = 206, 208 | Phosphate - Low; n = 206, 208 | Potassium - High; n = 206, 208 | Potassium - Low; n = 206, 208 |
---|
Early Epoetin Beta Therapy | 5 | 13 | 140 | 6 | 164 | 22 | 47 | 4 |
,Late Epoetin Beta Therapy | 0 | 15 | 128 | 9 | 150 | 23 | 46 | 6 |
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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
Intervention | participants (Number) |
---|
| Total Cardiovascular Death Events | Cardiac Failure | Cardiac Failure Acute | Acute Myocardial Infarction | Angina Pectoris | Arrhythmia | Cardiac Arrest | Cardio-Respiratory Arrest | Cardiopulmonary Failure | Myocardial Infarction |
---|
Early Epoetin Beta Therapy | 8 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
,Late Epoetin Beta Therapy | 6 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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Volume of Transfusions
(NCT00334737)
Timeframe: From birth to 36 weeks gestational age
Intervention | mL/kg (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 30 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 23 |
Placebo/Control | 51 |
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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
Intervention | units on a scale (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 2.8 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 2.4 |
Placebo/Control | 2.2 |
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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
Intervention | participants (Number) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 4 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 5 |
Placebo/Control | 13 |
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Hematocrit
(NCT00334737)
Timeframe: From birth to 36 weeks gestational age
Intervention | L/L (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 0.35 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 0.36 |
Placebo/Control | 0.29 |
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Incidence of Retinopathy of Prematurity Stage 3 or Greater
(NCT00334737)
Timeframe: From birth to 36 weeks gestational age
Intervention | participants (Number) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 2 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 1 |
Placebo/Control | 2 |
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Reticulocyte Count
absolute retic count measured at the end of study (NCT00334737)
Timeframe: at day 60 of study
Intervention | 1000 cells per microliter (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 295 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 298 |
Placebo/Control | 130 |
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Number of Transfusions During Hospitalization
(NCT00334737)
Timeframe: From birth to 36 weeks gestational age
Intervention | number of transfusions (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 1.2 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 1.2 |
Placebo/Control | 2.4 |
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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
Intervention | BSID III compositie cognitive score (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 96.2 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 97.9 |
Placebo/Control | 88.7 |
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Epo Concentrations
(NCT00334737)
Timeframe: peak from birth to 36 weeks gestational age
Intervention | mU/mL (Mean) |
---|
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w | 1398.9 |
Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 | 515.4 |
Placebo/Control | 28.6 |
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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
Intervention | participants (Number) |
---|
Standard of Care | 21 |
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
Intervention | Days (Median) |
---|
Standard of Care | 114 |
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
Intervention | g/dL (Mean) |
---|
Standard of Care | 0.3 |
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)
Intervention | Months (Median) |
---|
Standard of Care (SOC) | 18.0 |
Epoetin Alfa | 17.8 |
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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
Intervention | Percentage of participants (Number) |
---|
Standard of Care (SOC) | 3.72 |
Epoetin Alfa | 4.86 |
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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)
Intervention | Months (Median) |
---|
Standard of Care (SOC) | 7.4 |
Epoetin Alfa | 7.4 |
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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)
Intervention | Months (Median) |
---|
Standard of Care (SOC) | 7.5 |
Epoetin Alfa | 7.5 |
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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)
Intervention | Percentage of participants (Number) |
---|
| Complete response (CR) | Partial response (PR) | Stable disease (SD) | Progressive disease (PD) | Not evaluable (NE) | Not available (NA) |
---|
Epoetin Alfa | 3 | 47 | 32 | 12 | 2 | 5 |
,Standard of Care (SOC) | 3 | 48 | 30 | 13 | 1 | 5 |
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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)
Intervention | g/dL (Mean) |
---|
PROCRIT (Epoetin Alfa) | 0.98 |
STANDARD THERAPY | 0.33 |
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Hospital Length of Stay
(NCT00350519)
Timeframe: Surgery to hospital discharge
Intervention | days (Mean) |
---|
PROCRIT (Epoetin Alfa) | 7.94 |
STANDARD THERAPY | 12.56 |
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Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions
(NCT00350519)
Timeframe: Day of surgery until hospital discharge
Intervention | participants (Number) |
---|
PROCRIT (Epoetin Alfa) | 4 |
STANDARD THERAPY | 9 |
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Number of pRBC Units Transfused During Study
(NCT00350519)
Timeframe: Baseline (Day -10) to end of study (Day 32)
Intervention | units (Mean) |
---|
PROCRIT (Epoetin Alfa) | 3.5 |
STANDARD THERAPY | 6.11 |
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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
Intervention | g/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
Intervention | percentage 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
Intervention | percentage of LVEDV (Mean) |
---|
| Baseline (n=88, 82) | Month 6 (n=84, 76) | Month 15 (n=85, 79) |
---|
Group 1 (Early Epoetin Beta) | 36.45 | 37.80 | 37.58 |
,Group 2 (No/Late Epoetin Beta) | 36.58 | 38.49 | 38.86 |
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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
Intervention | percentage of LVEDV (Mean) |
---|
| Baseline (n=57, 56) | Month 6 (n=47, 53) | Month 15 (n=54, 55) |
---|
Group 1 (Early Epoetin Beta) | 63.44 | 57.22 | 58.63 |
,Group 2 (No/Late Epoetin Beta) | 63.84 | 59.92 | 59.97 |
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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
Intervention | mL/m^2 (Mean) |
---|
| Baseline (n=57, 56) | Month 6 (n=47, 53) | Month 15 (n=54, 55) |
---|
Group 1 (Early Epoetin Beta) | 61.08 | 62.74 | 62.26 |
,Group 2 (No/Late Epoetin Beta) | 58.13 | 60.40 | 62.07 |
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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
Intervention | mL/m^2 (Mean) |
---|
| Baseline (n=57, 56) | Month 6 (n=47, 53) | Month 15 (n=54, 55) |
---|
Group 1 (Early Epoetin Beta) | 22.40 | 26.86 | 25.99 |
,Group 2 (No/Late Epoetin Beta) | 21.04 | 24.54 | 25.03 |
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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
Intervention | Participants (Number) |
---|
| SGOT, High | Albumin, Low | Total protein, Low |
---|
Cohort A (0.4/150, 1x/ Week) | 1 | 0 | 0 |
,Cohort B (0.4/150, 1x/ 3 Weeks) | 0 | 0 | 0 |
,Cohort C (0.4/150, 1x/ 4 Weeks) | 0 | 0 | 1 |
,Cohort D (0.8/150, 1x/ Week) | 0 | 0 | 0 |
,Cohort E (0.8/150, 1x/ 3 Weeks) | 0 | 0 | 0 |
,Cohort F (0.8/150, 1x/ 4 Weeks) | 0 | 0 | 0 |
,Cohort G (1.2/150, 1x/ Week) | 0 | 0 | 1 |
,Cohort H (1.2/150, 1x/ 3 Weeks) | 0 | 0 | 0 |
,Cohort I (1.2/150, 1x/ 4 Weeks) | 0 | 1 | 0 |
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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
Intervention | Millimeters of Mercury (Mean) |
---|
| SBP before dialysis | SBP after dialysis | DBP before dialysis | DBP after dialysis |
---|
Cohort A (0.4/150, 1x/ Week) | -1 | 0 | -1 | -3 |
,Cohort B (0.4/150, 1x/ 3 Weeks) | 7 | 10 | 1 | 4 |
,Cohort C (0.4/150, 1x/ 4 Weeks) | 2 | 1 | 3 | -1 |
,Cohort D (0.8/150, 1x/ Week) | -8 | -4 | -3 | -3 |
,Cohort E (0.8/150, 1x/ 3 Weeks) | -4 | 7 | -2 | 0 |
,Cohort F (0.8/150, 1x/ 4 Weeks) | -6 | -5 | 2 | 2 |
,Cohort G (1.2/150, 1x/ Week) | -2 | 0 | -3 | -3 |
,Cohort H (1.2/150, 1x/ 3 Weeks) | 1 | -1 | -0 | 5 |
,Cohort I (1.2/150, 1x/ 4 Weeks) | -7 | -7 | 1 | -5 |
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Mean Change in Pulse Rate
Mean change in pulse rate was reported. (NCT00364832)
Timeframe: Up to Week 126
Intervention | Beats 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
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs | Deaths |
---|
RO0503821 (1x/ 3 Weeks) | 33 | 13 | 4 |
,RO0503821 (1x/ 4 Weeks) | 40 | 20 | 10 |
,RO0503821 (1x/ Week) | 44 | 15 | 7 |
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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
Intervention | seconds (Median) |
---|
Placebo | 1020 |
rHuEPO | 1020 |
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Platelet Function Assay Closure Time
(NCT00367991)
Timeframe: Change from Day 3 to Day 10
Intervention | seconds (Median) |
---|
Placebo | 251 |
rHuEPO | 281 |
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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
Intervention | U/L (Median) |
---|
Placebo | 817 |
rHuEPO | 652 |
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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
Intervention | pg/mL (Mean) |
---|
| Day 1 | Day 10 |
---|
Placebo | 45 | 60 |
,rHuEPO | 56 | 63 |
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Vital Signs
(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Intervention | mmHg (Mean) |
---|
| SBP, baseline | SBP at 24 hours | SBP at 48 hours | SBP, 14 days | SBP, 30 days | DBP, baseline | DBP, 24 hours | DBP, 48 hours | DBP, 14 days | DBP, 30 days |
---|
Epoetin Alfa | 129.7 | 118.7 | 114.3 | 119.2 | 117.4 | 78.5 | 70.5 | 68.0 | 71.2 | 71.0 |
,Placebo | 126.2 | 112.9 | 114.3 | 115.2 | 117.9 | 75.8 | 66.3 | 67.9 | 69.2 | 71.3 |
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Hemoglobin Levels
(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Intervention | g/dL (Mean) |
---|
| Baseline | 24 hours | 48 hours | 14 days | 30 days |
---|
Epoetin Alfa | 13.8 | 13.4 | 13.3 | 14.1 | 14.2 |
,Placebo | 13.6 | 13.1 | 13.1 | 13.5 | 13.7 |
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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)
Intervention | ml/m^2 (Mean) |
---|
| End systolic, First CMR | End systolic, Second CMR | End diastolic, First CMR | End diastolic, Second CMR |
---|
Epoetin Alfa | 34.7 | 34.1 | 65.6 | 70.0 |
,Placebo | 32.6 | 32.0 | 63.4 | 66.6 |
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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)
Intervention | g/m^2 (Mean) |
---|
| First CMR | Second CMR |
---|
Epoetin Alfa | 74.2 | 67.3 |
,Placebo | 69.2 | 61.8 |
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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)
Intervention | percent (Mean) |
---|
| First CMR | Second CMR |
---|
Epoetin Alfa | 48.2 | 52.5 |
,Placebo | 48.9 | 52.0 |
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Number of Participants With Clinical Events
(NCT00378352)
Timeframe: from randomization to second CMR
Intervention | Participants (Count of Participants) |
---|
| Death | Recurrent myocardial infarction | Unstaged Percutaneous Coronary Intervention | Coronary Artery Bypass Graft | Stroke | Stent thrombosis | Left Ventricular thrombus | New or worsening Congestive Heart Failur |
---|
Epoetin Alfa | 1 | 2 | 6 | 0 | 1 | 3 | 3 | 5 |
,Placebo | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 |
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Reticulocyte Counts
(NCT00378352)
Timeframe: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Intervention | percentage of red blood cells (Mean) |
---|
| Baseline | 24 hours | 48 hours | 14 days | 30 days |
---|
Epoetin Alfa | 1.4 | 1.6 | 1.8 | 1.4 | 1.2 |
,Placebo | 1.3 | 1.3 | 1.3 | 1.4 | 1.3 |
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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
Intervention | percentage of participants responding (Number) |
---|
Arm A Azacitidine + Erythropoietin | 50 |
Arm B Azacitidine | 33.3 |
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Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
(NCT00379912)
Timeframe: Six months
Intervention | percentage of cells (Mean) |
---|
| % apoptosis at baseline | % apoptosis after three cycles | % apoptosis after six cycles |
---|
Non-Responders | 31.19 | 63.43 | 38.10 |
,Responders | 17.04 | 24.70 | 42.58 |
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BclXL Expression
(NCT00379912)
Timeframe: Six months
Intervention | percentage L27 mRNA (Mean) |
---|
| BclXL Expression at baseline | BclXL Expression after three cycles | BclXL Expression after six cycles |
---|
Non-Responders | 1.00 | .77 | 1.21 |
,Responders | 1.0 | 1.50 | 3.89 |
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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
Intervention | cells of BM (10e^6/ML) (Mean) |
---|
| CD34 Baseline | CD34 After Three Cycles | CD34 After Six Cycles | CD71 at Baseline | CD71 After Three Cycles | CD71 After Six Cycles | CD36 at Baseline | CD36 after Three Cycles | CD36 after Six Cycles |
---|
Non-Responders | .49 | .58 | .52 | 7.23 | 10.13 | 9.69 | 5.12 | 6.08 | 3.57 |
,Responders | .86 | .93 | 1.15 | 18.32 | 27.31 | 35.45 | 11.69 | 14.33 | 21.35 |
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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
Intervention | percentage of participants (Number) |
---|
Arm A Azacitidine + Erythropoietin | 66.7 |
Arm B Azacitidine | 66.4 |
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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
Intervention | percentage of participants responding (Number) |
---|
Arm B Azacitidine | 33.3 |
Arm A Azacitidine + Erythropoietin | 33.3 |
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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
Intervention | participants (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
Intervention | participants (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
Intervention | days (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
Intervention | g/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
Intervention | participants (Number) |
---|
Epoetin Alfa - 80,000 U sc | 13 |
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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
Intervention | g/dL (Median) |
---|
Epoetin Alfa - 80,000 U sc | 1.3 |
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Number of Patients With an at Least 2gm/dL Increase in Hgb
(NCT00400686)
Timeframe: Baseline to Day 28
Intervention | participants (Number) |
---|
Epoetin Alfa - 80,000 U sc | 9 |
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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)
Intervention | percentage of participants (Number) |
---|
| Without Dose Modification (n=178) | With Dose Modification (n=166) |
---|
C.E.R.A | 88.8 | 61.5 |
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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)
Intervention | percentage of participants (Number) |
---|
| Without Dose Modification (n=288) | With Dose Modification (n=128) |
---|
C.E.R.A | 93.1 | 88.3 |
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Percentage of Participants Requiring Erythrocyte Transfusions
(NCT00413894)
Timeframe: Visits 1 to 10 (Months -2 to 8)
Intervention | percentage of participants (Number) |
---|
| During Screening Phase | During Titration or Evaluation Phase |
---|
C.E.R.A | 0.7 | 5.0 |
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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)
Intervention | percentage of participants (Number) |
---|
| Without Dose Modification (n=178) | With Dose Modification (n=166) |
---|
C.E.R.A | 44.9 | 17.5 |
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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)
Intervention | percentage of participants (Number) |
---|
| Without Dose Modification (n=288) | With Dose Modification (n=128) |
---|
C.E.R.A | 43.4 | 21.9 |
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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)
Intervention | percentage of participants (Number) |
---|
| ≤ ± 1.0 g/dl | > ± 1.0 to ± 1.5 g/dl | > ± 1.5 to ± 2.0 g/dl |
---|
C.E.R.A | 90.6 | 8.7 | 0.7 |
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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)
Intervention | percentage of participants (Number) |
---|
| ≤ ± 1.0 g/dl | > ± 1.0 to ± 1.5 g/d | > ± 1.5 to ± 2.0 g/dl | > ± 2.0 g/dl | Missing |
---|
C.E.R.A | 82.9 | 7.9 | 2.9 | 0.5 | 5.8 |
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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)
Intervention | percentage of participants (Number) |
---|
| Category A | Category B | Category C | Category D |
---|
C.E.R.A | 59.4 | 19.5 | 4.3 | 14.9 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 75.6 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 91.6 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 36.8 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 31.7 |
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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
Intervention | units on a scale (Mean) |
---|
| Fatigue Now | Usual Fatigue | Worst Fatigue | BFI Interference |
---|
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 4.7 | 4.7 | 5.3 | 4.4 |
,Epoetin Alfa - 120k Every 3 Weeks | 4.6 | 4.7 | 5.4 | 4.3 |
,Epoetin Alfa - 40k Weekly | 4.8 | 4.7 | 5.5 | 4.3 |
,Epoetin Alfa - 80k Every 3 Weeks | 4.6 | 4.7 | 5.6 | 4.1 |
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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
Intervention | percentage of Participants (Number) |
---|
Epoetin Alfa - 40k Weekly | 63.9 |
Epoetin Alfa - 80k Every 3 Weeks | 30 |
Epoetin Alfa - 120k Every 3 Weeks | 34.5 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 45.6 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Alfa - 40k Weekly | 27.9 |
Epoetin Alfa - 80k Every 3 Weeks | 33.3 |
Epoetin Alfa - 120k Every 3 Weeks | 22.4 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 29.8 |
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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
Intervention | units on a scale (Mean) |
---|
| FACT Fatigue Concerns | FACT Nonfatigue Concerns | FACT Total Anemia |
---|
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 49.8 | 59.4 | 53.1 |
,Epoetin Alfa - 120k Every 3 Weeks | 52.6 | 61.3 | 55.6 |
,Epoetin Alfa - 40k Weekly | 48.6 | 60.6 | 52.8 |
,Epoetin Alfa - 80k Every 3 Weeks | 52.0 | 62.2 | 55.6 |
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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
Intervention | units on a scale (Mean) |
---|
| Overall QOL | Mental QOL | Physical QOL | Emotional QOL | Social Activity Level | Spiritual QOL | Pain Frequency | Pain Severity | Fatigue | Anxiety |
---|
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 6.1 | 6.5 | 5.8 | 6.3 | 5.1 | 6.8 | 4.2 | 4.0 | 5.4 | 4.2 |
,Epoetin Alfa - 120k Every 3 Weeks | 6.6 | 7.2 | 5.9 | 6.7 | 5.4 | 7.3 | 3.9 | 3.7 | 5.6 | 4.6 |
,Epoetin Alfa - 40k Weekly | 6.4 | 6.9 | 5.7 | 6.5 | 5.5 | 7.4 | 4.5 | 4.1 | 5.6 | 4.1 |
,Epoetin Alfa - 80k Every 3 Weeks | 6.5 | 7.0 | 5.8 | 6.8 | 5.5 | 7.4 | 4.3 | 3.8 | 5.5 | 3.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Nausea Frequency | Nausea Severity | Appetite | Insomnia | Pain Frequency | Pain Severity | Fatigue | Bowel | Concentration | Appearance | Breathing | Outlook | Cough | Depression |
---|
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 1.6 | 1.6 | 2.4 | 2.4 | 2.7 | 2.1 | 2.9 | 2.3 | 2.2 | 2.2 | 1.7 | 2.4 | 2.0 | 2.0 |
,Epoetin Alfa - 120k Every 3 Weeks | 1.6 | 1.4 | 2.2 | 2.3 | 2.4 | 2.0 | 2.8 | 2.3 | 1.9 | 2.0 | 1.6 | 2.1 | 1.8 | 1.8 |
,Epoetin Alfa - 40k Weekly | 1.6 | 1.5 | 2.3 | 2.4 | 2.7 | 2.2 | 3.1 | 2.2 | 2.2 | 2.1 | 1.5 | 2.2 | 1.8 | 1.8 |
,Epoetin Alfa - 80k Every 3 Weeks | 1.5 | 1.4 | 2.3 | 2.0 | 2.5 | 2.0 | 3.0 | 2.4 | 2.0 | 2.2 | 1.6 | 2.1 | 1.7 | 1.7 |
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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
Intervention | g/dL (Mean) |
---|
| Week 4 Minus Baseline | Week 7 Minus Baseline | Week 10 Minus Baseline | Week 13 Minus Baseline | Week 16 Minus Baseline |
---|
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 0.4 | 1.5 | 1.5 | 1.6 | 1.9 |
,Epoetin Alfa - 120k Every 3 Weeks | 0.7 | 1.1 | 1.2 | 1.3 | 1.6 |
,Epoetin Alfa - 40k Weekly | 1.0 | 1.7 | 1.7 | 2.1 | 1.7 |
,Epoetin Alfa - 80k Every 3 Weeks | 0.6 | 1.0 | 1.2 | 1.2 | 1.2 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Alfa - 40k Weekly | 68.9 |
Epoetin Alfa - 80k Every 3 Weeks | 61.7 |
Epoetin Alfa - 120k Every 3 Weeks | 65.5 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 66.7 |
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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
Intervention | g/dL (Mean) |
---|
Epoetin Alfa - 40k Weekly | 1.1 |
Epoetin Alfa - 80k Every 3 Weeks | 1.2 |
Epoetin Alfa - 120k Every 3 Weeks | 0.6 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 1.1 |
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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
Intervention | days (Median) |
---|
Epoetin Alfa - 40k Weekly | 32 |
Epoetin Alfa - 80k Every 3 Weeks | 50 |
Epoetin Alfa - 120k Every 3 Weeks | 49 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 49 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Alfa - 40k Weekly | 22 |
Epoetin Alfa - 80k Every 3 Weeks | 22 |
Epoetin Alfa - 120k Every 3 Weeks | 17 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 13 |
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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
Intervention | g/dL (Mean) |
---|
Epoetin Alfa - 40k Weekly | 11.0 |
Epoetin Alfa - 80k Every 3 Weeks | 10.3 |
Epoetin Alfa - 120k Every 3 Weeks | 10.6 |
Darbepoetin Alfa - 500 mcg Every 3 Weeks | 10.7 |
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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
Intervention | number of participants (Number) |
---|
| Hematocrit - low | Hemoglobin - low | Platelets - low | Creatine Phosphokinase - high | Potassium - high | Fasting Glusose - high | Phosphate - high | Phosphate - low |
---|
Epoetin Alfa | 24 | 28 | 4 | 8 | 20 | 20 | 48 | 12 |
,Methoxy Polyethylene Glycol-epoetin Beta | 32 | 36 | 9 | 4 | 20 | 20 | 52 | 9 |
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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
Intervention | number of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 123 |
Epoetin Alfa | 129 |
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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
Intervention | ml/min (Mean) |
---|
Erythropoietin | 47 |
Placebo | 46 |
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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
Intervention | g/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
Intervention | g/dL (Mean) |
---|
Epoetin Alfa QW | 12.35 |
Epoetin Alfa Q2W | 12.48 |
Epoetin Alfa Q4W | 12.46 |
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Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
(NCT00440466)
Timeframe: 36 weeks of treatment
Intervention | g/dL/2 weeks (Mean) |
---|
Epoetin Alfa QW | 1.77 |
Epoetin Alfa Q2W | 1.69 |
Epoetin Alfa Q4W | 1.81 |
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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
Intervention | Proportion (Median) |
---|
Epoetin Alfa QW | 0.87 |
Epoetin Alfa Q2W | 0.88 |
Epoetin Alfa Q4W | 0.83 |
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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
Intervention | Participants (Number) |
---|
Epoetin Alfa QW | 37 |
Epoetin Alfa Q2W | 33 |
Epoetin Alfa Q4W | 68 |
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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
Intervention | Participants (Number) |
---|
Epoetin Alfa QW | 52 |
Epoetin Alfa Q2W | 57 |
Epoetin Alfa Q4W | 124 |
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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
Intervention | Particpants (Number) |
---|
Epoetin Alfa QW | 84 |
Epoetin Alfa Q2W | 91 |
Epoetin Alfa Q4W | 191 |
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Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
(NCT00440466)
Timeframe: 36 weeks of treatment
Intervention | Participants (Number) |
---|
Epoetin Alfa QW | 79 |
Epoetin Alfa Q2W | 89 |
Epoetin Alfa Q4W | 161 |
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Number of Participants Who Died
(NCT00440466)
Timeframe: 36 weeks of treatment
Intervention | Participants (Number) |
---|
Epoetin Alfa QW | 4 |
Epoetin Alfa Q2W | 3 |
Epoetin Alfa Q4W | 9 |
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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
Intervention | g/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
Intervention | g/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
Intervention | g/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
Intervention | participants (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
Intervention | participants (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
Intervention | participants (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
Intervention | participants (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
Intervention | participants (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
Intervention | millimeter 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 Alfa | 9 | 2 | -7 | -2 | 5 | -1 | -6 | -5 |
,RO0503821 | 3 | 3 | 5 | 1 | 7 | -5 | 6 | -6 |
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Mean Change From Baseline in Temperature
(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8
Intervention | Degree 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 | -0.0 | 0.2 | 0.5 | 0.1 |
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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
Intervention | mg 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 Alfa | 1.94 | -9.57 | 4.67 | 8.60 | 21.25 | 3.00 | -43.00 |
,RO0503821 | 20.94 | -3.29 | 15.17 | 19.67 | 9.29 | 3.25 | NA |
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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
Intervention | Percentage 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 Alfa | 4.08 | -2.44 | 1.36 | 3.47 | 0.39 | -1.80 | 15.13 |
,RO0503821 | 7.10 | 8.51 | 4.55 | 5.94 | 7.07 | 8.59 | 24.13 |
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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
Intervention | Participants (Number) |
---|
| Quantifiable at Baseline | BLQ at Baseline | Quantifiable at M 9 final visit/early termination | BLQ at M 9 final visit/early termination |
---|
Epoetin Alfa | 1 | 37 | 4 | 34 |
,RO0503821 | 2 | 33 | 1 | 29 |
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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
Intervention | Participants (Number) |
---|
| Quantifiable at Baseline | BLQ at Baseline | Quantifiable at M 9 final visit/early termination | BLQ at M 9 final visit/early termination |
---|
RO0503821 | 0 | 35 | 0 | 29 |
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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
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs | Death |
---|
Epoetin Alfa | 23 | 2 | 0 |
,RO0503821 | 24 | 11 | 1 |
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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
Intervention | Participants (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 Alfa | 3 | 3 | 1 | 0 | 1 | 2 | 2 | 3 | 1 | 0 | 4 | 5 | 1 | 7 |
,RO0503821 | 8 | 11 | 0 | 1 | 0 | 0 | 1 | 7 | 1 | 6 | 3 | 6 | 0 | 17 |
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Mean Change From Baseline in Weight
(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8
Intervention | kilogram (Mean) |
---|
| M7 D1 (n = 9, 6) | M7 D15 (n = 5, 3) | M8 D1 (n = 2, 3) | M8 D15 (n = 2, 2) |
---|
Epoetin Alfa | 3.2 | 1.1 | 1.9 | 2.5 |
,RO0503821 | 0.5 | 1.2 | 3.0 | 1.5 |
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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
Intervention | g/dL (Mean) |
---|
RO0503821 | -0.32 |
Epoetin Alfa | 0.51 |
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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
Intervention | microgram 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 |
,RO0503821 | 59 | 83 | 48 | 85 | 86 | 55 | -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
Intervention | micromole 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 Alfa | 1.8 | -1.3 | 0.2 | 0.9 | 0.6 | -1.3 | 7.7 |
,RO0503821 | 3.4 | 3.9 | 2.0 | 3.1 | 2.9 | 3.4 | 11.0 |
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Mean Change From Baseline in Pulse Rate
(NCT00442416)
Timeframe: From Baseline (D 0) to D1 and D15 of M7, M8
Intervention | Beats 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 | -2 | 3 | 2 | 7 |
,RO0503821 | -2 | 1 | -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
Intervention | milligram (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 | -6.64 | 1.50 | -5.60 | -6.50 |
,RO0503821 | -9.27 | -0.25 | 7.25 | 9.89 | 10.50 | 2.50 | -15.50 |
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Length of Hospitalization
(NCT00451698)
Timeframe: At hospital discharge, up to 30 days
Intervention | days (Mean) |
---|
Acyanotic Placebo | 4.6 |
Acyanotic Study Drug | 6 |
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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
Intervention | ng/ml (Mean) |
---|
| 60 minutes post bypass | 4 hrs post bypass | 24 hrs post bypass | 48 hrs post bypass |
---|
Acyanotic Placebo | 31.1 | 27.2 | 10 | 5.2 |
,Acyanotic Study Drug | 12.3 | 15 | 10.7 | 5.2 |
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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)
Intervention | participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 69 |
Epoetin Alfa | 26 |
Darbepoetin Alfa | 9 |
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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
Intervention | days (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 24.6 |
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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)
Intervention | days (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 42.5 |
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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)
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 53.9 |
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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)
Intervention | grams per deciliter (g/dL) (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 1.32 |
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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)
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 66.7 |
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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
Intervention | Scores 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 & Niferex | 35.7 | 42.3 | 38.6 |
,Placebo & Niferex | 38.3 | 39.8 | 42.7 |
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Grip Strength
kilograms measured by hand held dynamometer (NCT00511901)
Timeframe: 3, 8, and 12 weeks following randomization
Intervention | kg (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 & Niferex | 18.4 | 19.6 | 19.0 |
,Placebo & Niferex | 19.0 | 19.4 | 17.4 |
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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
Intervention | Scores 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 & Niferex | 77.7 | 85.0 | 85.1 |
,Placebo & Niferex | 76.9 | 81.7 | 85.2 |
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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
Intervention | Scores 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 & Niferex | 3.5 | 0 | 0 |
,Placebo & Niferex | 1 | 1 | 1 |
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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
Intervention | Counts (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 & Niferex | 41.56 | 70.17 | 77.75 |
,Placebo & Niferex | 51.13 | 58.78 | 61.60 |
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Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
(NCT00511901)
Timeframe: 8 weeks following randomization
Intervention | g/dL (Mean) |
---|
Placebo & Niferex | 11.9 |
Epoetin Alpha & Niferex | 13.6 |
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Length of Stay in Subacute Rehabilitation Facility
Days from randomization to discharge (NCT00511901)
Timeframe: 12 weeks following randomization
Intervention | Days (Mean) |
---|
Placebo & Niferex | 13.1 |
Epoetin Alpha & Niferex | 17.4 |
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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.
