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

• Published in: Nephrology, dialysis, transplantation Vol. 25; no. 7; pp. 2368 - 2375
• Main Authors: Szczech, Lynda A., Bregman, David B., Harrington, Robert A., Morris, David, Butcher, Angelia, Koch, Todd A., Goodnough, Lawrence T., Wolf, Myles, Onken, Jane E.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.07.2010
• Subjects: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency - blood; Anemia, Iron-Deficiency - drug therapy; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Biomarkers - blood; Blood. Blood coagulation. Reticuloendothelial system; Cardiovascular Diseases - epidemiology; Chronic Disease; Emergency and intensive care: renal failure. Dialysis management; Female; Ferric Compounds - adverse effects; Ferric Compounds - therapeutic use; Fibroblast Growth Factors - blood; Glucaric Acid; Hemoglobins - metabolism; Humans; Intensive care medicine; intravenous iron; iron deficiency anaemia; kidney disease; Kidney Diseases - blood; Kidney Diseases - physiopathology; Male; Maltose - adverse effects; Maltose - analogs & derivatives; Maltose - therapeutic use; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Risk Factors; Sucrose - adverse effects; Sucrose - therapeutic use; Treatment Outcome; Human; Kidney disease; intravenous iron; Urinary system disease; Renal function; Intravenous administration; Hemodialysis; Deficiency; Iron; Ferric carboxymaltose; Extrarenal dialysis; iron deficiency anaemia; Renal failure
• ISSN: 0931-0509; 1460-2385
• DOI: 10.1093/ndt/gfq218

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® (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® (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) ≤ 11.5 g/dL and CKD defined as (1) GFR < 60 mL/min/1.73 m2 on two occasions or (2) GFR < 90 mL/min/1.73 m2 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® 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. Conclusion. 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.