A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis- dependent chronic kidney disease patients

Nephrology Dialysis Transplantation

Volumn 26, Issue 5, 2011, Pages 1599-1607

  Qunibi, Wajeh Y ^a   Martinez, Carlos ^b   Smith, Mark ^c   Benjamin, Joseph ^d   Mangione, Antoinette ^e   Roger, Simon D ^f  

^a Mays Cancer Center at UT Health San Antonio   (United States)

^b Renal Physicians of Georgia   (United States)

^c Kidney Care Associates   (United States)

^d TEMPLE UNIVERSITY HOSPITAL   (United States)

^e Luitpold Pharmaceuticals Inc   (United States)

^f Renal Research   (Australia)

Author keywords

anaemia; CKD; ferritin; intravenous iron; transferrin saturation

Indexed keywords

FERRIC CARBOXYMALTOSE; FERRITIN; FERROUS SULFATE; HEMOGLOBIN; IRON; TRANSFERRIN;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BRONCHITIS; CHRONIC KIDNEY DISEASE; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; ERUCTATION; FECES; FEMALE; FERRITIN BLOOD LEVEL; FLATULENCE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL HEMORRHAGE; GLOMERULUS FILTRATION RATE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERKALEMIA; HYPOTENSION; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; IRON DEFICIENCY ANEMIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NAUSEA AND VOMITING; OPEN STUDY; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RIGOR; SIDE EFFECT; SKIN DISCOLORATION; TRANSFERRIN BLOOD LEVEL; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

ADMINISTRATION, ORAL; AGED; ANEMIA, IRON-DEFICIENCY; FEMALE; FERRIC COMPOUNDS; GLOMERULAR FILTRATION RATE; HUMANS; INJECTIONS, INTRAVENOUS; IRON; KIDNEY FAILURE, CHRONIC; MALE; MALTOSE; PROGNOSIS;

EID: 79955586213     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfq613     Document Type: Article

References (40)