Intervention | Percentage (Mean) |
---|
EPO Group | 12.1 |
Placebo Group | 9.44 |
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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
Intervention | units on a scale (Mean) |
---|
| 12-Month BSID-III Cognitive | 12-Month BSID-III Language | 12-Month BSID-III Motor |
---|
EPO 1000 Units/kg QDx3 | 101.4 | 85.0 | 89.3 |
,EPO 500 Units/kg QODx3 | 100.9 | 92.0 | 90.5 |
,Placebo | 106.3 | 92.4 | 92.6 |
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EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).
(NCT00513240)
Timeframe: 72 hours postoperatively.
Intervention | minutes (Mean) |
---|
EPO Group | 0 |
Placebo Group | 0 |
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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.
Intervention | mIU/mL (Mean) |
---|
EPO Group | 6931 |
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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
Intervention | μmol/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.A | 847.1 | 823.4 | 814.0 | 822.9 | 804.5 | 809.7 | 816.6 | 13.9 | 16.0 | 17.6 | 16.5 | 16.0 | 16.3 | 14.4 | 38.5 | 39.7 | 41.5 | 42.0 | 41.4 | 39.6 | 44.0 |
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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
Intervention | mcg/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.A | 591.8 | 617.0 | 598.8 | 578.5 | 583.0 | 591.2 | 590.3 |
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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
Intervention | Percentage of participants (Number) |
---|
| Dose adjustment during DTP | Dose adjustment during EEP |
---|
C.E.R.A | 65.8 | 51.1 |
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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)
Intervention | mcg (Mean) |
---|
C.E.R.A | 139.6 |
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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
Intervention | mg/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.A | 54.1 | 87.5 | 186.8 | 64.0 | 53.4 | 250.6 | 61.7 |
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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
Intervention | 10^9 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.A | 6.8 | 6.5 | 6.7 | 6.6 | 6.6 | 6.6 | 6.6 | 219.7 | 204.4 | 207.4 | 205.2 | 207.9 | 209.3 | 209.0 |
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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
Intervention | participants (Number) |
---|
| Participants with AE | Participants with SAE |
---|
C.E.R.A | 120 | 53 |
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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
Intervention | Percentage 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.A | 34.7 | 39.8 | 46.3 | 42.1 | 39.3 | 40.2 | 36.8 |
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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
Intervention | g/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.A | 39.5 | 39.3 | 39.3 | 39.3 | 39.4 | 39.9 | 39.6 | 1.82 | 1.84 | 1.81 | 1.90 | 1.91 | 1.96 | 2.96 |
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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)
Intervention | Percentage of participants (Number) |
---|
C.E.R.A | 43.7 |
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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)
Intervention | Percentage of participants (Number) |
---|
C.E.R.A | 47.8 |
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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)
Intervention | days (Mean) |
---|
C.E.R.A | 30 |
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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)
Intervention | g/dL (Mean) |
---|
C.E.R.A | 0.08 |
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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
Intervention | mmol/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.A | 1.61 | 1.69 | 1.70 | 1.68 | 1.60 | 1.59 | 1.61 | 4.90 | 4.80 | 4.90 | 4.90 | 4.80 | 4.80 | 5.00 |
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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
Intervention | participants (Number) |
---|
C.E.R.A | 13 |
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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
Intervention | mcg (Mean) |
---|
| Mean monthly dose during DTP | Mean monthly dose during EEP |
---|
C.E.R.A | 142.5 | 139.6 |
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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
Intervention | Proportion 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.A | 0.35 | 0.35 | 0.36 | 0.35 | 0.35 | 0.35 | 0.36 | 0.36 | 0.36 | 0.36 | 0.35 | 0.35 |
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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
Intervention | g/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.A | 11.4 | 11.7 | 11.7 | 11.6 | 11.5 | 11.6 | 11.8 | 11.6 | 11.7 | 11.7 | 11.5 | 11.4 |
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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
Intervention | percentage 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
Intervention | days (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
Intervention | percentage 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
Intervention | g/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
Intervention | percentage 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
Intervention | percentage of participants (Number) |
---|
| DTP (n = 29) | EEP (n = 26) |
---|
C.E.R.A. | 62 | 31 |
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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
Intervention | participants (Number) |
---|
| AEs | SAEs |
---|
C.E.R.A. | 22 | 9 |
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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
Intervention | participants (Number) |
---|
| Complete Remission | Partial Response | Hematologic Improvement | No Response |
---|
Cytokine-Immunotherapy | 2 | 2 | 4 | 6 |
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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)
Intervention | Participants (Count of Participants) |
---|
Conventional Therapy | 146 |
Intensified Therapy | 116 |
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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
Intervention | Participants (Count of Participants) |
---|
Standard of Care (SoC) Therapy | 150 |
Multifactorial Intensified Therapy | 191 |
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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
Intervention | g/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
Intervention | days (Mean) |
---|
Mircera in Renal Anemia | 130 |
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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
Intervention | months (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 Anemia | 1.1 | 0.4 | 0.6 | 1.5 | 0.7 | 0.8 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 48.4 |
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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
Intervention | mcg (Mean) |
---|
| DTP (n=91) | LTSP (n=72) |
---|
Mircera in Renal Anemia | 140 | 133.8 |
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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
Intervention | g/dL (Mean) |
---|
| Above (n=32) | Below (n=51) |
---|
Mircera in Renal Anemia | 0.5 | -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
Intervention | days (Mean) |
---|
| Above (n=35) | Below (n=51) |
---|
Mircera in Renal Anemia | 43 | 48 |
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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
Intervention | percentage of Hb values (Number) |
---|
| Above (n=32) | Below (n=51) |
---|
Mircera in Renal Anemia | 22 | 38 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 15.4 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 75.6 |
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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
Intervention | Grams per deciliter (g/dL) (Mean) |
---|
Correction Phase: CERA | 2.00 |
Correction Phase: Epoetin Beta | 2.03 |
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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
Intervention | Beats 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
Intervention | Days (Median) |
---|
Correction Phase: CERA | 84 |
Correction Phase: Epoetin Beta | 72 |
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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
Intervention | Number of participants (Number) |
---|
Correction Phase: CERA | 8 |
Correction Phase: Epoetin Beta | 2 |
Maintenance Phase: CERA | 1 |
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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
Intervention | Number of participants (Number) |
---|
Correction Phase: CERA | 3 |
Correction Phase: Epoetin Beta | 3 |
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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
Intervention | Percentage of participants (Number) |
---|
Correction Phase: CERA | 79.5 |
Correction Phase: Epoetin Beta | 87.8 |
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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
Intervention | millimeters of mercury (Mean) |
---|
| Pre-dialysis: SBP | Pre-dialysis: DBP | Post-dialysis: SBP | Post-dialysis: DBP |
---|
Correction Phase: CERA | 2.74 | -1.74 | 5.26 | 0.84 |
,Correction Phase: Epoetin Beta | 2.72 | 3.87 | 2.59 | 3.28 |
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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
Intervention | Number of participants (Number) |
---|
| Number of participants with any AE | Number of participants with any SAE |
---|
Correction Phase: CERA | 34 | 10 |
,Correction Phase: Epoetin Beta | 39 | 6 |
,Maintenance Phase: CERA | 51 | 8 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 53.7 |
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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
Intervention | participants (Number) |
---|
Mircera in Renal Anemia | 3 |
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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
Intervention | days (Mean) |
---|
Mircera in Renal Anemia | 34 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 53.7 |
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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
Intervention | g/dL (Mean) |
---|
Mircera in Renal Anemia | 0.0 |
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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
Intervention | percentage of participants (Number) |
---|
| DTP (n=187) | EEP (n=160) |
---|
Mircera in Renal Anemia | 68 | 38 |
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Mean Number of Blood Transfusions Per Visit
(NCT00551291)
Timeframe: Up to approximately 2 years
Intervention | transfusions/visit (Mean) |
---|
| Baseline (n=8) | Week 12 (n=6) | Week 18 (n=5) | End of Study (n=3) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 4.13 | 5.83 | 2.80 | 2.33 |
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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
Intervention | percentage of participants (Number) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 90.00 |
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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
Intervention | percentage of participants (Number) |
---|
| Week 12 (n=4) | Week 18 (n=7) | End of study (n=3) |
---|
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | 50.00 | 71.43 | 100.00 |
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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
Intervention | months (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 3.62 |
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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
Intervention | dose adjustments (Number) |
---|
| Total number of dose adjustments | Total number of dose increases | Total number of dose reductions | Total number of dose interruptions |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 595 | 249 | 210 | 136 |
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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
Intervention | number of transfusions (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 39 |
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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)
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 29.21 |
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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
Intervention | months (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 2.40 |
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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)
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 10.67 |
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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)
Intervention | g/dL (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 1.6 |
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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
Intervention | months (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 2.28 |
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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
Intervention | fraction (Mean) |
---|
| Hematocrit, Baseline, n = 112, 121 | Hematocrit, Week 36, n = 75, 98 |
---|
C.E.R.A. | 0.35 | 0.35 |
,Epoetin Alpha | 0.35 | 0.36 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline, n = 112, 121 | Week 36; n = 75, 98 |
---|
C.E.R.A. | 11.6 | 11.5 |
,Epoetin Alpha | 11.6 | 11.7 |
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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
Intervention | 10^9/Litre (Mean) |
---|
| Leukocytes, Baseline, n = 112, 121 | Leukocytes, Week 36, n = 75, 98 | Platelets counts, Baseline, n = 112, 121 | Platelets counts, Week 36, n = 75, 98 |
---|
C.E.R.A. | 6.8 | 6.5 | 194.8 | 193.3 |
,Epoetin Alpha | 6.6 | 6.5 | 204.4 | 210.6 |
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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
Intervention | femtoliters (Mean) |
---|
| Baseline; n = 112, 121 | Week 36; n = 74, 97 |
---|
C.E.R.A. | 91.9 | 90.6 |
,Epoetin Alpha | 92.2 | 91.6 |
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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
Intervention | percentage (Mean) |
---|
| TS, Baseline; n = 112, 121 | TS, Week 36; n = 70, 91 |
---|
C.E.R.A. | 38.0 | 44.4 |
,Epoetin Alpha | 36.2 | 31.7 |
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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
Intervention | participants (Number) |
---|
| Any AE | Any SAE |
---|
C.E.R.A. | 99 | 27 |
,Epoetin Alpha | 106 | 16 |
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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
Intervention | micrograms per liter (Mean) |
---|
| Ferritin, Baseline, n = 112,121 | Ferritin, Week 36, n = 72, 93 |
---|
C.E.R.A. | 777.8 | 736.9 |
,Epoetin Alpha | 621.4 | 609.9 |
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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)
Intervention | g/dL (Mean) |
---|
C.E.R.A. | -0.02 |
Epoetin Alpha | 0.05 |
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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)
Intervention | days (Mean) |
---|
C.E.R.A. | 30.4 |
Epoetin Alpha | 33.9 |
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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
Intervention | participants (Number) |
---|
C.E.R.A. | 8 |
Epoetin Alpha | 3 |
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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)
Intervention | participants (Number) |
---|
C.E.R.A. | 88 |
Epoetin Alpha | 98 |
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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)
Intervention | participants (Number) |
---|
C.E.R.A. | 35 |
Epoetin Alpha | 39 |
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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
Intervention | participants (Number) |
---|
C.E.R.A. | 0 |
Epoetin Alpha | 0 |
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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
Intervention | participants (Number) |
---|
C.E.R.A. | 0 |
Epoetin Alpha | 0 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A. | 30.9 |
Epoetin Alpha | 39.4 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A. | 50.7 |
Epoetin Alpha | 53.0 |
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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
Intervention | gram/litre (Mean) |
---|
| Albumin, Baseline, n = 111, 118 | Albumin, Week 36, n = 72, 92 | Transferrin, Baseline, n = 56, 66 | Transferrin, Week 36, n = 39, 49 |
---|
C.E.R.A. | 39.2 | 39.3 | 1.65 | 1.76 |
,Epoetin Alpha | 39.9 | 39.8 | 1.77 | 1.67 |
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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
Intervention | International units/Liter (Mean) |
---|
| AST, Baseline, n = 109, 117 | AST, Week 36, n = 74, 96 | ALP, Baseline, n = 108, 119 | ALP, Week 36, n = 73, 93 |
---|
C.E.R.A. | 16.4 | 17.2 | 106.4 | 116.2 |
,Epoetin Alpha | 16.6 | 17.1 | 118.0 | 129.7 |
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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
Intervention | micromoles per liter (Mean) |
---|
| Creatinine, Baseline, n = 109, 116 | Creatinine, Week 36, n = 72, 95 | Potassium, Baseline, n = 112, 121 | Potassium, Week 36, n = 75, 99 | TIBC, Baseline, n = 60, 59 | TIBC, Week 36, n = 31, 43 | Iron, Baseline, n = 112, 121 | Iron, Week 36, n = 73, 97 | PTH, Baseline, n = 111, 121 | PTH, Week 36, n = 18, 24 |
---|
C.E.R.A. | 850.4 | 881.0 | 5.2 | 5.0 | 37.0 | 39.5 | 14.2 | 17.5 | 228.3 | 313.4 |
,Epoetin Alpha | 916.6 | 876.1 | 5.2 | 5.0 | 38.6 | 39.4 | 14.5 | 12.5 | 217.9 | 368.2 |
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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)
Intervention | percentage 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
Intervention | number 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)
Intervention | number 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)
Intervention | percentage 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)
Intervention | number of participants (Number) |
---|
| DTP, No dose change | DTP, Dose increase only | DTP, Dose decrease only | DTP, Dose decrease and increase | DTP, Only one dose | EEP, No dose change | EEP, Dose increase only | EEP, Dose decrease only | EEP, Dose decrease and increase | EEP, Only one dose | LTSP, No dose change | LTSP, Dose increase only | LTSP, Dose decrease only | LTSP, Dose decrease and increase | LTSP, Only one dose |
---|
RO0503821 (1x/4 Weeks) | 50 | 37 | 68 | 41 | 3 | 81 | 46 | 42 | 12 | 2 | 39 | 41 | 55 | 40 | 3 |
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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)
Intervention | g/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
Intervention | micromoles/liter (Mean) |
---|
| Iron, Baseline, n = 125 | Iron, Week 8, n = 113 | Iron, Week 16, n = 103 | Iron, Week 24, n = 96 | Iron, Week 32, n = 84 | Iron, Week 40, n = 79 | Iron, Week 48, n = 81 | TIBC, Baseline, n = 58 | TIBC, Week 8, n = 55 | TIBC, Week 16, n = 45 | TIBC, Week 24, n = 44 | TIBC, Week 32, n = 38 | TIBC, Week 40, n = 35 | TIBC, Week 48, n = 36 |
---|
C.E.R.A | 16.0 | 14.0 | 14.9 | 15.9 | 16.6 | 15.7 | 16.4 | 49.2 | 53.7 | 53.5 | 54.8 | 50.6 | 54.0 | 51.5 |
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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
Intervention | days (Mean) |
---|
C.E.R.A | 37.4 |
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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
Intervention | participants (Number) |
---|
C.E.R.A | 1 |
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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
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 66.7 |
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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)
Intervention | participants (Number) |
---|
C.E.R.A | 61 |
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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)
Intervention | participants (Number) |
---|
C.E.R.A | 34 |
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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
Intervention | days (Mean) |
---|
C.E.R.A | 30.8 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline, n = 125 | Week 8, n = 115 | Week 16, n = 104 | Week 24, n = 101 | Week 32, n = 90 | Week 40, n = 85 | Week 48, n = 82 |
---|
C.E.R.A | 10.0 | 11.7 | 12.2 | 11.6 | 12.0 | 11.8 | 11.6 |
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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
Intervention | fraction (Mean) |
---|
| Baseline, n = 124 | Week 8, n = 112 | Week 16, n = 103 | Week 24, n = 101 | Week 32, n = 90 | Week 40; n = 85 | Week 48, n = 82 |
---|
C.E.R.A | 0.30 | 0.34 | 0.36 | 0.34 | 0.35 | 0.35 | 0.34 |
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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
Intervention | grams per liter (Mean) |
---|
| Albumin, Baseline, n = 125 | Albumin, Week 8, n = 111 | Albumin, Week 16, n = 98 | Albumin, Week 24, n = 96 | Albumin, Week 32, n = 84 | Albumin, Week 40, n = 80 | Albumin, Week 48, n = 81 | Transferrin, Baseline, n = 86 | Transferrin, Week 8, n = 74 | Transferrin, Week 16, n = 81 | Transferrin, Week 24, n = 73 | Transferrin, Week 32, n = 67 | Transferrin, Week 40, n = 59 | Transferrin, Week 48, n = 61 |
---|
C.E.R.A | 41.0 | 40.5 | 41.5 | 40.9 | 42.4 | 41.3 | 40.7 | 2.0 | 2.1 | 2.1 | 2.2 | 2.1 | 2.1 | 2.1 |
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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
Intervention | micromoles/liter (Mean) |
---|
| Creatinine, Baseline, n = 125 | Creatinine, Week 32, n = 84 |
---|
C.E.R.A | 317.8 | 361.3 |
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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
Intervention | milligrams per liter (Mean) |
---|
| CRP, Baseline, n = 123 | CRP, Week 8, n = 109 | CRP, Week 16, n = 101 | CRP, Week 24, n = 94 | CRP, Week 32, n = 81 | CRP, Week 40, n = 76 | CRP, Week 48, n = 79 |
---|
C.E.R.A | 4.1 | 6.0 | 6.5 | 6.2 | 4.5 | 3.8 | 4.1 |
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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
Intervention | micrograms per liter (Mean) |
---|
| Ferritin, Baseline, n = 125 | Ferritin, Week 8, n = 112 | Ferritin, Week 16, n = 102 | Ferritin, Week 24, n = 94 | Ferritin, Week 32, n = 79 | Ferritin, Week 40, n = 74 | Ferritin, Week 48, n = 75 |
---|
C.E.R.A | 231.6 | 152.4 | 149.3 | 154.1 | 171.8 | 179.6 | 187.0 |
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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
Intervention | millimoles per litre (Mean) |
---|
| Phosphate, Baseline, n = 124 | Phosphate, Week 8, n = 113 | Phosphate, Week 16, n = 102 | Phosphate, Week 24, n = 94 | Phosphate, Week 32, n = 85 | Phosphate, Week 40, n = 80 | Phosphate, Week 48, n = 79 | Potassium, Baseline, n = 125 | Potassium, Week 8, n=113 | Potassium, Week 16, n = 102 | Potassium, Week 24, n= 96 | Potassium, Week 32, n = 85 | Potassium, Week 40, n = 79 | Potassium, Week 48, n = 80 |
---|
C.E.R.A | 1.5 | 1.6 | 1.5 | 1.6 | 1.6 | 1.6 | 1.6 | 5.1 | 5.1 | 5.1 | 5.0 | 5.1 | 5.1 | 5.2 |
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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
Intervention | percentage of saturation (Mean) |
---|
| TSAT, Baseline, n = 125 | TSAT, Week 8, n = 113 | TSAT, Week 16, n = 103 | TSAT, Week 24, n = 96 | TSAT, Week 32, n = 84 | TSAT, Week 40, n = 79 | TSAT, Week 48, n = 81 |
---|
C.E.R.A | 32.1 | 25.7 | 27.8 | 30.1 | 32.1 | 30.0 | 32.7 |
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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
Intervention | 10^9 cells/liter (Mean) |
---|
| WBC, Baseline, n = 125 | WBC, Week 8, n = 114 | WBC, Week 16, n = 103 | WBC, Week 24, n = 97 | WBC, Week 32, n = 86 | WBC, Week 40, n = 80 | WBC, Week 48, n = 81 | Thrombocyte, Baseline, n = 125 | Thrombocyte, Week 8, n = 110 | Thrombocyte, Week 16, n = 102 | Thrombocyte, Week 24, n = 97 | Thrombocyte, Week 32, n = 85 | Thrombocyte, Week 40, n = 80 | Thrombocyte, Week 48, n = 81 |
---|
C.E.R.A | 7.1 | 7.2 | 7.1 | 7.1 | 7.2 | 6.9 | 6.6 | 255.4 | 240.2 | 237.3 | 237.2 | 237.0 | 226.1 | 222.5 |
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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
Intervention | g/dL (Mean) |
---|
C.E.R.A | 1.75 |
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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
Intervention | RBC Transfusions (Mean) |
---|
Usual Care | 1.8 |
Exercise | 1.0 |
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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Platelet transfusions (Mean) |
---|
Usual Care | 3.1 |
Exercise | 2.3 |
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Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Platelet Transfusions (Mean) |
---|
Usual Care | 3.6 |
Exercise | 2.0 |
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Total Number of Days of Stem Cell Collection (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Days (Mean) |
---|
Usual Care | 4.9 |
Exercise | 4.5 |
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Number of Stem Cell Collection Attempts (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Stem Cell Collection Attempts (Mean) |
---|
Usual Care | 1.4 |
Exercise | 1.1 |
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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
Intervention | RBC Transfusions (Mean) |
---|
Usual Care | 2.3 |
Exercise | 1.8 |
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Number of Stem Cell Collection Attempts (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
Intervention | Stem Cell Collection Attempts (Mean) |
---|
Usual Care | 1.3 |
Exercise | 1.1 |
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Total Number of Days of Stem Cell Collection (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
Intervention | Days (Mean) |
---|
Usual Care | 5.3 |
Exercise | 4.0 |
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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
Intervention | g/dl (Mean) |
---|
| Baseline | Before Transplantation | During Transplanation | At Discharge |
---|
Exercise | 11.7 | 12.0 | 10.8 | 11.0 |
,Usual Care | 11.5 | 12.0 | 10.8 | 10.9 |
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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
Intervention | g/dl (Mean) |
---|
| Baseline | Before transplantation | During transplantation | At discharge |
---|
Exercise | 11.6 | 11.0 | 10.4 | 10.6 |
,Usual Care | 12.1 | 10.8 | 10.1 | 10.6 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline [N=542, 273] | Evaluation Period [N=488, 237] | Change from Baseline [N=488, 237] |
---|
Epoetin | 11.21 | 11.05 | -0.17 |
,Peginesatide | 11.20 | 11.13 | -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
Intervention | percentage of participants (Number) |
---|
Peginesatide | 0.635 |
Epoetin | 0.659 |
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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
Intervention | percentage of participants (Number) |
---|
Peginesatide | 0.077 |
Epoetin | 0.099 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline [N=524, 269] | Evaluation Period [N=445, 248] | Change from Baseline [N=445, 248] |
---|
Epoetin Alfa | 11.32 | 11.25 | -0.09 |
,Peginesatide | 11.30 | 11.06 | -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
Intervention | percentage of participants (Number) |
---|
Peginesatide | 0.630 |
Epoetin Alfa | 0.717 |
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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
Intervention | percentage of participants (Number) |
---|
Peginesatide | 0.103 |
Epoetin Alfa | 0.086 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 45.45 |
Epoetin Alfa | 55.17 |
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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)
Intervention | g/dL (Mean) |
---|
C.E.R.A | -0.35 |
Epoetin Alfa | 0.32 |
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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)
Intervention | percentage 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.A | 30.8 | 67.7 | 18.5 | 24.6 | 24.6 | 1.5 | 60.0 | 30.9 | 20.0 | 10.9 | 0.0 | 9.1 |
,Epoetin Alfa | 44.4 | 55.6 | 19.4 | 25.0 | 11.1 | 0.0 | 65.6 | 34.4 | 12.5 | 18.8 | 3.1 | 0.0 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 12.3 |
Epoetin Alfa | 2.8 |
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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)
Intervention | days (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.A | 26.7 | 67.5 | 32.2 |
,Epoetin Alfa | 27.1 | 72.9 | 28.9 |
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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)
Intervention | percentage of participants (Number) |
---|
C.E.R.A | 32.7 |
Epoetin Alfa | 40.6 |
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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
Intervention | adverse events (Number) |
---|
Procrit | 1 |
Saline | 2 |
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Percentage of Participants With Blood Transfusion
(NCT00642304)
Timeframe: Baseline up to Week 28
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 10 |
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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)
Intervention | Days (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 36.5 |
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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)
Intervention | g/dL (Mean) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 0.2 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 60 |
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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)
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 40 |
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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)
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-epoetin Beta | 50.0 |
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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
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 41 |
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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
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 23.5 |
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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
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 97 |
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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
Intervention | grams/deciliter (g/dL) (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.99 |
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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
Intervention | days (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 28.6 |
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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
Intervention | g/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
Intervention | days (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
Intervention | participants (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
Intervention | percentage 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
Intervention | percentage 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
Intervention | participants (Number) |
---|
| Week -4 | Early Withdrawal or Week 28 |
---|
C.E.R.A. | 0 | 0 |
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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
Intervention | percentage of participants (Number) |
---|
| DTP (n = 186) | EEP (n = 165) |
---|
C.E.R.A. | 75.0 | 32.0 |
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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
Intervention | ml/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
Intervention | participants (Number) |
---|
Erythropoietin (EPO) Group | 3 |
Placebo Group | 10 |
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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.
