FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia

• Published in: Nephrology, dialysis, transplantation Vol. 29; no. 11; pp. 2075 - 2084
• Main Authors: Macdougall, Iain C, Bock, Andreas H, Carrera, Fernando, Eckardt, Kai-Uwe, Gaillard, Carlo, Van Wyck, David, Roubert, Bernard, Nolen, Jacqueline G, Roger, Simon D
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.11.2014
• Subjects: Administration, Oral; Aged; Anemia, Iron-Deficiency - blood; Anemia, Iron-Deficiency - drug therapy; Anemia, Iron-Deficiency - etiology; CLINICAL SCIENCE; Dose-Response Relationship, Drug; Female; Ferric Compounds - administration & dosage; Ferritins - blood; Follow-Up Studies; Hemoglobins - metabolism; Humans; Injections, Intravenous; Iron - administration & dosage; Male; Maltose - administration & dosage; Maltose - analogs & derivatives; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic - blood; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - drug therapy; Time Factors; Treatment Outcome; chronic kidney disease; anaemia
• ISSN: 0931-0509; 1460-2385
• DOI: 10.1093/ndt/gfu201

The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown. Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L) ferritin or oral iron therapy. The primary end point was time to initiation of other anaemia management (ESA, other iron therapy or blood transfusion) or haemoglobin (Hb) trigger of two consecutive values <10 g/dL during Weeks 8-52. The primary end point occurred in 36 patients (23.5%), 49 patients (32.2%) and 98 patients (31.8%) in the high-ferritin FCM, low-ferritin FCM and oral iron groups, respectively [hazard ratio (HR): 0.65; 95% confidence interval (CI): 0.44-0.95; P = 0.026 for high-ferritin FCM versus oral iron]. The increase in Hb was greater with high-ferritin FCM versus oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase ≥1 g/dL with high-ferritin FCM versus oral iron (HR: 2.04; 95% CI: 1.52-2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups. Compared with oral iron, IV FCM targeting a ferritin of 400-600 µg/L quickly reached and maintained Hb level, and delayed and/or reduced the need for other anaemia management including ESAs. Within the limitations of this trial, no renal toxicity was observed, with no difference in cardiovascular or infectious events. NCT00994318.