ferric oxide, saccharated profile

Ferric Oxide, Saccharated: A glucaric acid-iron conjugate that is used in the treatment of IRON-DEFICIENCY ANEMIA, including in patients with chronic kidney disease, when oral iron therapy is ineffective or impractical. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	91663255
MeSH ID	M0051786

Synonym
ferrum vitis
fz7nyf5n8l ,
fesin
ferosoft s
iron sucrose [usan:usp:ban]
ferum hausmann
colliron i.v.
nsc 27278
ferrum hausmann i.v.
ferplex ss
velphoro
encifer
unii-fz7nyf5n8l
venoferrum
fe-lib
ferijet
fe-back
succharated ferric oxide
saccharated ferric oxide
sucroferric oxyhydroxide
xi 921
iviron
saccharated iron oxide
saccharated iron
ferric saccharate ...iron oxide (mix.)
proferrin
neo-ferrum
einecs 232-464-7
succharated ferric oxide [usan:jan]
ferric oxide, saccharated
iron sugar
sucrofer
ferrivenin
iron oxide, saccharated
feojectin
hippiron
xi-921
iron oxide saccharated
DB09146
Q27888379

Excerpt	Reference	Relevance
" During the maintenance phase (period of epoetin therapy after correction of iron deficiency), the use of low-dose intravenous iron supplementation (10 to 20 mg per haemodialysis treatment or 100 mg every second week) avoids iron overtreatment and minimises potential adverse effects."	( Safety aspects of parenteral iron in patients with end-stage renal disease. Hörl, WH; Sunder-Plassmann, G, 1997)	0.3
" We prospectively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment."	( Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Adhikarla, R; Cavallo, G; Charytan, C; Gagnon, S; Levin, N; Spinowitz, BS; Van Wyck, DB, 2000)	0.31
" This drug has been associated with occasional serious adverse reactions, including full-blown anaphylaxis."	( The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Fishbane, S; Kowalski, EA, )	0.13
" We assessed safety by recording blood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control period."	( Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Al-Saloum, M; Charytan, C; Gagnon, S; Hafeez, T; Levin, N; Van Wyck, DB, 2001)	0.31
" Of the IV iron preparations available, iron sucrose has proved its efficacy and safety; however, there are no guidelines or systematic studies examining the optimum safe dosage regimen for this compound."	( Intravenous iron sucrose: establishing a safe dose. Chandler, G; Harchowal, J; Macdougall, IC, 2001)	0.31
" None of patient discontinued the therapy due to any adverse effect."	( Comparative study--efficacy, safety and compliance of intravenous iron sucrose and intramuscular iron sorbitol in iron deficiency anemia of pregnancy. Mushtaq, A; Wali, A, 2002)	0.31
"Administration of 250 mg SFGC over 1 hour is safe and well tolerated."	( Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration. Agarwal, R; Coyne, DW; Dahl, N; Folkert, VW; Michael, B; Myirski, P; Warnock, DG, 2003)	0.32
" Two patients had seven adverse events that were considered related to iron sucrose."	( The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease. Avram, MM; Blaustein, DA; Chattopadhyay, J; Daoui, R; Gadh, R; Schwenk, MH; Singh, H, 2003)	0.32
"An accelerated regimen of high-dose intravenous iron sucrose therapy in CKD patients is safe and effective in restoring iron stores, and may potentially save time and improve patient adherence."	( The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease. Avram, MM; Blaustein, DA; Chattopadhyay, J; Daoui, R; Gadh, R; Schwenk, MH; Singh, H, 2003)	0.32
"There were no serious adverse events related to iron sucrose therapy in the 130 patients intolerant to other iron preparations."	( Safety of iron sucrose in hemodialysis patients intolerant to other parenteral iron products. Al-Saloum, MM; Charytan, C; Schwenk, MH; Spinowitz, BS, 2004)	0.32
"Iron sucrose therapy is safe and well tolerated in hemodialysis patients intolerant to iron dextran and/or sodium ferric gluconate."	( Safety of iron sucrose in hemodialysis patients intolerant to other parenteral iron products. Al-Saloum, MM; Charytan, C; Schwenk, MH; Spinowitz, BS, 2004)	0.32
" Safety and tolerability of the therapy was assessed by the occurrence of adverse events under therapy and up to one week after completion of the study."	( A study for the evaluation of safety and tolerability of intravenous high-dose iron sucrose in patients with iron deficiency anemia due to gastrointestinal bleeding. Blumenstein, I; Dignass, AU; Jahnel, J; Schröder, O; Schrott, M; Stein, J, 2004)	0.32
"A total of 14 adverse events were observed in 10 patients, of which two adverse events in two patients were considered as being definitely related to drug administration."	( A study for the evaluation of safety and tolerability of intravenous high-dose iron sucrose in patients with iron deficiency anemia due to gastrointestinal bleeding. Blumenstein, I; Dignass, AU; Jahnel, J; Schröder, O; Schrott, M; Stein, J, 2004)	0.32
"A single intravenous high-dose iron sucrose therapy in patients with IDA due to gastrointestinal blood loss appears to be safe and therefore is a therapeutic option which may save time and improve patient compliance."	( A study for the evaluation of safety and tolerability of intravenous high-dose iron sucrose in patients with iron deficiency anemia due to gastrointestinal bleeding. Blumenstein, I; Dignass, AU; Jahnel, J; Schröder, O; Schrott, M; Stein, J, 2004)	0.32
" However, serious adverse events have been reported after single doses of some intravenous iron products."	( Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Aronoff, GR; Bennett, WM; Blumenthal, S; Charytan, C; Pennell, JP; Reed, J; Rothstein, M; Strom, J; Van Wyck, D; Wolfe, A; Yee, J, 2004)	0.32
" With each dosing regimen, adverse events, if any, were recorded and described."	( Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Aronoff, GR; Bennett, WM; Blumenthal, S; Charytan, C; Pennell, JP; Reed, J; Rothstein, M; Strom, J; Van Wyck, D; Wolfe, A; Yee, J, 2004)	0.32
" There were no serious or life-threatening drug-related adverse events."	( Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Aronoff, GR; Bennett, WM; Blumenthal, S; Charytan, C; Pennell, JP; Reed, J; Rothstein, M; Strom, J; Van Wyck, D; Wolfe, A; Yee, J, 2004)	0.32
"Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores."	( Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Aronoff, GR; Bennett, WM; Blumenthal, S; Charytan, C; Pennell, JP; Reed, J; Rothstein, M; Strom, J; Van Wyck, D; Wolfe, A; Yee, J, 2004)	0.32
"We have not observed any adverse reactions upon iron administration."	( [Safety and usefulness of parenteral iron in the management of anemia due to hip fracture in the elderly]. Cuenca Espiérrez, J; García Erce, JA; Martínez Martín, AA; Modrego Aranda, FJ; Solano, VM, 2004)	0.32
"Parenteral administration of iron could be a safe and effective way to avoid or reduce allogeneic blood transfusions in THF patients."	( [Safety and usefulness of parenteral iron in the management of anemia due to hip fracture in the elderly]. Cuenca Espiérrez, J; García Erce, JA; Martínez Martín, AA; Modrego Aranda, FJ; Solano, VM, 2004)	0.32
"To define the adverse events following two different rates and methods of intravenous iron sucrose infusions in children with anaemia due to chronic renal impairment."	( Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin. Anbu, AT; Bradbury, MG; Kemp, T; O'donnell, K; Smith, PA, 2005)	0.33
"Two prospective observational studies were undertaken to characterize the adverse events following iron sucrose administration in children with renal impairment and on erythropoietin."	( Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin. Anbu, AT; Bradbury, MG; Kemp, T; O'donnell, K; Smith, PA, 2005)	0.33
" Sixty-five doses were administered over 3 min to 20 children, and six minor adverse events were documented."	( Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin. Anbu, AT; Bradbury, MG; Kemp, T; O'donnell, K; Smith, PA, 2005)	0.33
"Although 90 min infusion is associated with fewer adverse events, no life-threatening events were documented in either method."	( Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin. Anbu, AT; Bradbury, MG; Kemp, T; O'donnell, K; Smith, PA, 2005)	0.33
" Variables evaluated in the intent-to-treat population included adverse events (AEs), hemoglobin, and iron indices."	( The safety of intravenous iron sucrose use in the elderly patient. Charytan, C; Reed, J; Yee, J, 2007)	0.34
"Serious adverse events that occur with the administration of iron dextran are due to the high molecular weight preparations."	( Low-molecular weight iron dextran and iron sucrose have similar comparative safety profiles in chronic kidney disease. Al Talib, K; Auerbach, M, 2008)	0.35
"To describe the efficacy and adverse effects of intravenous iron sucrose therapy in a group of children with iron deficiency anemia who did not respond to oral iron therapy."	( Efficacy and safety of intravenous iron sucrose therapy in a group of children with iron deficiency anemia. Kapelushnik, J; Levy, J; Moser, A; Pinsk, V; Yerushalmi, B, 2008)	0.35
" One patient demonstrated a severe side effect with temporary and reversible reduced blood pressure during treatment."	( Efficacy and safety of intravenous iron sucrose therapy in a group of children with iron deficiency anemia. Kapelushnik, J; Levy, J; Moser, A; Pinsk, V; Yerushalmi, B, 2008)	0.35
"These preliminary data suggest that administration of intravenous iron in pediatric patients is well tolerated and has a good clinical result, with minimal adverse reactions."	( Efficacy and safety of intravenous iron sucrose therapy in a group of children with iron deficiency anemia. Kapelushnik, J; Levy, J; Moser, A; Pinsk, V; Yerushalmi, B, 2008)	0.35
"45% per patient) and a total of 56 adverse events (1."	( The comparative safety of various intravenous iron preparations in chronic kidney disease patients. Anirban, G; Gupta, KL; Jha, V; Kohli, HS; Sakhuja, V, 2008)	0.35
" There were tolerable adverse events in both groups."	( Safety and usefulness of intravenous iron sucrose in the management of preoperative anemia in patients with menorrhagia: a phase IV, open-label, prospective, randomized study. Chung, HH; Kang, SB; Kim, SC; Kim, YH; Kim, YT, 2009)	0.35
"Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia."	( Safety and usefulness of intravenous iron sucrose in the management of preoperative anemia in patients with menorrhagia: a phase IV, open-label, prospective, randomized study. Chung, HH; Kang, SB; Kim, SC; Kim, YH; Kim, YT, 2009)	0.35
"Iron sucrose and low-molecular-weight iron dextran (LMW-ID), two commonly used iron solutions, have been compared in terms of allergic adverse event profiles to date."	( Safety profiles of total dose infusion of low-molecular-weight iron dextran and high-dose iron sucrose in renal patients. Acar, K; Atalay, H; Govec, N; Solak, Y; Turk, S, 2011)	0.37
"Spontaneously-reported rates of adverse events (AEs) of intravenous (i."	( Differences in spontaneously reported hypersensitivity and serious adverse events for intravenous iron preparations: comparison of Europe and North America. Bailie, GR; Hörl, WH; Verhoef, JJ, 2011)	0.37
" Safety and tolerability of both groups were compared on the basis of reported systemic and local adverse events."	( Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia. Christoph, P; Pfenniger, A; Schuller, C; Surbek, D, 2012)	0.38
"Rapid administration of high ICM doses was as well tolerated as IS with overall adverse events of 5% (ICM) vs."	( Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia. Christoph, P; Pfenniger, A; Schuller, C; Surbek, D, 2012)	0.38