Intervention | participants (Number) |
---|
| Complete Remission | Early Death | Partial Response |
---|
No Procruit: Standard Arm | 18 | 3 | 4 |
,Procrit Arm | 24 | 0 | 1 |
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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
Intervention | percentage of participants (Number) |
---|
| DTP (n=114) | EEP (n=110) |
---|
Mircera in Renal Anemia | 79.8 | 48.2 |
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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
Intervention | g/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
Intervention | mcg (Mean) |
---|
| DTP (n=114) | EEP (n=110) |
---|
Mircera in Renal Anemia | 113 | 100.3 |
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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
Intervention | participants (Number) |
---|
| DTP (n=114) | EEP (n=110) |
---|
Mircera in Renal Anemia | 3 | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 79.0 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in Renal Anemia | 72.7 |
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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
Intervention | days (Mean) |
---|
Mircera in Renal Anemia | 43.5 |
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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
Intervention | blood transfusions (Number) |
---|
| DTP (n=114) | EEP (n=110) |
---|
Mircera in Renal Anemia | 4 | 0 |
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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
Intervention | Days (Mean) |
---|
C.E.R.A | 24.2 |
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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
Intervention | Percentage of participants (Number) |
---|
C.E.R.A | 43.9 |
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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
Intervention | g/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.A | 0.45 | 0.06 | -0.30 | 0.24 | -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
Intervention | Milligrams /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 | -1.80 | 0.03 | -0.33 | -1.49 | 0.86 |
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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
Intervention | Micromole/L (Median) |
---|
| Week 8 (n = 4) | Week 16 (n = 2) | Week 32 (n = 2) | Week 40 (n = 1) |
---|
C.E.R.A | 23.87 | 123.67 | -8.40 | 17.7 |
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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
Intervention | Femtoliters (Mean) |
---|
| Week 8 (n = 65) | Week 16 (n = 57) | Week 24 (n = 55) | Week 32 (n = 52) | Week 48 (n = 47) |
---|
C.E.R.A | 0.17 | -1.31 | -1.10 | -0.34 | 0.97 |
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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
Intervention | mcg/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
Intervention | g/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.A | 1.50 | 2.03 | 1.86 | 1.85 | 1.84 | 1.59 |
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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
Intervention | Fraction (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.A | 0.05 | 0.06 | 0.06 | 0.06 | 0.06 | 0.05 |
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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
Intervention | Millimoles /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.A | 0.11 | 0.06 | 0.07 | 0.13 | 0.06 | 0.07 | 0.12 | 0.03 | 0.02 | -0.04 | 0.16 | 0.03 |
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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
Intervention | Micromole /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.A | 0.09 | -0.21 | 0.34 | 0.15 | 2.24 | -2.02 | -1.93 | 0.31 | 0.55 | 0.68 | 1.64 | 0.80 |
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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
Intervention | Percentage 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 | -5.91 | 1.69 | 1.42 | 2.52 | 3.52 | 5.32 |
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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
Intervention | 10^9 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.A | 0.04 | 0.06 | 0.12 | 0.01 | -0.13 | 0.04 | -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
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs |
---|
C.E.R.A | 58 | 24 |
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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
Intervention | Number of participants (Number) |
---|
| DTP (n = 75) | EEP (n = 57) | LSTP (n = 54) |
---|
C.E.R.A | 2 | 1 | 1 |
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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
Intervention | Percentage of participants (Number) |
---|
| Any dose adjustment in DTP | Dose increased in DTP | Dose decreased in DTP | Dose increased and decreased in DTP | Any dose adjustment in EEP | Dose increased in EEP | Dose decreased in EEP | Dose increased and decreased in EEP |
---|
C.E.R.A | 85.4 | 14.6 | 24.4 | 46.3 | 56.1 | 17.1 | 31.7 | 7.3 |
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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)
Intervention | g/dL (Mean) |
---|
C.E.R.A | 1.99 |
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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
Intervention | Days (Mean) |
---|
C.E.R.A | 40.6 |
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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
Intervention | Number of cells x 10^9/L (Mean) |
---|
| Leucocytes, Change from BL to Week 16, n = 102 | Leucocytes, Change from BL to Week 24, n = 95 | Platelet, Change from BL to Week 16, n = 102 | Platelet, Change from BL to Week 24, n = 96 |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.27 | -0.03 | 2.56 | 0.17 |
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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
Intervention | Number of participants (Number) |
---|
| Antibacterials for systemic use | Vitamins | Vaccines | Agents acting on the renin-angiotensin system | Analgesics | Antianemic preparations | Antithrombotic agents | Drug for acid related disorders | Mineral supplements | Other |
---|
C.E.R.A. 120, 200, or 360 mcg | 13 | 13 | 7 | 5 | 4 | 4 | 4 | 4 | 4 | 4 |
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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
Intervention | gram/liter (Mean) |
---|
| Transferrin, Change from BL to Week 16, n = 33 | Transferrin, Change from BL to Week 24, n = 29 | Albumin, Change from BL to Week 16, n = 98 | Albumin, Change from BL to Week 24, n = 93 |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.19 | 0.09 | 0.13 | -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)
Intervention | g/dL (Mean) |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.29 |
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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)
Intervention | mcg (Mean) |
---|
C.E.R.A. 120, 200, or 360 mcg | 103.5 |
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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
Intervention | micromole/Liter (Mean) |
---|
| Iron, Change from BL to Week 16, n = 98 | Iron, Change from BL to Week 24, n = 93 | TIBC, Change from BL to Week 16, n = 84 | TIBC, Change from BL to Week 24, n = 80 | Creatinine, Change from BL to Week 16, n = 2 | Creatinine, Change from BL to Week 24, n = 92 |
---|
C.E.R.A. 120, 200, or 360 mcg | 2.08 | 1.15 | 0.24 | 0.05 | -20.33 | 16.73 |
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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
Intervention | millimole/liter (Mean) |
---|
| Phosphate, Change from BL to Week 16, n = 97 | Phosphate, Change from BL to Week 24, n = 94 | Potassium, Change from BL to Week 16, n = 94 | Potassium, Change from BL to Week 24, n = 95 |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.04 | 0.06 | -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)
Intervention | Percentage of participants (Number) |
---|
| DTP, n = 127 | EEP, n = 107 |
---|
C.E.R.A. 120, 200, or 360 mcg | 75.6 | 36.4 |
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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
Intervention | Number of participants (Number) |
---|
| During DTP | During EEP |
---|
C.E.R.A. 120, 200, or 360 mcg | 1 | 0 |
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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
Intervention | g/dL (Mean) |
---|
| Change from BL to Week 16, n = 104 | Change from BL to Week 24, n = 98 |
---|
C.E.R.A. 120, 200, or 360 mcg | -0.00 | 0.22 |
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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
Intervention | percentage of red blood cells (Mean) |
---|
| Change from BL to Week 16, n = 104 | Change from BL to Week 24, n = 99 |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.00 | 0.01 |
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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
Intervention | microgram/liter (Mean) |
---|
| Change from BL to Week 16, n = 93 | Change from BL to Week 24, n = 75 |
---|
C.E.R.A. 120, 200, or 360 mcg | 20.80 | 31.51 |
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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
Intervention | Femtoliter (Mean) |
---|
| Change from BL to Week 16, n = 102 | Change 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
Intervention | milligram/liter (Mean) |
---|
| Change from BL to Week 16, n = 88 | Change from BL to Week 16, n = 81 |
---|
C.E.R.A. 120, 200, or 360 mcg | 1.92 | -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)
Intervention | Percentage of participants (Number) |
---|
C.E.R.A. 120, 200, or 360 mcg | 46.43 |
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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)
Intervention | Percentage of participants (Number) |
---|
C.E.R.A. 120, 200, or 360 mcg | 51.18 |
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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
Intervention | Number of participants (Number) |
---|
C.E.R.A. 120, 200, or 360 mcg | 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
Intervention | Percentage of TSAT (Mean) |
---|
| Change from BL to Week 16, n = 89 | Change from BL to Week 24, n = 86 |
---|
C.E.R.A. 120, 200, or 360 mcg | 4.11 | 2.41 |
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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
Intervention | kilogram (Mean) |
---|
| Change from BL to Week 16, n = 103 | Change from BL to Week 24, n = 100 |
---|
C.E.R.A. 120, 200, or 360 mcg | 0.5 | 0.7 |
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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
Intervention | Millimeters of Mercury (Mean) |
---|
| SBP Before Dialysis,Change from BL to W 16,n = 105 | DBP Before Dialysis,Change from BL to W 16,n = 105 | SBP Before Dialysis,Change from BL to W 24,n = 101 | DBP Before Dialysis,Change from BL to W 24,n = 101 | SBP After Dialysis,Change from BL to W 16, n = 100 | DBP After Dialysis,Change from BL to W 16, n = 100 | SBP After Dialysis,Change from BL to W 24, n = 95 | DBP After Dialysis, Change from BL to W 24, n = 95 |
---|
C.E.R.A. 120, 200, or 360 mcg | 2.1 | 2.4 | 3.0 | 2.2 | -0.3 | 1.7 | 1.0 | 1.8 |
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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)
Intervention | mcg (Mean) |
---|
| During DTP, n = 127 | During EEP, n = 107 |
---|
C.E.R.A. 120, 200, or 360 mcg | 121.6 | 112.4 |
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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
Intervention | Number of participants (Number) |
---|
| Number of participants with any AE | Number of participants with any SAE |
---|
C.E.R.A. 120, 200, or 360 mcg | 44 | 13 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
HX575 Epoetin Alfa Hexal AG | 0.003 |
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
Intervention | g/dL (Least Squares Mean) |
---|
HX575 Epoetin Alfa Hexal AG | 0.147 |
ERYPO®, Janssen-Cilag | 0.063 |
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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
Intervention | percentage of participants (Number) |
---|
Peginesatide 0.04 mg/kg | 0.923 |
Peginesatide 0.08 mg/kg | 0.973 |
Epoetin Alfa | 1.0 |
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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
Intervention | percentage of participants (Number) |
---|
Peginesatide 0.04 mg/kg | 0.026 |
Peginesatide 0.08 mg/kg | 0.0 |
Epoetin Alfa | 0.0 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline [N=39, 37, 38] | Evaluation Period [N=37, 37, 36] | Change from Baseline [N=37, 37, 36] |
---|
Epoetin Alfa | 9.07 | 11.49 | 2.41 |
,Peginesatide 0.04 mg/kg | 9.34 | 11.45 | 2.15 |
,Peginesatide 0.08 mg/kg | 9.20 | 11.59 | 2.39 |
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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)
Intervention | participants (Number) |
---|
Placebo | 4 |
Epoetin Alfa 40000 IU | 2 |
Epoetin Alfa 80000 IU | 1 |
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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
Intervention | participants (Number) |
---|
Placebo | 5 |
Epoetin Alfa 40000 IU | 3 |
Epoetin Alfa 80000 IU | 1 |
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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
Intervention | participants (Number) |
---|
Placebo | 2 |
Epoetin Alfa 40000 IU | 2 |
Epoetin Alfa 80000 IU | 1 |
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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
Intervention | percentage 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
Intervention | percentage of participants (Number) |
---|
| DTP | EEP |
---|
C.E.R.A. | 70.3 | 50.9 |
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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
Intervention | percentage 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
Intervention | g/dL (Mean) |
---|
C.E.R.A. | -0.10 |
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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
Intervention | participants (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
Intervention | IU/kg (Mean) |
---|
HX575, EPO HEXAL | 55.1 |
ERYPO | 57.9 |
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Immunogenicity
Number of participants with antibody formation against Epoetin during treatment period (safety set) (NCT00701714)
Timeframe: 13 weeks
Intervention | participants (Number) |
---|
Treatmen HX575 EPO HEXAL | 5 |
Treatment ERYPO | 2 |
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Change in Hemoglobin Level
Mean absolute change in hemoglobin (baseline to end of study week 13) (NCT00701714)
Timeframe: 13 weeks
Intervention | g/dL (Mean) |
---|
HX575, EPO HEXAL | 2.2 |
ERYPO | 2.1 |
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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)
Intervention | 10^3 cells/microliter (Mean) |
---|
| Baseline (n=15,48) | Change at Evaluation Period (n=11,36) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 46.08 | 23.38 |
,MIRCERA Group 2: High-Conversion-Factor Group | 43.70 | 24.80 |
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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)
Intervention | participants (Number) |
---|
| Above 12 g/dL | Within 10-12 g/dL | Below 10 g/dL |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 0 | 9 | 3 |
,MIRCERA Group 2: High-Conversion-Factor Group | 3 | 29 | 4 |
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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
Intervention | picograms per milliliter (pg/mL) (Geometric Mean) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 37700 |
MIRCERA Group 2: High-Conversion-Factor Group | 66100 |
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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)
Intervention | g/dL (Mean) |
---|
| Baseline (n=16,48) | Change at Evaluation Period (n=12,36) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 11.26 | -0.78 |
,MIRCERA Group 2: High-Conversion-Factor Group | 11.08 | -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
Intervention | hours (Median) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 2.00 |
MIRCERA Group 2: High-Conversion-Factor Group | 2.00 |
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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
Intervention | picograms*hour/milliliter (pg*h/mL) (Geometric Mean) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 3630000 |
MIRCERA Group 2: High-Conversion-Factor Group | 7170000 |
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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)
Intervention | participants (Number) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 7 |
MIRCERA Group 2: High-Conversion-Factor Group | 27 |
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Number of Participants With Blood Transfusions
(NCT00717366)
Timeframe: Baseline to Week 20
Intervention | participants (Number) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 1 |
MIRCERA Group 2: High-Conversion-Factor Group | 2 |
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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
Intervention | hours (Geometric Mean) |
---|
MIRCERA Group 1: Intermediate-Conversion-Factor Group | 147 |
MIRCERA Group 2: High-Conversion-Factor Group | 121 |
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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
Intervention | nanogram 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) |
---|
Mircera | 1806.30 | 1422.48 | 1109.07 | 1109.80 |
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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
Intervention | millimole 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) |
---|
Mircera | 5.00 | 6.26 | 5.11 | 5.03 | 137.1 | 136.2 | 137.0 | 136.9 |
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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
Intervention | miligram per mililiter (Mean) |
---|
| Transferrin, Week -2 (n = 25) | Transferrin, Week 4 (n = 16) | Transferrin, Week 8 (n = 18) | Transferrin, Week 12 (n = 18) |
---|
Mircera | 168.24 | 160.00 | 165.72 | 159.22 |
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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
Intervention | Percentage (Mean) |
---|
| TSAT, Week -2 (n = 125) | TSAT, Week 4 (n = 116) | TSAT, Week 8 (n = 109) | TSAT, Week 12 (n = 106) |
---|
Mircera | 45.55 | 48.70 | 46.08 | 45.71 |
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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
Intervention | Per 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) |
---|
Mircera | 7527.50 | 7369.74 | 7506.61 | 7484.35 | 211772.73 | 199508.77 | 208745.76 | 208566.37 |
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Number of Participants With Abnormal Electrocardiogram
Participants with abnormal electrocardiogram were reported. (NCT00737464)
Timeframe: At Week -2 and Week 12
Intervention | Number of participants (Number) |
---|
| Week -2 (n=132) | Week 12 (n=115) |
---|
Mircera | 61 | 50 |
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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
Intervention | Number of participants (Number) |
---|
| TEAEs | SAEs | Deaths |
---|
Mircera | 27 | 9 | 3 |
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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
Intervention | Percentage 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) |
---|
Mircera | 3.58 | 3.73 | 3.88 | 3.97 |
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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
Intervention | units 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) |
---|
Mircera | 23.48 | 23.26 | 22.86 | 23.17 | 31.34 | 30.18 | 29.44 | 31.07 | 154.7 | 163.3 | 162.1 | 159.3 |
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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)
Intervention | gm/dL (Mean) |
---|
| Hb in SVP | Avg of Hb in Last 4 Weeks TP |
---|
Mircera | 10.76 | 11.28 |
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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
Intervention | Beats 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) |
---|
Mircera | 78.79 | 79.54 | 78.64 | 78.98 | 78.61 | 79.55 | 79.83 | 79.56 | 79.80 |
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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
Intervention | mmHg (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) |
---|
Mircera | 145.04 | 145.51 | 146.72 | 143.26 | 145.05 | 143.75 | 147.02 | 144.02 | 146.85 | 144.92 | 146.68 | 143.65 | 145.16 | 145.55 | 144.77 | 143.42 | 144.14 | 143.98 | 144.55 | 143.80 | 82.92 | 84.05 | 83.90 | 83.22 | 84.05 | 84.04 | 84.68 | 83.27 | 83.77 | 83.69 | 84.15 | 83.29 | 83.31 | 83.97 | 83.28 | 84.35 | 83.91 | 84.33 | 84.17 | 83.23 |
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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)
Intervention | Percentage of participants (Number) |
---|
Mircera | 57.89 |
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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
Intervention | Weeks (Mean) |
---|
Mircera | 3.15 |
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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
Intervention | microgram 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) |
---|
Mircera | 102.13 | 108.56 | 116.79 | 110.53 | 273.44 | 266.98 | 283.50 | 276.43 |
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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
Intervention | gram 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) |
---|
Mircera | 3.60 | 3.54 | 3.58 | 3.64 | 3.48 | 3.41 | 3.55 | 3.51 |
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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
Intervention | miligram 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) |
---|
Mircera | 7.89 | 8.34 | 8.03 | 8.19 | 57.72 | 60.67 | 60.10 | 61.79 | 5.00 | 5.02 | 4.81 | 5.37 | 0.52 | 0.50 | 0.52 | 0.51 |
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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
Intervention | femtoliters (Mean) |
---|
| MCV, Week -2 (n = 125) | MCV, Week 4 (n = 107) | MCV, Week 8 (n = 112) | MCV, Week 12 (n = 108) |
---|
Mircera | 90.32 | 89.99 | 89.41 | 88.09 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in CKD-Related Anemia | 3.2 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera in CKD-Related Anemia | 50.0 |
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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
Intervention | g/dL (Mean) |
---|
Mircera in CKD-Related Anemia | 0.4 |
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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
Intervention | mcg (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 Anemia | 25.8 | 37.8 | 28.4 | 42.9 | 24.5 | 52.5 | 24.0 | 47.5 | 29.1 | 34.5 | 29.0 | 50.5 | 38.5 | 35.0 | 27.0 | 37.5 | 28.5 | 75.0 | 37.3 | 22.5 | 18.5 | 32.0 | NA | 40.0 |
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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
Intervention | dose adjustments (Mean) |
---|
| Weeks 4 to 20 (n=95) | Weeks 24 to 48 (n=76) | Weeks 4 to 48 (n=95) |
---|
Mircera in CKD-Related Anemia | 2.0 | 5.6 | 3.3 |
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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
Intervention | percent 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 Anemia | 23.7 | 22.2 | 33.3 | 21.4 | 30.3 | 22.0 | 41.1 | 25.6 | 57.6 | 21.5 | 45.0 | 29.6 | 38.5 | 29.7 | 36.5 | 24.6 | 43.7 | 22.5 | 51.6 | 26.7 | 35.8 | 24.0 | NA | 22.5 |
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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
Intervention | percentage 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 Anemia | 84.2 | 69.3 | 43.3 | 34.7 | 100 | 74.0 | 46.0 | 30.3 | 96.8 | 84.0 | 71.3 | 47.4 |
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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
Intervention | weeks (Mean) |
---|
| EEP (Weeks 16 to 24; n=80) | Overall Study (Weeks 0 to 48; n=94) |
---|
Mircera in CKD-Related Anemia | 5.9 | 22.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Weeks 4 to 16 | Weeks 16 to 24 | Weeks 24 to 44 |
---|
Mircera in CKD-Related Anemia | 16.7 | 11.1 | 72.2 |
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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
Intervention | percentage 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 Anemia | 37.5 | 35.5 | 44.0 | 39.7 | 44.4 | 51.5 | 44.6 | 44.4 | 38.7 |
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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
Intervention | percentage 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 Anemia | 78.8 | 49.4 | 23.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Weeks 4 to 16 | Weeks 16 to 24 | Weeks 24 to 44 |
---|
Mircera in CKD-Related Anemia | 31.8 | 45.5 | 22.7 |
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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
Intervention | percentage of participants (Number) |
---|
| At Least One Cycle | At Least One Excursion | At Least One Up Excursion | At Least One Down Excursion |
---|
Mircera in CKD-Related Anemia | 5.3 | 60.0 | 46.3 | 18.9 |
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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
Intervention | g/dL (Mean) |
---|
| Week 0, n = 185 | Week 4, n = 172 | Week 10, n = 167 | Week 16, n = 155 |
---|
MIRCERA | 3.51 | 3.48 | 3.57 | 3.61 |
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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
Intervention | U/L (Mean) |
---|
| Week 0, n = 175 | Week 4, n = 159 | Week 10, n = 156 | Week 16, n = 145 |
---|
MIRCERA | 176.2 | 161.7 | 161.7 | 153.5 |
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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
Intervention | mg/dL (Mean) |
---|
| Week 0, n = 142 | Week 4, n = 124 | Week 10, n = 123 | Week 16, n = 117 |
---|
MIRCERA | 0.58 | 0.68 | 0.70 | 0.62 |
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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
Intervention | mg/dL (Mean) |
---|
| Week 0, n = 186 | Week 4, n = 171 | Week 10, n = 168 | Week 16, n = 158 |
---|
MIRCERA | 8.25 | 8.65 | 9.48 | 9.05 |
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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
Intervention | nanogram /milliliter (ng/mL) (Mean) |
---|
| Week 0, n = 188 | Week 4, n = 170 | Week 10, n = 161 | Week 16, n = 153 |
---|
MIRCERA | 963.28 | 702.37 | 686.42 | 641.26 |
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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
Intervention | microgram/deciliter (mcg/dL) (Mean) |
---|
| Week 0, n = 187 | Week 4, n = 171 | Week 10, n = 166 | Week 16, n = 157 |
---|
MIRCERA | 91.72 | 80.17 | 87.62 | 91.70 |
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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
Intervention | mg/dL (Mean) |
---|
| Week 0, n = 166 | Week 4, n = 156 | Week 10, n = 155 | Week 16, n = 146 |
---|
MIRCERA | 6.20 | 6.32 | 8.71 | 6.17 |
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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
Intervention | millimoles per liter (mmol/L) (Mean) |
---|
| Week 0, n = 183 | Week 4, n = 168 | Week 10, n = 168 | Week 16, n = 157 |
---|
MIRCERA | 5.76 | 5.23 | 7.53 | 8.30 |
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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
Intervention | mmol/L (Mean) |
---|
| Week 0, n = 184 | Week 4, n = 168 | Week 10, n = 168 | Week 16, n = 156 |
---|
MIRCERA | 136.4 | 136.3 | 133.9 | 137.0 |
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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
Intervention | mcg/dL (Mean) |
---|
| Week 0, n = 185 | Week 4, n = 166 | Week 10, n = 160 | Week 16, n = 153 |
---|
MIRCERA | 247.06 | 243.25 | 245.30 | 245.30 |
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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
Intervention | milligram per deciliter (mg/dL) (Mean) |
---|
| Week 0, n = 73 | Week 4, n = 66 | Week 10, n = 55 | Week 16, n = 58 |
---|
MIRCERA | 173.48 | 176.97 | 237.98 | 181.50 |
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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
Intervention | Percentage of transferrin saturation (Mean) |
---|
| Week 0, n = 186 | Week 4, n=168 | Week 10, n=161 | Week 16, n = 153 |
---|
MIRCERA | 40.39 | 35.31 | 36.91 | 38.31 |
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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
Intervention | Femtoliter (Mean) |
---|
| Week 0, n = 183 | Week 4, n = 169 | Week 10, n = 167 | Week 16, n = 159 |
---|
MIRCERA | 87.05 | 89.17 | 88.46 | 88.03 |
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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
Intervention | cells per cubic millimeter (Mean) |
---|
| Week 0, n = 187 | Week 4, n = 173 | Week 10, n = 167 | Week 16, n = 159 |
---|
MIRCERA | 9382.89 | 9181.27 | 9361.38 | 9023.71 |
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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
Intervention | Participants (Number) |
---|
| Participants with abnormal ECG, Week 0, n=189 | Participants with abnormal ECG, Week 16, n=164 |
---|
MIRCERA | 52 | 49 |
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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
Intervention | Participants (Number) |
---|
| Participants with any AE | Participants with SAE | Deaths |
---|
MIRCERA | 53 | 24 | 8 |
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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
Intervention | Participants (Number) |
---|
| White blood cells transfusions | Pack cell transfusions | Pure red cell transfusions |
---|
MIRCERA | 1 | 6 | 0 |
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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
Intervention | g/dL (Mean) |
---|
| Week 0, n = 179 | Week 4, n = 163 | Week 10, n = 159 | Week 16, n = 150 |
---|
MIRCERA | 3.36 | 3.24 | 3.33 | 3.50 |
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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
Intervention | gram/deciliter (g/dL) (Mean) |
---|
MIRCERA | 2.11 |
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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
Intervention | Weeks (Mean) |
---|
MIRCERA | 6.10 |
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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
Intervention | Weeks (Mean) |
---|
MIRCERA | 3.07 |
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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
Intervention | Participants (Number) |
---|
MIRCERA | 0 |
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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
Intervention | percentage of participants (Number) |
---|
MIRCERA | 46.20 |
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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
Intervention | U/L (Mean) |
---|
| Week 0, n = 185 | Week 4, n = 171 | Week 10, n = 166 | Week 16, n = 157 |
---|
MIRCERA | 27.89 | 26.80 | 28.11 | 29.21 |
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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
Intervention | Units/Liter (U/L) (Mean) |
---|
| Week 0, n = 184 | Week 4, n = 171 | Week 10, n = 166 | Week 16, n = 157 |
---|
MIRCERA | 22.33 | 21.69 | 24.61 | 22.63 |
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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
Intervention | mg/dL (Mean) |
---|
| Week 0, n = 181 | Week 4, n = 170 | Week 10, n = 168 | Week 16, n = 157 |
---|
MIRCERA | 68.98 | 66.19 | 67.21 | 69.88 |
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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
Intervention | cells per cubic millimeter (Mean) |
---|
| Week 0, n = 39 | Week 4, n = 39 | Week 10, n = 36 | Week 16, n = 31 |
---|
MIRCERA | 3.84 | 2.74 | 3.23 | 3.52 |
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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
Intervention | cells per cubic millimeter (Mean) |
---|
| Week 0, n = 186 | Week 4, n = 177 | Week 10, n = 167 | Week 16, n = 158 |
---|
MIRCERA | 214629.03 | 203050.85 | 204922.16 | 194550.63 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 53 |
Placebo | 60.5 |
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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
Intervention | g/dl (Median) |
---|
Erythropoietin (EPO) | 14.7 |
Placebo | 13.6 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 14 |
Placebo | 19 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 20 |
Placebo | 25 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 11 |
Placebo | 14 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 22 |
Placebo | 28 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 47.8 |
Placebo | 53.2 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 59.6 |
Placebo | 70.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin (EPO) | 0 |
Placebo | 0 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 62.2 |
Placebo | 73.7 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 43.6 |
Placebo | 49.4 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 33 |
Placebo | 40 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 37.5 |
Placebo | 51 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 50 |
Placebo | 55 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 70.8 |
Placebo | 79.2 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 20.8 |
Placebo | 37.5 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 37.5 |
Placebo | 45.8 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin (EPO) | 66.7 |
Placebo | 70.8 |
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Time to Non-Fatal and Fatal Stroke
(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years
Intervention | years (Median) |
---|
Erythropoiesis Stimulating Agents | NA |
Methoxy Polyethylene Glycol-Epoetin Beta | NA |
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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
Intervention | years (Median) |
---|
Erythropoiesis Stimulating Agents | NA |
Methoxy Polyethylene Glycol-Epoetin Beta | NA |
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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
Intervention | percentage of participants (Number) |
---|
Erythropoiesis Stimulating Agents | 0 |
Methoxy Polyethylene Glycol-Epoetin Beta | 0 |
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Percentage of Participants With Gastrointestinal Bleeding
(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years
Intervention | percentage of participants (Number) |
---|
Erythropoiesis Stimulating Agents | 11.1 |
Methoxy Polyethylene Glycol-Epoetin Beta | 11.7 |
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Percentage of Participants With Thromboembolic Events
(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years
Intervention | percentage of participants (Number) |
---|
Erythropoiesis Stimulating Agents | 34.5 |
Methoxy Polyethylene Glycol-Epoetin Beta | 32.8 |
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Time to All-Cause Mortality
(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years
Intervention | years (Median) |
---|
Erythropoiesis Stimulating Agents | 6.1 |
Methoxy Polyethylene Glycol-Epoetin Beta | 5.9 |
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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
Intervention | years (Median) |
---|
Erythropoiesis Stimulating Agents | 5.1 |
Methoxy Polyethylene Glycol-Epoetin Beta | 5.1 |
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Time to Non-Fatal and Fatal Myocardial Infarction
(NCT00773513)
Timeframe: Baseline up to approximately 8.5 years
Intervention | years (Median) |
---|
Erythropoiesis Stimulating Agents | NA |
Methoxy Polyethylene Glycol-Epoetin Beta | NA |
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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
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 73.17 |
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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
Intervention | g/dL (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.27 |
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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
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 65.85 |
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Percentage of Participants Who Required Red Blood Cell Transfusions
(NCT00773968)
Timeframe: Weeks 1 to 28
Intervention | percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.9 |
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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
Intervention | percentage of participants (Number) |
---|
| DTP: Dose Increase Only | DTP: Dose Decrease Only | DTP: Both Dose Increase and Decrease | EEP: Dose Increase Only | EEP: Dose Decrease Only | EEP: Both Dose Increase and Decrease |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 17.1 | 39.0 | 22.0 | 31.7 | 9.8 | 9.8 |
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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
Intervention | months (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
Intervention | months (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
Intervention | proportion 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
Intervention | proportion 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
Intervention | mU/mL (Median) |
---|
Arm A Patients With Major Erythroid Response | 514.5 |
Arm A Patients Without Major Erythroid Response | 150 |
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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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | beats 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. | 0.37 | 0.02 | 0.30 | 0.40 | 0.52 | 0.76 |
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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
Intervention | kilogram (Mean) |
---|
| Week 16 (n = 185) | Week 48 (n = 191) |
---|
C.E.R.A. | -0.20 | 0.06 |
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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
Intervention | micromole/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. | 775.7 | 692.5 | 676.1 | 683.7 | 670.2 | 674.8 | 699.6 | 15.9 | 15.1 | 15.1 | 14.3 | 14.9 | 15.6 | 15.2 | 44.5 | 44.2 | 44.8 | 43.7 | 44.1 | 42.6 | 44.0 |
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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
Intervention | Proportion 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. | 0.34 | 0.36 | 0.36 | 0.36 | 0.36 | 0.36 | 0.35 |
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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
Intervention | g/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. | 11.2 | 11.7 | 11.8 | 11.8 | 11.8 | 11.8 | 11.6 |
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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
Intervention | milimole/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. | 1.7 | 1.7 | 1.7 | 1.7 | 1.6 | 1.4 | 1.6 | 5.3 | 5.4 | 5.4 | 5.5 | 5.5 | 5.5 | 5.3 |
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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
Intervention | Percentage 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. | 37.3 | 35.0 | 36.0 | 34.9 | 35.4 | 38.0 | 36.5 |
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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
Intervention | 10^9 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. | 6.5 | 6.5 | 6.3 | 6.4 | 6.3 | 6.3 | 6.5 | 213.9 | 207.5 | 202.5 | 200.5 | 208.6 | 206.1 | 204.7 |
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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
Intervention | Participants (Number) |
---|
| Any AEs | Any SAEs |
---|
C.E.R.A. | 39 | 19 |
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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)
Intervention | g/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
Intervention | mcg/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. | 547.6 | 522.2 | 517.6 | 508.6 | 522.6 | 562.8 | 505.6 |
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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)
Intervention | Days (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)
Intervention | Percentage 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)
Intervention | Percentage 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
Intervention | Number of RBCs transfusion (Number) |
---|
| During DTP | During EEP | During LTSP |
---|
C.E.R.A. | 3 | 1 | 2 |
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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
Intervention | g/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. | 43.1 | 41.0 | 41.3 | 40.2 | 39.9 | 40.4 | 39.9 |
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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
Intervention | miligrams/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. | 6.9 | 7.9 | 8.6 | 9.3 | 7.1 | 7.2 | 7.4 |
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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
Intervention | millimeter 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 | -1.28 | 0.27 | -0.52 | 1.68 | 0.48 | 0.60 | 0.40 | 1.22 | 1.63 | -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)
Intervention | Percentage of participants (Number) |
---|
| Dose adjustment during DTP (n = 193) | Dose adjustment during EEP (n = 185) |
---|
C.E.R.A. | 56 | 34.6 |
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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.