1. Hsu CY, McCulloch CE, Curhan GC. Iron status and hemoglobin level in chronic renal insufficiency. JAm Soc Nephrol 2002; 13: 2783-2786 (Pubitemid 35216049)
2. Gotloib L, Silverberg D, Fudin R et al. Iron deficiency is a common cause of anemia in chronic kidney disease and can often be corrected with intravenous iron. J Nephrol 2006; 19: 161-167 (Pubitemid 44420105)
3. Post JB, Wilkes BM, Michelis MF. Iron deficiency in patients with chronic kidney disease: potential role for intravenous iron therapy independent of erythropoietin. Int Urol Nephrol 2006; 38: 719-723 (Pubitemid 46336031)
4. Silverberg DS, Iaina A, Peer G et al. Intravenous iron supplementa-tion for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis 1996; 27: 234-238 (Pubitemid 26055136)
5. 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
6. Aggarwal HK, Nand N, Singh S et al. Comparison of oral versus intravenous iron therapy in predialysis patients of chronic renal fail-ure receiving recombinant human erythropoietin. JAssoc Physicians India 2003; 51: 170-174 (Pubitemid 44227894)
7. Besarab A, Amin N, Ahsan M et al. Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients. JAm Soc Nephrol 2000; 11: 530-538 (Pubitemid 30115083)
8. DeVita MV, Frumkin D, Mittal S et al. Targeting higher ferritin concentrations with intravenous iron dextran lowers erythropoietin requirement in hemodialysis patients. Clin Nephrol 2003; 60: 335-340 (Pubitemid 37407691)
9. Macdougall IC, Tucker B, Thompson J et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int 1996; 50: 1694-1699 (Pubitemid 26364277)
10. Taylor JE, Peat N, Porter C et al. Regular low-dose intravenous iron therapy improves response to erythropoietin in haemodialysis patients. Nephrol Dial Transplant 1996; 11: 1079-1083 (Pubitemid 26182502)
11. Sunder-Plassmann G, Hörl WH. Importance of iron supply for erythro-poietin therapy. Nephrol Dial Transplant 1995; 10: 2070-2076
12. K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification. Part 6. Association of Level of GFR with Complications in Adults. Guideline 12. Associ-ation of Level of GFR with Indices of Functioning and Well-Being. http://www.kidney.org/Professionals/ Kdoqi/guidelines-ckd/p6- comp-g12.htm (21 May 2010, last accessed date)
13. Macdougall IC Strategies for iron supplementation: oral versus intra-venous. Kidney Int Suppl 1999; 69: S61-S66
14. Van Wyck DB, Roppolo M, Martinez CO et al. For the United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, con-trolled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int 2005; 68: 2846-2856 (Pubitemid 43251032)
15. Charytan C, Qunibi W, Bailie GR. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not ondialysis. Nephron Clin Pract 2005; 100: c55-c62 (Pubitemid 40868986)
16. Agarwal R, Rizkala AR, Bastani B et al. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol 2006; 26: 445-454 (Pubitemid 44971735)
17. Folkert VW, Michael B, Agarwal R et al. Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (≥250 mg) administration. Am J Kidney Dis 2003; 41: 651-657 (Pubitemid 36278383)
18. Fishbane S. Safety in iron management. Am J Kidney Dis 2003; 41: S18-S26 (Pubitemid 36637965)
19. Nissenson AR, Charytan C Controversies in iron management. Kidney Int 2003; 64: S64-S71 (Pubitemid 37315510)
20. Geisser P. The pharmacology and safety profile of ferric carboxymal-tose (Ferinject(r)): structure/reactivity relationships of iron prepara-tions. Port J Nephrol Hypert 2009; 23: 11-16
21. Kulnigg S, Stoinov S, Simanenkov V et al. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol 2008; 103: 1182-1192 (Pubitemid 351677967)
22. van Wyck DB, Martens MG, Seid MH et al. Intravenous ferric car-boxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol 2007; 110: 267-278 (Pubitemid 47356650)
23. Srigiridhar K, Nair KM, Subramanian R et al. Oral repletion of iron induces free radical mediated alterations in the gastrointestinal tract of rat Mol Cell Biochem 2001; 219: 91-98 (Pubitemid 32331449)
24. Stoves J, Inglis H, Newstead CG A randomized study of oral vs intravenous iron supplementation in patients with progressive renal insufficiency treated with erythropoietin. Nephrol Dial Transplant 2001; 16: 967-974 (Pubitemid 32440369)
25. Spinowitz BS, Kausz AT, Baptista J et al. Ferumoxytol fortreating iron deficiency anemia in CKD. JAm Soc Nephrol 2008; 19: 1599-1605
26. Bailie GR, Clark JA, Lane CE et al. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 2005; 20: 1443-1449 (Pubitemid 41430619)
27. Chertow GM, Mason PD, Vaage-Nilsen O et al. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant 2006; 21: 378-382 (Pubitemid 43159991)
28. Faich G, Strobos J. Sodium ferric gluconate complex in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis 1999; 33: 464-470
29. Chandler G, Harchowal J, Macdougall IC Intravenous iron sucrose: establishing a safe dose. Am JKidney Dis 2001; 38: 988-991 (Pubitemid 33022176)
30. Bastani B, Jain A, Pandurangan G Incidence of side-effects asso-ciated with high-dose ferric gluconate in patients with severe chronic renal failure. Nephrology (Carlton) 2003; 8: 8-10 (Pubitemid 36237944)
31. Schroder O, Mickisch O, Seidler U et al. Intravenous iron sucrose versus oral iron supplementation for the treatment of iron deficiency anemia in patients with inflammatory bowel disease-a randomized, controlled, open-label, multicenter study. Am J Gastroenterol 2005; 100: 2503-2509
32. Ferrlecit® [package insert]. Corona, CA: Watson Pharma, Inc., 2001;
33. Venofer® [package insert]. Shirley, NY American Regent Laboratories, Inc., 2000
34. Mohammed S, Knoll S, van AA III et al. Cefotetan-induced hemolytic anemia causing severe hypophosphatemia. Am J Hematol 1994; 46: 369-370 (Pubitemid 24243887)
35. Sahara N, Tamashima S, Ihara M. Hereditary spherocytosis asso-ciated with severe hypophosphatemia in patients recovering from aplastic crisis. Rinsho Ketsueki 1998; 39: 386-391
36. Steiner M, Steiner B, Wilhelm S et al. Severe hypophosphatemia dur-ing hematopoietic reconstitution after allogeneic peripheral blood stem cell transplantation. Bone Marrow Transplant 2000; 25: 1015-1016 (Pubitemid 30255739)
37. Campos MS, Barrionuevo M, Alferez MJ et al. Interactions among iron, calcium, phosphorus and magnesium in the nutritionally iron-deficient rat. Exp Physiol 1998; 83: 771-781 (Pubitemid 28531937)
38. McLane JA, Fell RD, McKay RH et al. Physiological andbiochemical effects of iron deficiency on rat skeletal muscle. Am J Physiol 1981; 241: C47-C54 (Pubitemid 11044051)
39. 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
40. Szczech LA, Bregman DB, Harrington RA et al. Randomized evalu-ation of efficacy and safety of ferric carboxymaltose in patients with iron deficiency anaemia and impaired renal function (REPAIR-IDA): rationale and study design. Nephrol Dial Transplant 2010; 25: 2368-2375