"IV ICM is as safe as IS in the management of postpartum (IDA) iron deficiency anemia despite five times of higher dosage."	( Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia. Christoph, P; Pfenniger, A; Schuller, C; Surbek, D, 2012)	0.38
" Among 619 unique patients who received IV iron over a 2-year period, we found 32 adverse events (AEs), ranging from urticaria to chest pain."	( Comparative rates of adverse events with different formulations of intravenous iron. Abel, GA; Hevelone, N; Mandell, E; Okam, MM; Ross, A; Wentz, R, 2012)	0.38
"We assessed adverse event rates between dosing groups."	( Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Goldstein, SL; Morris, D; Warady, BA, 2013)	0.39
" No differences were noted between regimens in reported adverse effects, which were all minor."	( Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Goldstein, SL; Morris, D; Warady, BA, 2013)	0.39
" Post several months of use we observed increased rates of adverse events from patients and hence performed this analysis to confirm these findings."	( Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Choi, GY; Kim, JS; Lee, ES; Lee, IS; Lee, JJ; Park, BR, 2013)	0.39
"Data on adverse events was retrospectively collected from 658 patients treated between September 2004 and December 2011."	( Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Choi, GY; Kim, JS; Lee, ES; Lee, IS; Lee, JJ; Park, BR, 2013)	0.39
" Adverse drug reactions were more frequent in the ISS(FRX) groups vs."	( Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Choi, GY; Kim, JS; Lee, ES; Lee, IS; Lee, JJ; Park, BR, 2013)	0.39
"This is the first large analysis suggesting increased adverse events due to an ISS."	( Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Choi, GY; Kim, JS; Lee, ES; Lee, IS; Lee, JJ; Park, BR, 2013)	0.39
" However, parenteral iron supplementation is usually safe and without major side effects."	( [Safety aspects of parenteral iron supplementation therapies in patients with chronic kidney disease]. Münch, HG; Potthoff, SA, 2013)	0.39
" Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated."	( Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study. Akizawa, T; Fukagawa, M; Koiwa, F; Terao, A; Yokoyama, K, 2017)	0.46
" The proportion of patients reporting at least one treatment-emergent adverse event was 86."	( One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis. Covic, AC; Floege, J; Ketteler, M; Lisk, LJ; Mann, J; Rakov, V; Rastogi, A; Spinowitz, B; Sprague, SM, 2017)	0.46
"Safety was evaluated based on the development of adverse events and adverse drug reactions (ADRs)."	( Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study. Akizawa, T; Fukagawa, M; Koiwa, F; Yokoyama, K, 2017)	0.46
" The median prevalence of adverse drug reactions for IPM (2."	( Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: A systematic review. Grivell, RM; Grzeskowiak, LE; Mol, BW; Qassim, A, 2018)	0.48
" Intravenous iron compounds were in the past associated with serious adverse reactions and historically were considered a last resort in children."	( Safety and efficacy of parenteral iron in children with inflammatory bowel disease. Epstein, J; Fell, JME; Goto, E; Korologou-Linden, R; Papadopoulos, M; Patel, D; Soondrum, K, 2018)	0.48
" Safety, tolerability and adverse events were established by case note review."	( Safety and efficacy of parenteral iron in children with inflammatory bowel disease. Epstein, J; Fell, JME; Goto, E; Korologou-Linden, R; Papadopoulos, M; Patel, D; Soondrum, K, 2018)	0.48
" No serious adverse effects were reported."	( Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: phase IV clinical trials. Ara, R; Bader, GN; Naqash, A, 2018)	0.48
"Parenteral therapy is effective in IDA, but FCM elevates hemoglobin level and restored iron stores faster than IS with minimum adverse drug reactions."	( Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: phase IV clinical trials. Ara, R; Bader, GN; Naqash, A, 2018)	0.48
" The proportion of patients reporting serious adverse events (AEs) was 27."	( Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Covic, AC; Floege, J; Ketteler, M; Rakov, V; Rastogi, A; Sprague, SM; Walpen, S, 2018)	0.48
" Incidence of adverse events was < 60% in both groups, and no significant difference was observed between the treatment groups."	( Comparison of efficacy and safety between intravenous ferric carboxymaltose and saccharated ferric oxide in Japanese patients with iron-deficiency anemia due to hypermenorrhea: a multi-center, randomized, open-label noninferiority study. Hanashi, H; Hirai, K; Ikuta, K; Matsuyama, Y; Momoeda, M; Ota, Y; Shimura, A; Terauchi, M, 2019)	0.51
" We reviewed the medical record for adverse reactions to any TDI of iron sucrose as well as pre-TDI and post-TDI hemoglobin (Hgb) levels to assess efficacy."	( Retrospective Safety Evaluation of a Pharmacist-Assisted Total Dose Iron Sucrose Protocol in Hospital Inpatients With Iron Deficiency Anemia. Adams, K; Gasperi, L; Lukenbill, JC; Schneider, R; Sharma, V; Taylor, MJ; Wall, G, 2021)	0.62
" 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events."	( Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial. Agarwal, S; Baswal, D; Batra, A; Bhaskaran, S; Bhushan, H; Chauhan, MB; Devasenapathy, N; Divakar, H; Dongre, H; Francis, P; Gupta, A; Kotru, M; Malhotra, V; Malik, S; Mittal, P; Mwinga, K; Nanda, S; Neogi, SB; Radhika, AG; Saluja, S; Sangwan, R; Shah, D; Sikka, M; Singh, A; Singh, R; Yadav, S; Zodpey, S, 2019)	0.51
"A monthly maintenance intravenous dose of 100 mg iron sucrose may be a practical, effective, and safe in the short term, treatment of anemia in PD patients resulting in improved hemoglobin levels, iron indices, and erythropoietin response."	( Efficacy and safety of a low monthly dose of intravenous iron sucrose in peritoneal dialysis patients. Anagnostou, N; Intzevidou, E; Katsaounou, C; Kougioumtzidou, O; Lamprou, V; Lemonidis, N; Lysitska, A; Minasidis, I; Mitsopoulos, E; Papadopoulou, D; Pateinakis, P, 2020)	0.56
"The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time."	( Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Belo, D; Berkowitz, M; Bhandari, S; Kalra, PA; Thomsen, LL; Wolf, M, 2021)	0.62
" Secondary endpoints included incidence of composite cardiovascular adverse events (AEs)."	( Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Belo, D; Berkowitz, M; Bhandari, S; Kalra, PA; Thomsen, LL; Wolf, M, 2021)	0.62
" Safety endpoints included treatment-emergent adverse events (TEAEs)."	( Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease. Abitbol, CL; Ahn, SY; Balgradean, M; Enoiu, M; Fathallah-Shaykh, S; Fila, M; Greenbaum, LA; Jankauskiene, A; Jeck, N; Klaus, G; Nelson, R; Paredes, A; Perrin, A; Stoica, C; Swinford, RD; Wickman, L, 2021)	0.62
" The objective of this comparative study was to assess adverse events associated with four intravenous iron preparations and estimated medical costs, in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database."	( Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System. Goodnough, LT; Kaluza, K; Numan, S; Trumbo, H, 2021)	0.62
" Adverse event-associated medical costs were estimated using Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project 2016 data."	( Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System. Goodnough, LT; Kaluza, K; Numan, S; Trumbo, H, 2021)	0.62
" Downstream medical costs per adverse event were highest with iron dextran (US$8615) and ferumoxytol (US$8164), followed by iron sucrose (US$4212), and ferric carboxymaltose (US$1832)."	( Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System. Goodnough, LT; Kaluza, K; Numan, S; Trumbo, H, 2021)	0.62
" Adverse event-related medical costs were highest for iron dextran and ferumoxytol, and lowest for ferric carboxymaltose."	( Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System. Goodnough, LT; Kaluza, K; Numan, S; Trumbo, H, 2021)	0.62
" The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement."	( Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Choi, YJ; Go, DY; Jang, YK; Ko, EJ; Lee, SW; Shin, HW; You, HS, 2021)	0.62
"FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients."	( Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Choi, YJ; Go, DY; Jang, YK; Ko, EJ; Lee, SW; Shin, HW; You, HS, 2021)	0.62
" No severe adverse drug reactions were observed in either the patients receiving FCH or SFOH."	( Long-term efficacy and safety of iron-based phosphate binders, ferric citrate hydrate and sucroferric oxyhydroxide, in hemodialysis patients. Fujino, T; Kaburagi, N; Morimoto, K; Oya, M; Takemitsu, TY; Yamashita, N; Yoshida, T, 2022)	0.72
"The results of the present study suggest that the iron-based phosphate binders, FCH and SFOH, decrease serum phosphate concentrations consistently and are safe to use over the long-term in maintenance hemodialysis patients."	( Long-term efficacy and safety of iron-based phosphate binders, ferric citrate hydrate and sucroferric oxyhydroxide, in hemodialysis patients. Fujino, T; Kaburagi, N; Morimoto, K; Oya, M; Takemitsu, TY; Yamashita, N; Yoshida, T, 2022)	0.72
" Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia."	( Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery. Achebe, MM; Auerbach, M; Derman, RJ; Thomsen, LL, 2022)	0.72
"PN with iron sucrose for prevention of anemia in preterm infants is safe and efficacious to some extent."	( Efficacy and safety of parenteral nutrition with iron sucrose for anemia prevention in preterm infants: A randomized, double-blind controlled study. Lu, L; Tang, Q; Tao, Y; Wang, W; Wang, Y; Wu, Q; Yan, W; Zhang, Y, 2022)	0.72
" This systematic review investigated the occurrence of adverse events (AEs) during or after treatment with iron and/or ESAs."	( Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review. Avau, B; Bekkering, G; Compernolle, V; De Buck, E; Georgsen, J; Laermans, J; Manzini, PM; Meybohm, P; Ozier, Y; Van Remoortel, H; Vandekerckhove, P, 2022)	0.72
" Her serum iron concentration decreased below the toxic range over the next 14 h, and she was discharged home the next day."	( Decreased Clinical Toxicity and Two-Phase Elimination Kinetics Observed After Intravenous Iron Sucrose Overdose. Brent, J; Furmaga, J; Meadows, J; Weiss, ST, 2022)	0.72
" The infusions were well tolerated, and no short-term adverse reactions or laboratory abnormalities were observed."	( Efficacy and safety of intravenous iron sucrose in children younger than 2 years with intestinal failure. Lepus, CA; Mokha, JS; Samela, K, 2023)	0.91
" Primary safety variables were the incidence of adverse drug reactions (ADRs), medical events of special interest (MESIs), and variations in iron-related parameters."	( Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study. Arenas, MD; Bajo, MA; Cannata-Andia, J; Delgado, M; Devesa-Such, RJ; García-Fernández, N; Martín-De Francisco, ÁL; Martin-Malo, A; Molina, P; Molina-Higueras, MJ; Peiró-Jordán, R; Ríos-Moreno, F, )	0.13
"SFOH showed a favorable effectiveness profile, a similar safety profile to that observed in the international study with most adverse events of mild/moderate severity, and a low daily pill burden in Spanish patients in dialysis."	( Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study. Arenas, MD; Bajo, MA; Cannata-Andia, J; Delgado, M; Devesa-Such, RJ; García-Fernández, N; Martín-De Francisco, ÁL; Martin-Malo, A; Molina, P; Molina-Higueras, MJ; Peiró-Jordán, R; Ríos-Moreno, F, )	0.13

Excerpt	Reference	Relevance
" Development of these pharmaceutical agents requires pharmacokinetic studies monitoring levels of both the administered agent and transferrin-bound iron (TBI)."	( Analysis of total and transferrin-bound iron in human serum for pharmacokinetic studies of iron-sucrose formulations. Burrows, DM; Corcoran, HF; Dotzauer, H; Goggin, MM; Gozum, SD; Janis, GC; Lundberg, RA; Nguyen, A; Tann, CM, 2011)	0.37
" This post hoc analysis of a Phase 3 study evaluated the pharmacodynamic effects of the iron-based phosphate binder sucroferric oxyhydroxide (SFOH) and sevelamer (SEV) carbonate on VDRA activity in dialysis patients."	( Pharmacodynamic Effects of Sucroferric Oxyhydroxide and Sevelamer Carbonate on Vitamin D Receptor Agonist Bioactivity in Dialysis Patients. Botha, J; Chong, EM; Covic, AC; Floege, J; Ketteler, M; Rastogi, A; Sprague, SM, 2016)	0.43
" Potential interactions of SFOH and SEV with VDRAs were assessed using serum intact parathyroid hormone (iPTH) concentrations as a pharmacodynamic biomarker."	( Pharmacodynamic Effects of Sucroferric Oxyhydroxide and Sevelamer Carbonate on Vitamin D Receptor Agonist Bioactivity in Dialysis Patients. Botha, J; Chong, EM; Covic, AC; Floege, J; Ketteler, M; Rastogi, A; Sprague, SM, 2016)	0.43

Excerpt	Reference	Relevance
") once per week for 5 doses in combination with 2,000 international units (IU) EPO (Eprex, Cilag-Janssen), subcutaneously given simultaneously also for 5 doses."	( The effect of i.v. iron alone or in combination with low-dose erythropoietin in the rapid correction of anemia of chronic renal failure in the predialysis period. Agbaria, Z; Baruch, R; Blum, M; Deutsch, V; Iaina, A; Irony, M; Schwartz, D; Silverberg, DS; Steinbruch, S; Yachnin, T, 2001)	0.31
"In IBD patients with refractory anaemia the administration of darbepoetin in combination with intravenous iron sucrose can raise haemoglobin levels."	( Effectiveness of darbepoetin-alfa in combination with intravenous iron sucrose in patients with inflammatory bowel disease and refractory anaemia: a pilot study. Karmiris, K; Kouroumalis, EA; Koutroubakis, IE; Makreas, S; Niniraki, M; Xidakis, C, 2006)	0.33
" Therefore, the potential pharmacokinetic drug-drug interactions between sucroferric oxyhydroxide and selected drugs commonly taken by dialysis patients were investigated."	( Drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, omeprazole, digoxin and warfarin in healthy subjects. Chong, E; Kalia, V; Willsie, S; Winkle, P, 2014)	0.4
"Systemic exposure based on AUC0-∞ for all drugs, and AUC0-24 for all drugs except omeprazole (for which AUC 0-8 h was measured), was unaffected to a clinically significant extent by the presence of sucroferric oxyhydroxide, irrespective of whether sucroferric oxyhydroxide was administered with the drug or 2 h earlier."	( Drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, omeprazole, digoxin and warfarin in healthy subjects. Chong, E; Kalia, V; Willsie, S; Winkle, P, 2014)	0.4
"There is a low risk of drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, digoxin and warfarin."	( Drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, omeprazole, digoxin and warfarin in healthy subjects. Chong, E; Kalia, V; Willsie, S; Winkle, P, 2014)	0.4
"To explore the clinical efficacy of iron sucrose combined with recombinant human erythropoietin(EPO) for the treatment of anemia in elderly patients with hip fracture."	( [Clinical observation of iron sucrose combined with recombinant human erythropoietin in the treatment of anemia of hip fracture in elderly patients]. Dai, ZH; Huang, H; Xu, HY, 2019)	0.51
" Among them, 32 cases in group A were treated with iron sucrose alone, 32 cases in group B were treated with recombinant human erythropoietin alone, and 32 cases in group C were treated with iron sucrose combined with recombinant human erythropoietin."	( [Clinical observation of iron sucrose combined with recombinant human erythropoietin in the treatment of anemia of hip fracture in elderly patients]. Dai, ZH; Huang, H; Xu, HY, 2019)	0.51

Excerpt	Reference	Relevance
" Oral iron administration with appraisable bioavailability was able to compensate blood losses up to 151 and with increasing doses up to 361 per year with maintenance of normal or borderline haemoglobin values."	( [Chronic hemorrhagic iron deficiency. Sources of hemorrhage, blood loss and systematic iron substitution]. Balling, A; Hausmann, K; Kuse, R, 1987)	0.27
" Oral iron is a low cost treatment however its effectiveness is limited by low bioavailability and poor tolerability."	( State of the iron: how to diagnose and efficiently treat iron deficiency anemia in inflammatory bowel disease. Bhandari, S; Muñoz, M; Reinisch, W; Staun, M, 2013)	0.39
"Currently, most countries apply the standard generic approach for the approval of intended copies of originator nanoparticle iron medicinal products, requiring only demonstration of bioequivalence to a reference medicinal product by bioavailability studies."	( Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Borchard, G; Flühmann, B; Mühlebach, S, 2012)	0.38
"The bioavailability of Venofer® and ISA was investigated in both cell types by a ferrozin-based assay."	( Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD. Cornelius, C; Goldenberg, H; Praschberger, M; Scheiber-Mojdehkar, B; Schitegg, M; Sturm, B, 2015)	0.42
"ISA shows identical physico-chemical features and identical bioavailability in vitro."	( Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD. Cornelius, C; Goldenberg, H; Praschberger, M; Scheiber-Mojdehkar, B; Schitegg, M; Sturm, B, 2015)	0.42
" In conclusion, FCM has low bioavailability for liver parenchyma cells, therefore liver iron deposition is unlikely."	( Iron sucrose and ferric carboxymaltose: no correlation between physicochemical stability and biological activity. Cornelius, C; Goldenberg, H; Haider, K; Praschberger, M; Scheiber-Mojdehkar, B; Schitegg, M; Sturm, B, 2015)	0.42
" In vitro studies with Caco-2 cells suggested that newly synthesized microemulsions had better iron bioavailability as compared to commercially available iron dextran formulations."	( Potential of Alginate Encapsulated Ferric Saccharate Microemulsions to Ameliorate Iron Deficiency in Mice. Angmo, S; Mukhija, K; Sandhir, R; Singhal, K; Singhal, NK; Yadav, H; Yadav, K, 2016)	0.43
" Oral iron is simple and cheap to administer and does not require hospital visits, but is poorly absorbed in advanced CKD and is associated with unpleasant gastrointestinal side effects."	( Iron Treatment Strategies in Nondialysis CKD. Macdougall, IC, 2016)	0.43
" Our data show that the application of (phospho-)proteomics can lead to a better understanding of metabolic processes, including the uptake, biodegradation and bioavailability of nanomedicines."	( Uncovering the dynamics of cellular responses induced by iron-carbohydrate complexes in human macrophages using quantitative proteomics and phosphoproteomics. Ayala-Nunez, V; Barton Alston, AE; Bossart, J; Buljan, M; Digigow, R; Flühmann, B; Rippl, A; Wick, P, 2023)	0.91

Excerpt	Relevance	Reference
") treatment with epoetin alfa 300 IU/kg twice weekly for 3 weeks was the optimum dosage for facilitation of AB donation and minimization of the decrease in Hct prior to elective orthopedic surgery."	( Epoetin alfa for autologous blood donation in patients with rheumatoid arthritis and concomitant anemia. Mercuriali, F, 1996)	0.29
" Adequate intravenous iron supplementation allows reduction of epoetin dosage by approximately 40%."	( Safety aspects of parenteral iron in patients with end-stage renal disease. Hörl, WH; Sunder-Plassmann, G, 1997)	0.3
" The dosage of iron was individually adapted according to a target hemoglobin level of 13 g/100 ml and to the actual lowest hemoglobin level measured."	( [Intravenous iron in the treatment of postoperative anemia in surgery of the spine in infants and adolescents]. Bernière, J; Dehullu, JP; Gall, O; Murat, I, 1998)	0.3
"Iron balance is critical for adequate erythropoiesis and there remains much debate concerning the optimal timing and dosage of iron therapy for haemodialysis patients receiving recombinant human erythropoietin therapy."	( Enhanced oxidative stress in haemodialysis patients receiving intravenous iron therapy. Kho, B; Lim, PS; Wei, YH; Yu, YL, 1999)	0.3
"To determine the effect of different dosing schedules of intravenous iron therapy on the hematocrit level, we randomly assigned 18 patients to 3 groups."	( Clinical characteristic of parenteral iron supplementation in hemodialysis patients receiving erythropoietin therapy. Chang, HY; Chen, KS; Kao, HH; Lee, CC; Tsai, CJ, 2000)	0.31
" To save manpower and costs, we recommend the large single dosing schedule."	( Clinical characteristic of parenteral iron supplementation in hemodialysis patients receiving erythropoietin therapy. Chang, HY; Chen, KS; Kao, HH; Lee, CC; Tsai, CJ, 2000)	0.31
" iron preparations with respect to haemoglobin levels, iron status and recombinant human erythropoetin (rHuEpo) dosage requirements in stable, rHuEpo-treated haemodialysis patients (maintenance phase of iron treatment) over 6 months."	( A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo. Bahner, U; Bettger, H; Kosch, M; Matzkies, F; Schaefer, RM; Teschner, M, 2001)	0.31
"5 ng/ml with iron gluconate), while rHuEpo dosage did not change significantly throughout the study."	( A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo. Bahner, U; Bettger, H; Kosch, M; Matzkies, F; Schaefer, RM; Teschner, M, 2001)	0.31
" Of the IV iron preparations available, iron sucrose has proved its efficacy and safety; however, there are no guidelines or systematic studies examining the optimum safe dosage regimen for this compound."	( Intravenous iron sucrose: establishing a safe dose. Chandler, G; Harchowal, J; Macdougall, IC, 2001)	0.31
" Three patients had nonserious events that did not preclude further dosing of SFGC."	( Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration. Agarwal, R; Coyne, DW; Dahl, N; Folkert, VW; Michael, B; Myirski, P; Warnock, DG, 2003)	0.32
" We summarize the advantages and disadvantages of each product, including risk of anaphylaxis and hypersensitivity, dosage regimens, and costs."	( Parenteral iron therapy options. Rodgers, GM; Silverstein, SB, 2004)	0.32
"Isolated mouse proximal tubule segments (PTS) or cultured proximal tubular [human kidney (HK-2)] cells were exposed to four representative iron preparations [iron sucrose (FeS), iron dextran (FeD), iron gluconate (FeG), or iron oligosaccharide (FeOS)] over a broad dosage range (0, 30 to 1000 microg iron/mL)."	( Parenteral iron nephrotoxicity: potential mechanisms and consequences. Hanson, SY; Johnson, AC; Zager, RA, 2004)	0.32
"In this safety study, iron sucrose was given in two dosing regimens."	( Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Aronoff, GR; Bennett, WM; Blumenthal, S; Charytan, C; Pennell, JP; Reed, J; Rothstein, M; Strom, J; Van Wyck, D; Wolfe, A; Yee, J, 2004)	0.32
" Although peak serum concentrations of all compounds were inversely proportional to body weight, the percentage of change during dialysis was not related to dosage or body weight."	( Effects of different dialysis membranes on serum concentrations of epoetin alfa, darbepoetin alfa, enoxaparin, and iron sucrose during dialysis. Chester, K; McMahon, LP; Walker, RG, 2004)	0.32
" The iron gluconate was given in a dosage of 62."	( Intravenous iron in a primary-care clinic. Maslovsky, I, 2005)	0.33
"Administration of 200 mg of iron sucrose as an intravenous bolus injection over 2 minutes is a practical dosing regimen in patients with chronic kidney disease, resulting in considerable savings in time and cost."	( Administration of intravenous iron sucrose as a 2-minute push to CKD patients: a prospective evaluation of 2,297 injections. Macdougall, IC; Roche, A, 2005)	0.33
"We performed a prospective multicentre clinical trial in iron-replete haemodialysis patients to evaluate the efficacy of weekly low-dose (50 mg) intravenous iron sucrose administration for 6 months to maintain the iron status, and to examine the effect on epoetin dosage needed to maintain stable haemoglobin values in these patients."	( Weekly low-dose treatment with intravenous iron sucrose maintains iron status and decreases epoetin requirement in iron-replete haemodialysis patients. Ambühl, PM; Binet, I; Dickenmann, M; Keusch, G; Lüthi, L; Schiesser, D; Schmidli, M; Tsinalis, D; Wüthrich, RP, 2006)	0.33
"A regular 50 mg weekly dosing schedule of iron sucrose maintains stable iron stores and haemoglobin levels in haemodialysed patients and allows considerable dose reductions for epoetins."	( Weekly low-dose treatment with intravenous iron sucrose maintains iron status and decreases epoetin requirement in iron-replete haemodialysis patients. Ambühl, PM; Binet, I; Dickenmann, M; Keusch, G; Lüthi, L; Schiesser, D; Schmidli, M; Tsinalis, D; Wüthrich, RP, 2006)	0.33
" Patients received IV iron sucrose therapy in treatment and maintenance dosing cycles over 10-week periods."	( The safety of intravenous iron sucrose use in the elderly patient. Charytan, C; Reed, J; Yee, J, 2007)	0.34
" Iron needs and erythropoietin dosing were similar in both the elder and younger adult patients."	( The safety of intravenous iron sucrose use in the elderly patient. Charytan, C; Reed, J; Yee, J, 2007)	0.34
" groups in terms of sex, age, duration of hemodialysis, dialysis frequency per week, EPO dosage per week, the level of intact parathyroid hormone, serum creatinine, blood urea nitrogen, or hematological parameters at baseline."	( Intravenous iron sucrose in Chinese hemodialysis patients with renal anemia. Li, H; Wang, SX, 2008)	0.35
" Differences in iron formulation, dosing regiment, and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment studies."	( A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome. Allen, RP; Barker, PB; Beard, JL; Earley, CJ; Horská, A; Mohamed, MA, 2009)	0.35
"There were no differences between the IV and oral groups in terms of sex, age, duration of PD, mean dialysate dosage per day, erythropoietin dosage per week, or hematological parameters at baseline."	( Intravenous iron sucrose in peritoneal dialysis patients with renal anemia. Li, H; Wang, SX, )	0.13
" Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS."	( A randomized, double-blind, placebo controlled, multi-center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome. Grote, L; Hedner, J; Leissner, L; Ulfberg, J, 2009)	0.35
" ESA dosage used in the iron sucrose group at week 8 was significantly lower than in the Fe chloride group (244."	( Comparison of parenteral iron sucrose and ferric chloride during erythropoietin therapy of haemodialysis patients. Chen, HH; Chen, YC; Chuang, CK; Lee, KF; Lin, HC; Wu, CJ, 2010)	0.36
"Although the differences in ESA dosage, ferritin and iron dosage between two groups were found during the study period while similar results were shown at the end of 24 week study."	( Comparison of parenteral iron sucrose and ferric chloride during erythropoietin therapy of haemodialysis patients. Chen, HH; Chen, YC; Chuang, CK; Lee, KF; Lin, HC; Wu, CJ, 2010)	0.36