Intervention | ng/mL (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 185 | 104 | 80.7 |
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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.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 563 | 315 | 248 |
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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.
Intervention | percent of administered dose (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 34.0 | 35.4 | 32.5 |
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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)
Intervention | percentage of participants (Number) |
---|
| Baseline EPO ≤ 500 mIU/mL | Baseline EPO > 500 mIU/mL |
---|
Non-responders | 47.8 | 39.1 |
,Overall | 53.8 | 38.5 |
,Responders | 62.5 | 37.5 |
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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).
Intervention | percentage of participants (Number) |
---|
| Major response | Minor response |
---|
10 mg Del 5q | 85.7 | 0 |
,10 mg Non-del 5q | 17.6 | 5.9 |
,15 mg Non-del 5q | 40.0 | 0 |
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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.
Intervention | ng/mL (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 179 | 101 | 78.3 |
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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.
Intervention | percent of administered dose (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 65.1 | 67.9 | 62.2 |
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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.
Intervention | hours (Geometric Mean) |
---|
| Total Lenalidomide | S-Lenalidomide | R-Lenalidomide |
---|
10 mg Lenalidomide | 3.72 | 4.14 | 3.58 |
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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)
Intervention | days (Median) |
---|
| Grade 4 Neutropenia | Grade 4 Thrombocytopenia |
---|
Del 5q | 28.0 | 29.0 |
,Non-del 5q | 69.0 | 53.0 |
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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.
Intervention | ng*h/mL (Geometric Mean) |
---|
10 mg Lenalidomide | 817 |
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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)
Intervention | grams per deciliter (g/dL) (Mean) |
---|
Mircera | 0.55 |
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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
Intervention | percentage of participants (Number) |
---|
Mircera | 87.2 |
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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
Intervention | microgram (mcg) (Mean) |
---|
| Week 0-4 | Week 4-8 | Week 8-12 | Week 12-16 | Week 16-20 | Week 20-24 |
---|
Mircera | 121.2 | 100.8 | 78.8 | 72.7 | 66.9 | 66.2 |
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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
Intervention | days (Mean) |
---|
Mircera | 103.6 |
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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)
Intervention | percentage of participants (Number) |
---|
Mircera | 73.0 |
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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)
Intervention | percentage of participants (Number) |
---|
Mircera | 53.9 |
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Number of Participants With Composite Events of Infusion Reactions
(NCT00924781)
Timeframe: 12 weeks
Intervention | Participants (Number) |
---|
MK2578 1mcg/600U QW | 0 |
MK2578 1mcg/600 QM | 0 |
MK2578 1mcg/350U QW | 0 |
MK2578 1mcg/350U QM | 0 |
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Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
(NCT00924781)
Timeframe: 12 weeks
Intervention | Participants (Number) |
---|
MK2578 1mcg/600U QW | 0 |
MK2578 1mcg/600U QM | 1 |
MK2578 1mcg/350U QW | 0 |
MK2578 1mcg/350U QM | 0 |
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Change From Baseline in Hg Level at Week 12
(NCT00924781)
Timeframe: 12 weeks
Intervention | g/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
Intervention | g/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
Intervention | Participants (Number) |
---|
| Death | MI | CVA | Peripheral vascular thromboses | Vascular access thrombosis | CHF | Hypertension | Seizure | Pure red cell aplasia |
---|
MK2578 1mcg/350U QM | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,MK2578 1mcg/350U QW | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,MK2578 1mcg/600U QM | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,MK2578 1mcg/600U QW | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
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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
Intervention | scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 4.67 |
NTx®-265 Medium Dose | 4.29 |
NTx®-265 High Dose | 5.00 |
Saline Placebo | 5.33 |
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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
Intervention | seconds (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
Intervention | seconds (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
Intervention | scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 10.67 |
NTx®-265 Medium Dose | 33.50 |
NTx®-265 High Dose | 30.33 |
Saline Placebo | 23.75 |
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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
Intervention | Scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 68.18 |
NTx®-265 Medium Dose | 80.17 |
NTx®-265 High Dose | 85.25 |
Saline Placebo | 90.89 |
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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
Intervention | scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 6.79 |
NTx®-265 Medium Dose | 6.50 |
NTx®-265 High Dose | 6.08 |
Saline Placebo | 7.17 |
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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
Intervention | participants (Number) |
---|
| No Response (<4) | Response (>=4) |
---|
NTx®-265 High Dose | 5 | 19 |
,NTx®-265 Low Dose | 6 | 18 |
,NTx®-265 Medium Dose | 7 | 17 |
,Saline Placebo | 5 | 19 |
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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
Intervention | participants (Number) |
---|
| response (mRS <=2) | No response (mRS > 2) |
---|
NTx®-265 High Dose | 15 | 9 |
,NTx®-265 Low Dose | 11 | 13 |
,NTx®-265 Medium Dose | 11 | 13 |
,Saline Placebo | 18 | 6 |
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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
Intervention | Scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 3.93 |
NTx®-265 Medium Dose | 4.17 |
NTx®-265 High Dose | 0.20 |
Saline Placebo | 3.69 |
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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
Intervention | seconds (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
Intervention | scores on a scale (Mean) |
---|
NTx®-265 Low Dose | 7.25 |
NTx®-265 Medium Dose | 3.88 |
NTx®-265 High Dose | 3.56 |
Saline Placebo | 4.74 |
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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
Intervention | scores 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
Intervention | percentage of participants (Number) |
---|
Ribavirin Dose Reduction Arm | 29 |
Erythropoietin Use Arm | 34 |
Treated/Not Randomized | 63 |
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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
Intervention | percentage of participants (Number) |
---|
Ribavirin Dose Reduction Arm | 71.5 |
Erythropoietin Use Arm | 70.9 |
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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
Intervention | units on a scale (Mean) |
---|
LBH589 | 1.0 |
LBH589 + Epoetin Alfa | 1.0 |
Not Randomized | 0.0 |
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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
Intervention | Percentage of participants (Number) |
---|
| Week 32 ( n=5,1,1) | Week 48 (n=6,5,1) |
---|
LBH589 | 0.0 | 0.0 |
,LBH589 + Epoetin Alfa | 0.0 | 0.0 |
,Not Randomized | 0.0 | 0.0 |
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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
Intervention | units on a scale (Mean) |
---|
LBH589 | 0.43 |
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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
Intervention | Percentage of participants (Number) |
---|
| Week 52 (randomized phase), Low | Week 52 (randomized phase), , INT-1 | Week 52 (randomized phase), INT-2 | Week 52 (randomized phase), HIgh |
---|
LBH589 | 0.0 | 16.7 | 0.0 | 0.0 |
,LBH589 + Epoetin Alfa | 0.0 | 16.7 | 0.0 | 0.0 |
,Not Randomized | 100.0 | 0.0 | 0.0 | 0.0 |
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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
Intervention | Percentage of participants (Number) |
---|
| Baseline (core phase), Low | Baseline (core phase),, INT-1 | Baseline (core phase),, INT-2 | Baseline (core phase), High |
---|
LBH589 | 32.4 | 67.6 | 0.0 | 0.0 |
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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
Intervention | Percentage of participants (Number) |
---|
LBH589 | 0.0 |
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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
Intervention | Percentage of participants (Number) |
---|
| 32 weeks (n=5,1,1) | 52 weeks (n=4,3,1) |
---|
LBH589 | 0.0 | 0.0 |
,LBH589 + Epoetin Alfa | 0.0 | 0.0 |
,Not Randomized | 0.0 | 0.0 |
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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
Intervention | Percentage of participants (Number) |
---|
LBH589 | 0.0 |
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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
Intervention | months (Median) |
---|
LBH589 | NA |
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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
Intervention | Weeks (Mean) |
---|
Mircera | 3.92 |
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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
Intervention | g/dL (Mean) |
---|
| At baseline | Mean change at EEP |
---|
Mircera | 10.89 | 0.04 |
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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
Intervention | Months (Mean) |
---|
Mircera | 1 |
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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
Intervention | Percentage of participants (Number) |
---|
Mircera | 45.8 |
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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
Intervention | Percentage of participants (Number) |
---|
| Participants maintaining Hb >10 g/dl | Participants maintaining Hb within 10-12 g/dl |
---|
Mircera | 62.5 | 16.7 |
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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
Intervention | Participants (Number) |
---|
| Number of participants serious AE | Total number of participants with at least one AE |
---|
Mircera | 4 | 15 |
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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
Intervention | μg/month (Mean) |
---|
| At Baseline | At Week 4 | At Week 8 | At Week 12 | At Week 16 | At Week 20 |
---|
Mircera | 97.9 | 103.1 | 107.3 | 119 | 114.6 | 120.8 |
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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
Intervention | Participants (Number) |
---|
| At Baseline, Hb-Low | At Baseline, Hct-Low | At Baseline, WBC-Low | At Baseline, WBC-High | At Baseline, MCV-Low | At Baseline, MCV- High | At Baseline, RBC-Low | At Baseline, RBC -High | At Baseline, Platelets-Low | At Baseline, Iron-Low | At Baseline, Iron-High | At Baseline, Feritin-High | At Baseline, Transferin-Low | At Baseline, TIBC-Low | At Baseline, TSAT-Low | At Baseline, TSAT-High | At Baseline, Albumin-Low | At Baseline, hs-CRP-High | At Baseline, Potassium-High | At Baseline, Phosphorus-High | At Week 8, Hb-Low | At Week 8, Hct-Low | At Week 8, WBC-High | At Week 8, MCV-Low | At Week 8, RBC -High | At Week 8, Platelets-Low | At Week 8, Platelets-High | At Week 8, Iron-Low | At Week 8, Iron-High | At Week 8, Feritin-High | At Week 8, Transferin-Low | At Week 8, TIBC-Low | At Week 24, Hb-Low | At Week 24, Hct-Low | At Week 24, WBC-High | At Week 24, RBC -High | At Week 24, Platelets-Low | At Week 24, Platelets-High | At Week 24, Iron-Low | At Week 24, Iron-High | At Week 24, Feritin-High | At Week 24, Transferin-Low | At Week 24, Transferin-High | At Week 24, TIBC-Low | At Week 24, TSAT-Low | At Week 24, TSAT-High | At Week 24, Albumin-High | At Week 24, hs-CRP-High | At Week 24,Potassium-Low | At Week 24, Potassium-High | At Week 24, Phosphorus-High |
---|
Mircera | 30 | 28 | 1 | 2 | 3 | 4 | 1 | 2 | 7 | 10 | 1 | 25 | 9 | 24 | 8 | 8 | 3 | 2 | 9 | 19 | 22 | 22 | 3 | 5 | 25 | 1 | 21 | 1 | 22 | 6 | 6 | 24 | 18 | 14 | 2 | 4 | 4 | 1 | 4 | 1 | 8 | 6 | 1 | 12 | 1 | 3 | 1 | 2 | 2 | 3 | 11 |
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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
Intervention | PRBC Units (Mean) |
---|
Procrit | 10.63 |
No Procrit | 13.11 |
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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
Intervention | transfusions (Mean) |
---|
Procrit | 6.22 |
No Procrit | 7.44 |
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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
Intervention | Units 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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
| Week 8 | Week 10 | Week 12 | Week 14 | Week 17 | Week 19 | Week 20 |
---|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) | 6 | 6 | 5 | 6 | 6 | 6 | 5 |
,Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 3 | 3 | 3 | 3 | 2 | 2 | 3 |
,Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | 6 | 6 | 6 | 6 | 5 | 4 | 3 |
,Cohort A-6 (Roxadustat 1.3 mg/kg TIW) | 4 | 4 | 6 | 6 | 5 | 5 | 5 |
,Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) | 4 | 4 | 4 | 4 | 4 | 2 | 2 |
,Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) | 4 | 5 | 3 | 1 | 4 | 4 | 5 |
,Cohort A-9 (Roxadustat 2.0 mg/kg) | 1 | 0 | 1 | 1 | 1 | 1 | 2 |
,Cohorts A (Epoetin Alfa) | 9 | 7 | 9 | 6 | 6 | 8 | 7 |
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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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
| Dose Increased | Dose Reduced | Dose Interrupted | Dose Resume |
---|
Cohort A (Epoetin Alfa) | 9 | 6 | 3 | 0 |
,Cohort A-1 (Roxadustat 1.0 mg/kg TIW) | 0 | 0 | 4 | 0 |
,Cohort A-2 (Roxadustat 1.5 mg/kg TIW) | 3 | 0 | 7 | 6 |
,Cohort A-3 (Roxadustat 2.0 mg/kg TIW) | 0 | 0 | 4 | 4 |
,Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 0 | 2 | 0 | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
| Dose Increased | Dose Reduced | Dose Interrupted | Dose Resume |
---|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) | 8 | 6 | 3 | 1 |
,Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 2 | 3 | 1 | 0 |
,Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | 5 | 3 | 5 | 3 |
,Cohort A-6 (Roxadustat 1.3 mg/kg TIW) | 5 | 5 | 2 | 1 |
,Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg) | 4 | 4 | 0 | 0 |
,Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg) | 7 | 4 | 1 | 1 |
,Cohort A-9 (Roxadustat 2.0 mg/kg) | 1 | 1 | 0 | 0 |
,Cohorts A (Epoetin Alfa) | 12 | 11 | 9 | 8 |
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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
Intervention | g/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
Intervention | Participants (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
Intervention | g/dL (Mean) |
---|
| Change at Week 8 | Change at Week 10 | Change at Week 12 | Change at Week 14 | Change at Week 17 | Change at Week 19 | Change at Week 20 |
---|
Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg) | 0.20 | 0.26 | 0.38 | 0.33 | 0.02 | -0.10 | -0.57 |
,Cohort A-4 (Roxadustat 1.8 mg/kg TIW) | 0.49 | 0.56 | 0.26 | 0.53 | -0.09 | -0.11 | -0.39 |
,Cohort A-5 (Roxadustat 1.8 mg/kg TIW) | 0.08 | 0.17 | 0.04 | -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 | -0.30 | 0.05 | 0.15 |
,Cohort B (Epoetin Alfa) | -0.41 | 0.19 | -0.08 | 0.42 | 0.16 | 0.12 | 0.12 |
,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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | g/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
Intervention | Participants (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
Intervention | Participants (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
Intervention | days (Mean) |
---|
Mircera - CMUH | 112.6 |
Mircera - KMUH | 105.0 |
Mircera - BTCH | 107.6 |
Mircera | 108.9 |
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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
Intervention | percentage 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) |
---|
Mircera | 7.4 | 61.7 | 21.0 | 9.9 | 4.0 | 69.3 | 16.0 | 10.7 | 6.9 | 59.7 | 19.4 | 13.9 | 4.4 | 64.7 | 16.2 | 14.7 | 11.9 | 61.2 | 11.9 | 14.9 | 6.1 | 59.1 | 21.2 | 13.6 | 12.5 | 65.6 | 9.4 | 12.5 | 3.1 | 84.4 | 0.0 | 12.5 |
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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
Intervention | g/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) |
---|
Mircera | 10.8 | 10.9 | 10.9 | 11.1 | 10.9 | 11.0 | 10.9 | 11.1 | 11.2 |
,Mircera - BTCH | 10.8 | 10.9 | 11.2 | 11.8 | 11.4 | 11.5 | 11.4 | 11.0 | 11.1 |
,Mircera - CMUH | 10.7 | 10.7 | 10.8 | 10.8 | 10.9 | 11.0 | 10.9 | 11.3 | 11.5 |
,Mircera - KMUH | 11.1 | 11.3 | 10.9 | 10.9 | 10.5 | 10.5 | 10.4 | 10.9 | 10.8 |
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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
Intervention | g/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) |
---|
Mircera | 0.1 | 0.0 | 0.2 | 0.0 | 0.1 | 0.0 | 0.2 | 0.4 |
,Mircera - BTCH | 0.1 | 0.4 | 1.0 | 0.6 | 0.7 | 0.6 | 0.2 | 0.4 |
,Mircera - CMUH | -0.0 | 0.1 | 0.2 | 0.2 | 0.4 | 0.3 | 0.7 | 0.9 |
,Mircera - KMUH | 0.1 | -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
Intervention | percentage of participants (Number) |
---|
Mircera - CMUH | 77.1 |
Mircera - KMUH | 88.5 |
Mircera - BTCH | 90.9 |
Mircera | 84.3 |
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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
Intervention | percent 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) | 11.9 | 16.6 | 19.5 |
,Hematological Malignancy Participants | 13.0 | 18.6 | 24.7 |
,Solid Tumor Participants | 11.3 | 15.6 | 16.6 |
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Percentage of Participants With Vitamins Prescription
(NCT01168349)
Timeframe: Week 4 to 6, Week 12 to 16, Week 24 to 48
Intervention | percentage 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) | 6.8 | 5.4 | 3.4 |
,Breast Cancer Participants | 1.6 | 0.8 | 0.9 |
,Chronic Lymphocytic Leukemia Participants | 10.3 | 10.0 | 9.5 |
,Colon/Rectum Cancer Participants | 0.7 | 3.9 | 1.8 |
,Hodgkin's Lymphoma Participants | 17.4 | 17.4 | 5.9 |
,Lung Cancer Participants | 12.4 | 6.5 | 6.1 |
,Multiple Myeloma Participants | 3.2 | 4.2 | 0.0 |
,Non-Hodgkin's Lymphoma Participants | 9.8 | 8.2 | 3.9 |
,Ovary Cancer Participants | 4.1 | 3.5 | 2.8 |
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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
Intervention | percentage 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) | 99.1 | 99.2 | 99.0 | 99.0 |
,Hematological Malignancy Participants | 100.0 | 100.0 | 100.0 | 100.0 |
,Solid Tumor Participants | 98.7 | 98.8 | 98.3 | 98.3 |
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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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 52.4 |
Hematological Malignancy Participants | 55.7 |
Anemic Cancer Participants (Total Participants) | 53.5 |
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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
Intervention | percentage of participants (Number) |
---|
Responders | 59.2 |
Non-responders | 74.4 |
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
Intervention | percentage of participants (Number) |
---|
Responders | 17.2 |
Non-responders | 31.4 |
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
Intervention | IU/kg/weeks (Mean) |
---|
Solid Tumor Participants | 471.2 |
Hematological Malignancy Participants | 447.3 |
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
Intervention | percentage of participants (Number) |
---|
| Active | Disability | No occupation | Retired | Sick leave | Student, training | Unemployment |
---|
Anemic Cancer Participants (Total Participants) | 3.6 | 2.9 | 6.3 | 65.7 | 19.5 | 0.4 | 1.7 |
,Non-responders | 3.0 | 3.3 | 6.3 | 65 | 20.1 | 0.6 | 1.7 |
,Responders | 4.1 | 2.6 | 6.2 | 66.3 | 18.9 | 0.2 | 1.7 |
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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
Intervention | percentage 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) | 96.5 | 2.0 | 1.1 | 0.4 | 93.1 | 1.7 | 1.2 | 0.9 | 1.1 | 1.2 | 0.8 | 88.7 | 2.5 | 1.5 | 1.2 | 2.7 | 3.4 | 89.7 | 2.1 | 2.1 | 2.1 | 4.1 |
,Hematological Malignancy Participants | 93.7 | 3.7 | 2.3 | 0.3 | 89.7 | 3.1 | 1.5 | 0.8 | 1.5 | 2.7 | 0.8 | 84.7 | 2.5 | 3.7 | 1.2 | 3.1 | 4.9 | 89.5 | 1.3 | 2.6 | 3.9 | 2.6 |
,Solid Tumor Participants | 97.8 | 1.2 | 0.6 | 0.4 | 94.9 | 1.0 | 1.0 | 1.0 | 0.8 | 0.4 | 0.8 | 91.4 | 2.5 | 0.0 | 1.2 | 2.5 | 2.5 | 89.9 | 2.5 | 1.7 | 0.8 | 5.0 |
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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
Intervention | percentage 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) | 16.3 | 49.0 | 71.3 |
,Hematological Malignancy Participants | 8.5 | 37.1 | 65.6 |
,Solid Tumor Participants | 19.9 | 54.6 | 74.2 |
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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
Intervention | RBC units (Mean) |
---|
Responders | 3.4 |
Non-responders | 4.3 |
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
Intervention | percentage 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) | 43.1 | 20.4 | 31.0 | 63.3 |
,Hematological Malignancy Participants | 47.7 | 16.7 | 38.9 | 70.6 |
,Solid Tumor Participants | 37.9 | 22.6 | 25.0 | 53.8 |
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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
Intervention | weeks (Median) |
---|
Responders | NA |
Non-responders | NA |
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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
Intervention | percentage of participants (Number) |
---|
Responders | 5.8 |
Non-responders | 6.2 |
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
Intervention | percentage of participants (Number) |
---|
Responders | 4.9 |
Non-responders | 4.1 |
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
Intervention | percentage of participants (Number) |
---|
Responders | 4.3 |
Non-responders | 4.3 |
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
Intervention | percentage of participants (Number) |
---|
Responders | 6.8 |
Non-responders | 8.1 |
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
Intervention | RBC transfusions (Mean) |
---|
Responders | 1.7 |
Non-responders | 2.1 |
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
Intervention | days (Mean) |
---|
Responders | 89.4 |
Non-responders | 93.3 |
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
Intervention | units on a scale (Mean) |
---|
Responders | 81.2 |
Non-responders | 76.7 |
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
Intervention | units on a scale (Mean) |
---|
Responders | 79.7 |
Non-responders | 75.6 |
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
Intervention | units on a scale (Mean) |
---|
Responders | 78.4 |
Non-responders | 74.7 |
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
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 4 to 6 |
---|
Anemic Cancer Participants (Total Participants) | 6.2 | -0.9 |
,Non-responders | 6.2 | -0.8 |
,Responders | 6.2 | -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
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 24 to 28 |
---|
Anemic Cancer Participants (Total Participants) | 5.8 | -1.5 |
,Non-responders | 5.7 | -1.4 |
,Responders | 5.9 | -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
Intervention | units on a scale (Mean) |
---|
| Baseline | Change at Week 12 to 16 |
---|
Anemic Cancer Participants (Total Participants) | 6.0 | -1.4 |
,Non-responders | 5.9 | -1.3 |
,Responders | 6.1 | -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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 8.1 |
Hematological Malignancy Participants | 10.3 |
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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 69.9 |
Hematological Malignancy Participants | 67.6 |
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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 86.2 |
Hematological Malignancy Participants | 82.7 |
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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 7.2 |
Hematological Malignancy Participants | 12.0 |
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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 36.0 |
Hematological Malignancy Participants | 18.5 |
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
Intervention | percentage of participants (Number) |
---|
Solid Tumor Participants | 52.4 |
Hematological Malignancy Participants | 56.5 |
Anemic Cancer Participants (Total Participants) | 53.8 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month | 3 months | 6 months |
---|
Erythropoietin & Rehabilitation | 36.6 | 37.5 | 38.5 | 40.3 |
,Only Rehabilitation | 31.4 | 33.2 | 37.1 | 37.7 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 34.1 | 35.6 | 38.7 | 41.1 |
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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
Intervention | units on a scale (Mean) |
---|
| BSID-II Mental Scale: Baseline | BSID-II Mental Scale: 1 month - Baseline | BSID-II Mental Scale: 3 months - Baseline | BSID-II Mental Scale: 6 months - Baseline | BSID-II Mental Scale: 3 months - 1 month | BSID-II Mental Scale: 6 months - 1 month | BSID-II Mental Scale: 6 months - 3 months |
---|
Erythropoietin & Rehabilitation | 105.9 | 3.4 | 7.4 | 11.5 | 4.0 | 8.1 | 4.1 |
,Only Rehabilitation | 86.6 | 3.3 | 5.8 | 9.9 | 2.5 | 6.6 | 4.1 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 94.1 | 8.2 | 12.0 | 17.6 | 3.8 | 9.4 | 5.6 |
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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
Intervention | units on a scale (Mean) |
---|
| Anterior portion of Rt. posterior Internal Capsule | Posterior portion of Rt posterior Internal Capsule | Anterior portion of Lt. posterior Internal Capsule | Posterior portion of Lt posterior Internal Capsule |
---|
Erythropoietin & Rehabilitation | 0.01 | 0.02 | 0.02 | 0.04 |
,Only Rehabilitation | 0.01 | 0.02 | 0.04 | 0.05 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 0.03 | 0.04 | 0.03 | 0.05 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month - Baseline | 3 months - Baseline | 6 months - Baseline | 3 months - 1 month | 6 months - 1 month | 6 months - 3 months |
---|
Erythropoietin & Rehabilitation | 42.6 | 4.3 | 6.8 | 9.0 | 2.5 | 4.7 | 2.2 |
,Only Rehabilitation | 36.8 | 4.6 | 6.4 | 7.8 | 1.8 | 3.1 | 1.3 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 36.0 | 3.7 | 6.5 | 9.1 | 2.9 | 5.4 | 2.6 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month | 3 months | 6 months |
---|
Erythropoietin & Rehabilitation | 104.8 | 106.8 | 107.7 | 109.3 |
,Only Rehabilitation | 100.3 | 101.8 | 103.6 | 104.3 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 100.7 | 105.0 | 107.8 | 109.9 |
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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
Intervention | units on a scale (Mean) |
---|
| BSID-II Motor Scale: Baseline | BSID-II Motor Scale: 1 month - Baseline | BSID-II Motor Scale: 3 months - Baseline | BSID-II Motor Scale: 6 months - Baseline | BSID-II Motor Scale: 3 months - 1 month | BSID-II Motor Scale: 6 months - 1 month | BSID-II Motor Scale: 6 months - 3 months |
---|
Erythropoietin & Rehabilitation | 53.3 | 5.2 | 6.8 | 7.6 | 1.6 | 2.5 | 0.9 |
,Only Rehabilitation | 45.5 | 2.7 | 4.3 | 5.2 | 1.5 | 2.5 | 1.0 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 45.2 | 5.0 | 9.5 | 11.7 | 4.5 | 6.7 | 2.2 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 1 month - Baseline | 3 months - Baseline | 6 months - Baseline | 3 months - 1 month | 6 months - 1 month | 6 months - 3 months |
---|
Erythropoietin & Rehabilitation | 52.8 | 5.7 | 8.8 | 10.7 | 3.1 | 5.1 | 2.4 |
,Only Rehabilitation | 43.0 | 6.6 | 10.5 | 13.0 | 3.5 | 6.4 | 3.1 |
,Umbilical Cord Blood & Erythropoietin & Rehabilitation | 36.0 | 5.0 | 11.1 | 13.9 | 5.7 | 8.4 | 2.8 |
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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
Intervention | percentage of participants (Number) |
---|
| SAEs | AEs |
---|
Mircera | 35.6 | 84.7 |
,Placebo | 41.0 | 86.3 |
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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
Intervention | mg/g (Mean) |
---|
| Baseline (n=110, 107) | Change at Month 24 (n=43, 53) |
---|
Mircera | 261.1 | 173.8 |
,Placebo | 237.3 | 70.59 |
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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
Intervention | mcmol/L (Mean) |
---|
| Baseline (n=115, 120) | Change at Month 24 (n=68, 91) |
---|
Mircera | 147.8 | 7.04 |
,Placebo | 149.3 | 4.04 |
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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
Intervention | mL/min (Mean) |
---|
| Baseline (n=115, 120) | Change at Month 24 (n=67, 91) |
---|
Mircera | 53.18 | -2.97 |
,Placebo | 52.48 | -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
Intervention | mL/min/1.73m^2/year (Least Squares Mean) |
---|
Mircera | 3.04 |
Placebo | 0.82 |
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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
Intervention | mL/min/1.73m^2/year (Least Squares Mean) |
---|
Mircera | 3.02 |
Placebo | 0.78 |
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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
Intervention | mg/L (Mean) |
---|
| Baseline (n=115, 120) | Change at Month 24 (n=67, 91) |
---|
Mircera | 1.79 | 0.10 |
,Placebo | 1.76 | 0.02 |
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Baseline Retic Count
retic count measured at study entry (NCT01235923)
Timeframe: baseline
Intervention | x1000 cells/microliter (Mean) |
---|
Weekly Epo | 122 |
Three Times a Week Epo | 140 |
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Reticulocyte Count
reticulocyte count at 4 weeks (end of study) (NCT01235923)
Timeframe: 4 weeks
Intervention | cells x 1000/microliter (Mean) |
---|
Weekly Epo | 275 |
Three Times a Week Epo | 268 |
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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
Intervention | Grams per deciliter (gm/dL) (Mean) |
---|
| Baseline (n=53) | Change at Week 20 (n=35) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 8.820 | 1.440 |
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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
