A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients

• Published in: Nephrology, dialysis, transplantation Vol. 26; no. 5; pp. 1599 - 1607
• Main Authors: Qunibi, Wajeh Y., Martinez, Carlos, Smith, Mark, Benjamin, Joseph, Mangione, Antoinette, Roger, Simon D.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.05.2011
• Subjects: Administration, Oral; Aged; Anemia, Iron-Deficiency - drug therapy; Anemia, Iron-Deficiency - etiology; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Emergency and intensive care: renal failure. Dialysis management; Female; Ferric Compounds - administration & dosage; Glomerular Filtration Rate; Humans; Injections, Intravenous; Intensive care medicine; Iron - administration & dosage; Kidney Failure, Chronic - complications; Kidney Failure, Chronic - drug therapy; Male; Maltose - administration & dosage; Maltose - analogs & derivatives; Medical sciences; Original; Pharmacology. Drug treatments; Prognosis; Human; Kidney disease; intravenous iron; transferrin saturation; Transferrin; Urinary system disease; Intravenous administration; anaemia; Hemodialysis; Deficiency; Saturation; Ferritin; Oral administration; Iron; Ferric carboxymaltose; Extrarenal dialysis; Treatment; Renal failure; Dialysis; CKD
• ISSN: 0931-0509; 1460-2385; 1460-2385
• DOI: 10.1093/ndt/gfq613

Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. Current intravenous iron agents cannot be administered in a single high dose because of adverse effects. Ferric carboxymaltose, a non-dextran parenteral iron preparation, can be rapidly administered in high doses. This open-label trial randomized 255 subjects with glomerular filtration rates ≤ 45 mL/min/1.73 m(2), haemoglobin ≤ 11 g/dL, transferrin saturation ≤ 25%, ferritin ≤ 300 ng/mL, and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min (with up to two additional doses of 500 mg at 2-week intervals) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days. In the modified intent-to-treat population, the proportion of subjects achieving a haemoglobin increase ≥ 1 g/dL at any time was 60.4% with ferric carboxymaltose and 34.7% with oral iron (P < 0.001). At Day 42, mean increase in haemoglobin was 0.95 ± 1.12 vs 0.50 ± 1.23 g/dL (P = 0.005), mean increase in ferritin was 432 ± 189 ng/mL vs 18 ± 45 ng/mL (P < 0.001) and mean increase in transferrin saturation was 13.6 ± 11.9% vs 6.1 ± 8.1% (P < 0.001). Treatment-related adverse events were significantly fewer with ferric carboxymaltose than with oral iron (2.7% and 26.2%, respectively; P < 0.0001). We conclude that 1000 mg ferric carboxymaltose can be rapidly administered, is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients.