Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial
Open Access
- 20 August 2013
- journal article
- research article
- Published by Oxford University Press (OUP) in Nephrology Dialysis Transplantation
- Vol. 29 (4), 833-842
- https://doi.org/10.1093/ndt/gft251
Abstract
Background Iron-deficiency anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) frequently requires parenteral iron replacement, but existing therapies often require multiple administrations. We evaluated the efficacy and cardiovascular safety of ferric carboxymaltose (FCM), a non-dextran parenteral iron permitting large single-dose infusions, versus iron sucrose in patients with iron-deficiency anemia and NDD-CKD. Methods A total of 2584 participants were randomized to two doses of FCM 750 mg in one week, or iron sucrose 200 mg administered in up to five infusions in 14 days. The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56. The primary composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, congestive heart failure, arrhythmias and hyper- and hypotensive events. Results The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group (95% CI, 0.13–0.28). Similar results were observed across all subgroups, except Stage 2 CKD. More subjects in the FCM group achieved a hemoglobin increase of ≥1.0 g/dL between baseline and Day 56 (48.6 versus 41.0%; 95% CI, 3.6–11.6%). There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint, including the major adverse cardiac events of death, myocardial infarction, or stroke. A significant difference in the number of protocol-defined, predominantly transient hypertensive episodes was observed in the FCM group. Conclusions Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia.Keywords
This publication has 18 references indexed in Scilit:
- Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center studyNephrology Dialysis Transplantation, 2012
- FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel DiseaseGastroenterology, 2011
- A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patientsNephrology Dialysis Transplantation, 2010
- Ferric Carboxymaltose in Patients with Heart Failure and Iron DeficiencyThe New England Journal of Medicine, 2009
- Ferric CarboxymaltoseDrugs, 2009
- Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Postpartum AnemiaObstetrics & Gynecology, 2007
- Association of Kidney Function With AnemiaArchives of Internal Medicine, 2002
- Epidemiology of anemia associated with chronic renal insufficiencyCurrent Opinion in Nephrology and Hypertension, 2002
- Iron management in end-stage renal diseaseAmerican Journal of Kidney Diseases, 1997
- Treatment of the Anemia of Chronic Renal Failure with Recombinant Human ErythropoietinAnnual Review of Medicine, 1990