" However, there are no guidelines about safety limits in dosage amounts or intervals."	( Postoperative high-dose intravenous iron sucrose with low dose erythropoietin therapy after total hip replacement. Kim, S; Lee, SC; Lim, H; Yoon, J, 2010)	0.36
" The outcomes of administering this dosage regimen are reported as observational retrospective analysis using patient record data in 2009."	( Total dose infusion of intravenous iron in patients with chronic kidney disease receiving haemodialysis. Fenwick, S; Peebles, G, 2011)	0.37
" We aimed to compare adverse-effect profiles of LMW-ID and iron sucrose with varying dosing schedules in PD patients with a hope to foster use of parenteral iron solutions in PD patients."	( Comparison of adverse-event profiles of intravenous low-molecular-weight iron dextran and iron sucrose in peritoneal dialysis patients. Atalay, H; Guney, I; Kaya, E; Solak, Y; Turk, S; Turkmen, K, 2011)	0.37
"The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen."	( FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Bokemeyer, B; Chopey, IV; Evstatiev, R; Gasche, C; Gutzwiller, FS; Iqbal, T; Khalif, IL; Marteau, P; Riopel, L; Stein, J, 2011)	0.37
" Ferric carboxymaltose has a comparable safety profile to iron sucrose but offers the advantage of a much higher iron dosage at a time reducing the need for repeated applications and increasing patients' comfort."	( Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose. Christoph, P; De Tejada, BM; Irion, O; Schuller, C; Studer, H; Surbek, D, 2012)	0.38
"We assessed adverse event rates between dosing groups."	( Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Goldstein, SL; Morris, D; Warady, BA, 2013)	0.39
" Costs per 200/500/1,000 mg total dosage treatment cycle were CHF 101/210/420 for ferric carboxymaltose and CHF 144/375/721 for iron sucrose."	( Budget impact of parenteral iron treatment of iron deficiency: methodological issues raised by using real-life data. Braunhofer, P; Brock, E; Schneider, H; Troxler, J, 2014)	0.4
" Therefore, sucroferric oxyhydroxide may be administered concomitantly without the need to adjust the dosage regimens of these drugs."	( Drug-drug interactions between sucroferric oxyhydroxide and losartan, furosemide, omeprazole, digoxin and warfarin in healthy subjects. Chong, E; Kalia, V; Willsie, S; Winkle, P, 2014)	0.4
" Additionally, sucroferric oxyhydroxide at maintenance dosages was significantly more effective than low dosage sucroferric oxyhydroxide (250 mg/day) with regard to maintaining controlled serum phosphorus levels during weeks 24-27 of treatment."	( Sucroferric oxyhydroxide: a review in hyperphosphataemia in chronic kidney disease patients undergoing dialysis. Greig, SL; Plosker, GL, 2015)	0.42
" Bolus dosing was associated with an increase in infection-related events among both ferric gluconate and iron sucrose users."	( Comparative Short-term Safety of Sodium Ferric Gluconate Versus Iron Sucrose in Hemodialysis Patients. Brookhart, MA; Ellis, AR; Freburger, JK; Kshirsagar, AV; Wang, L; Winkelmayer, WC, 2016)	0.43
" Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling outside target, and reducing ESA dosing to prevent adverse outcomes requires considerable attention from caregivers."	( Performance of a Predictive Model for Long-Term Hemoglobin Response to Darbepoetin and Iron Administration in a Large Cohort of Hemodialysis Patients. Amato, C; Barbieri, C; Bellocchio, F; Bolzoni, E; Canaud, B; Cattinelli, I; Gatti, E; Macdougall, IC; Mari, F; Martin, JD; Stopper, A; Stuard, S, 2016)	0.43
" IV iron can be given as large intermittent doses (loading therapy) or in smaller doses at frequent intervals (maintenance dosing regimen)."	( Iron Treatment Strategies in Dialysis-Dependent CKD. Coyne, DW; Daloul, R; Pandey, R, 2016)	0.43
" Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations."	( A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Achebe, MM; Auerbach, M; Derman, R; Modiano, MR; Roman, E; Thomsen, LL, 2017)	0.46
" Iron deficiency was modeled using dosing tables and retreatments were modeled based on a pooled retrospective analysis."	( Intravenous iron treatments for iron deficiency anemia in inflammatory bowel disease: a budget impact analysis of iron isomaltoside 1000 (Monofer) in the UK. Muduma, G; Pollock, RF, 2017)	0.46
" These patients tended to have increased levels of serum calcium, hematocrit, and serum ferritin; a decreased number of phosphate binder tablets (from 21 tablets/d to 8 tablets/d); and a decreased dosage of erythropoiesis-stimulating agents."	( [Low Continuity Rate of Sucroferric Oxyhydroxide among Japanese Hemodialysis Patients with High Phosphate Binder Pill Burden]. Mitsuboshi, S; Nagai, K; Okajima, H; Yamada, H, 2018)	0.48
"Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown."	( Randomized Trial Comparing Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL): Study Design and Baseline Data. Anker, SD; Bhandari, S; Farrington, K; Ford, I; Kalra, PA; Macdougall, IC; McMurray, JJV; Murray, H; Steenkamp, R; Tomson, CRV; Wheeler, DC; White, C; Winearls, CG, 2018)	0.48
"PIVOTAL will provide important information about the optimum dosing of IV iron in HD patients representative of usual clinical practice."	( Randomized Trial Comparing Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL): Study Design and Baseline Data. Anker, SD; Bhandari, S; Farrington, K; Ford, I; Kalra, PA; Macdougall, IC; McMurray, JJV; Murray, H; Steenkamp, R; Tomson, CRV; Wheeler, DC; White, C; Winearls, CG, 2018)	0.48
" The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting."	( Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. Bhatla, N; Jose, A; Kalaivani, M; Kriplani, A; Mahey, R; Saxena, R; Sharma, JB, 2019)	0.51
" PB treatment, number of pills, serum phosphorus levels, and intravenous iron medication and dosage were collected monthly during the six months of treatment with either PB or SO."	( Effectiveness of sucroferric oxyhydroxide in patients on on-line hemodiafiltration in real-world clinical practice: A retrospective study. Aniceto, J; Ferreira, A; Navarro, D; Neves, PL; Pinto, B; Ponce, P, )	0.13
"This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients."	( Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience. Bhandari, S; Burton, JO; Dhada, S; Jesus-Silva, JA; Lamplugh, A, 2020)	0.56
" The goal of this study was to investigate if a pharmacist-managed dosing algorithm for darbepoetin alfa (DA) and iron sucrose improves the attainment of target hemoglobin levels."	( A pharmacist-managed dosing algorithm for darbepoetin alfa and iron sucrose in hemodialysis patients: A randomized, controlled trial. Birnie, E; Heetman-Meijer, CFM; Schrama, YC; Swart, EL; van den Oever, FJ; Vasbinder, EC, 2020)	0.56
" Erythropoiesis-stimulating agent dosing did not differ between groups."	( Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial. Bielesz, B; Gabriel, M; Gleiss, A; Hörl, WH; Lorenz, M; Monteforte, R; Prikoszovich, T; Sunder-Plassmann, G; Wolzt, M, 2021)	0.62
"Intravenous iron sucrose is becoming a prevailing treatment for individuals undergoing maintenance haemodialysis, but comparisons of dosing regimens are lacking."	( High-dose versus low-dose iron sucrose in individuals undergoing maintenance haemodialysis: a retrospective study. Cheng, H; Liu, L; Liu, Q; Lv, Y; Wu, Y; Xu, B; Yu, W, 2021)	0.62
"Data from 26 RCTs and 16 cohort studies involving a total of 6062 patients were extracted, on 6 treatment comparisons: (1) intravenous (IV) versus oral iron, (2) IV iron versus usual care/no iron, (3) IV ferric carboxymaltose versus IV iron sucrose, (4) ESA+iron versus control (placebo and/or iron, no treatment), (5) ESA+IV iron versus ESA+oral iron, and (6) ESA+IV iron versus ESA+IV iron (different ESA dosing regimens)."	( Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review. Avau, B; Bekkering, G; Compernolle, V; De Buck, E; Georgsen, J; Laermans, J; Manzini, PM; Meybohm, P; Ozier, Y; Van Remoortel, H; Vandekerckhove, P, 2022)	0.72