Intervention | gm/dL (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 1.680 |
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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
Intervention | gm/dL (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 1.470 |
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Incidence of Acute Kidney Injury Based on RIFLE Criteria
(NCT01369732)
Timeframe: upto 7 days after surgery
Intervention | participants (Number) |
---|
Saline Group | 18 |
Erythropoietin Group | 18 |
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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)
Intervention | Participants (Count of Participants) |
---|
Control | 284 |
Epo 1000 U/kg Followed by 400 U/kg | 282 |
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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
Intervention | Participants (Count of Participants) |
---|
Control | 94 |
Epo 1000 U/kg Followed by 400 U/kg | 97 |
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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
Intervention | mU/mL (Median) |
---|
| Baseline | Peak Epo | Trough Epo | Random (day 14) |
---|
Control | 7.6 | 2.2 | 5.1 | 4.6 |
,Epo 1000 U/kg Followed by 400 U/kg | 7 | 2,907 | 15.3 | 25 |
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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
Intervention | score on a scale (Mean) |
---|
Control | 4.1 |
Epo 1000 U/kg Followed by 400 U/kg | 3.8 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 38 |
Epoetin Alfa TIW | 42 |
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Mortality
Number of participants who died during the study. (NCT01394991)
Timeframe: during the study (randomization through week 26)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 25 |
Epoetin Alfa TIW | 26 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 179 |
Epoetin Alfa TIW | 187 |
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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
Intervention | particpants (Number) |
---|
Epoetin Alfa QW | 5 |
Epoetin Alfa TIW | 10 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 5 |
Epoetin Alfa TIW | 13 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 9 |
Epoetin Alfa TIW | 20 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 5 |
Epoetin Alfa TIW | 13 |
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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)
Intervention | participants (Number) |
---|
Epoetin Alfa QW | 9 |
Epoetin Alfa TIW | 20 |
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Mean Weekly Hemoglobin Level From Week 21 to Week 24
(NCT01473407)
Timeframe: Week 21 up to Week 24
Intervention | g/dL (Mean) |
---|
Epoetin Hospira | 10.17 |
Epogen | 10.28 |
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Mean Weekly Hemoglobin Level Through 24 Weeks
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | g/dL (Mean) |
---|
Epoetin Hospira | 10.25 |
Epogen | 10.26 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira | 9 |
Epogen | 11 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira | 0 |
Epogen | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira | 0 |
Epogen | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira | 0 |
Epogen | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 13.1 |
Epogen | 14.5 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 0.4 |
Epogen | 0.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Week 12 | Week 24 |
---|
Epoetin Hospira | 81.0 | 73.2 |
,Epogen | 73.2 | 71.4 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira | 0 |
Epogen | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 5.3 |
Epogen | 10.9 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 21.6 |
Epogen | 23.0 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 44.1 |
Epogen | 43.2 |
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Percentage of Participants Who Received Blood Transfusions
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 6.3 |
Epogen | 5.9 |
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Percentage of Participants Who Required Permanent Dose Changes of Study Medication
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 86.3 |
Epogen | 93.2 |
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Percentage of Participants Who Required Temporary Dose Changes of Study Medication
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira | 7.4 |
Epogen | 4.2 |
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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
Intervention | Participants (Count of Participants) |
---|
| Dose Decrease: Hb <9.0 g/dL | Dose Decrease: Hb (9 to 11 g/dL) | Dose Decrease: Hb >11.0 g/dL | Dose Increase: Hb <9.0 g/dL | Dose Increase: Hb (9 to 11 g/dL) | Dose Increase: Hb >11.0 g/dL |
---|
Epoetin Hospira | 49 | 49 | 147 | 50 | 27 | 36 |
,Epogen | 37 | 46 | 150 | 67 | 26 | 54 |
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Mean Weekly Dosage of Study Medication From Week 21 to Week 24
(NCT01473407)
Timeframe: Week 21 up to Week 24
Intervention | unit per kilogram per week (U/kg/week) (Mean) |
---|
Epoetin Hospira | 89.61 |
Epogen | 90.37 |
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Mean Weekly Dosage of Study Medication Through 24 Weeks
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | U/kg/week (Mean) |
---|
Epoetin Hospira | 87.51 |
Epogen | 90.95 |
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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
Intervention | percentage of participants (Number) |
---|
| Week 12 | Week 24 |
---|
Epoetin Hospira | 19.0 | 26.8 |
,Epogen | 26.8 | 28.6 |
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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
Intervention | Participants (Count of Participants) |
---|
| Mild | Moderate | Severe |
---|
Epoetin Hospira | 116 | 74 | 42 |
,Epogen | 111 | 69 | 49 |
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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
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Epoetin Hospira | 232 | 75 |
,Epogen | 229 | 82 |
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Total Dose of Study Medication Administered
(NCT01473407)
Timeframe: Week 1 up to Week 24
Intervention | units of study medication (Mean) |
---|
Epoetin Hospira | 146752.6 |
Epogen | 147145.2 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira: Titration Period | 0 |
Epogen: Titration Period | 0 |
Epoetin Hospira: Maintenance Period | 0 |
Epogen: Maintenance Period | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira: Titration Period | 0 |
Epogen: Titration Period | 0 |
Epoetin Hospira: Maintenance Period | 0 |
Epogen: Maintenance Period | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira: Titration Period | 4 |
Epogen: Titration Period | 6 |
Epoetin Hospira: Maintenance Period | 4 |
Epogen: Maintenance Period | 4 |
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Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
(NCT01473420)
Timeframe: Week 30 up to Week 34
Intervention | g/dL (Mean) |
---|
Epoetin Hospira: Maintenance Period | 10.17 |
Epogen: Maintenance Period | 10.11 |
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Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
(NCT01473420)
Timeframe: Week 19 up to Week 34
Intervention | g/dL (Mean) |
---|
Epoetin Hospira: Maintenance Period | 10.20 |
Epogen: Maintenance Period | 10.22 |
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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
Intervention | unit per kilogram per week (U/kg/week) (Mean) |
---|
Epoetin Hospira: Maintenance Period | 82.07 |
Epogen: Maintenance Period | 79.14 |
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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
Intervention | U/kg/week (Mean) |
---|
Epoetin Hospira: Maintenance Period | 81.93 |
Epogen: Maintenance Period | 75.08 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira: Titration Period | 0 |
Epogen: Titration Period | 0 |
Epoetin Hospira: Maintenance Period | 0 |
Epogen: Maintenance Period | 0 |
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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
Intervention | percentage of participants (Number) |
---|
| Excellent Tolerability | Good Tolerability | Mild Intolerability | Moderate Intolerability | Severe Intolerability |
---|
Epoetin Hospira: Maintenance Period | 63.9 | 27.0 | 4.9 | 0.0 | 1.6 |
,Epoetin Hospira: Titration Period | 68.8 | 28.8 | 2.5 | 0.0 | 0.0 |
,Epogen: Maintenance Period | 50.8 | 27.9 | 16.4 | 2.5 | 1.6 |
,Epogen: Titration Period | 67.4 | 25.6 | 2.3 | 2.3 | 0.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Week 26 | Week 34 |
---|
Epoetin Hospira: Maintenance Period | 73.5 | 79.8 |
,Epogen: Maintenance Period | 60.9 | 74.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Week 26 | Week 34 |
---|
Epoetin Hospira: Maintenance Period | 13.5 | 10.1 |
,Epogen: Maintenance Period | 19.3 | 13.0 |
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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
Intervention | percentage of participants (Number) |
---|
| Excellent Tolerability | Good Tolerability | Mild Intolerability | Moderate Intolerability | Severe Intolerability |
---|
Epoetin Hospira: Maintenance Period | 67.2 | 24.6 | 4.1 | 1.6 | 0.0 |
,Epoetin Hospira: Titration Period | 70.0 | 25.0 | 3.8 | 1.3 | 0.0 |
,Epogen: Maintenance Period | 54.1 | 30.3 | 9.0 | 3.3 | 2.5 |
,Epogen: Titration Period | 66.3 | 25.6 | 5.8 | 1.2 | 0.0 |
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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
Intervention | Participants (Count of Participants) |
---|
| Mild | Moderate | Severe |
---|
Epoetin Hospira: Maintenance Period | 42 | 24 | 19 |
,Epoetin Hospira: Titration Period | 21 | 15 | 9 |
,Epogen: Maintenance Period | 41 | 27 | 18 |
,Epogen: Titration Period | 23 | 16 | 15 |
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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
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Epoetin Hospira: Maintenance Period | 85 | 23 |
,Epoetin Hospira: Titration Period | 45 | 12 |
,Epogen: Maintenance Period | 86 | 33 |
,Epogen: Titration Period | 54 | 22 |
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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
Intervention | Participants (Count of Participants) |
---|
| Dose Decrease: Hb <9.0 g/dL | Dose Decrease: Hb (9.0 to 11.0 g/dL) | Dose Decrease: Hb >11.0 g/dL | Dose Increase: Hb <9.0 g/dL | Dose Increase: Hb (9.0 to 11.0 g/dL) | Dose Increase: Hb >11.0 g/dL |
---|
Epoetin Hospira: Maintenance Period | 9 | 20 | 35 | 24 | 11 | 7 |
,Epogen: Maintenance Period | 10 | 14 | 40 | 23 | 3 | 13 |
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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
Intervention | units of study medication (Mean) |
---|
Epoetin Hospira: Maintenance Period | 102003.2 |
Epogen: Maintenance Period | 86478.5 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 4.1 |
Epogen: Maintenance Period | 9.0 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 9.8 |
Epogen: Maintenance Period | 19.7 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 6.6 |
Epogen: Maintenance Period | 10.7 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 29.1 |
Epogen: Maintenance Period | 52.2 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Titration Period | 0.0 |
Epogen: Titration Period | 0.0 |
Epoetin Hospira: Maintenance Period | 0.0 |
Epogen: Maintenance Period | 0.0 |
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Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period
(NCT01473420)
Timeframe: Week 19 up to Week 34
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 55.8 |
Epogen: Maintenance Period | 62.0 |
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Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
(NCT01473420)
Timeframe: Week 19 up to Week 34
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 30.2 |
Epogen: Maintenance Period | 25.0 |
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Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period
(NCT01473420)
Timeframe: Week 1 up to Week 18
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Titration Period | 47.5 |
Epogen: Titration Period | 47.7 |
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Percentage of Participants Who Received Blood Transfusions: Maintenance Period
(NCT01473420)
Timeframe: Week 19 up to Week 34
Intervention | percentage of participants (Number) |
---|
Epoetin Hospira: Maintenance Period | 4.0 |
Epogen: Maintenance Period | 4.1 |
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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
Intervention | Participants (Count of Participants) |
---|
Epoetin Hospira: Titration Period | 0 |
Epogen: Titration Period | 0 |
Epoetin Hospira: Maintenance Period | 0 |
Epogen: Maintenance Period | 0 |
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Percentage of Participants Undergoing Conversion to Peginesatide Injection
(NCT01478971)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
Peginesatide Injection | 88 |
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Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
(NCT01478971)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
Epoetin Standard of Care | 10.7 |
Peginesatide Treatment Period | 8.3 |
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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
Intervention | mg (Mean) |
---|
| Starting Dose | Average Dose During Treatment Period | Last Weekly Average Dose |
---|
Peginesatide Injection | 5.1 | 4.9 | 5.2 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Standard of Care | 85.4 |
Peginesatide Treatment Period | 73.2 |
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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
Intervention | percentage 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 Care | 39.1 | 40.8 | 41.0 | 44.9 | 42.7 | 58.0 |
,Peginesatide Treatment Period | 44.5 | 46.5 | 45.2 | 49.0 | 44.9 | 39.0 |
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Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
(NCT01519947)
Timeframe: Up to approximately 20 months
Intervention | micrograms (mcg) (Mean) |
---|
Pre-dialysis, Sea Level | 150.3 |
Dialysis, Sea Level | 194.7 |
Pre-dialysis, >1800 Meters | 98.7 |
Dialysis, >1800 Meters | 66.6 |
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Change in Hemoglobin Concentration
(NCT01519947)
Timeframe: From baseline to 6 months
Intervention | grams per deciliter (g/dL) (Mean) |
---|
Pre-dialysis, Sea Level | 1.4 |
Dialysis, Sea Level | 2.5 |
Pre-dialysis, >1800 Meters | 2.0 |
Dialysis, >1800 Meters | 2.4 |
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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
Intervention | percentage of participants (Number) |
---|
Pre-dialysis, Sea Level | 84.2 |
Dialysis, Sea Level | 90.0 |
Pre-dialysis, >1800 Meters | 66.7 |
Dialysis, >1800 Meters | 85.7 |
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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
Intervention | percentage of participants (Number) |
---|
| 3 months | 6 months |
---|
Dialysis, >1800 Meters | 28.6 | 19.0 |
,Dialysis, Sea Level | 10.0 | 0.0 |
,Pre-dialysis, >1800 Meters | 0.0 | 13.3 |
,Pre-dialysis, Sea Level | 36.8 | 52.6 |
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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
Intervention | g/dL (Mean) |
---|
| Actual Value | Change from Baseline Period |
---|
HX575 | 10.83 | 1.02 |
,HX575 - ESA Maintenance | 10.86 | 0.22 |
,HX575 - ESA Naive | 10.81 | 1.61 |
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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
Intervention | percentage of participants (Number) |
---|
HX575 | 1.7 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 2 |
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Number of Participants Who Received Concomitant Medication
(NCT01628107)
Timeframe: Week 1 up to Week 48
Intervention | Participants (Number) |
---|
Epoetin Hospira | 406 |
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Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48
(NCT01628107)
Timeframe: Week 1 up to Week 48
Intervention | Unit per kilogram per week (U/kg/week) (Mean) |
---|
Epoetin Hospira | 95.30 |
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Mean Hemoglobin Levels: Over Week 1 to 48
(NCT01628107)
Timeframe: Week 1 up to Week 48
Intervention | g/dL (Mean) |
---|
Epoetin Hospira | 10.21 |
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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
Intervention | Percentage of red blood cells (Mean) |
---|
Epoetin Hospira | 32.17 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 20.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 13.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 90.1 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 59.4 |
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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
Intervention | U/kg/week (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 94.93 | 94.84 | 94.01 | 99.55 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 57.5 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 54.3 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 51.7 |
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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)
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 13.0 |
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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
Intervention | Percentage of red blood cells (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 32.26 | 32.21 | 32.03 | 32.17 |
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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
Intervention | g/dL (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 10.26 | 10.25 | 10.18 | 10.21 |
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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
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 48 |
---|
Epoetin Hospira | 0 | 0.6 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 85.7 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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Percentage of Participants Who Received Blood Transfusions
(NCT01628107)
Timeframe: Week 1 up to Week 48
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 9.7 |
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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
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 48 |
---|
Epoetin Hospira | 0.6 | 0.7 |
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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
Intervention | U/kg/week (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 80.49 | 83.14 | 85.98 | 88.86 |
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Mean Hemoglobin Levels: Over Week 1 to 48
(NCT01628120)
Timeframe: Week 1 up to Week 48
Intervention | g/dL (Mean) |
---|
Epoetin Hospira | 10.24 |
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Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
(NCT01628120)
Timeframe: Week 1 up to Week 48
Intervention | Unit per kilogram per week (U/kg/week) (Mean) |
---|
Epoetin Hospira | 83.74 |
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Number of Participants Who Received Concomitant Medication
(NCT01628120)
Timeframe: Week 1 up to Week 48
Intervention | Participants (Number) |
---|
Epoetin Hospira | 170 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 67.1 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 87.6 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 60.5 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 57.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 20.7 |
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Percentage of Participants Who Received Blood Transfusions
(NCT01628120)
Timeframe: Week 1 up to Week 48
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 8.3 |
[back to top]
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
(NCT01628120)
Timeframe: Week 1 up to Week 48
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 13.0 |
[back to top]
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
Intervention | Participants (Number) |
---|
Epoetin Hospira | 0 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 48.5 |
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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)
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 17.4 |
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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
Intervention | Percentage of participants (Number) |
---|
Epoetin Hospira | 86.4 |
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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
Intervention | Percentage of red blood cells (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 31.90 | 32.32 | 32.40 | 32.31 |
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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
Intervention | Percentage of red blood cells (Mean) |
---|
Epoetin Hospira | 32.22 |
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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
Intervention | g/dL (Mean) |
---|
| Week 1 to Week 12 | Week 13 to Week 24 | Week 25 to Week 36 | Week 37 to Week 48 |
---|
Epoetin Hospira | 10.16 | 10.28 | 10.30 | 10.25 |
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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
Intervention | international units (Mean) |
---|
HX575 Epoetin Alfa | 5876.5 |
US-licensed Epoetin Alfa | 5804.0 |
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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
Intervention | g/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
Intervention | Participants (Count of Participants) |
---|
HX575 Epoetin Alfa | 7 |
US-licensed Epoetin Alfa | 2 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline period | Evaluation period | Change from baseline period to evaluation period |
---|
HX575 Epoetin Alfa | 10.53 | 10.42 | -0.11 |
,US-licensed Epoetin Alfa | 10.50 | 10.51 | 0.01 |
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Reticulocyte Count
Reticulocytes are immature red blood cells. (NCT01736215)
Timeframe: Baseline, Week 1, Week 2, Week 4 and Week 8
Intervention | Nanogram 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 Anemia | 92.33 | 64.81 | 200.74 | 120.68 | 111.74 |
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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
Intervention | Participants (Number) |
---|
| EPO level less than or equal to 45.2 | EPO level greater than 45.3 |
---|
Participants With Cancer Related Anemia | 12 | 13 |
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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
Intervention | Percentage of participants (Number) |
---|
Participants With Cancer Related Anemia | 52.63 |
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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
Intervention | Participants (Number) |
---|
| CRP less than or equal to 10.3 | CRP greater than 10.4 |
---|
Participants With Cancer Related Anemia | 13 | 12 |
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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
Intervention | Percentage 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 Anemia | 30.75 | 30.59 | 30.76 | 33.19 | 33.01 |
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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
Intervention | Mcg per dl (Mean) |
---|
| Baseline (n=19) | Week 1 (n=18) | Week 2 (n=18) |
---|
Participants With Cancer Related Anemia | 275.26 | 281.39 | 288.17 |
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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
Intervention | Microgram per deciliter (Mcg per dl) (Mean) |
---|
| Baseline | Week 1 | Week 2 |
---|
Participants With Cancer Related Anemia | 66.06 | 89.22 | 53.06 |
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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
Intervention | Gram 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 Anemia | 9.96 | 9.94 | 10.00 | 10.64 | 10.43 |
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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
Intervention | Microgram per liter (Mean) |
---|
| Baseline (n=19) | Week 1 (n=18) | Week 2 (n=18) |
---|
Participants With Cancer Related Anemia | 807.28 | 870.28 | 685.11 |
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Peginesatide Dose by Visit
(NCT01737879)
Timeframe: Baseline and Weeks 5, 9, 13, and 17
Intervention | mg (Mean) |
---|
| Baseline (n=30) | Week 5 (n=16) | Week 9 (n=15) | Week 13 (n=9) | Week 17 (n=9) |
---|
Peginesatide | 5.42 | 5.04 | 4.98 | 4.00 | 5.12 |
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Hemoglobin Concentration by Visit
(NCT01737879)
Timeframe: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Intervention | g/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) |
---|
Peginesatide | 10.51 | 11.09 | 10.86 | 11.03 | 10.59 | 10.80 | 10.50 | 10.70 | 10.35 | 10.93 | 10.10 | 10.55 |
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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
Intervention | Participants (Count of Participants) |
---|
Recombinant Human Erythropoietin (EPO) | 28 |
Methylprednisolone | 3 |
Observation | 5 |
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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
Intervention | Participants (Count of Participants) |
---|
Recombinant Human Erythropoietin (EPO) | 26 |
Methylprednisolone | 7 |
Observation | 8 |
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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
Intervention | percentage 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 Anemia | 4.1 | 4.1 | 3.8 | 3.9 |
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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
Intervention | g/L (Mean) |
---|
NeoRecormon in Symptomatic Anemia | 14.58 |
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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
Intervention | percentage 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
Intervention | g/dL (Median) |
---|
| Responders - Week 5 | Responders - Week 9 | Responders - Week 13 | Responders - Week 17 | Responders - Week 21 | Non-responders - Week 5 | Non-responders - Week 9 | Non-responders - Week 13 | Non-responders - Week 17 | Non-responders - Week 21 |
---|
Deferasirox + Erythropoietin Alpha | 0.7 | 1.6 | 2.9 | 2.4 | 1.7 | -0.1 | 0.0 | 0.2 | -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
Intervention | g/dL (Median) |
---|
| Responders - Week 5 | Non-responders - Week 5 | Non-responders - Week 13 | Non-responders - Week 21 |
---|
EPO+DFX at 12 Weeks | 1.2 | 0.3 | 0.4 | 0.0 |
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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
Intervention | g/dL (Median) |
---|
| Responders - Week 5 | Responders - Week 9 | Responders - Week 13 | Responders - Week 17 | Responders - Week 21 | Non-responders - Week 5 | Non-responders - Week 9 | Non-responders - Week 13 |
---|
Erythropoietin Alpha | 1.5 | 1.9 | 1.7 | 1.6 | 0.8 | -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
Intervention | ng/mL (Median) |
---|
| Responders - Week 5 | Responders - Week 9 | Responders - Week 17 | Responders - Week 21 | Non-responders - Week 5 | Non-responders - Week 17 | Non-responders - Week 21 |
---|
Deferasirox + Erythropoietin Alpha | -82.5 | -139 | 16.5 | -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
Intervention | ng/mL (Median) |
---|
| Responders - Week 5 | Responders - Week 9 | Responders - Week 13 | Responders - Week 17 | Responders - Week 21 | Non-responders - Week 5 | Non-responders - Week 9 | Non-responders - Week 13 |
---|
Erythropoietin Alpha | -98.5 | -79.0 | 24.8 | -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
Intervention | 10^9 cells/L (Mean) |
---|
| Platelets | Neutrophils |
---|
Deferasirox + Erythropoietin Alpha | 66.3 | 2.4 |
,Erythropoietin Alpha | 58.7 | 1.2 |
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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
Intervention | percentage of participants (Number) |
---|
| Hematologic improvement | Neutropil improvement | Platelet improvement | Hemoglobin improvement |
---|
Deferasirox + Erythropoietin Alpha | 45.5 | 80.0 | 80.0 | 60.0 |
,Erythropoietin Alpha | 100 | 66.7 | 50.0 | 66.7 |
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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
Intervention | Absolute change in serum ferritin from baseline (ng/mL) |
---|
| "Responders - Week 1372023740 | "Non-responders - Week 972023740 | "Non-responders - Week 1372023740 |
---|
| " |
---|
Deferasirox + Erythropoietin Alpha | Median |
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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
Intervention | This 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 Weeks | Median |
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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
Intervention | ng/mL (Median) |
---|
| Responders - Week 5 | Responders - Week 9 | Responders - Week 13 | Responders - Week 17 | Non-responders - Week 5 | Non-responders - Week 9 | Non-responders - Week 13 | Non-responders - Week 17 | Non-responders - Week 21 |
---|
EPO+DFX at 12 | -116 | -136 | 59.5 | 74.5 | -68.3 | -148 | 220.4 | -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
Intervention | participants (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
Intervention | g/dL (Mean) |
---|
Erythropoietin Alpha | 1.3 |
Deferasirox + Erythropoietin Alpha | 1.4 |
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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
Intervention | g/dL (Mean) |
---|
Erythropoietin Alpha | 1.8 |
Deferasirox + Erythropoietin Alpha | 2.1 |
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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
Intervention | percentage of participants (Number) |
---|
Erythropoietin Alpha | 41.7 |
Deferasirox + Erythropoietin Alpha | 27.3 |
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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)
Intervention | Participants (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
Intervention | participants (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
Intervention | percentile (Mean) |
---|
Erythropoietin | 53.5 |
Normal Saline | 42.8 |
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Growth Parameters: Head Circumference
(NCT01913340)
Timeframe: 12-months
Intervention | cm (Mean) |
---|
Erythropoietin | 45.7 |
Normal Saline | 45.5 |
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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
Intervention | units on a scale (Mean) |
---|
| Total score (50-200) | Self-care (7-28) | Mobility (9-36) | Communication (13-52) | Social Cognition (11-44) |
---|
Erythropoietin | 75.3 | 28.1 | 14.1 | 16.4 | 16.7 |
,Normal Saline | 68.8 | 26.1 | 12.4 | 15.3 | 14.9 |
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Growth Parameters: Weight
(NCT01913340)
Timeframe: 12-months
Intervention | kg (Mean) |
---|
Erythropoietin | 9.9 |
Normal Saline | 9.7 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 2 |
Normal Saline | 5 |
