Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients

Abstract

Background and objectives: Intravenous iron is a key component of anemia management for chronic kidney disease (CKD). Ferumoxytol is a unique intravenous iron product that can be administered as a rapid injection in doses up to 510 mg.

Design, setting, participants, & measurements: This was a randomized, open-label, controlled, multicenter Phase 3 trial to evaluate the safety and efficacy of intravenous ferumoxytol compared with oral iron. Anemic patients with CKD stage 5D on hemodialysis and on a stable erythropoiesis-stimulating agent regimen received either two injections of 510 mg of ferumoxytol within 7 d (n = 114) or 200 mg elemental oral iron daily for 21 d (n = 116). The primary efficacy endpoint was the change in hemoglobin from baseline to day 35. Safety was closely monitored.

Results: Ferumoxytol resulted in a mean increase in hemoglobin of 1.02 +/- 1.13 g/dl at day 35 compared with 0.46 +/- 1.06 g/dl with oral iron (P = 0.0002). Twice as many ferumoxytol-treated patients than oral iron-treated patients achieved a > or =1 g/dl hemoglobin increase at day 35 (P = 0.0002). There was a greater mean increase in transferrin saturation (TSAT) with ferumoxytol compared with oral iron at day 35 (P < 0.0001). The larger hemoglobin increase after ferumoxytol compared with oral iron at day 35 persisted after adjustment for baseline hemoglobin, TSAT, and serum ferritin. Overall adverse event rates were comparable between groups.

Conclusions: In patients on hemodialysis, rapid intravenous injection of 510 mg of ferumoxytol led to significantly greater hemoglobin increases compared with oral iron, with comparable tolerability.

Trial registration: ClinicalTrials.gov NCT00233597.

Figure 1.

Patient flow diagram.

Figure 2.

Change in hemoglobin at day 35 by baseline hemoglobin and TSAT. Mean change in hemoglobin from baseline at day 35 stratified by baseline quartiles of (a) hemoglobin and (b) TSAT. Circles represent means and bars represent 95% confidence intervals around the means.

Figure 3.

Mean systolic blood pressure measurements after the administration of the first dose of (a) ferumoxytol or (b) oral iron. Boxplots show median (line inside box), 25^th, and 75th percentiles (bottom and top of box, respectively), and whiskers extending to values nearest 1.5 times the interquartile range.