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	54 (8.31)	18.7374
1990's	38 (5.85)	18.2507
2000's	193 (29.69)	29.6817
2010's	274 (42.15)	24.3611
2020's	91 (14.00)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	193 (27.97%)	5.53%
Reviews	69 (10.00%)	6.00%
Case Studies	47 (6.81%)	4.05%
Observational	13 (1.88%)	0.25%
Other	368 (53.33%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (97)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans. [NCT01265108]	Phase 1	12 participants (Actual)	Interventional	2010-11-30	Completed
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA) [NCT02940886]	Phase 3	1,512 participants (Actual)	Interventional	2016-11-08	Completed
Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study [NCT03917394]		780 participants (Anticipated)	Observational	2019-04-24	Recruiting
Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum) [NCT01151592]	Phase 4	0 participants (Actual)	Interventional		Withdrawn(stopped due to Sponsor Decision)
Colorado-Oregon Altitude Study [NCT05734716]	Phase 4	121 participants (Actual)	Interventional	2021-02-17	Completed
A Randomized Controlled Pilot Study of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients With Functional Iron Deficiency, With and Without Oxandrolone [NCT02047552]	Phase 2	0 participants (Actual)	Interventional	2015-01-31	Withdrawn(stopped due to No Participants enrolled)
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Dis [NCT02940860]	Phase 3	1,538 participants (Actual)	Interventional	2016-11-29	Completed
Effects of Iron Loading and Iron Chelation Therapy on Innate Immunity During Human Endotoxemia [NCT01349699]		30 participants (Actual)	Interventional	2010-02-28	Completed
A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients [NCT03610230]		16 participants (Actual)	Interventional	2019-02-01	Terminated(stopped due to Difficult patient recruitment due to COVID-19 epidemic)
Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease [NCT01052779]	Phase 2	162 participants (Actual)	Interventional	2010-03-01	Completed
Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia [NCT01084122]	Phase 4	360 participants (Anticipated)	Interventional	2010-05-31	Not yet recruiting
Predictors of Response to Iron and Erythropoietin Stimulating Agents [NCT03658876]	Phase 4	197 participants (Actual)	Interventional	2015-06-03	Completed
An Open-label, Randomised Controlled Multi-centre Study to Assess the Impact of Ferric Carboxymaltose in Correcting Iron Deficiency Anaemia Compared With Venofer® (Iron Sucrose) in Chinese Subjects [NCT03591406]	Phase 3	371 participants (Actual)	Interventional	2017-07-03	Completed
Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy [NCT03317210]	Phase 4	50 participants (Actual)	Interventional	2002-09-01	Completed
Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial [NCT05251493]	Phase 3	280 participants (Anticipated)	Interventional	2022-06-06	Recruiting
Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study [NCT02392910]	Phase 4	40 participants (Actual)	Interventional	2006-03-31	Completed
Iron Deficiency and Fibroblast Growth Factor 23 Regulation in Chronic Kidney Disease and Heart Failure [NCT03106298]		77 participants (Actual)	Observational	2015-12-18	Completed
To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy [NCT02441439]		0 participants (Actual)	Interventional	2022-01-01	Withdrawn(stopped due to The investigators decided not to proceed with this study)
A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4 [NCT03630029]	Phase 1	0 participants (Actual)	Interventional	2018-09-15	Withdrawn(stopped due to The trial has been enhanced, a new NCT(NCT03893799) listing was created.)
This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma [NCT03516500]		20 participants (Actual)	Interventional	2018-05-09	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.)
Fetal Vascular Hemodynamic Changes Before and After Treatment of Maternal Iron Deficiency Anemia [NCT03883841]		60 participants (Anticipated)	Observational	2019-05-31	Not yet recruiting
A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women [NCT01290315]	Phase 2	49 participants (Actual)	Interventional	2009-08-31	Completed
Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy [NCT05800600]	Phase 2	34 participants (Anticipated)	Interventional	2023-03-15	Recruiting
Physiology Study Investigating the Effects of Supplementation and Depletion of Iron on Hypoxia-related Pulmonary Hypertension [NCT00952302]		33 participants (Actual)	Interventional	2008-10-31	Completed
A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects. [NCT00719459]	Phase 1	60 participants (Actual)	Interventional	2008-06-30	Completed
A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia [NCT00802139]	Phase 4	58 participants (Actual)	Interventional	2008-02-29	Completed
Rationale and Design of Ferric Polymaltose Hydroxide and Iron Sucrose Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study [NCT04225728]	Phase 4	45 participants (Actual)	Interventional	2017-12-01	Completed
Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study [NCT02743572]		129 participants (Actual)	Interventional	2015-09-30	Completed
Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients [NCT02787824]	Phase 4	27 participants (Actual)	Interventional	2016-05-31	Completed
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial [NCT00660933]	Phase 4	70 participants (Actual)	Interventional	2005-09-30	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 III Study of Z-213 in Subjects With Iron-deficiency Anemia [NCT02731534]	Phase 3	238 participants (Actual)	Interventional	2016-05-31	Completed
Darbepoetin-alpha and i.v. Iron Administration After Autologous Hematopoietic Stem Cell Transplantation : a Prospective Randomized Trial [NCT00557817]	Phase 2/Phase 3	125 participants (Actual)	Interventional	2004-03-31	Completed
Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration [NCT00560976]		100 participants (Anticipated)	Interventional	2005-12-31	Recruiting
Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial [NCT00746551]	Phase 4	80 participants (Actual)	Interventional	2008-09-30	Completed
Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Infl [NCT00810030]	Phase 3	484 participants (Actual)	Interventional	2008-10-31	Completed
Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome [NCT04016922]		500 participants (Anticipated)	Observational [Patient Registry]	2019-07-31	Not yet recruiting
Does Intraoperative Intravenous Iron Sucrose Enhance Postoperative Oxygenation Profile in Total Arthroplasty Surgery? [NCT02544828]	Phase 4	76 participants (Anticipated)	Interventional	2015-11-30	Not yet recruiting
Study of the Effects of Iron Supplementation on High Altitude Pulmonary Hypertension. [NCT00960921]	Phase 2	0 participants (Actual)	Interventional		Withdrawn(stopped due to Study never started.)
A Randomised Controlled Trial Comparing the Efficacy of Intravenous Iron Sucrose and Oral Iron Sulfate in Patients With Iron Deficiency. [NCT01067547]	Phase 4	130 participants (Actual)	Interventional	2010-03-31	Completed
Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients [NCT02198495]	Phase 4	143 participants (Actual)	Interventional	2014-09-30	Completed
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9) [NCT06061393]	Phase 4	200 participants (Anticipated)	Interventional	2023-10-30	Not yet recruiting
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced. [NCT00210002]	Phase 2	55 participants	Interventional	2003-11-30	Terminated
A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD) [NCT03619850]	Phase 3	129 participants (Anticipated)	Interventional	2018-08-13	Recruiting
A Randomized Pilot Study of Ferric Carboxymaltose as Compared to Iron Sucrose for the Treatment of Functional Iron Deficiency Associated With Surgical Critical Illness [NCT02009943]	Phase 1	0 participants (Actual)	Interventional	2017-02-28	Withdrawn(stopped due to Inadequate funds)
A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study [NCT00593619]	Phase 4	200 participants (Anticipated)	Interventional	2008-01-31	Suspended(stopped due to Interim Analysis and review by Data Safety Monitoring Board)
A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia [NCT01114204]	Phase 3	605 participants (Actual)	Interventional	2010-08-10	Completed
A Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 200 ng/mL [NCT01309659]	Phase 2	19 participants (Actual)	Interventional	2011-05-31	Terminated(stopped due to Lack of Enrollment)
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis [NCT01227616]	Phase 4	296 participants (Actual)	Interventional	2013-08-31	Completed
Bioequivalence Study Assessing a Single Dose of Iron Sucrose Injection (Baxter) or a Single Dose of Venofer® Injection in Healthy Adult Subjects [NCT04155814]	Phase 1	196 participants (Actual)	Interventional	2019-09-19	Completed
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial [NCT01857011]	Phase 3	56 participants (Actual)	Interventional	2014-04-30	Completed
Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function [NCT00981045]	Phase 3	2,561 participants (Actual)	Interventional	2009-08-31	Completed
A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients [NCT00534144]	Phase 1	74 participants (Actual)	Interventional	2007-09-30	Completed
Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy [NCT05921968]	Phase 4	100 participants (Anticipated)	Interventional	2023-07-30	Not yet recruiting
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
Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's) [NCT00721188]	Phase 2	11 participants (Actual)	Interventional	2006-01-31	Completed
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic [NCT01222884]	Phase 3	351 participants (Actual)	Interventional	2011-06-30	Completed
Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders [NCT00145652]	Phase 3	66 participants	Interventional	2003-12-31	Completed
A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure [NCT00125996]	Phase 1/Phase 2	42 participants	Interventional	2004-07-31	Recruiting
Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin [NCT00239616]	Phase 4	8 participants	Interventional	2002-06-30	Completed
Assessment of the Use of Intravenous Iron Sucrose to Maintain Haemoglobin Levels and Delay the Onset of Use of Erythropoietic Agents and/or Dialysis in Stage 3/4 Chronic Kidney Disease [NCT00202345]	Phase 3	120 participants	Interventional	2004-08-31	Completed
Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease [NCT00204256]	Phase 4	50 participants	Interventional	2004-03-31	Active, not recruiting
ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial [NCT03214627]		88 participants (Actual)	Interventional	2018-12-10	Terminated(stopped due to Standard clinical practice at site caused unforeseen issues for the use of the ACM)
Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia. [NCT00199277]	Phase 4	150 participants	Interventional		Not yet recruiting
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 IV Study of Iron Indices' Kinetics in Hemodialysis Patients [NCT00308490]	Phase 4	160 participants	Interventional	2005-09-30	Completed
Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial ) [NCT05151679]		0 participants	Expanded Access		Available
Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial [NCT03009578]	Phase 3	100 participants (Actual)	Interventional	2017-02-01	Completed
Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy [NCT01435200]	Phase 3	64 participants (Actual)	Interventional	2011-06-30	Completed
Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease [NCT01438372]	Phase 2	0 participants (Actual)	Interventional	2011-11-30	Withdrawn(stopped due to The study was terminated prior to enrolling patients as we were unable to secure enough funding to complete the study.)
Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers Versus Critical Care Patients [NCT01443624]		80 participants (Actual)	Interventional	2011-10-31	Completed
A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects [NCT03893045]	Phase 3	75 participants (Anticipated)	Interventional	2019-09-18	Recruiting
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population [NCT02977611]	Phase 2	0 participants (Actual)	Interventional	2017-01-31	Withdrawn(stopped due to FDA Clinical Hold)
Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial. [NCT05489952]	Phase 4	444 participants (Anticipated)	Interventional	2022-09-15	Recruiting
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy [NCT03933813]	Phase 1/Phase 2	9 participants (Actual)	Interventional	2019-07-29	Terminated(stopped due to slow accrual)
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia [NCT00236977]	Phase 3	182 participants (Actual)	Interventional	2003-08-31	Completed
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
A Multicenter, Randomized, Double-blind Comparison of Intravenous Iron Supplementation to Placebo for the Treatment of Anemia of Traumatic Critical Illness [NCT01180894]		150 participants (Actual)	Interventional	2011-06-30	Completed
Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study [NCT00386126]	Phase 2/Phase 3	117 participants	Interventional	2006-08-31	Recruiting
A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS) [NCT01978535]	Phase 1/Phase 2	3 participants (Actual)	Interventional	2014-12-17	Terminated(stopped due to Difficulty in recruiting subjects.)
A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients [NCT00354692]	Phase 4	12 participants (Actual)	Interventional	2006-06-30	Completed
