Abstract
Background: Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). Materials and methods: 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. Results: 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, in TP 2 (0.30; 0.06 – 0.55). Treatment-related and serious adverse events were similar in both groups; no new safety signals emerged. Conclusion: Long-term administration of ferumoxytol has noninferior efficacy and a similar safety profile to iron sucrose when used to treat IDA in patients with CKD undergoing hemodialysis.
Highlights
Iron deficiency anemia (IDA) is a common condition among patients with chronic kidney disease (CKD) undergoing hemodialysis [1]
In the ITT population, the mean change from baseline in hemoglobin at week 5 was 0.5 and 0.4 g/dL with ferumoxytol and iron sucrose, respectively, for treatment period (TP) 1 (least-squares mean (LSM) difference, 0.13; 95% confidence interval (CI), –0.11 to 0.36) and 0.6 and 0.3 g/dL for TP 2 (LSM difference, 0.30; 95% CI, 0.06 – 0.55) (Figure 2a)
Administration of ferumoxytol in this study provided changes from baseline in mean hemoglobin that were comparable with those seen with iron sucrose after each TP, with similar dose requirements of erythropoiesis-stimulating agent (ESA) therapy; the efficacy of ferumoxytol met the criteria for noninferiority versus iron sucrose
Summary
Iron deficiency anemia (IDA) is a common condition among patients with chronic kidney disease (CKD) undergoing hemodialysis [1]. Comparative data evaluating the efficacy and safety of ferumoxytol versus other IV iron preparations among patients with CKD are limited to one shortterm study [11], highlighting the need for long-term, repeat-dosing, head-to-head studies of these agents. The Ferumoxytol for Anemia of CKD Trial (FACT) evaluated IV ferumoxytol versus iron sucrose in the treatment of IDA among patients with CKD undergoing hemodialysis over a 1-year period [15]. Noninferiority of ferumoxytol compared with iron sucrose at increasing hemoglobin levels for IDA treatment, as well as safety, when used as needed in patients with CKD undergoing hemodialysis over a 1-year period. Patients were excluded if serum ferritin was > 800 ng/mL
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
