Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Onken, JE; Bregman, DB; Harrington, RA; Morris, D; Buerkert, J; Hamerski, D; Iftikhar, H; Mangoo-Karim, R; Martin, ER; Martinez, CO; Newman, GE; Qunibi, WY; Ross, DL; Singh, B; Smith, MT; Butcher, A; Koch, TA; Goodnough, LT

Published Date

  • April 2014

Published In

Volume / Issue

  • 29 / 4

Start / End Page

  • 833 - 842

PubMed ID

  • 23963731

Pubmed Central ID

  • 23963731

Electronic International Standard Serial Number (EISSN)

  • 1460-2385

Digital Object Identifier (DOI)

  • 10.1093/ndt/gft251

Language

  • eng

Conference Location

  • England