The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease [NCT00384657]	Phase 3	0 participants (Actual)	Interventional	2008-01-31	Withdrawn(stopped due to Lack of cooperation among centers, Financial reasons)
A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia [NCT02458625]		158 participants (Actual)	Interventional	2016-04-30	Completed
Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia [NCT02707757]	Phase 4	197 participants (Actual)	Interventional	2015-07-31	Completed
The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron [NCT02390921]	Phase 4	40 participants (Actual)	Interventional	2015-02-28	Completed
An Open-label, Randomized, Crossover-design Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in [NCT02391181]	Phase 1	30 participants (Actual)	Interventional	2014-11-30	Completed
A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE [NCT02130063]	Phase 3	511 participants (Actual)	Interventional	2014-05-31	Completed
Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients [NCT00239642]	Phase 4	141 participants (Actual)	Interventional	2005-07-31	Completed
Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study [NCT00318812]	Phase 2/Phase 3	55 participants (Actual)	Interventional	2007-05-31	Completed
Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments [NCT00895232]	Phase 2	21 participants (Actual)	Interventional	2003-11-30	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
Open-label, Randomized, Crossover-design Bioequivalence Study With Comparing a Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection of Vifor AG in Healthy Male Volunteers [NCT03093883]	Phase 1	48 participants (Actual)	Interventional	2017-03-13	Completed
A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS) [NCT04855266]	Phase 2	0 participants (Actual)	Interventional	2021-04-30	Withdrawn(stopped due to Unable to recruit participants)
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00236938 (4) [back to overview]	The Mean Change From Baseline to the Highest Ferritin up to Day 71
NCT00236938 (4) [back to overview]	The Mean Change From Baseline to the Highest Reticulocyte Count 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).
NCT00236977 (7) [back to overview]	Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
NCT00236977 (7) [back to overview]	Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
NCT00236977 (7) [back to overview]	Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
NCT00236977 (7) [back to overview]	Mean Change in Ferritin (ng/mL) From Baseline to Day 56
NCT00236977 (7) [back to overview]	Number of Subjects With a Clinical Response
NCT00236977 (7) [back to overview]	Patients With an Increase in Hemoglobin >= 1gm/dL.
NCT00236977 (7) [back to overview]	Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
NCT00239642 (9) [back to overview]	Number of Subjects Achieving Clinical Success
NCT00239642 (9) [back to overview]	Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
NCT00239642 (9) [back to overview]	Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
NCT00239642 (9) [back to overview]	Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
NCT00239642 (9) [back to overview]	Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
NCT00239642 (9) [back to overview]	Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
NCT00239642 (9) [back to overview]	Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
NCT00239642 (9) [back to overview]	Percentage (%) of Subjects Achieving Clinical Success
NCT00239642 (9) [back to overview]	Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
NCT00318812 (3) [back to overview]	Ferritin
NCT00318812 (3) [back to overview]	Hemoglobin Concentration at 6 Months
NCT00318812 (3) [back to overview]	Transferrin Saturation
NCT00721188 (12) [back to overview]	Terminal Phase Elimination Rate Constant (λz)
NCT00721188 (12) [back to overview]	Volume of Distribution at Steady State (Vdss)
NCT00721188 (12) [back to overview]	Volume of Distribution Based on the Terminal Phase (Vdarea)
NCT00721188 (12) [back to overview]	Total Body Clearance (Cl)
NCT00721188 (12) [back to overview]	Time to Maximum Serum Concentration (Tmax)
NCT00721188 (12) [back to overview]	Serum Terminal Phase Elimination Half-life (T1/2)
NCT00721188 (12) [back to overview]	Number of Participants With Serious Adverse Events (SAE's)
NCT00721188 (12) [back to overview]	Mean Residence Time (MRtime)
NCT00721188 (12) [back to overview]	Maximum Observed Serum Concentration (Cmax)
NCT00721188 (12) [back to overview]	Initial Volume of Distribution (Vdc)
NCT00721188 (12) [back to overview]	Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
NCT00721188 (12) [back to overview]	Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
NCT00746551 (2) [back to overview]	Haemoglobin Level
NCT00746551 (2) [back to overview]	Serum Ferritin Level
NCT00895232 (3) [back to overview]	Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale
NCT00895232 (3) [back to overview]	Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)
NCT00895232 (3) [back to overview]	Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.
NCT00981045 (2) [back to overview]	Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
NCT00981045 (2) [back to overview]	Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
NCT01052779 (2) [back to overview]	Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
NCT01052779 (2) [back to overview]	Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
NCT01114204 (6) [back to overview]	Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline
NCT01114204 (6) [back to overview]	Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
NCT01114204 (6) [back to overview]	Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
NCT01114204 (6) [back to overview]	Mean Change In TSAT From Baseline To Week 5
NCT01114204 (6) [back to overview]	Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
NCT01114204 (6) [back to overview]	Mean Change In Hemoglobin From Baseline To Week 5
NCT01180894 (4) [back to overview]	RBC Transfusion
NCT01180894 (4) [back to overview]	The Number of Participants Who Died
NCT01180894 (4) [back to overview]	Iron-deficient Erythropoeisis (IDE)
NCT01180894 (4) [back to overview]	Infection
NCT01222884 (2) [back to overview]	Change in Hemoglobin Concentration
NCT01222884 (2) [back to overview]	Ability to Maintain Hemoglobin Level
NCT01227616 (3) [back to overview]	Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP
NCT01227616 (3) [back to overview]	Hemoglobin Changes
NCT01227616 (3) [back to overview]	Changes in Transferrin Saturation (TSAT)
NCT01290315 (4) [back to overview]	Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
NCT01290315 (4) [back to overview]	Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
NCT01290315 (4) [back to overview]	Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
NCT01290315 (4) [back to overview]	Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
NCT01309659 (18) [back to overview]	Change in Frailty Component Related to Fatigue/ Exhaustion
NCT01309659 (18) [back to overview]	Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance
NCT01309659 (18) [back to overview]	Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)
NCT01309659 (18) [back to overview]	Change in 6 Minute Walk Test Results
NCT01309659 (18) [back to overview]	Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing
NCT01309659 (18) [back to overview]	Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory
NCT01309659 (18) [back to overview]	Change in Cognitive Outcome Measures as Determined by Speed of Processing
NCT01309659 (18) [back to overview]	Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B
NCT01309659 (18) [back to overview]	Change in Frailty Component as Determined by Grip Strength
NCT01309659 (18) [back to overview]	Change in Frailty Component as Determined by the 4 Meter Walk Speed
NCT01309659 (18) [back to overview]	Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score
NCT01309659 (18) [back to overview]	Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)
NCT01309659 (18) [back to overview]	Change in the Frailty Component as Determined by Self-reported Activity Level
NCT01309659 (18) [back to overview]	Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks
NCT01309659 (18) [back to overview]	Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance
NCT01309659 (18) [back to overview]	Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin
NCT01309659 (18) [back to overview]	Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance
NCT01309659 (18) [back to overview]	Number of Participants Who Had a Hemoglobin Increase >= 1g/dL
NCT01888003 (2) [back to overview]	Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
NCT01888003 (2) [back to overview]	Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
NCT02130063 (4) [back to overview]	Change in Transferrin Saturation (TSAT)
NCT02130063 (4) [back to overview]	Change in Hb Concentration
NCT02130063 (4) [back to overview]	Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
NCT02130063 (4) [back to overview]	Change in Serum (s)-Ferritin Concentration
NCT02707757 (1) [back to overview]	Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
NCT02940860 (20) [back to overview]	Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
NCT02940860 (20) [back to overview]	Time to Change in Hb Concentration ≥1 g/dL
NCT02940860 (20) [back to overview]	S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
NCT02940860 (20) [back to overview]	Change in Hemoglobin (Hb) From Baseline to Week 8
NCT02940860 (20) [back to overview]	Composite Cardiovascular Adverse Events (AEs)
NCT02940860 (20) [back to overview]	Change in Hb Concentration From Baseline to Week 1, 2, and 4
NCT02940860 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
NCT02940860 (20) [back to overview]	Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
NCT02940860 (20) [back to overview]	Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
NCT02940860 (20) [back to overview]	Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
NCT02940860 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
NCT02940860 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
NCT02940860 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
NCT02940860 (20) [back to overview]	Health Care Resource Use Questionnaire
NCT02940860 (20) [back to overview]	Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8
NCT02940860 (20) [back to overview]	S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
NCT02940860 (20) [back to overview]	Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8
NCT02940860 (20) [back to overview]	Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
NCT02940860 (20) [back to overview]	Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8
NCT02940860 (20) [back to overview]	Time to First Composite Cardiovascular Safety AE
NCT02940886 (20) [back to overview]	Composite Cardiovascular Adverse Events (AEs)
NCT02940886 (20) [back to overview]	Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
NCT02940886 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
NCT02940886 (20) [back to overview]	Time to Change in Hb Concentration ≥2 g/dL
NCT02940886 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
NCT02940886 (20) [back to overview]	Change in Hemoglobin (Hb) From Baseline to Week 8
NCT02940886 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
NCT02940886 (20) [back to overview]	Health Care Resource Use Questionnaire
NCT02940886 (20) [back to overview]	Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8
NCT02940886 (20) [back to overview]	Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
NCT02940886 (20) [back to overview]	Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8
NCT02940886 (20) [back to overview]	Change in Hb Concentration From Baseline to Week 1, 2, and 4
NCT02940886 (20) [back to overview]	Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
NCT02940886 (20) [back to overview]	Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
NCT02940886 (20) [back to overview]	Time to First Composite Cardiovascular Safety AE
NCT02940886 (20) [back to overview]	S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
NCT02940886 (20) [back to overview]	S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
NCT02940886 (20) [back to overview]	Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
NCT02940886 (20) [back to overview]	Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
NCT02940886 (20) [back to overview]	Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
NCT03591406 (12) [back to overview]	Change in Hb From Baseline to Weeks 2, 4, 6, and 8
NCT03591406 (12) [back to overview]	Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Participants With Iron Deficiency Correction Over Time by Treatment
NCT03591406 (12) [back to overview]	Change in TSAT From Baseline to Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
NCT03591406 (12) [back to overview]	Heart Rate at Baseline and Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Participants With Any Treatment Emergent Adverse Event (TEAE)
NCT03591406 (12) [back to overview]	Blood Pressure at Baseline and Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Body Temperature at Baseline and Weeks 2, 4, 6 and 8
NCT03591406 (12) [back to overview]	Body Weight at Baseline and Week 8
NCT03658876 (1) [back to overview]	Hemoglobin Incrementation

