Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial


Clinical Nephrology
Iain C MacdougallZhu Li

Abstract

Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients with CKD undergoing hemodialysis. Patients with IDA and CKD undergoing hemodialysis were randomized 2:1 to ferumoxytol 1.02 g (2 × 510 mg) or iron sucrose 1.0 g (10 × 100 mg) for a 5-week treatment period (TP). Over 11 months, patients underwent additional 5-week TPs whenever IDA (hemoglobin < 11.5 g/dL and transferrin saturation < 30%) was detected. The primary efficacy endpoint was mean change in hemoglobin from baseline to week 5 for each TP. Adverse events were recorded during the study. Overall, 293 patients received ferumoxytol (n = 196) or iron sucrose (n = 97). Ferumoxytol was noninferior to iron sucrose regarding hemoglobin change from baseline to week 5. The mean change in hemoglobin in the ferumoxytol and iron sucrose groups was 0.5 and 0.4 g/dL, respectively, in TP 1 (least-squares mean difference, 0.13; 95% confidence interval, -0.11 to 0.36) and 0.6 and 0.3 g/dL, respectively, ...Continue Reading

Citations

Jun 2, 2020·Transfusion·Maureen Achebe, Thomas G DeLoughery
Apr 17, 2020·Advances in Therapy·Iain C MacdougallIoannis E Koutroubakis
Oct 17, 2019·Nutrients·Sajidah Begum, Gladys O Latunde-Dada
Jan 14, 2021·Calcified Tissue International·Ping WangDan Peng
Sep 3, 2021·Clinical Journal of the American Society of Nephrology : CJASN·Bernhard BieleszGere Sunder-Plassmann

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NCT01227616

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