title: Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial.
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.
authors: Duke Clinical Research Institute, Durham, NC, USA.
authors: Jane E
authors: JE
authors: Onken
authors: David B
authors: DB
authors: Bregman
authors: Robert A
authors: RA
authors: Harrington
authors: David
authors: D
authors: Morris
authors: John
authors: J
authors: Buerkert
authors: Douglas
authors: D
authors: Hamerski
authors: Hussain
authors: H
authors: Iftikhar
authors: Roberto
authors: R
authors: Mangoo-Karim
authors: Edouard R
authors: ER
authors: Martin
authors: Carlos O
authors: CO
authors: Martinez
authors: George Edward
authors: GE
authors: Newman
authors: Wajeh Y
authors: WY
authors: Qunibi
authors: Dennis L
authors: DL
authors: Ross
authors: Bhupinder
authors: B
authors: Singh
authors: Mark T
authors: MT
authors: Smith
authors: Angelia
authors: A
authors: Butcher
authors: Todd A
authors: TA
authors: Koch
authors: Lawrence T
authors: LT
authors: Goodnough
mesh_terms: D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000209:etiology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D000077605:Ferric Oxide, Saccharated; D005919:Glomerular Filtration Rate / Q000502:physiology*; D005937:Glucaric Acid / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000097:blood*; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000503:physiopathology*; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose; D007501:Iron; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid
keywords: anemia; chronic; iron repletion; iron-deficiency; renal insufficiency