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Brain Injury, as Determined by Neonatal Brain MRI
(NCT01913340)
Timeframe: neonatal hospitalization
Intervention | participants (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: Subcortical | Presence of brain injury: Cortical | Presence of brain injury: White matter | Presence of brain injury: Brainstem | Presence of brain injury: Cerebellar | Presence of brain injury: >=2 regions injured |
---|
Erythropoietin | 8 | 14 | 0 | 1 | 7 | 4 | 12 | 1 | 0 | 7 |
,Normal Saline | 3 | 11 | 6 | 5 | 17 | 9 | 15 | 4 | 5 | 14 |
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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
Intervention | participants (Number) |
---|
| Liver dysfunction (ALT >100 IU/L) | Hypotension (requiring inotrope or vasopressor) | Thrombocytopenia (platelet < 100,000 per uL) | Persistent pulmonary hypertension | Disseminated intravascular coagulation | Sepsis (positive blood culture and antibiotics >=7 | Renal dysfunction (creatinine > 1.5) | Hypertension (requiring anti-hypertensive) | Polycythemia (requiring intervention) | Death during birth hospitalization | Cardiopulmonary collapse within 2 hours of drug | Thrombosis of major vessel | Unexpected event related to study drug |
---|
Erythropoietin | 10 | 9 | 6 | 5 | 3 | 0 | 4 | 1 | 0 | 2 | 1 | 1 | 0 |
,Normal Saline | 6 | 12 | 10 | 4 | 5 | 5 | 5 | 0 | 0 | 5 | 0 | 1 | 0 |
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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
Intervention | units on a scale (Mean) |
---|
| Total score (50-200) | Self-care (17-68) | Mobility (9-36) | Communication (13-52) | Social Cognition (11-44) |
---|
Erythropoietin | 122 | 36.7 | 28.6 | 28.2 | 28.8 |
,Normal Saline | 110 | 33.8 | 23.8 | 25.5 | 26.9 |
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Growth Parameters: Height
(NCT01913340)
Timeframe: 12-months
Intervention | cm (Mean) |
---|
Erythropoietin | 74.3 |
Normal Saline | 71.7 |
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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)
Intervention | mcg (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 Participants | 106.59 | 108.91 | 117.38 | 122.47 | 127.35 | 133.73 |
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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)
Intervention | participants (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 Participants | 0 | 0 | 6 | 4 | 1 | 7 | 4 | 18 | 3 | 16 | 2 | 11 | 4 | 11 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 24 |
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Mean Hemoglobin Value at Visit 3 (Month 2)
(NCT01940484)
Timeframe: Visit 3 (Month 2)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 10.81 |
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Mean Hemoglobin Value at Visit 7 (Month 6)
(NCT01940484)
Timeframe: Visit 7 (Month 6)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 10.94 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 22 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 24 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 17 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 26 |
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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)
Intervention | participants (Number) |
---|
Chronic Renal Anemia Participants | 23 |
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Mean Hemoglobin Value at Visit 6 (Month 5)
(NCT01940484)
Timeframe: Visit 6 (Month 5)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 10.82 |
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Mean Hemoglobin Value at Visit 5 (Month 4)
(NCT01940484)
Timeframe: Visit 5 (Month 4)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 10.80 |
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Mean Hemoglobin Value at Visit 4 (Month 3)
(NCT01940484)
Timeframe: Visit 4 (Month 3)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 10.61 |
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Mean Hemoglobin Value at Visit 2 (Month 1)
(NCT01940484)
Timeframe: Visit 2 (Month 1)
Intervention | g/dL (Mean) |
---|
Chronic Renal Anemia Participants | 11.31 |
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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
Intervention | percentage of participants (Number) |
---|
Roxadustat | 14.0 |
Epoetin Alfa | 15.2 |
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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
Intervention | percentage of participants (Number) |
---|
Roxadustat | 88.2 |
Epoetin Alfa | 84.4 |
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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
Intervention | g/dL (Mean) |
---|
Roxadustat | 2.70 |
Epoetin Alfa | 2.46 |
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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
Intervention | weeks (Median) |
---|
Roxadustat | 7.1 |
Epoetin Alfa | 8.1 |
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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
Intervention | weeks (Median) |
---|
Roxadustat | NA |
Epoetin Alfa | NA |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Week 18 to 24 |
---|
Epoetin Alfa | 8.38 | 2.48 |
,Roxadustat | 8.54 | 2.34 |
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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)
Intervention | weeks (Median) |
---|
Roxadustat | NA |
Epoetin Alfa | NA |
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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
Intervention | percentage of participants (Number) |
---|
Roxadustat | 84.3 |
Epoetin Alfa | 79.5 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Week 28 to 52 |
---|
Epoetin Alfa | 8.43 | 2.44 |
,Roxadustat | 8.43 | 2.62 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Week 28 to 52 |
---|
Epoetin Alfa | 8.46 | 2.36 |
,Roxadustat | 8.43 | 2.57 |
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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
Intervention | percentage of participants (Number) |
---|
| Weeks 28 to 36 | Weeks 28 to 52 |
---|
Epoetin Alfa | 70.8 | 72.5 |
,Roxadustat | 73.4 | 73.6 |
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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
Intervention | millimeters of mercury (mmHg) (Mean) |
---|
| Baseline | Change at Weeks 8 to 12 |
---|
Epoetin Alfa | 99.04 | 1.15 |
,Roxadustat | 99.33 | -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
Intervention | mg/dL (Mean) |
---|
| Baseline | Change at Weeks 12 to 24 |
---|
Epoetin Alfa | 109.22 | -5.39 |
,Roxadustat | 109.12 | -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
Intervention | Percentage of Participants (Number) |
---|
Epoetin Beta | 16 |
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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 = 9.0 g/dL pre-treatment were counted in the RBC transfusion response evaluation. (NCT02145026)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
Epoetin Beta | 60 |
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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)
Intervention | Percentage of Participants (Number) |
---|
Epoetin Beta | 48.48 |
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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
Intervention | Percentage of Participants (Number) |
---|
Epoetin Beta | 33.3 |
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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)
Intervention | events per 100 participant years (Number) |
---|
Roxadustat | 6.0 |
Epoetin Alfa | 7.2 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
Roxadustat | 0.77 |
Epoetin Alfa | 0.68 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
Roxadustat | 0.80 |
Epoetin Alfa | 0.59 |
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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
Intervention | millimole 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)
Intervention | milligram per month (Mean) |
---|
Roxadustat | 58.71 |
Epoetin Alfa | 91.37 |
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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
Intervention | proportion of total time (Least Squares Mean) |
---|
Roxadustat | 0.79 |
Epoetin Alfa | 0.76 |
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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
Intervention | proportion of total time (Least Squares Mean) |
---|
Roxadustat | 0.65 |
Epoetin Alfa | 0.63 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
Roxadustat | 0.88 |
Epoetin Alfa | 0.74 |
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Serum IL-6 Level
(NCT02238080)
Timeframe: Baseline, Month 6
Intervention | picograms per milliliter (pg/mL) (Mean) |
---|
| Baseline | Month 6 |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 15.8 | 16.7 |
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Serum Hemoglobin Level
(NCT02238080)
Timeframe: Baseline, Month 6
Intervention | grams per deciliter (g/dL) (Mean) |
---|
| Baseline | Month 6 |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 11.2 | 11.2 |
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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
Intervention | correlation coefficient (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.19473 |
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Serum CRP Level
(NCT02238080)
Timeframe: Baseline, Month 6
Intervention | milligrams per liter (mg/L) (Mean) |
---|
| Baseline | Month 6 |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 13.7 | 16.3 |
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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
Intervention | percentage of participants (Number) |
---|
| No change | Dose increase | Dose decrease |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 46.5 | 29.9 | 23.5 |
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Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
(NCT02238080)
Timeframe: Baseline, Month 6
Intervention | mcg/kg (Mean) |
---|
| Baseline | Change at Month 6 |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 175.2 | 13.6 |
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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
Intervention | correlation coefficient (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.05557 |
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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
Intervention | correlation coefficient (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.12684 |
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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
Intervention | correlation coefficient (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 0.1485 |
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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)
Intervention | g/dL (Mean) |
---|
Epoetin Alfa Alternative Titration | 0.74 |
Epoetin Alfa USPI Titration | 0.70 |
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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
Intervention | participants (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 Titration | 1 | 2 | 1 | 2 | 0 | 1 | 1 | 0 | 1 | 3 | 1 | 0 | 0 | 1 | 0 | 0 |
,Epoetin Alfa USPI Titration | 4 | 5 | 2 | 1 | 1 | 0 | 0 | 0 | 3 | 4 | 2 | 1 | 0 | 1 | 0 | 0 |
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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
Intervention | percentage 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 Titration | 91.0 | 48.3 | 80.9 | 25.8 | 3.4 | 3.4 | 0.0 | 0.0 | 29.2 | 2.2 | 27.0 | 5.6 | 36.0 | 1.1 | 34.8 | 5.6 | 27.3 | 6.8 | 20.5 | 3.4 | 29.2 | 9.0 | 20.2 | 3.4 | 22.7 | 4.5 | 18.2 | 2.3 | 25.8 | 7.9 | 18.0 | 4.5 | 27.0 | 5.6 | 21.3 | 6.7 | 23.6 | 9.0 | 14.6 | 4.5 | 28.1 | 9.0 | 19.1 | 9.0 | 27.6 | 8.0 | 19.5 | 3.4 | 29.5 | 6.8 | 22.7 | 5.7 | 28.7 | 2.3 | 26.4 | 5.7 | 29.5 | 10.2 | 19.3 | 3.4 | 25.8 | 5.6 | 20.2 | 4.5 | 20.0 | 4.7 | 15.3 | 5.9 | 22.1 | 7.0 | 15.1 | 3.5 | 26.4 | 11.5 | 14.9 | 4.6 | 20.7 | 8.0 | 12.6 | 3.4 |
,Epoetin Alfa USPI Titration | 93.0 | 61.0 | 83.0 | 19.0 | 11.0 | 11.0 | 0.0 | 0.0 | 27.0 | 6.0 | 21.0 | 5.0 | 29.3 | 4.0 | 25.3 | 7.1 | 28.9 | 8.2 | 20.6 | 4.1 | 17.0 | 10.0 | 7.0 | 0.0 | 23.2 | 7.1 | 16.2 | 1.0 | 21.0 | 9.0 | 12.0 | 1.0 | 24.0 | 13.0 | 11.0 | 0.0 | 21.0 | 12.0 | 9.0 | 3.0 | 19.0 | 13.0 | 6.0 | 0.0 | 17.2 | 12.1 | 5.1 | 0.0 | 20.4 | 10.2 | 10.2 | 0.0 | 20.4 | 13.3 | 7.1 | 2.0 | 21.3 | 16.0 | 5.3 | 0.0 | 29.3 | 16.3 | 13.0 | 2.2 | 28.1 | 16.9 | 11.2 | 1.1 | 22.2 | 11.1 | 11.1 | 2.2 | 21.6 | 13.6 | 8.0 | 0.0 | 17.2 | 12.9 | 4.3 | 0.0 |
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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
Intervention | percentage 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 Titration | 6.7 | 2.2 | 5.6 | 1.2 |
,Epoetin Alfa USPI Titration | 12.0 | 1.0 | 10.0 | 1.1 |
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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
Intervention | units (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 Titration | 13139.9 | 9683.7 | 8324.2 | 9319.1 | 9253.4 | 10039.3 | 10358.4 | 8889.3 | 10251.7 | 10475.8 | 9605.1 | 8905.1 | 7543.8 | 9765.7 | 9088.8 | 8543.2 | 9019.0 | 8709.2 |
,Epoetin Alfa USPI Titration | 10400 | 6912.5 | 6874.0 | 6411.0 | 8003.0 | 6483.0 | 7387.5 | 6874.5 | 6924.5 | 7112.5 | 6909.6 | 6830.1 | 7486.7 | 6662.5 | 6083.0 | 6673.1 | 6235.6 | 5950.6 |
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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
Intervention | g/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 Titration | 0.36 | 0.10 | -0.22 | -0.12 | 0.02 | -0.05 | 0.19 | -0.22 | 0.18 | -0.02 | 0.16 | 0.07 | -0.18 | 0.04 | -0.02 | -0.16 | -0.05 | -0.04 |
,Epoetin Alfa USPI Titration | 0.27 | 0.13 | -0.19 | -0.28 | 0.19 | -0.19 | -0.01 | 0.02 | -0.06 | -0.06 | 0.09 | -0.06 | 0.01 | 0.05 | -0.03 | 0.06 | -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
Intervention | g/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 Titration | 10.15 | 10.54 | 10.66 | 10.45 | 10.32 | 10.33 | 10.28 | 10.46 | 10.20 | 10.37 | 10.33 | 10.46 | 10.56 | 10.32 | 10.34 | 10.34 | 10.18 | 10.12 | 10.10 |
,Epoetin Alfa USPI Titration | 10.04 | 10.34 | 10.51 | 10.28 | 9.97 | 10.15 | 9.99 | 9.98 | 10.01 | 9.94 | 9.92 | 10.03 | 9.94 | 9.97 | 10.02 | 9.96 | 10.05 | 9.94 | 9.86 |
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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)
Intervention | percentage of hemoglobin measurements (Mean) |
---|
Epoetin Alfa Alternative Titration | 46.41 |
Epoetin Alfa USPI Titration | 46.02 |
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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
Intervention | mg/PEM (Mean) |
---|
Roxadustat | 17.07 |
Epoetin Alfa | 37.02 |
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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
Intervention | percentage of participants (Number) |
---|
Roxadustat | 64.1 |
Epoetin Alfa | 60.8 |
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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
Intervention | weeks (Median) |
---|
Roxadustat | NA |
Epoetin Alfa | NA |
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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)
Intervention | weeks (Median) |
---|
Roxadustat | NA |
Epoetin Alfa | NA |
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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
Intervention | percentage of participants (Number) |
---|
Roxadustat | 66.1 |
Epoetin Alfa | 58.6 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Weeks 18-24 |
---|
Epoetin Alfa | 10.24 | -0.03 |
,Roxadustat | 10.30 | 0.61 |
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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
Intervention | mg/dL (Mean) |
---|
| Baseline | Change at Weeks 12 to 28 |
---|
Epoetin Alfa | 84.45 | 1.23 |
,Roxadustat | 84.53 | -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
Intervention | millimeters of mercury (mmHg) (Mean) |
---|
| Baseline | Change at Weeks 20 to 28 |
---|
Epoetin Alfa | 100.34 | 0.04 |
,Roxadustat | 101.41 | 0.46 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Weeks 28 to 36 |
---|
Epoetin Alfa | 10.35 | -0.03 |
,Roxadustat | 10.33 | 0.54 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Weeks 28 to 52 |
---|
Epoetin Alfa | 10.31 | -0.09 |
,Roxadustat | 10.30 | 0.39 |
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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
Intervention | mg per month (Least Squares Mean) |
---|
| Weeks 37-52 | Weeks 53-104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 70.0 | 98.1 |
,Roxadustat | 34.9 | 49.5 |
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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
Intervention | Number of participants (Number) |
---|
| Antihypertensive Treatment Achievement - Yes | Antihypertensive Treatment Achievement - No | Antihypertensive Treatment Achievement-Missing |
---|
ESA (Erythropoiesis-Stimulating Agent) | 261 | 149 | 10 |
,Roxadustat | 264 | 130 | 19 |
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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
Intervention | Number 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) | 231 | 181 | 8 | 85 | 80 | 255 |
,Roxadustat | 275 | 119 | 19 | 111 | 61 | 241 |
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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)
Intervention | Participants (Count of Participants) |
---|
| TEAE | Drug-Related TEAE | Serious TEAE | Drug-Related Serious TEAE | TEAE Leading to Death | Drug-Related TEAE Leading to Death | TEAE Leading to Withdrawal of Treatment | Drug-Related TEAE Leading to Withdraw of Treatment | TEAE NCI CTC Grades 3 or Higher | Death During the Safety Emergent Period | Death |
---|
ESA (Erythropoiesis-Stimulating Agent) | 361 | 35 | 189 | 10 | 55 | 2 | 16 | 1 | 149 | 51 | 59 |
,Roxadustat | 359 | 77 | 210 | 33 | 67 | 5 | 35 | 9 | 181 | 64 | 78 |
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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
Intervention | percentage of Hb values (Mean) |
---|
| Weeks 28-36 | Weeks 44-52 | Weeks 96-104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 87.286 | 86.914 | 83.543 |
,Roxadustat | 93.002 | 89.421 | 88.858 |
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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
Intervention | percentage of Hb values (Mean) |
---|
| Weeks 28-36 | Weeks 44-52 | Weeks 96-104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 76.098 | 74.634 | 73.690 |
,Roxadustat | 76.326 | 75.891 | 76.522 |
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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
Intervention | Percentage of participants (Number) |
---|
| Week 8 | Week 12 | Week 28 | Week 36 | Week 52 | Week 76 | Week 104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 49.5 | 49.5 | 57.1 | 56.3 | 55.3 | 51.9 | 51.3 |
,Roxadustat | 59.6 | 65.5 | 62.3 | 60.4 | 57.1 | 61.2 | 61.6 |
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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)
Intervention | Percentage of participants (Number) |
---|
| Year 0.5 | Year 1 | Year 1.5 | Year 2 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 18.3 | 32.7 | 41.9 | 48.3 |
,Roxadustat | 19.4 | 32.0 | 43.5 | 52.6 |
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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
Intervention | Percentage of participants (Number) |
---|
| Week 12 | Week 24 | Week 36 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 12.0 | 16.2 | 24.1 |
,Roxadustat | 11.6 | 16.1 | 21.2 |
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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
Intervention | Percentage of participants (Number) |
---|
| Week 12 | Week 24 | Week 36 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 11.1 | 15.4 | 23.5 |
,Roxadustat | 11.7 | 15.9 | 21.1 |
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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)
Intervention | Percentage of participants (Number) |
---|
| Year 0.5 | Year 1 | Year 1.5 | Year 2 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 3.2 | 8.4 | 10.9 | 14.4 |
,Roxadustat | 3.6 | 7.4 | 10.0 | 11.4 |
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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)
Intervention | Percentage of participants (Number) |
---|
| Year 0.5 | Year 1 | Year 1.5 | Year 2 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 33.5 | 44.1 | 55.0 | 59.3 |
,Roxadustat | 11.2 | 17.4 | 23.6 | 33.3 |
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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)
Intervention | Percentage of participants (Number) |
---|
| Year 0.5 | Year 1 | Year 1.5 | Year 2 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 3.2 | 8.4 | 10.9 | 14.4 |
,Roxadustat | 3.9 | 8.2 | 11.4 | 12.8 |
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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
Intervention | Units on a scale (Least Squares Mean) |
---|
Roxadustat | 0.400 |
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
Intervention | g/dL (Least Squares Mean) |
---|
Roxadustat | 0.428 |
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
Intervention | mmol/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
Intervention | mmHg (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
Intervention | mmHg (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
Intervention | Units on a scale (Least Squares Mean) |
---|
Roxadustat | 0.460 |
ESA (Erythropoiesis-Stimulating Agent) | -0.396 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
Roxadustat | 0.363 |
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
Intervention | Units on a scale (Mean) |
---|
Roxadustat | 3.041 |
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
Intervention | Units on a scale (Least Squares Mean) |
---|
Roxadustat | 0.560 |
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
Intervention | Units 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
Intervention | mg per month (Least Squares Mean) |
---|
Roxadustat | 21.6 |
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)
Intervention | RBC packs per month (Least Squares Mean) |
---|
Roxadustat | 0.026 |
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)
Intervention | mL per month (Least Squares Mean) |
---|
Roxadustat | 6.061 |
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)
Intervention | Days per year (Mean) |
---|
Roxadustat | 12.186 |
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)
Intervention | Hospitalizations (Mean) |
---|
Roxadustat | 0.9 |
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
Intervention | Percentage of participants (Number) |
---|
Roxadustat | 83.1 |
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
Intervention | Percentage of participants (Number) |
---|
Roxadustat | 84.2 |
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)
Intervention | Percentage of participants (Number) |
---|
Roxadustat | 31.0 |
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)
Intervention | percentage of Glycated Hemoglobin (Mean) |
---|
| Week 12 | Week 28 | Week 36 | Week 44 | Week 52 | Week 60 | Week 84 | Week 104 | EOS |
---|
ESA (Erythropoiesis-Stimulating Agent) | -0.0005 | -0.0006 | -0.0004 | -0.0006 | -0.0007 | -0.0004 | 0.0001 | -0.0003 | 0.0001 |
,Roxadustat | 0.0009 | -0.0004 | -0.0001 | -0.0001 | -0.0001 | 0.0000 | 0.0003 | 0.0000 | 0.0011 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
| Hb Change From BL to Week 1 | Hb Change From BL to Week 2 | Hb Change From BL to Week 3 | Hb Change From BL to Week 4 | Hb Change From BL to Week 5 | Hb Change From BL to Week 6 | Hb Change From BL to Week 7 | Hb Change From BL to Week 8 | Hb Change From BL to Week 10 | Hb Change From BL to Week 12 | Hb Change From BL to Week 14 | Hb Change From BL to Week 16 | Hb Change From BL to Week 18 | Hb Change From BL to Week 20 | Hb Change From BL to Week 22 | Hb Change From BL to Week 24 | Hb Change From BL to Week 26 | Hb Change From BL to Week 28 | Hb Change From BL to Week 30 | Hb Change From BL to Week 32 | Hb Change From BL to Week 34 | Hb Change From BL to Week 36 | Hb Change From BL to Week 40 | Hb Change From BL to Week 44 | Hb Change From BL to Week 48 | Hb Change From BL to Week 52 | Hb Change From BL to Week 56 | Hb Change From BL to Week 60 | Hb Change From BL to Week 64 | Hb Change From BL to Week 68 | Hb Change From BL to Week 72 | Hb Change From BL to Week 76 | Hb Change From BL to Week 80 | Hb Change From BL to Week 84 | Hb Change From BL to Week 88 | Hb Change From BL to Week 92 | Hb Change From BL to Week 96 | Hb Change From BL to Week 100 | Hb Change From BL to Week 104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 0.068 | 0.054 | 0.071 | 0.095 | -0.045 | 0.138 | -0.031 | 0.116 | -0.019 | 0.139 | 0.005 | 0.244 | 0.017 | 0.217 | 0.069 | 0.075 | 0.073 | 0.342 | 0.106 | 0.111 | 0.084 | 0.225 | 0.064 | 0.252 | 0.131 | 0.186 | 0.069 | 0.171 | -0.093 | 0.100 | -0.009 | 0.189 | -0.015 | 0.126 | -0.018 | 0.154 | -0.058 | 0.138 | 0.133 |
,Roxadustat | 0.232 | 0.496 | 0.633 | 0.803 | 0.723 | 0.868 | 0.698 | 0.816 | 0.640 | 0.732 | 0.508 | 0.613 | 0.380 | 0.501 | 0.266 | 0.262 | 0.316 | 0.549 | 0.333 | 0.310 | 0.364 | 0.482 | 0.199 | 0.335 | 0.158 | 0.385 | 0.217 | 0.368 | 0.181 | 0.306 | 0.109 | 0.401 | 0.087 | 0.318 | 0.026 | 0.357 | 0.126 | 0.302 | 0.232 |
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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
Intervention | g/dL (Least Squares Mean) |
---|
| Hb Change From BL to Weeks 28-36 | Hb Change From BL to Weeks 44-52 | Hb Change From BL to Weeks 96-104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 0.173 | 0.194 | 0.076 |
,Roxadustat | 0.408 | 0.298 | 0.225 |
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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)
Intervention | pmol/L (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | Week 60 | Week 68 | Week 76 | Week 84 | Week 92 | Week 100 | Week 104 | EOS |
---|
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)
Intervention | µg/L (Mean) |
---|
| Week 4 | Week 12 | Week 20 | Week 36 | Week 52 | Week 104 | EOS |
---|
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)
Intervention | Percentage of saturation (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | Week 60 | Week 68 | Week 76 | Week 84 | Week 92 | Week 100 | Week 104 | EOS |
---|
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
Intervention | Ratio (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change 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
Intervention | mmol/L (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change 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
Intervention | Ratio (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change from BL to Week 104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 0.013 | 0.002 | 0.007 | 0.007 |
,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
Intervention | g/L (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change 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
Intervention | mg/dL (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change 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
Intervention | mmol/L (Mean) |
---|
| Change from BL to Week 8 | Change from BL to Week 28 | Change from BL to Week 52 | Change 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
Intervention | g/dL (Least Squares Mean) |
---|
| Average Hb Over Weeks 28-36 | Average Hb Over Weeks 44-52 | Average Hb Over Weeks 96-104 |
---|
ESA (Erythropoiesis-Stimulating Agent) | 10.946 | 10.994 | 10.858 |
,Roxadustat | 11.183 | 11.099 | 11.007 |
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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
Intervention | Units 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
Intervention | Percentage of Weeks (Number) |
---|
Epoetin Hospira | 61.9330 |
Epogen | 63.3305 |
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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)
Intervention | g/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 Participants | 11.23 | 11.40 | 11.65 | 11.51 | 11.75 | 11.57 | 11.53 | 11.50 | 11.57 | 11.53 | 11.59 | 11.37 | 11.24 | 11.32 | 11.40 | 11.45 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 40.4 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 12.2 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 21.2 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 20.7 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 41.2 |
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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)
Intervention | g/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 Participants | 11.20 | 11.44 | 11.61 | 11.51 | 11.76 | 11.68 | 11.56 | 11.46 | 11.55 | 11.50 | 11.53 | 11.41 | 11.26 | 11.42 | 11.55 | 11.48 |
,Inflammatory Diseases Present-Kidney Transplant Participants | 11.30 | 11.33 | 11.75 | 11.54 | 11.71 | 11.34 | 11.46 | 11.58 | 11.61 | 11.63 | 11.75 | 11.23 | 11.17 | 11.07 | 11.03 | 11.38 |
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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)
Intervention | g/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 Participants | 11.15 | 11.17 | 11.60 | 11.26 | 11.40 | 11.32 | 11.46 | 11.46 | 11.50 | 11.22 | 11.55 | 11.41 | 11.44 | 11.29 | 11.20 | 11.26 |
,GFR (30-60 mL/Min)-Kidney Transplant Participants | 11.44 | 11.42 | 11.65 | 11.75 | 11.87 | 11.90 | 11.62 | 11.66 | 11.85 | 11.88 | 11.69 | 11.67 | 11.41 | 11.40 | 11.81 | 11.62 |
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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
Intervention | percentage of participants (Number) |
---|
Kidney Transplant Participants | 52.6 |
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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)
Intervention | g/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 Participants | 11.27 | 11.42 | 11.79 | 11.37 | 11.88 | 11.62 | 11.71 | 11.71 | 11.88 | 11.60 | 11.96 | 11.33 | 11.32 | 11.59 | 11.40 | 11.52 |
,Other Reason-Kidney Transplant Participants | 11.44 | 11.48 | 11.75 | 11.76 | 11.72 | 11.68 | 11.52 | 11.60 | 11.46 | 11.67 | 11.47 | 11.37 | 11.20 | 11.26 | 11.47 | 11.52 |
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Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment
(NCT02538107)
Timeframe: Up to 50 months
Intervention | months (Mean) |
---|
Kidney Transplant Participants | 9.31 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 75 |
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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
Intervention | Events (Number) |
---|
| Total dose adaptations | Inflammation or infection | Kidney function decline | Over response | Iron deficiency | Insufficient response | Adverse effect | Start of maintenance phase | Kidney function improvement | Re-introduction of treatment | Other |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 729 | 11 | 32 | 314 | 14 | 213 | 2 | 71 | 4 | 41 | 27 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 71.3 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 32.3 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 35.1 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 31.4 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 73.6 |
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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
