title: 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.
abstract: BACKGROUND
  Patients with iron deficiency anaemia (IDA) in the setting of non-dialysis-dependent chronic kidney disease (NDD-CKD) may benefit from treatment with intravenous (IV) iron. Ferric carboxymaltose (FCM) is a novel IV iron formulation designed to permit larger infusions compared to currently available IV standards such as Venofer(R) (iron sucrose).
  
  
  METHODS
  The primary objective of REPAIR-IDA is to estimate the cardiovascular safety and efficacy of FCM (two doses at 15 mg/kg to a maximum of 750 mg per dose) compared to Venofer(R) (1000 mg administered as five infusions of 200 mg) in subjects who have IDA and NDD-CKD. REPAIR-IDA is a multi-centre, randomized, active-controlled, open-label study. Eligible patients must have haemoglobin (Hgb) < or = 11.5 g/dL and CKD defined as (1) GFR < 60 mL/min/1.73 m(2) on two occasions or (2) GFR < 90 mL/min/1.73 m(2) and either evidence of renal injury by urinalysis or elevated Framingham cardiovascular risk score. Two thousand and five hundred patients will be randomized to FCM or Venofer(R) in a 1:1 ratio. The primary efficacy endpoint is mean change in Hgb from baseline to the highest observed Hgb between baseline and Day 56. The primary safety endpoint is the proportion of subjects experiencing at least one of the following events: death due to any cause, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalization, congestive heart failure requiring hospitalization or medical intervention, arrhythmias, hypertension or hypotension during the 120 days following randomization.
  
  
  CONCLUSIONS
  REPAIR-IDA will assess the efficacy and safety of two 750-mg infusions of FCM compared to an FDA-approved IV iron regimen in patients with NDD-CKD at increased risk for cardiovascular disease.
authors.affiliation: Renal Division, Department of Medicine, Duke University Medical Center, Durham, NC, USA. szcze001@mc.duke.edu
authors.forename: Lynda A
authors.initials: LA
authors.lastname: Szczech
authors.forename: David B
authors.initials: DB
authors.lastname: Bregman
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: David
authors.initials: D
authors.lastname: Morris
authors.forename: Angelia
authors.initials: A
authors.lastname: Butcher
authors.forename: Todd A
authors.initials: TA
authors.lastname: Koch
authors.forename: Lawrence T
authors.initials: LT
authors.lastname: Goodnough
authors.forename: Myles
authors.initials: M
authors.lastname: Wolf
authors.forename: Jane E
authors.initials: JE
authors.lastname: Onken
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000453:epidemiology; D002908:Chronic Disease; D005260:Female; D005290:Ferric Compounds / Q000009:adverse effects* / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D000089703:Fibroblast Growth Factor-23; D005346:Fibroblast Growth Factors / Q000097:blood; D005937:Glucaric Acid; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000503:physiopathology*; D008297:Male; D008320:Maltose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D012307:Risk Factors; D013395:Sucrose / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D005290:Ferric Compounds; D006454:Hemoglobins; D013395:Sucrose; D005346:Fibroblast Growth Factors; C522335:ferric carboxymaltose; D008320:Maltose; D000089703:Fibroblast Growth Factor-23; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid