Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial

Clinical Nephrology

Volumn 91, Issue 4, 2019, Pages 237-245

  Macdougall, Iain C ^a   Strauss, William E ^b   Dahl, Naomi V ^b   Bernard, Kristine ^b   Li, Zhu ^b  

^a KING S COLLEGE HOSPITAL   (United Kingdom)

^b AMAG PHARMACEUTICALS INC   (United States)

Author keywords

Anemia; Chronic kidney disease; Dialysis; Iron overload; Iron sucrose

Indexed keywords

FERRITIN; FERUMOXYTOL; HEMOGLOBIN; IRON SACCHARATE; TRANSFERRIN; ANTIANEMIC AGENT; MAGNETITE;

ADULT; AGED; ARTICLE; CHRONIC KIDNEY FAILURE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FERRITIN BLOOD LEVEL; HEMODIALYSIS; HEMODIALYSIS PATIENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERSENSITIVITY; HYPOTENSION; IRON DEFICIENCY ANEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; OPEN STUDY; OXIDATIVE STRESS; PHASE 4 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; TRANSFERRIN BLOOD LEVEL; URTICARIA; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; METABOLISM; MIDDLE AGED; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANEMIA, IRON-DEFICIENCY; FEMALE; FERRIC OXIDE, SACCHARATED; FERROSOFERRIC OXIDE; HEMATINICS; HEMOGLOBINS; HUMANS; MALE; MIDDLE AGED; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC; YOUNG ADULT;

EID: 85063794759     PISSN: 03010430     EISSN: None     Source Type: Journal    
DOI: 10.5414/CN109512     Document Type: Article

References (19)

1. Macdougall IC, Geisser P. Use of intravenous iron supplementation in chronic kidney disease: an update. Iran J Kidney Dis. 2013; 7: 9-22. PubMed
2. Babitt JL, Lin HY. Mechanisms of anemia in CKD. J Am Soc Nephrol. 2012; 23: 1631-1634. CrossRef PubMed
3. Charytan DM, Pai AB, Chan CT, Coyne DW, Hung AM, Kovesdy CP, Fishbane S; Dialysis Advisory Group of the American Society of Nephrology. Considerations and challenges in defining optimal iron utilization in hemodialysis. J Am Soc Nephrol. 2015; 26: 1238-1247. CrossRef PubMed
4. Bailie GR, Larkina M, Goodkin DA, Li Y, Pisoni RL, Bieber B, Mason N, Tong L, Locatelli F, Marshall MR, Inaba M, Robinson BM. Variation in intravenous iron use internationally and over time: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2013; 28: 2570-2579. CrossRef PubMed
5. Kidney Disease Improving Global Outcomes (KDIGO). KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl. 2012; 2: 279-335.
6. Anirban G, Kohli HS, Jha V, Gupta KL, Sakhuja V. The comparative safety of various intravenous iron preparations in chronic kidney disease patients. Ren Fail. 2008; 30: 629-638. CrossRef PubMed
7. Besarab A, Amin N, Ahsan M, Vogel SE, Zazuwa G, Frinak S, Zazra JJ, Anandan JV, Gupta A. Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients. J Am Soc Nephrol. 2000; 11: 530-538. PubMed
8. Charytan C, Bernardo MV, Koch TA, Butcher A, Morris D, Bregman DB. Intravenous ferric car-boxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study. Nephrol Dial Transplant. 2013; 28: 953-964. CrossRef PubMed
9. Goldstein SL, Morris D, Warady BA. 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. Am J Kidney Dis. 2013; 61: 588-597. CrossRef PubMed
10. Kosch M, Bahner U, Bettger H, Matzkies F, Teschner M, Schaefer RM. A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo. Nephrol Dial Transplant. 2001; 16: 1239-1244. CrossRef PubMed
11. Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014; 9: 705-712. CrossRef PubMed
12. Sav T, Tokgoz B, Sipahioglu MH, Deveci M, Sari I, Oymak O, Utas C. Is there a difference between the allergic potencies of the iron sucrose and low molecular weight iron dextran? Ren Fail. 2007; 29: 423-426. CrossRef PubMed
13. Sheashaa H, El-Husseini A, Sabry A, Hassan N, Salem A, Khalil A, El-Agroudy A, Sobh M. Parenteral iron therapy in treatment of anemia in end-stage renal disease patients: a comparative study between iron saccharate and gluconate. Nephron Clin Pract. 2005; 99: c97-c101. CrossRef PubMed
14. Warady BA, Zobrist RH, Wu J, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex therapy in anemic children on hemodialysis. Pediatr Nephrol. 2005; 20: 1320-1327. CrossRef PubMed
15. Macdougall IC, Dahl NV, Bernard K, Li Z, Batycky A, Strauss WE. The Ferumoxytol for Anemia of CKD Trial (FACT) – a randomized controlled trial of repeated doses of ferumoxytol or iron sucrose in patients on hemodialysis: background and rationale. BMC Nephrol. 2017; 18: 117. CrossRef PubMed
16. Storey P, Lim RP, Chandarana H, Rosenkrantz AB, Kim D, Stoffel DR, Lee VS. MRI assessment of hepatic iron clearance rates after USPIO administration in healthy adults. Invest Radiol. 2012; 47: 717-724. CrossRef PubMed
17. Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009; 4: 386-393. CrossRef PubMed
18. Fishbane S, Mathew A, Vaziri ND. Iron toxicity: relevance for dialysis patients. Nephrol Dial Transplant. 2014; 29: 255-259. CrossRef PubMed
19. Van Buren P, Velez RL, Vaziri ND, Zhou XJ. Iron overdose: a contributor to adverse outcomes in randomized trials of anemia correction in CKD. Int Urol Nephrol. 2012; 44: 499-507. CrossRef PubMed