Intervention | microgram (Mean) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 88 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 79.7 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 78.2 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 75.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 77.2 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 68.6 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 32.6 |
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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
Intervention | Months (Median) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | NA |
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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
Intervention | Months (Median) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | NA |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 26 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 31.4 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 74.1 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 33.5 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 35.2 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 34 |
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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
Intervention | Percentage of participants (Number) |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 22.8 |
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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
Intervention | Percentage of participants (Number) |
---|
| Oral Iron Replacement | Intravenous Iron Replacment | Oral and Intravenous Iron Replacment | No Iron Replacment |
---|
Methoxy Polyethylene Glycol-Epoetin Beta | 37.7 | 31.6 | 10.9 | 19.8 |
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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
Intervention | percentage of participants (Number) |
---|
Peritoneal Dialysis Participants | 14.8 |
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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
Intervention | percentage of participants (Number) |
---|
Peritoneal Dialysis Participants | 38.9 |
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Average Duration in Days Mircera Was Administered at a Stable Dose
(NCT02596945)
Timeframe: Up to 9 months
Intervention | days (Mean) |
---|
Peritoneal Dialysis Participants | 182.1 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Beta | 46.2 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline; Adjuvant Chemotherapy | Baseline; Metastatic 1st or 2nd Line | Baseline; Metastatic 3rd Line | Change at Week 12; Adjuvant Chemotherapy | Change at Week 12; Metastatic 1st or 2nd Line | Change at Week 12; Metastatic 3rd Line |
---|
Epoetin Beta | 10.2 | 9.8 | 10.2 | 1.7 | 1.6 | 1.2 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline; Hb <10 g/dL | Baseline; 10≤ Hb <11 g/dL | Change at Week 12; Hb <10 g/dL | Change at Week 12; 10≤ Hb <11 g/dL |
---|
Epoetin Beta | 9.4 | 10.5 | 2.1 | 1.1 |
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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
Intervention | g/dL (Mean) |
---|
| Baseline; <6 Months on Chemotherapy | Baseline; ≥6 Months on Chemotherapy | Change at Week 12; <6 Months on Chemotherapy | Change at Week 12; ≥6 Months on Chemotherapy |
---|
Epoetin Beta | 10.0 | 10.0 | 1.6 | 1.4 |
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Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment
(NCT02761642)
Timeframe: Baseline, Week 12
Intervention | g/dL (Mean) |
---|
| Baseline | Change at Week 12 |
---|
Epoetin Beta | 10.0 | 1.6 |
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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
Intervention | days (Mean) |
---|
Epoetin Beta | 34.2 |
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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
Intervention | percentage of participants (Number) |
---|
Epoetin Beta | 45.4 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 12 |
---|
Epoetin Beta | 65.6 | 71.9 |
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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
Intervention | percentage of participants (Number) |
---|
r-HuEPO | 50.8 |
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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
Intervention | percentage of participants (Number) |
---|
r-HuEPO | 50.8 |
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Percentage of Participants Who Required Transfusion
(NCT02767765)
Timeframe: Baseline, Week 2, Week 4
Intervention | percentage of participants (Number) |
---|
| Baseline | Week 2 | Week 4 |
---|
r-HuEPO | 8.2 | 4.9 | 1.7 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline (n=56) | Change at Week 4 (n=35) |
---|
r-HuEPO | 23.59 | -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
Intervention | days (Median) |
---|
r-HuEPO | 19 |
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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
Intervention | percentage of participants (Number) |
---|
r-HuEPO | 78.7 |
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Number of Participants With Epilepsy
≥ 2 afebrile, unprovoked seizures (NCT02811263)
Timeframe: Prior to 22-26 months
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 5 |
Placebo | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 126 |
Placebo | 110 |
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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
Intervention | score on a scale (Median) |
---|
Erythropoietin | 8 |
Placebo | 7 |
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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
Intervention | score on a scale (Mean) |
---|
Erythropoietin | 87.9 |
Placebo | 86.7 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 15 |
Placebo | 3 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 19 |
Placebo | 20 |
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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
Intervention | Participants (Count of Participants) |
---|
Erythropoietin | 10 |
Placebo | 13 |
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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
Intervention | mU/ml (Median) |
---|
| Baseline | Day 2 | Day 4 |
---|
Erythropoietin | 32.7 | 1530 | 2682 |
,Placebo | 36.0 | 34.4 | 20.5 |
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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
Intervention | score on a scale (Mean) |
---|
Erythropoietin | 89.1 |
Placebo | 89.5 |
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Cost of Erythropoiesis Stimulating Agent
total cost over 12 months in Canadian dollars (NCT02817555)
Timeframe: 12 months
Intervention | dollars Canadian (Median) |
---|
Epoetin Alfa | 4178.70 |
Darbepoetin Alfa | 2302.92 |
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Iron Cost
total iron cost over 12 months in Canadian dollars (NCT02817555)
Timeframe: 12 months
Intervention | canadian dollars (Median) |
---|
Epoetin Alfa | 726.56 |
Darbepoetin Alfa | 750 |
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Hemoglobin
median hemoglobin (g/L) over 12 months (NCT02817555)
Timeframe: 12 months
Intervention | g/L (Median) |
---|
Epoetin Alfa | 108 |
Darbepoetin Alfa | 109.8 |
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Iron Dose
median weekly iron dose (mg) over 12 months (NCT02817555)
Timeframe: 12 months
Intervention | mg/week (Median) |
---|
Epoetin Alfa | 40.36 |
Darbepoetin Alfa | 41.67 |
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Transferrin Saturation (TSAT)
median TSAT (%) over 12 months (NCT02817555)
Timeframe: 12 months
Intervention | percentage saturation (Median) |
---|
Epoetin Alfa | 26.71 |
Darbepoetin Alfa | 28.58 |
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Ferritin
mean ferritin (ug/L) over 12 months (NCT02817555)
Timeframe: 12 months
Intervention | ug/L (Mean) |
---|
Epoetin Alfa | 847.58 |
Darbepoetin Alfa | 726.29 |
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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
Intervention | participants (Number) |
---|
Control Group | 0 |
Erythropoietin Group | 0 |
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Number of Participants With Acute Kidney Injury
Occurrence of acute kidney injury according to KDIGO guideline (NCT03007537)
Timeframe: 7 days
Intervention | participants (Number) |
---|
Control Group | 15 |
Erythropoietin Group | 9 |
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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
Intervention | mmHg*Hours (Least Squares Mean) |
---|
| AUEC of SBP | AUEC of DBP | AUEC of MAP |
---|
Daprodustat | 3288.43 | 1736.11 | 2299.42 |
,Recombinant Human Erythropoietin | 3433.40 | 1853.60 | 2431.36 |
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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
Intervention | mmHg*Hours (Least Squares Mean) |
---|
| AUEC of SBP | AUEC of DBP | AUEC of MAP |
---|
Daprodustat | 3337.91 | 1763.11 | 2324.69 |
,Recombinant Human Erythropoietin | 3351.33 | 1834.82 | 2378.93 |
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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
Intervention | Hour*nanograms per milliliter (Geometric Mean) |
---|
| Daprodustat, Day 1, n=42 | Daprodustat, Day 57, n=28 | GSK2391220, Day 1, n=42 | GSK2391220, Day 57, n=31 | GSK2487818, Day 1, n=41 | GSK2487818, Day 57, n=28 | GSK2506102, Day 1, n=42 | GSK2506102, Day 57, n=31 | GSK2506104, Day 1, n=42 | GSK2506104, Day 57, n=31 | GSK2531398, Day 1, n=42 | GSK2531398, Day 57, n=31 | GSK2531401, Day 1, n=42 | GSK2531401, Day 57, n=31 |
---|
Daprodustat | 767.95 | 616.12 | 483.12 | 516.59 | 177.39 | 171.09 | 166.89 | 199.85 | 662.23 | 756.39 | 204.02 | 212.04 | 334.86 | 430.10 |
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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
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline (Day1, predose), n=45, 43 | SBP, Day 1: 3 hours, n=44, 43 | SBP, Day1: 12 hours, n=44, 43 | SBP, Day 1: 24 hours, n=41, 40 | SBP, Day 29: pre-dialysis, n=38, 40 | SBP, Day 29: post dialysis, n=38, 40 | SBP, Day 57: pre-dialysis, n=32, 36 | SBP, Day 57: post dialysis, n=32, 36 | SBP, Day 57: 3 hours, n=32, 36 | SBP, Day 57: 12 hours, n=32, 36 | SBP, Day 57: 24 hours, n=32, 36 | SBP, Week 10: pre-dialysis, n=42, 42 | SBP, Week 10: post dialysis, n=41, 42 | DBP, Baseline (Day1, predose), n=45, 43 | DBP, Day 1: 3 hours, n=44, 43 | DBP, Day1: 12 hours, n=44, 43 | DBP, Day 1: 24 hours, n=41, 40 | DBP, Day 29: pre-dialysis, n=38, 40 | DBP, Day 29: post dialysis, n=38, 40 | DBP, Day 57: pre-dialysis, n=32, 36 | DBP, Day 57: post dialysis, n=32, 36 | DBP, Day 57: 3 hours, n=32, 36 | DBP, Day 57: 12 hours, n=32, 36 | DBP, Day 57: 24 hours, n=32, 36 | DBP, Week 10: pre-dialysis, n=42, 42 | DBP, Week 10: post dialysis, n=41, 42 |
---|
Daprodustat | 135.87 | 140.64 | 142.05 | 140.24 | 143.05 | 130.97 | 142.75 | 135.66 | 140.94 | 130.47 | 143.78 | 142.71 | 138.73 | 70.00 | 74.91 | 77.11 | 74.22 | 71.92 | 69.47 | 72.69 | 71.47 | 72.44 | 67.38 | 76.44 | 73.86 | 71.05 |
,Recombinant Human Erythropoietin | 137.00 | 144.05 | 143.56 | 142.05 | 148.10 | 141.93 | 151.53 | 141.64 | 148.06 | 145.47 | 144.83 | 147.12 | 136.74 | 72.05 | 75.53 | 77.19 | 76.18 | 77.95 | 73.30 | 76.69 | 72.56 | 75.72 | 75.94 | 74.81 | 75.83 | 69.52 |
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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
Intervention | Degrees celsius (Mean) |
---|
| Baseline (Day1, predose), n=45, 43 | Day 1: 3 hours, n=44, 43 | Day1: 12 hours, n=44, 43 | Day 1: 24 hours, n=41, 40 | Day 29: pre-dialysis, n=38, 40 | Day 29: post dialysis, n=38, 40 | Day 57: pre-dialysis, n=32, 36 | Day 57: post dialysis, n=32, 36 | Day 57: 3 hours, n=32, 36 | Day 57: 12 hours, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10: pre-dialysis, n=42, 42 | Week 10: post dialysis, n=41, 42 |
---|
Daprodustat | 36.456 | 36.427 | 36.470 | 36.459 | 36.389 | 36.316 | 36.419 | 36.384 | 36.422 | 36.525 | 36.447 | 36.414 | 36.461 |
,Recombinant Human Erythropoietin | 36.442 | 36.374 | 36.507 | 36.380 | 36.418 | 36.380 | 36.403 | 36.378 | 36.497 | 36.414 | 36.506 | 36.383 | 36.450 |
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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
Intervention | Beats per minute (Mean) |
---|
| Baseline (Day1, predose), n=45, 43 | Day 1: 3 hours, n=44, 43 | Day1: 12 hours, n=44, 43 | Day 1: 24 hours, n=41, 40 | Day 29: pre-dialysis, n=38, 40 | Day 29: post dialysis, n=38, 40 | Day 57: pre-dialysis, n=32, 36 | Day 57: post dialysis, n=32, 36 | Day 57: 3 hours, n=32, 36 | Day 57: 12 hours, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10: pre-dialysis, n=42, 42 | Week 10: post dialysis, n=41, 42 |
---|
Daprodustat | 72.09 | 72.48 | 71.95 | 73.37 | 72.92 | 74.00 | 74.59 | 72.63 | 70.91 | 70.50 | 71.16 | 73.07 | 71.76 |
,Recombinant Human Erythropoietin | 76.19 | 76.21 | 72.65 | 76.43 | 76.05 | 76.18 | 77.17 | 75.75 | 75.25 | 75.11 | 75.36 | 75.81 | 74.55 |
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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
Intervention | Grams per liter (Mean) |
---|
| Hemoglobin, Baseline (Day 1), n=45, 42 | Hemoglobin, Day 29, n=37, 39 | Hemoglobin, Day 57, n=31, 35 | Hemoglobin, Week 10, n=39, 38 | ery.MCHC, Baseline (Day 1), n=45, 42 | ery.MCHC, Day 29, n=37, 39 | ery.MCHC, Day 57, n=31, 35 | ery.MCHC, Week 10, n=39, 38 |
---|
Daprodustat | 102.2 | 100.2 | 105.2 | 99.6 | 326.7 | 327.1 | 329.0 | 326.7 |
,Recombinant Human Erythropoietin | 104.5 | 99.7 | 107.9 | 102.9 | 322.6 | 320.8 | 318.3 | 320.6 |
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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
Intervention | 10^12 cells per liter (Mean) |
---|
| Erythrocytes, Baseline (Day 1), n=45, 42 | Erythrocytes, Day 29, n=37, 39 | Erythrocytes, Day 57, n=31, 35 | Erythrocytes, Week 10, n=39, 38 | Reticulocytes, Baseline (Day 1), n=45, 42 | Reticulocytes, Day 29, n=37, 39 | Reticulocytes, Day 57, n=31, 35 | Reticulocytes, Week 10, n=39, 38 |
---|
Daprodustat | 3.31 | 3.20 | 3.34 | 3.13 | 0.0302 | 0.0486 | 0.0489 | 0.0613 |
,Recombinant Human Erythropoietin | 3.45 | 3.27 | 3.53 | 3.38 | 0.0401 | 0.0733 | 0.0627 | 0.0566 |
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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
Intervention | 10^9 cells per liter (Mean) |
---|
| Basophils, Baseline (Day 1), n=45, 41 | Basophils, Day 29, n=37, 39 | Basophils, Day 57, n=30, 35 | Basophils, Week 10, n=39, 38 | Eosinophils, Baseline (Day 1), n=45, 41 | Eosinophils, Day 29, n=37, 39 | Eosinophils, Day 57, n=30, 35 | Eosinophils, Week 10, n=39, 38 | Lymphocytes, Baseline (Day 1), n=45, 41 | Lymphocytes, Day 29, n=37, 39 | Lymphocytes, Day 57, n=30, 35 | Lymphocytes, Week 10, n=39, 38 | Monocytes, Baseline (Day 1), n=45, 41 | Monocytes, Day 29, n=37, 39 | Monocytes, Day 57, n=30, 35 | Monocytes, Week 10, n=39, 38 | Neutrophils, Baseline (Day 1), n=45, 41 | Neutrophils, Day 29, n=37, 39 | Neutrophils, Day 57, n=30, 35 | Neutrophils, Week 10, n=39, 38 | Platelets, Baseline (Day 1), n=45, 42 | Platelets, Day 29, n=37, 38 | Platelets, Day 57, n=30, 34 | Platelets, Week 10, n=39, 38 | Leukocytes, Baseline (Day 1), n=45, 41 | Leukocytes, Day 29, n=37, 39 | Leukocytes, Day 57, n=30, 35 | Leukocytes, Week 10, n=39, 38 |
---|
Daprodustat | 0.050 | 0.045 | 0.049 | 0.044 | 0.196 | 0.238 | 0.218 | 0.231 | 1.257 | 1.385 | 1.209 | 1.367 | 0.398 | 0.442 | 0.432 | 0.469 | 4.091 | 4.319 | 4.381 | 4.250 | 188.5 | 195.2 | 207.8 | 209.3 | 6.00 | 6.43 | 6.29 | 6.35 |
,Recombinant Human Erythropoietin | 0.044 | 0.054 | 0.045 | 0.054 | 0.229 | 0.191 | 0.160 | 0.184 | 1.307 | 1.436 | 1.225 | 1.408 | 0.408 | 0.460 | 0.448 | 0.443 | 4.053 | 4.242 | 4.377 | 4.369 | 193.8 | 222.1 | 213.5 | 229.5 | 6.04 | 6.38 | 6.25 | 6.45 |
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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
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline (Day 1), n=45, 42 | Day 29, n=37, 39 | Day 57, n=31, 35 | Week 10, n=39, 38 |
---|
Daprodustat | 0.3133 | 0.3066 | 0.3196 | 0.3050 |
,Recombinant Human Erythropoietin | 0.3242 | 0.3113 | 0.3397 | 0.3209 |
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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
Intervention | Percentage of width (Mean) |
---|
| Baseline (Day 1), n=45, 42 | Day 29, n=37, 39 | Day 57, n=31, 35 | Week 10, n=39, 38 |
---|
Daprodustat | 16.06 | 16.52 | 16.11 | 16.42 |
,Recombinant Human Erythropoietin | 15.71 | 16.75 | 16.67 | 16.45 |
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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
Intervention | Femtoliters (Mean) |
---|
| Baseline (Day 1), n=45, 42 | Day 29, n=37, 39 | Day 57, n=31, 35 | Week 10, n=39, 38 |
---|
Daprodustat | 95.0 | 96.5 | 96.5 | 97.9 |
,Recombinant Human Erythropoietin | 94.8 | 96.2 | 97.1 | 95.7 |
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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
Intervention | Picograms (Mean) |
---|
| ery. MCH, Baseline (Day 1), n=45, 42 | ery. MCH, Day 29, n=37, 39 | ery. MCH, Day 57, n=31, 35 | ery. MCH, Week 10, n=39, 38 | CHr, Baseline (Day 1), n=45, 43 | CHr, Day 29, n=36, 40 | CHr, Day 57, n=32, 36 | CHr, Week 10, n=39, 39 |
---|
Daprodustat | 31.03 | 31.56 | 31.75 | 31.96 | 30.70 | 30.55 | 30.71 | 30.55 |
,Recombinant Human Erythropoietin | 30.57 | 30.83 | 30.88 | 30.66 | 29.97 | 30.19 | 29.85 | 29.76 |
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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
Intervention | Beats per minute (Mean) |
---|
| Baseline (Day 1-predose), n=45, 43 | Day 1: 24 hours, n=40, 38 | Day 57: predose, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10, n=39, 40 |
---|
Daprodustat | 72.2 | 71.6 | 71.2 | 71.2 | 72.3 |
,Recombinant Human Erythropoietin | 73.6 | 74.8 | 72.7 | 75.1 | 74.3 |
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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
Intervention | Micromoles per liter (Mean) |
---|
| Direct bilirubin,Baseline(Day1),n=45,43 | Direct bilirubin, Day 29, n=37, 39 | Direct bilirubin, Day 57, n=31, 35 | Direct bilirubin, Week 10, n=39, 38 | Total bilirubin, Baseline (Day 1),n=45,43 | Total bilirubin, Day 29, n=37, 39 | Total bilirubin, Day 57, n=31, 35 | Total bilirubin, Week 10, n=42, 41 | Indrt bilirubin, Baseline (Day 1), n=45,43 | Indrt bilirubin, Day 29, n=37, 39 | Indrt bilirubin, Day 57, n=31, 35 | Indrt bilirubin, Week 10, n=39, 38 |
---|
Daprodustat | 2.0 | 1.9 | 1.9 | 1.8 | 8.6 | 7.1 | 9.0 | 7.7 | 6.6 | 5.2 | 7.0 | 5.9 |
,Recombinant Human Erythropoietin | 1.8 | 1.7 | 1.8 | 1.7 | 7.7 | 7.2 | 8.6 | 7.0 | 6.0 | 5.4 | 6.9 | 5.3 |
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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
Intervention | Millimoles per liter (Mean) |
---|
| CCA, Baseline (Day 1),n=45,43 | CCA, Day 29, n=37, 40 | CCA, Day 57, n=31, 35 | CCA, Week 10, n=39, 38 | Glucose, Baseline (Day 1), n=45,43 | Glucose, Day 29, n=37, 40 | Glucose, Day 57, n=31, 35 | Glucose, Week 10, n=39, 38 | Potassium, Baseline (Day 1), n=45,43 | Potassium, Day 29, n=37, 40 | Potassium, Day 57, n=31, 35 | Potassium, Week 10, n=39, 38 | Phosphate, Baseline (Day 1), n=45,43 | Phosphate, Day 29, n=37, 40 | Phosphate, Day 57, n=31, 35 | Phosphate, Week 10, n=39, 38 | Sodium, Baseline (Day 1), n=45,43 | Sodium, Day 29, n=37, 40 | Sodium, Day 57, n=31, 35 | Sodium, Week 10, n=39, 38 |
---|
Daprodustat | 2.254 | 2.242 | 2.240 | 2.227 | 7.40 | 8.28 | 7.27 | 7.98 | 3.99 | 4.39 | 3.81 | 4.66 | 1.129 | 1.455 | 0.953 | 1.629 | 137.9 | 137.8 | 137.7 | 137.9 |
,Recombinant Human Erythropoietin | 2.266 | 2.242 | 2.265 | 2.232 | 7.67 | 7.35 | 7.01 | 7.36 | 4.06 | 4.60 | 4.01 | 4.65 | 1.242 | 1.761 | 1.274 | 1.849 | 138.0 | 138.4 | 138.6 | 138.6 |
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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
Intervention | International units per liter (Mean) |
---|
| ALP, Baseline (Day1), n=45, 43 | ALP, Day 29, n=37, 40 | ALP, Day 57, n=31, 35 | ALP, Week 10, n=42, 41 | ALT, Baseline (Day 1), n=45, 43 | ALT, Day 29, n=37, 40 | ALT, Day 57, n=31, 35 | ALT, Week 10, n=42, 41 | AST, Baseline (Day 1), n=45, 43 | AST, Day 29, n=37, 40 | AST, Day 57, n=31, 35 | AST, Week 10, n=42, 41 |
---|
Daprodustat | 100.9 | 104.4 | 109.0 | 98.3 | 13.8 | 10.4 | 11.0 | 10.6 | 16.8 | 13.2 | 14.9 | 14.0 |
,Recombinant Human Erythropoietin | 100.0 | 95.7 | 101.7 | 98.8 | 15.0 | 12.0 | 12.9 | 12.3 | 17.0 | 13.7 | 15.2 | 15.2 |
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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
Intervention | Grams per liter (Mean) |
---|
| Albumin, Baseline (Day1), n=45, 43 | Albumin, Day 29, n=37, 40 | Albumin, Day 57, n=31, 35 | Albumin, Week 10, n=39, 38 | Protein, Baseline (Day 1), n=45, 43 | Protein, Day 29, n=37, 40 | Protein, Day 57, n=31, 35 | Protein, Week 10, n=39, 38 |
---|
Daprodustat | 41.2 | 39.1 | 41.4 | 38.7 | 72.3 | 69.4 | 74.0 | 67.5 |
,Recombinant Human Erythropoietin | 40.5 | 38.3 | 40.9 | 38.0 | 72.6 | 68.0 | 73.1 | 67.8 |
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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
Intervention | Participants (Count of Participants) |
---|
Daprodustat | 10 |
Recombinant Human Erythropoietin | 4 |
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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
Intervention | Millimeters of mercury (mmHg) (Least Squares Mean) |
---|
Daprodustat | 142.87 |
Recombinant Human Erythropoietin | 143.03 |
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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
Intervention | Beats per minute (Least Squares Mean) |
---|
Daprodustat | 70.49 |
Recombinant Human Erythropoietin | 70.62 |
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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
Intervention | Beats per minute (Least Squares Mean) |
---|
Daprodustat | 70.77 |
Recombinant Human Erythropoietin | 73.72 |
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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
Intervention | Beats per minute*Hours (Least Squares Mean) |
---|
Daprodustat | 1579.38 |
Recombinant Human Erythropoietin | 1677.06 |
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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
Intervention | Beats per minute*Hours (Least Squares Mean) |
---|
Daprodustat | 1652.63 |
Recombinant Human Erythropoietin | 1727.03 |
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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
Intervention | Participants (Count of Participants) |
---|
| Adverse event | Protocol-specified withdrawal criteria met | Physician decision | Withdrawal by participant |
---|
Daprodustat | 2 | 7 | 1 | 3 |
,Recombinant Human Erythropoietin | 2 | 4 | 1 | 0 |
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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
Intervention | Hours (Median) |
---|
| Daprodustat, Day 1, n=44 | Daprodustat, Day 57, n=32 | GSK2391220, Day 1, n=44 | GSK2391220, Day 57, n=32 | GSK2487818, Day 1, n=44 | GSK2487818, Day 57, n=32 | GSK2506102, Day 1, n=44 | GSK2506102, Day 57, n=32 | GSK2506104, Day 1, n=44 | GSK2506104, Day 57, n=32 | GSK2531398, Day 1, n=44 | GSK2531398, Day 57, n=32 | GSK2531401, Day 1, n=44 | GSK2531401, Day 57, n=32 |
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Daprodustat | 2.000 | 2.000 | 4.160 | 4.000 | 3.090 | 4.000 | 6.000 | 6.000 | 6.000 | 5.990 | 4.160 | 4.000 | 8.015 | 8.000 |
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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
Intervention | Hours (Geometric Mean) |
---|
| Daprodustat, Day 1, n=22 | Daprodustat, Day 57, n=10 | GSK2391220, Day 1, n=9 | GSK2391220, Day 57, n=4 | GSK2487818, Day 1, n=20 | GSK2487818, Day 57, n=13 | GSK2506102, Day 1, n=1 | GSK2506102, Day 57, n=32 | GSK2506104, Day 1, n=1 | GSK2506104, Day 57, n=32 | GSK2531398, Day 1, n=11 | GSK2531398, Day 57, n=9 | GSK2531401, Day 1, n=44 | GSK2531401, Day 57, n=32 |
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Daprodustat | 3.031 | 3.635 | 6.820 | 7.447 | 3.388 | 3.524 | 8.530 | NA | 6.150 | NA | 5.582 | 6.182 | NA | NA |
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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
Intervention | Participants (Count of Participants) |
---|
Daprodustat | 10 |
Recombinant Human Erythropoietin | 5 |
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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
Intervention | Nanograms per milliliter (Mean) |
---|
| Day 1, Predose, n=45 | Day 1, 0.5 hours, n=43 | Day 1, 1 hour, n=43 | Day 1, 2 hours, n=43 | Day 1, 3 hours, n=43 | Day 1, 4 hours, n=44 | Day 1, 6 hours, n=44 | Day 1, 8 hours, n=43 | Day 1, 12 hours, n=41 | Day 1, 16 hours, n=43 | Day 1, 24 hours, n=43 | Day 57, Predose, n=31 | Day 57, 0.5 hours, n=31 | Day 57, 1 hour, n=31 | Day 57, 2 hours, n=30 | Day 57, 3 hours, n=31 | Day 57, 4 hours, n=32 | Day 57, 6 hours, n=31 | Day 57, 8 hours, n=31 | Day 57, 12 hours, n=30 | Day 57, 16 hours, n=30 | Day 57, 24 hours, n=31 |
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Daprodustat | 0.000 | 197.118 | 265.828 | 156.103 | 114.485 | 105.375 | 71.995 | 50.069 | 14.165 | 5.350 | 2.899 | 8.657 | 175.616 | 260.817 | 245.277 | 142.366 | 82.696 | 43.751 | 16.484 | 8.661 | 7.279 | 1.371 |
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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
Intervention | Nanograms per milliliter (Geometric Mean) |
---|
| Daprodustat, Day 1, n=44 | Daprodustat, Day 57, n=32 | GSK2391220, Day 1, n=44 | GSK2391220, Day 57, n=32 | GSK2487818, Day 1, n=44 | GSK2487818, Day 57, n=32 | GSK2506102, Day 1, n=44 | GSK2506102, Day 57, n=32 | GSK2506104, Day 1, n=44 | GSK2506104, Day 57, n=32 | GSK2531398, Day 1, n=44 | GSK2531398, Day 57, n=32 | GSK2531401, Day 1, n=44 | GSK2531401, Day 57, n=32 |
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Daprodustat | 218.841 | 163.795 | 39.506 | 44.703 | 26.678 | 24.846 | 9.933 | 12.114 | 43.169 | 51.643 | 18.454 | 20.362 | 18.335 | 23.337 |
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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
Intervention | mmHg (Mean) |
---|
| SBP, Hour 1, n=34, 31 | SBP, Hour 2, n=35, 31 | SBP, Hour 3, n=35, 31 | SBP, Hour 4, n=35, 31 | SBP, Hour 5, n=35, 31 | SBP, Hour 6, n=35, 31 | SBP, Hour 7, n=34, 26 | SBP, Hour 8, n=33, 29 | SBP, Hour 9, n=33, 30 | SBP, Hour 10, n=31, 28 | SBP, Hour 11, n=33, 27 | SBP, Hour 12, n=35, 28 | SBP, Hour 13, n=34, 28 | SBP, Hour 14, n=34, 31 | SBP, Hour 15, n=32, 26 | SBP, Hour 16, n=34, 31 | SBP, Hour 17, n=32, 30 | SBP, Hour 18, n=32, 27 | SBP, Hour 19, n=34, 27 | SBP, Hour 20, n=33, 27 | SBP, Hour 21, n=30, 27 | SBP, Hour 22, n=29, 27 | SBP, Hour 23, n=31, 26 | SBP, Hour 24, n=31, 27 | DBP, Hour 1, n=34, 31 | DBP, Hour 2, n=35, 31 | DBP, Hour 3, n=35, 31 | DBP, Hour 4, n=35, 31 | DBP, Hour 5, n=35, 31 | DBP, Hour 6, n=35, 31 | DBP, Hour 7, n=34, 26 | DBP, Hour 8, n=33, 29 | DBP, Hour 9, n=33, 30 | DBP, Hour 10, n=31, 28 | DBP, Hour 11, n=33, 27 | DBP, Hour 12, n=35, 28 | DBP, Hour 13, n=34, 28 | DBP, Hour 14, n=34, 31 | DBP, Hour 15, n=32, 26 | DBP, Hour 16, n=34, 31 | DBP, Hour 17, n=32, 30 | DBP, Hour 18, n=32, 27 | DBP, Hour 19, n=34, 27 | DBP, Hour 20, n=33, 27 | DBP, Hour 21, n=30, 27 | DBP, Hour 22, n=29, 27 | DBP, Hour 23, n=31, 26 | DBP, Hour 24, n=31, 27 | MAP, Hour 1, n=34, 31 | MAP, Hour 2, n=35, 31 | MAP, Hour 3, n=35, 31 | MAP, Hour 4, n=35, 31 | MAP, Hour 5, n=35, 31 | MAP, Hour 6, n=35, 31 | MAP, Hour 7, n=34, 26 | MAP, Hour 8, n=33, 29 | MAP, Hour 9, n=33, 30 | MAP, Hour 10, n=31, 28 | MAP, Hour 11, n=33, 27 | MAP, Hour 12, n=35, 28 | MAP, Hour 13, n=34, 28 | MAP, Hour 14, n=34, 31 | MAP, Hour 15, n=32, 26 | MAP, Hour 16, n=34, 31 | MAP, Hour 17, n=32, 30 | MAP, Hour 18, n=32, 27 | MAP, Hour 19, n=34, 27 | MAP, Hour 20, n=33, 27 | MAP, Hour 21, n=30, 27 | MAP, Hour 22, n=29, 27 | MAP, Hour 23, n=31, 26 | MAP, Hour 24, n=31, 27 |
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Daprodustat | 1.00 | -4.99 | -5.85 | -1.68 | -1.86 | 0.29 | 2.30 | 0.43 | -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 | -3.93 | 2.73 | 2.63 | 0.01 | -0.82 | -1.30 | -1.06 | -0.69 | -0.06 | -0.12 | 1.35 | -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 | -0.25 | 4.05 | 4.48 | -1.87 | -4.79 | -5.13 | -4.78 | -3.48 | -1.27 | 0.45 | 0.08 | -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 | -2.77 | 0.88 | 2.02 |
,Recombinant Human Erythropoietin | 5.27 | 4.72 | 5.09 | 0.93 | -2.10 | -2.54 | 0.63 | 3.83 | 0.25 | 1.48 | 1.96 | -1.67 | -1.37 | 4.57 | -0.13 | 8.59 | 1.76 | 5.48 | 1.52 | 6.89 | 1.72 | 3.50 | 8.72 | 5.02 | 0.99 | 1.97 | 0.88 | -1.17 | -1.49 | -1.49 | -1.27 | 1.79 | -0.68 | -0.82 | -2.45 | -3.95 | -2.65 | -1.00 | -4.12 | 1.15 | -2.98 | 0.30 | -0.43 | 0.40 | 1.90 | -1.96 | -0.44 | 2.16 | 2.83 | 4.20 | 3.46 | -1.05 | -1.18 | -2.17 | 0.87 | 2.20 | 0.61 | 0.76 | -3.60 | -6.15 | -3.32 | -0.75 | -5.10 | 3.84 | -2.09 | 1.52 | -1.02 | 4.23 | 3.87 | 0.75 | 4.10 | 2.20 |
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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
Intervention | Beats per minute (Mean) |
---|
| Hour 1, n=34, 31 | Hour 2, n=35, 31 | Hour 3, n=35, 31 | Hour 4, n=35, 31 | Hour 5, n=35, 31 | Hour 6, n=35, 31 | Hour 7, n=34, 26 | Hour 8, n=33, 29 | Hour 9, n=33, 30 | Hour 10, n=31, 28 | Hour 11, n=33, 27 | Hour 12, n=35, 28 | Hour 13, n=34, 28 | Hour 14, n=34, 31 | Hour 15, n=32, 26 | Hour 16, n=34, 31 | Hour 17, n=32, 30 | Hour 18, n=32, 27 | Hour 19, n=34, 27 | Hour 20, n=33, 27 | Hour 21, n=30, 27 | Hour 22, n=29, 27 | Hour 23, n=31, 26 | Hour 24, n=31, 27 |
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Daprodustat | -1.16 | -1.05 | 0.76 | 3.18 | 0.91 | 0.97 | 2.14 | 0.62 | 0.20 | 2.54 | 2.07 | 0.77 | -0.25 | -1.54 | -0.92 | -1.02 | -0.85 | 0.60 | -0.56 | -1.91 | -1.82 | 0.82 | -1.01 | -0.89 |
,Recombinant Human Erythropoietin | 0.13 | -2.06 | -0.16 | -1.13 | -0.66 | -1.66 | -1.01 | -1.11 | 0.67 | 1.60 | 1.57 | -2.01 | -2.45 | 0.25 | -3.06 | -2.87 | -4.34 | 0.98 | -2.65 | -4.77 | -3.00 | -2.61 | 0.24 | -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
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Day 1: 3 hours, n=44, 43 | SBP, Day1: 12 hours, n=44, 43 | SBP, Day 1: 24 hours, n=41, 40 | SBP, Day 29: pre-dialysis, n=38, 40 | SBP, Day 29: post dialysis, n=38, 40 | SBP, Day 57: pre-dialysis, n=32, 36 | SBP, Day 57: post dialysis, n=32, 36 | SBP, Day 57: 3 hours, n=32, 36 | SBP, Day 57: 12 hours, n=32, 36 | SBP, Day 57: 24 hours, n=32, 36 | SBP, Week 10: pre-dialysis, n=42, 42 | SBP, Week 10: post dialysis, n=41, 42 | DBP, Day 1: 3 hours, n=44, 43 | DBP, Day1: 12 hours, n=44, 43 | DBP, Day 1: 24 hours, n=41, 40 | DBP, Day 29: pre-dialysis, n=38, 40 | DBP, Day 29: post dialysis, n=38, 40 | DBP, Day 57: pre-dialysis, n=32, 36 | DBP, Day 57: post dialysis, n=32, 36 | DBP, Day 57: 3 hours, n=32, 36 | DBP, Day 57: 12 hours, n=32, 36 | DBP, Day 57: 24 hours, n=32, 36 | DBP, Week 10: pre-dialysis, n=42, 42 | DBP, Week 10: post dialysis, n=41, 42 |
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Daprodustat | 5.34 | 6.75 | 3.90 | 8.24 | -3.84 | 6.63 | -0.47 | 4.81 | -5.66 | 7.66 | 7.36 | 2.73 | 5.07 | 7.27 | 4.07 | 2.63 | 0.18 | 2.94 | 1.72 | 2.69 | -2.38 | 6.69 | 3.71 | 1.00 |
,Recombinant Human Erythropoietin | 7.05 | 6.56 | 6.23 | 12.00 | 5.83 | 16.03 | 6.14 | 12.56 | 9.97 | 9.33 | 10.48 | 0.10 | 3.49 | 5.14 | 4.18 | 5.88 | 1.23 | 5.86 | 1.72 | 4.89 | 5.11 | 3.97 | 3.50 | -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
Intervention | Degrees celsius (Mean) |
---|