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

Intervention	percentage of change (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose	0.7226
Group B: Erythropoietin EPO Fixed Dose Only	0.4630

Intervention	percentage of change (Mean)
Group A: Venofer and Erythropoietin EPO Fixed Dose	18.176
Group B: Erythropoietin EPO Fixed Dose Only	10.383

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

Intervention	participants (Number)
Venofer (0.5 mg/kg)	44
Venofer (1.0 mg/kg)	40
Venofer (2.0 mg/kg)	33

Intervention	percentage of subjects (Number)
Venofer (0.5 mg/kg)	100.0
Venofer (1.0 mg/kg)	95.6
Venofer (2.0 mg/kg)	95.0

Intervention	percentage of subjects (Number)
Venofer (0.5 mg/kg)	95.7
Venofer (1.0 mg/kg)	93.3
Venofer (2.0 mg/kg)	92.5

Intervention	g/dL (Mean)
Iron Sucrose, Venofer, Intravenous Drug	10.6
Ferrous Fumarate, Ferri-6, Oral Tablet	10.2

Intervention	µg/dL (Mean)
Iron Sucrose, Venofer, Intravenous Drug	136.1
Ferrous Fumarate, Ferri-6, Oral Tablet	28.3

Intervention	units on a scale (Mean)
Cohort I (Venofer 500mg x 1 Dose)	-2.4
Cohort II (Venofer 500mg X 2 Doses)	-14.3
Cohort III (Venofer 500mg x 2 Doses)	-16.0

Intervention	PLM's per hour (Mean)
Cohort I (Venofer 500mg x 1 Dose)	-7.2
Cohort II (Venofer 500mg X 2 Doses)	-75.0
Cohort III (Venofer 500mg x 2 Doses)	-96.2

Intervention	percent of participants (Number)
Cohort I (Venofer 500mg x 1 Dose)	28.6
Cohort II (Venofer 500mg X 2 Doses)	66.7
Cohort III (Venofer 500mg x 2 Doses)	66.7

Intervention	Participants (Count of Participants)
	Week 2	Week 3	Week 4	Week 5
Ferumoxytol	20	32	37	40
Iron Sucrose	11	20	31	34

Intervention	g/dL (Least Squares Mean)
	With LOCF Imputation	Without Imputation (Sensitivity Analysis)
Ferumoxytol	0.84	0.89
Iron Sucrose	0.74	0.80

Intervention	Participants (Count of Participants)
	Up to Week 3	Up to Week 4	Up to Week 5
Ferumoxytol	291	327	341
Iron Sucrose	117	145	162

Intervention	g/dL (Mean)
	TP1	TP2	TP3	TP4	TP5	TP6
Ferumoxytol	0.5	0.6	0.6	0.5	0.4	0.5
Iron Sucrose	0.4	0.3	0.4	0.6	0.3	-0.3

Intervention	Percent (Mean)
	TP1	TP2	TP3	TP4	TP5	TP6
Ferumoxytol	6.6	8.2	8.5	9.8	6.3	7.1
Iron Sucrose	9.5	11.3	9.1	10.0	14.4	5.1

Intervention	mg (Mean)
	Carbonyl	8-isoprostane
Ferric Carboxymaltose (FCM) Cohort I	8.63	198.67
Ferric Carboxymaltose (FCM) Cohort II	8.94	-23.96
Iron Dextran Cohort II	-11.57	38.02
Iron Sucrose Cohort I	-6.92	119.26

Intervention	participants (Number)
	Frailty change - self reported exhaustion	Frailty change - self-reported low energy
Immediate Intervention Group	9	0
Wait List Control	10	0

Intervention	correlation coefficient (Number)
	Correlation for ferritin	Correlation for iron	Correlation TSAT
Immediate Intervention Group	0.617	0.332	0.400
Wait List Control	0.100	-0.133	-0.350

Intervention	correlation coefficient (Number)
	Correlation btw baseline ferritin & change in Hgb	Correlation btw baseline iron & change in Hgb	Correlation btw baseline TST & change in Hgb
Immediate Intervention Group	0.383	0.323	0.200
Wait List Control	0.189	0.541	0.584

ferric oxide, saccharated

Description

Cross-References

Synonyms (40)

Research Excerpts

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Research

Studies (650)

Study Types

Clinical Trials (97)

Trial Overview

Trial Outcomes

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

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

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

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

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

Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56

Mean Change From Baseline in Hemoglobin (g/dL) at Day 56

Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56

Mean Change in Ferritin (ng/mL) From Baseline to Day 56

Number of Subjects With a Clinical Response

Patients With an Increase in Hemoglobin >= 1gm/dL.

Highest Change From Baseline in Ferritin (ng/mL) up to Day 56

Number of Subjects Achieving Clinical Success

Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive

Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event

Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive

Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline

Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline

Percentage (%) of Subjects Achieving Clinical Success

Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

Ferritin

Hemoglobin Concentration at 6 Months

Transferrin Saturation

Terminal Phase Elimination Rate Constant (λz)

Volume of Distribution at Steady State (Vdss)

Volume of Distribution Based on the Terminal Phase (Vdarea)

Total Body Clearance (Cl)

Time to Maximum Serum Concentration (Tmax)

Serum Terminal Phase Elimination Half-life (T1/2)

Number of Participants With Serious Adverse Events (SAE's)

Mean Residence Time (MRtime)

Maximum Observed Serum Concentration (Cmax)

Initial Volume of Distribution (Vdc)

Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)

Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)

Haemoglobin Level

Serum Ferritin Level

Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale

Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)

Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.

Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.

Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.

Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5

Mean Change In Hemoglobin From Baseline (Day 1) To Week 5

Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5

Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5

Mean Change In TSAT From Baseline To Week 5

Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5

Mean Change In Hemoglobin From Baseline To Week 5

RBC Transfusion

The Number of Participants Who Died

Iron-deficient Erythropoeisis (IDE)

Infection

Change in Hemoglobin Concentration

Ability to Maintain Hemoglobin Level

Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP

Hemoglobin Changes

Changes in Transferrin Saturation (TSAT)

Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

Intervention	participants (Number)
Anemia Treatment Group (AMG)	0
Conventional Treatment Group (CTG)	1
Non Anemia Group (NAG)	0

Intervention	percent (Mean)
	Week 1	Week 2	Week 4	Week 5
Iron Isomaltoside 1000 (Monofer®)	15.7	17.9	16.3	15.6
Iron Sucrose (Venofer®)	3.3	5.7	11.5	11.8

Intervention	Hours (Median)
	Time spent on visit	Total time spent helping on visit
Iron Isomaltoside/Ferric Derisomaltose	2.00	2.00
Iron Sucrose	2.00	2.00

Intervention	Participants (Count of Participants)
	In employment, YES	Took time off work to attend, YES	Assistance by others to attend visit, YES	Others took time off work to attend, YES
Iron Isomaltoside/Ferric Derisomaltose	152	70	410	82
Iron Sucrose	57	26	197	40

Intervention	US dollars ($) (Median)
	Cost of public transport/taxi	Cost of parking
Iron Isomaltoside/Ferric Derisomaltose	0.0	0.0
Iron Sucrose	0.0	0.0

Intervention	hours (Median)
	Time spent per site staff	Time spent per subject
Iron Isomaltoside/Ferric Derisomaltose	1.17	2.58
Iron Sucrose	1.00	2.33

Intervention	Participants (Count of Participants)
	Responder YES week 1	Responder YES week 2	Responder YES week 4	Responder YES week 8
Iron Isomaltoside/Ferric Derisomaltose	200	339	430	474
Iron Sucrose	78	112	174	226

Intervention	score on a scale (Mean)
	Week 1	Week 2	Week 8
Iron Isomaltoside/Ferric Derisomaltose	5.04	7.29	9.13
Iron Sucrose	5.01	7.63	9.07

Intervention	hours (Median)
	Time spent per site staff median	Time spent per subject median
Iron Isomaltoside/Ferric Derisomaltose	1.08	3.38
Iron Sucrose	1.00	3.00

Intervention	g/dL (Mean)
	Week 2	Week 4	Week 6	Week 8
Ferric Carboxymaltose (FCM)	3.01	4.46	4.96	5.09
Iron Sucrose (IS)	2.53	4.08	4.61	4.87