Randomized Evaluation of efficacy and safety of ferric carboxymaltose in Patients with iron deficiency Anaemia and Impaired Renal function (REPAIR-IDA): Rationale and study design

Nephrology Dialysis Transplantation

Volumn 25, Issue 7, 2010, Pages 2368-2375

  Szczech, Lynda A ^a,b   Bregman, David B ^c,d   Harrington, Robert A ^a,b   Morris, David ^e   Butcher, Angelia ^c   Koch, Todd A ^c   Goodnough, Lawrence T ^f   Wolf, Myles ^g   Onken, Jane E ^b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c Luitpold Pharmaceuticals Inc   (United States)

^d ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^e WebbWrites   (United States)

^f STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

intravenous iron; iron deficiency anaemia; kidney disease

Indexed keywords

ANTIANEMIC AGENT; FERRIC CARBOXYMALTOSE; FERRIC HYDROXIDE SUCROSE; FIBROBLAST GROWTH FACTOR 23; HEMOGLOBIN; IRON DERIVATIVE; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; FERRIC ION; FIBROBLAST GROWTH FACTOR; IRON(III)-HYDROXIDE SUCROSE COMPLEX; MALTOSE; SUCROSE;

ADULT; CARDIOTOXICITY; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; HEART INFARCTION; HEART PROTECTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOTENSION; IRON DEFICIENCY ANEMIA; IRON THERAPY; MAJOR CLINICAL STUDY; MALE; METHODOLOGY; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; STROKE; UNSTABLE ANGINA PECTORIS; AGED; ANALOGS AND DERIVATIVES; ANEMIA, IRON-DEFICIENCY; BLOOD; CARDIOVASCULAR DISEASES; CHRONIC DISEASE; KIDNEY DISEASE; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; RISK FACTOR; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANEMIA, IRON-DEFICIENCY; BIOLOGICAL MARKERS; CARDIOVASCULAR DISEASES; CHRONIC DISEASE; FEMALE; FERRIC COMPOUNDS; FIBROBLAST GROWTH FACTORS; HEMOGLOBINS; HUMANS; KIDNEY DISEASES; MALE; MALTOSE; MIDDLE AGED; RISK FACTORS; SUCROSE; TREATMENT OUTCOME;

EID: 77954343566     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfq218     Document Type: Review

References (34)

1. Hocken AG, Marwah PK. Iatrogenic contribution to anaemia of chronic renal failure. Lancet 1971; 1: 164-165
2. Shaw AB. Haemolysis in chronic renal failure. Br Med J 1967; 2: 213-216
3. Loge JP, Lange RD, Moore CV. Characterization of the anemia associated with chronic renal insufficiency. Am J Med 1958; 24: 4-18
4. Goodnough LT. Erythropoietin and iron-restricted erythropoiesis. Exp Hematol 2007; 35: 167-172
5. Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med 2005; 352: 1011-1023
6. Astor BC, Muntner P, Levin A et al. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med 2002; 162: 1401-1408
7. Morbidity and mortality weekly report. Available at http://www.cdc. gov/mmwr/preview/mmwrhtml/mm5608a2.html (27 January 2010, date last accessed) 2010
8. McClellan W, Aronoff SL, Bolton WK et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004; 20: 1501-1510 (Pubitemid 39361354)
9. Fishbane S, Pollack S, Feldman HI et al. Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988-2004. Clin J Am Soc Nephrol 2009; 4: 57-61
10. Drueke TB, Locatelli F, Clyne N et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355: 2071-2084
11. Pfeffer MA, Burdmann EA, Chen CYet al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009; 361: 2019-2032
12. Singh AK, Szczech L, Tang KL et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355: 2085-2098
13. Goodnough LT. The new age of iron: evaluation and management of iron-restricted erythropoiesis. Semin Hematol 2009; 46: 325-327
14. Fishbane S, Ungureanu VD, Maesaka JK et al. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis 1996; 28: 529-534 (Pubitemid 26337591)
15. Van Wyck DB. Labile iron: manifestations and clinical implications. J Am Soc Nephrol 2004; 15: S107-S111
16. Shander A, Spence RK, Auerbach M. Can intravenous iron therapy meet the unmet needs created by the new restrictions on erythropoi-etic stimulating agents? Transfusion 2009
17. Schwenk MH. Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy 2010; 30: 70-79
18. Lyseng-Williamson KA, Keating GM. Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. Drugs 2009; 69: 739-756
19. Breymann C, Gliga F, Bejenariu C et al. Comparative efficacy and safetyof intravenous ferric carboxymaltosein the treatment of postpar-tum iron deficiency anemia. Int J Gynaecol Obstet 2008; 101: 67-73
20. Seid MH, Derman RJ, Baker JB et al. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008; 199: 435-437
21. Van Wyck DB, Martens MG, Seid MH et al. Intravenous ferric carboxymaltose compared with oral iron in the treatment of post-partum anemia: a randomized controlled trial. Obstet Gynecol 2007; 110: 267-278
22. Van Wyck DB, Mangione A, Morrison J et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009; 49: 2719-2728
23. Anker SD, Comin CJ, Filippatos G et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009; 361: 2436-2448
24. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. http://www.kidney.org/professionals/KDOQI/ guidelines-anemia/index.html 2006
25. Isakova T, Gutierrez OM, Wolf M. A blueprint for randomized trials targeting phosphorus metabolism in chronic kidney disease. Kidney Int 2009; 76: 705-716
26. Gutierrez OM, Mannstadt M, Isakova T et al. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. N Engl J Med 2008; 359: 584-592
27. Shimada T, Urakawa I, Isakova T et al. Circulating fibroblast growth factor 23 in patients with end-stage renal disease treated by peritoneal dialysis is intact and biologically active. J Clin Endocrinol Metab 2010; 95: 578-585
28. Schouten BJ, Hunt PJ, Livesey JH et al. FGF23 elevation and hypo-phosphatemia after intravenous iron polymaltose: a prospective study. J Clin Endocrinol Metab 2009; 94: 2332-2337
29. Szczech LA, Barnhart HX, Inrig JK et al. Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int 2008; 74: 791-798
30. Besarab A, Amin N, Ahsan M et al. Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients. J Am Soc Nephrol 2000; 11: 530-538
31. Auerbach M, Goodnough LT, Picard D et al. The role of intravenous iron in anemia management and transfusion avoidance. Transfusion 2008; 48: 988-1000
32. Medicare Programs; End-Stage Renal Disease Prospective Payment System; Town Hall Meeting on End-Stage Renal Disease Prospective Payment System; Proposed Rule and Notice. Centers for Medicare &Medicaid Services. Federal Register 74, No.187 (September 2009). http://edocket.access.gpo.gov/2009/pdf/E9- 22486.pdf (25 January 2010, date last accessed) 2010
33. Pizzi LT, Bunz TJ, Coyne DW et al. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int 2008; 74: 1588-1595
34. Wilson PW, D?Agostino RB, Levy D et al. Prediction of coronary heart disease using risk factor categories. Circulation 1998; 97: 1837-1847