| Day 1: 3 hours, n=44, 43 | Day1: 12 hours, n=44, 43 | Day 1: 24 hours, n=41, 40 | Day 29: pre-dialysis, n=38, 40 | Day 29: post dialysis, n=38, 40 | Day 57: pre-dialysis, n=32, 36 | Day 57: post dialysis, n=32, 36 | Day 57: 3 hours, n=32, 36 | Day 57: 12 hours, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10: pre-dialysis, n=42, 42 | Week 10: post dialysis, n=41, 42 |
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Daprodustat | -0.027 | 0.016 | 0.015 | -0.089 | -0.163 | -0.003 | -0.038 | 0.000 | 0.103 | 0.025 | -0.055 | -0.002 |
,Recombinant Human Erythropoietin | -0.067 | 0.065 | -0.050 | -0.033 | -0.070 | -0.028 | -0.053 | 0.067 | -0.017 | 0.075 | -0.062 | 0.005 |
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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
Intervention | Beats per minute (Mean) |
---|
| Day 1: 3 hours, n=44, 43 | Day1: 12 hours, n=44, 43 | Day 1: 24 hours, n=41, 40 | Day 29: pre-dialysis, n=38, 40 | Day 29: post dialysis, n=38, 40 | Day 57: pre-dialysis, n=32, 36 | Day 57: post dialysis, n=32, 36 | Day 57: 3 hours, n=32, 36 | Day 57: 12 hours, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10: pre-dialysis, n=42, 42 | Week 10: post dialysis, n=41, 42 |
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Daprodustat | 0.61 | 0.09 | 1.39 | 0.87 | 1.95 | 2.50 | 0.53 | -1.19 | -1.59 | -0.94 | 1.33 | -0.54 |
,Recombinant Human Erythropoietin | 0.02 | -3.53 | -0.35 | 0.03 | 0.15 | 2.14 | 0.72 | 0.22 | 0.08 | 0.33 | -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
Intervention | Grams per liter (Mean) |
---|
| Hemoglobin, Day 29, n=37, 38 | Hemoglobin, Day 57, n=31, 34 | Hemoglobin, Week 10, n=39, 37 | ery.MCHC, Day 29, n=37, 38 | ery.MCHC, Day 57, n=31, 34 | ery.MCHC, Week 10, n=39, 37 |
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Daprodustat | -4.1 | 0.5 | -3.2 | 0.3 | 2.3 | -0.6 |
,Recombinant Human Erythropoietin | -5.1 | 2.5 | -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
Intervention | 10^12 cells per liter (Mean) |
---|
| Erythrocytes, Day 29, n=37, 38 | Erythrocytes, Day 57, n=31, 34 | Erythrocytes, Week 10, n=39, 37 | Reticulocytes, Day 29, n=37, 38 | Reticulocytes, Day 57, n=31, 34 | Reticulocytes, Week 10, n=39, 37 |
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Daprodustat | -0.17 | -0.06 | -0.18 | 0.0156 | 0.0169 | 0.0314 |
,Recombinant Human Erythropoietin | -0.20 | 0.04 | -0.11 | 0.0315 | 0.0204 | 0.0159 |
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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
Intervention | Picograms (Mean) |
---|
| ery. MCH, Day 29, n=37, 38 | ery. MCH, Day 57, n=31, 34 | ery. MCH, Week 10, n=39, 37 | CHr, Day 29, n=36, 40 | CHr, Day 57, n=32, 36 | CHr, Week 10, n=39, 39 |
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Daprodustat | 0.39 | 0.70 | 0.78 | -0.23 | -0.12 | -0.29 |
,Recombinant Human Erythropoietin | 0.40 | 0.49 | 0.38 | 0.20 | -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
Intervention | 10^9 cells per liter (Mean) |
---|
| Basophils, Day 29, n=37, 37 | Basophils, Day 57, n=30, 33 | Basophils, Week 10, n=39, 36 | Eosinophils, Day 29, n=37, 37 | Eosinophils, Day 57, n=30, 33 | Eosinophils, Week 10, n=39, 36 | Lymphocytes, Day 29, n=37, 37 | Lymphocytes, Day 57, n=30, 33 | Lymphocytes, Week 10, n=39, 36 | Monocytes, Day 29, n=37, 37 | Monocytes, Day 57, n=30, 33 | Monocytes, Week 10, n=39, 36 | Neutrophils, Day 29, n=37, 37 | Neutrophils, Day 57, n=30, 33 | Neutrophils, Week 10, n=39, 36 | Platelets, Day 29, n=37, 37 | Platelets, Day 57, n=30, 33 | Platelets, Week 10, n=39, 37 | Leukocytes, Day 29, n=37, 37 | Leukocytes, Day 57, n=30, 33 | Leukocytes, Week 10, n=39, 36 |
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Daprodustat | -0.007 | -0.002 | -0.004 | 0.040 | 0.016 | 0.042 | 0.095 | -0.090 | 0.103 | 0.033 | 0.024 | 0.070 | 0.071 | 0.081 | 0.218 | 0.6 | 13.9 | 20.6 | 0.23 | 0.02 | 0.42 |
,Recombinant Human Erythropoietin | 0.010 | 0.004 | 0.009 | -0.039 | -0.038 | -0.036 | 0.102 | -0.099 | 0.078 | 0.035 | 0.025 | 0.053 | 0.061 | 0.325 | 0.181 | 22.7 | 16.4 | 26.3 | 0.17 | 0.21 | 0.28 |
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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
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Day 29, n=37, 38 | Day 57, n=31, 34 | Week 10, n=39, 37 |
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Daprodustat | -0.0131 | -0.0016 | -0.0096 |
,Recombinant Human Erythropoietin | -0.0136 | 0.0131 | -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
Intervention | Percentage of width (Mean) |
---|
| Day 29, n=37, 38 | Day 57, n=31, 34 | Week 10, n=39, 37 |
---|
Daprodustat | 0.38 | 0.12 | 0.35 |
,Recombinant Human Erythropoietin | 1.09 | 0.85 | 0.59 |
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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
Intervention | Femtoliters (Mean) |
---|
| Day 29, n=37, 38 | Day 57, n=31, 34 | Week 10, n=39, 37 |
---|
Daprodustat | 1.2 | 1.5 | 2.7 |
,Recombinant Human Erythropoietin | 1.8 | 2.9 | 1.4 |
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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
Intervention | Milliseconds (Mean) |
---|
| PR interval, Day 1: 24 hours, n=39, 38 | PR interval, Day 57: predose, n=32, 35 | PR interval, Day 57: 24 hours, n=32, 36 | PR interval, Week 10, n=39, 40 | QRS duration, Day 1: 24 hours, n=40, 38 | QRS duration, Day 57: predose, n=32, 36 | QRS duration, Day 57: 24 hours, n=32, 36 | QRS duration, Week 10, n=39, 40 | QTc interval, Day 1: 24 hours, n=7, 11 | QTc interval, Day 57: predose, n=4, 8 | QTc interval, Day 57: 24 hours, n=4, 8 | QTc interval, Week 10, n=6, 9 | QTcB, Day 1: 24 hours, n=40, 38 | QTcB, Day 57: predose, n=32, 36 | QTcB, Day 57: 24 hours, n=32, 36 | QTcB, Week 10, n=39, 39 |
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Daprodustat | 3.0 | 0.2 | 0.8 | 4.9 | -0.5 | 0.3 | 0.0 | 0.8 | 2.1 | -6.3 | -29.0 | -6.7 | -7.0 | -7.0 | -12.0 | -7.2 |
,Recombinant Human Erythropoietin | 1.9 | -3.9 | 1.8 | 1.2 | 0.0 | 2.8 | 1.4 | 0.7 | -9.4 | 1.0 | -3.4 | -10.3 | -3.1 | 4.9 | -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
Intervention | Beats per minute (Mean) |
---|
| Day 1: 24 hours, n=40, 38 | Day 57: predose, n=32, 36 | Day 57: 24 hours, n=32, 36 | Week 10, n=39, 40 |
---|
Daprodustat | -0.6 | -1.6 | -1.7 | -0.1 |
,Recombinant Human Erythropoietin | 0.8 | 0.1 | 2.5 | 0.4 |
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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
Intervention | Micromoles per liter (Mean) |
---|
| Direct bilirubin, Day 29, n=37, 39 | Direct bilirubin, Day 57, n=31, 35 | Direct bilirubin, Week 10, n=39, 38 | Total bilirubin, Day 29, n=37, 39 | Total bilirubin, Day 57, n=31, 35 | Total bilirubin, Week 10, n=42, 41 | Indrt bilirubin, Day 29, n=37, 39 | Indrt bilirubin, Day 57, n=31, 35 | Indrt bilirubin, Week 10, n=39, 38 |
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Daprodustat | -0.1 | -0.1 | -0.3 | -1.5 | 0.6 | -1.0 | -1.4 | 0.6 | -0.8 |
,Recombinant Human Erythropoietin | -0.1 | -0.1 | -0.1 | -0.8 | 0.7 | -0.8 | -0.7 | 0.9 | -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
Intervention | Millimoles per liter (Mean) |
---|
| CCA, Day 29, n=37, 40 | CCA, Day 57, n=31, 35 | CCA, Week 10, n=39, 38 | Glucose, Day 29, n=37, 40 | Glucose, Day 57, n=31, 35 | Glucose, Week 10, n=39, 38 | Potassium, Day 29, n=37, 40 | Potassium, Day 57, n=31, 35 | Potassium, Week 10, n=39, 38 | Phosphate, Day 29, n=37, 40 | Phosphate, Day 57, n=31, 35 | Phosphate, Week 10, n=39, 38 | Sodium, Day 29, n=37, 40 | Sodium, Day 57, n=31, 35 | Sodium, Week 10, n=39, 38 |
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Daprodustat | 0.000 | 0.004 | -0.010 | 0.75 | -0.45 | 0.62 | 0.45 | -0.14 | 0.67 | 0.389 | -0.123 | 0.505 | -0.1 | 0.2 | -0.2 |
,Recombinant Human Erythropoietin | -0.021 | -0.000 | -0.033 | -0.48 | -0.83 | -0.18 | 0.53 | -0.04 | 0.58 | 0.513 | 0.004 | 0.599 | 0.3 | 0.6 | 0.5 |
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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
Intervention | International units per liter (Mean) |
---|
| ALP, Day 29, n=37, 40 | ALP, Day 57, n=31, 35 | ALP, Week 10, n=42, 41 | ALT, Day 29, n=37, 40 | ALT, Day 57, n=31, 35 | ALT, Week 10, n=42, 41 | AST, Day 29, n=37, 40 | AST, Day 57, n=31, 35 | AST, Week 10, n=42, 41 |
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Daprodustat | -3.4 | 0.5 | -4.5 | -3.2 | -3.1 | -3.3 | -3.2 | -2.1 | -3.3 |
,Recombinant Human Erythropoietin | -5.3 | 3.4 | -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
Intervention | Grams per liter (Mean) |
---|
| Albumin, Day 29, n=37, 40 | Albumin, Day 57, n=31, 35 | Albumin, Week 10, n=39, 38 | Protein, Day 29, n=37, 40 | Protein, Day 57, n=31, 35 | Protein, Week 10, n=39, 38 |
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Daprodustat | -2.2 | 0.4 | -2.9 | -3.7 | 1.2 | -5.2 |
,Recombinant Human Erythropoietin | -2.4 | 0.5 | -2.4 | -4.7 | 0.7 | -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
Intervention | mmHg (Least Squares Mean) |
---|
| SBP | DBP | MAP |
---|
Daprodustat | 141.36 | 75.97 | 99.18 |
,Recombinant Human Erythropoietin | 142.68 | 77.92 | 101.58 |
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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
Intervention | mmHg (Least Squares Mean) |
---|
| DBP | MAP |
---|
Daprodustat | 75.58 | 98.98 |
,Recombinant Human Erythropoietin | 77.64 | 101.49 |
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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
Intervention | Participants (Count of Participants) |
---|
Vadadustat | 0 |
Epoetin Alfa | 0 |
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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)
Intervention | Millimeter of mercury (mmHg) (Mean) |
---|
| SBP | DBP | MAP |
---|
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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 8; n=248, 126 | Week 12; n=243, 120 | Week 28; n=211, 106 | Week 52; n=170, 85 |
---|
Daprodustat | -0.10 | -0.13 | -0.07 | -0.11 |
,Epoetin Alfa | 0.05 | -0.01 | 0.03 | 0.04 |
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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
Intervention | Percentage of days (Median) |
---|
Daprodustat | 70.83 |
Epoetin Alfa | 61.76 |
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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
Intervention | Percentage of participants (Number) |
---|
Daprodustat | 2.2 |
Epoetin Alfa | 2.2 |
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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
Intervention | Participants (Count of Participants) |
---|
Daprodustat | 151 |
Epoetin Alfa | 91 |
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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
Intervention | Events per 100 participant years (Number) |
---|
Daprodustat | 250.45 |
Epoetin Alfa | 356.91 |
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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
Intervention | Participants (Count of Participants) |
---|
Daprodustat | 172 |
Epoetin Alfa | 68 |
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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
Intervention | Millimeter of mercury (mmHg) (Least Squares Mean) |
---|
| SBP | DBP | MAP |
---|
Daprodustat | -3.18 | -2.52 | -2.72 |
,Epoetin Alfa | 0.55 | -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)
Intervention | Grams per deciliter (g/dL) (Least Squares Mean) |
---|
Daprodustat | -0.04 |
Epoetin Alfa | 0.02 |
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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
Intervention | Milligrams (Least Squares Mean) |
---|
Daprodustat | 98.11 |
Epoetin Alfa | 106.23 |
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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
Intervention | Grams per deciliter (Least Squares Mean) |
---|
Daprodustat | -0.03 |
Epoetin Alfa | 0.11 |
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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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | proportion 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
Intervention | Participants (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
Intervention | proportion 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
Intervention | percentage 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
Intervention | Participants (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
Intervention | Participants (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
Intervention | Participants (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
Intervention | IU/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
Intervention | g/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
Intervention | micrograms per liter (µg/L) (Mean) |
---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 |
---|
ESA Hyporesponder: Epoetin Alfa | 449.6 | -61.5 | 397.8 | -35.0 | 62.3 | 607.0 |
,ESA Hyporesponder: Vadadustat 600 mg | 1182.2 | 34.8 | 111.3 | -0.5 | 80.0 | 249.0 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 723.6 | -145.6 | -78.3 | -195.3 | -81.8 | -104.8 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 910.2 | 41.4 | 29.4 | -68.0 | -144.0 | -199.4 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 745.2 | 152.9 | -5.6 | -23.8 | 27.8 | 4.8 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 739.5 | 45.5 | -87.8 | -30.1 | -97.2 | -51.6 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 919.3 | -23.7 | 24.9 | -42.4 | 99.5 | 26.5 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 939.3 | -30.1 | -120.8 | -118.5 | -92.0 | -113.6 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 1043.6 | -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
Intervention | nanograms per milliliter (ng/mL) (Mean) |
---|
| Baseline | Week 12 | Week 20 |
---|
ESA Hyporesponder: Epoetin Alfa | 74.748 | -1.062 | -9.023 |
,ESA Hyporesponder: Vadadustat 600 mg | 239.958 | -128.587 | -152.243 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 143.519 | -62.787 | -80.680 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 185.852 | -55.283 | -93.412 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 215.608 | -34.868 | -83.012 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 160.760 | -74.797 | -43.701 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 259.161 | -66.646 | -83.685 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 194.870 | -50.565 | -86.025 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 208.816 | -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
Intervention | micrograms per deciliter (µg/dL) (Mean) |
---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 |
---|
ESA Hyporesponder: Epoetin Alfa | 58.4 | 3.8 | 2.0 | -12.6 | -12.0 | -10.3 |
,ESA Hyporesponder: Vadadustat 600 mg | 81.6 | 8.6 | 0.3 | -2.5 | 19.5 | -15.3 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 65.7 | -6.6 | -12.6 | -16.1 | -13.9 | -8.4 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 57.7 | 3.3 | 4.5 | -2.8 | -0.7 | 28.7 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 80.9 | 9.6 | -5.9 | -0.4 | 5.2 | -3.1 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 73.1 | 1.7 | 11.7 | -5.1 | -4.6 | 13.4 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 90.1 | -18.3 | -8.6 | -26.0 | -17.9 | -16.6 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 87.4 | -8.0 | -5.5 | -2.7 | -22.8 | -14.2 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 93.9 | -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
Intervention | 10^3 cells/microliter (µL) (Mean) |
---|
| Baseline | Week 1 | Week 4 | Week 8 | Week 11 | Week 12 | Week 13 | Week 16 | Week 20 |
---|
ESA Hyporesponder: Epoetin Alfa | 83.0 | -25.2 | 17.5 | -21.8 | -27.2 | -17.3 | 16.3 | 4.0 | 40.0 |
,ESA Hyporesponder: Vadadustat 600 mg | 77.6 | -35.8 | -26.8 | -3.3 | -6.7 | 3.8 | 2.0 | -31.5 | -3.3 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 62.6 | 20.4 | 22.5 | 14.0 | 3.9 | 4.6 | 0.1 | 26.6 | 38.5 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 59.3 | -18.1 | -5.6 | 9.1 | 26.2 | 47.7 | 46.3 | -2.2 | 10.3 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 48.4 | -3.9 | 2.9 | 20.4 | 32.5 | 20.3 | 15.9 | 9.7 | 16.4 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 51.5 | -6.6 | 6.1 | 23.1 | 9.2 | 26.9 | 10.5 | 0.2 | 10.9 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 48.8 | 1.0 | 0.8 | 23.1 | 21.0 | 22.2 | 16.4 | 8.3 | 23.8 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 51.9 | 3.1 | 14.6 | 14.0 | 11.7 | 16.1 | 16.7 | 13.9 | 14.5 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 47.2 | 6.9 | 14.9 | 23.9 | 20.2 | 16.3 | 12.1 | 19.6 | 13.2 |
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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
Intervention | µg/dL (Mean) |
---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 |
---|
ESA Hyporesponder: Epoetin Alfa | 225.6 | 7.8 | -24.8 | -0.6 | -2.5 | -6.0 |
,ESA Hyporesponder: Vadadustat 600 mg | 211.0 | 44.2 | 56.0 | 58.0 | 42.5 | 66.7 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 218.2 | -0.5 | -7.4 | -3.8 | -13.7 | -5.4 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 210.1 | 27.6 | 26.3 | 25.1 | 55.3 | 51.7 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 235.7 | 41.0 | 49.4 | 41.0 | 53.1 | 68.4 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 223.6 | 48.2 | 58.8 | 54.5 | 60.9 | 67.9 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 234.8 | -13.4 | -1.1 | -9.9 | -3.0 | -9.5 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 237.8 | 35.9 | 30.3 | 42.4 | 35.0 | 38.0 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 230.7 | 27.7 | 37.0 | 37.2 | 27.8 | 44.9 |
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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
Intervention | grams per deciliter (g/dL) (Mean) |
---|
| Baseline | Change from Baseline at PEP |
---|
ESA Hyporesponder: Epoetin Alfa | 9.620 | -0.290 |
,ESA Hyporesponder: Vadadustat 600 mg | 9.530 | -0.671 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 9.950 | 0.268 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 9.778 | -0.911 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 10.288 | -0.284 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 10.095 | -0.418 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 10.165 | 0.160 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 10.223 | -0.371 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 10.059 | 0.072 |
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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)
Intervention | Milliunits per milliliter (Geometric Mean) |
---|
| Baseline | Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 8.03 | 12.9 | 9.49 |
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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)
Intervention | Milliunits per milliliter (Geometric Mean) |
---|
| Baseline | Week 1 | Week 1 +1 (Day 8) | Week 11 | Week 13 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 9.93 | 15.3 | 16.1 | 19.4 | 39.2 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 6.98 | 20.2 | 17.4 | 17.3 | 10.5 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 9.53 | 17.5 | 18.9 | 14.9 | 15.7 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 6 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 7 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 9 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 2 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 3 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 2 |
High Dose of Epoetin Alfa: Epoetin Alfa | 6 |
ESA Hyporesponder: Vadadustat 600 mg | 1 |
ESA Hyporesponder: Epoetin Alfa | 1 |
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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
Intervention | Participants (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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 18 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 27 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 13 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 12 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 14 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 13 |
High Dose of Epoetin Alfa: Epoetin Alfa | 9 |
ESA Hyporesponder: Vadadustat 600 mg | 5 |
ESA Hyporesponder: Epoetin Alfa | 3 |
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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)
Intervention | Milliunits per milliliter (Geometric Mean) |
---|
| Baseline | Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 7.33 | 12.1 | 15.6 | 14.2 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 8.77 | 14.1 | 18.0 | 20.6 |
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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
Intervention | liters per hour (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 1.29 | 1.55 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 12 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 13 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 15 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 1 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 4 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 4 |
High Dose of Epoetin Alfa: Epoetin Alfa | 6 |
ESA Hyporesponder: Vadadustat 600 mg | 0 |
ESA Hyporesponder: Epoetin Alfa | 0 |
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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
Intervention | liters per hour (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 0.877 | 0.968 | 0.747 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 0.744 | 0.795 | 1.00 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 0.763 | 0.708 | 1.02 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0.888 | 1.04 | 0.872 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0.869 | 0.967 | 1.33 |
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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
Intervention | Liters (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 15.8 | 12.4 |
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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
Intervention | Liters (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 13.7 | 17.4 | 10.1 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 12.1 | 15.3 | 8.24 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 13.8 | 15.6 | 8.76 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 10.9 | 12.5 | 10.2 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 14.3 | 13.7 | 10.7 |
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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
Intervention | hours*µg/mL (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 464 | 388 |
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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
Intervention | hours*µg/mL (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 342 | 310 | 402 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 605 | 566 | 450 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 786 | 847 | 588 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 338 | 289 | 344 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 518 | 465 | 338 |
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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
Intervention | 1/hour (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 0.0771 | 0.0594 |
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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
Intervention | 1/hour (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 0.0560 | 0.0714 | 0.124 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 0.0681 | 0.0469 | 0.175 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0.0797 | 0.0720 | 0.0925 |
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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
Intervention | 1/hour (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 | Week 13 |
---|
High Dose of Epoetin Alfa: Vadadustat 600 mg | 0.0608 | 0.0469 | 0.116 | 0.138 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0.0665 | 0.0615 | 0.0687 | 0.0632 |
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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
Intervention | Micrograms per milliliter (μg/mL) (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) |
---|
ESA Hyporesponder: Vadadustat 600 mg | 44.2 | 31.6 |
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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
Intervention | Micrograms per milliliter (μg/mL) (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 |
---|
High Dose of Epoetin Alfa: Vadadustat 450 mg | 47.0 | 44.2 | 38.1 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 26.0 | 20.1 | 28.6 |
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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
Intervention | Micrograms per milliliter (μg/mL) (Geometric Mean) |
---|
| Week 1 | Week 1 +1 (Day 8) | Week 11 | Week 13 |
---|
High Dose of Epoetin Alfa: Vadadustat 300 mg | 26.5 | 23.8 | 32.4 | 11.5 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 56.5 | 60.1 | 41.2 | 60.2 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 40.8 | 37.6 | 24.4 | 30.6 |
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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
Intervention | Participants (Count of Participants) |
---|
| Hb >12.0 g/dL | Hb >13.0 g/dL | Hb >14.0 g/dL | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Hb increase >1.0 g/dL within any 2-week interval |
---|
ESA Hyporesponder: Epoetin Alfa | 0 | 0 | 0 | 1 | 2 |
,ESA Hyporesponder: Vadadustat 600 mg | 0 | 0 | 0 | 1 | 0 |
,High Dose of Epoetin Alfa: Epoetin Alfa | 1 | 0 | 0 | 1 | 6 |
,High Dose of Epoetin Alfa: Vadadustat 300 mg | 0 | 0 | 0 | 1 | 4 |
,High Dose of Epoetin Alfa: Vadadustat 450 mg | 1 | 0 | 0 | 1 | 2 |
,High Dose of Epoetin Alfa: Vadadustat 600 mg | 0 | 0 | 0 | 3 | 3 |
,Low Dose of Epoetin Alfa: Epoetin Alfa | 3 | 1 | 1 | 0 | 4 |
,Low Dose of Epoetin Alfa: Vadadustat 300 mg | 2 | 1 | 1 | 2 | 4 |
,Low Dose of Epoetin Alfa: Vadadustat 450 mg | 2 | 0 | 0 | 2 | 8 |
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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
Intervention | g/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 Alfa | 0.070 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 0.114 |
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 Alfa | 0.343 |
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
Intervention | g/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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 23 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 21 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 16 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 10 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 14 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 18 |
High Dose of Epoetin Alfa: Epoetin Alfa | 10 |
ESA Hyporesponder: Vadadustat 600 mg | 4 |
ESA Hyporesponder: Epoetin Alfa | 5 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 2 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 8 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 3 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 5 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 5 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 3 |
High Dose of Epoetin Alfa: Epoetin Alfa | 1 |
ESA Hyporesponder: Vadadustat 600 mg | 3 |
ESA Hyporesponder: Epoetin Alfa | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 1 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 0 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 3 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 1 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 2 |
High Dose of Epoetin Alfa: Epoetin Alfa | 0 |
ESA Hyporesponder: Vadadustat 600 mg | 1 |
ESA Hyporesponder: Epoetin Alfa | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 14 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 19 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 18 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 1 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 6 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 6 |
High Dose of Epoetin Alfa: Epoetin Alfa | 8 |
ESA Hyporesponder: Vadadustat 600 mg | 0 |
ESA Hyporesponder: Epoetin Alfa | 1 |
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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
Intervention | Participants (Count of Participants) |
---|
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg | 10 |
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg | 11 |
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa | 14 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 3 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 5 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 2 |
High Dose of Epoetin Alfa: Epoetin Alfa | 8 |
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg | 1 |
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa | 2 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 0 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 0 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 0 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 0 |
High Dose of Epoetin Alfa: Epoetin Alfa | 0 |
ESA Hyporesponder: Vadadustat 600 mg | 0 |
ESA Hyporesponder: Epoetin Alfa | 0 |
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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
Intervention | Participants (Count of Participants) |
---|
Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 |
Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0 |
Low Dose of Epoetin Alfa: Epoetin Alfa | 0 |
High Dose of Epoetin Alfa: Vadadustat 300 mg | 0 |
High Dose of Epoetin Alfa: Vadadustat 450 mg | 0 |
High Dose of Epoetin Alfa: Vadadustat 600 mg | 0 |
High Dose of Epoetin Alfa: Epoetin Alfa | 0 |
ESA Hyporesponder: Vadadustat 600 mg | 0 |
ESA Hyporesponder: Epoetin Alfa | 0 |
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Reticulocyte Response: AUC 0-120h
(NCT03822884)
Timeframe: 120hr
Intervention | mUI*h/mL (Mean) |
---|
Hemax® PFS 40,000 UI | 341.65 |
Hemax® 40,000 UI | 344.49 |
Erypo ® 40,000 UI | 345.58 |
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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
Intervention | mUI / ml (Mean) |
---|
Hemax® PFS 40,000 UI | 1.23 |
Hemax® 40,000 UI | 1.33 |
Erypo ® 40,000 UI | 1.31 |
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AUC0-∞
AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞. (NCT03822884)
Timeframe: 120hr
Intervention | mUI*h/mL (Mean) |
---|
Hemax® PFS 40,000 UI | 42487.04 |
Hemax® 40,000 UI | 36907.41 |
Erypo ® 40,000 UI | 43978.39 |
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Tmax
Tmax: time to the maximum serum concentration of epoetin alfa (NCT03822884)
Timeframe: 120hr
Intervention | h (Mean) |
---|
Hemax® PFS 40,000 UI | 14.17 |
Hemax® 40,000 UI | 15.04 |
Erypo ® 40,000 UI | 14.96 |
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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
Intervention | mUI*h/mL (Mean) |
---|
Hemax® PFS 40,000 UI | 37440.71 |
Hemax® 40,000 UI | 34483.73 |
Erypo ® 40,000 UI | 41150.49 |
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Cmax
Cmax: maximum serum concentration of epoetin alfa. (NCT03822884)
Timeframe: 120hr
Intervention | mUI / ml (Mean) |
---|
Hemax® PFS 40,000 UI | 853.11 |
Hemax® 40,000 UI | 808.29 |
Erypo ® 40,000 UI | 913.07 |
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