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Ferumoxytol as an Intravenous Iron Replacement Therapy in Hemodialysis Patients

Robert Provenzano^*, Brigitte Schiller, Madhumathi Rao, Daniel Coyne, Louis Brenner^||,¶, and Brian J.G. Pereira^¶

^* St. John Hospital and Medical Center, Detroit, Michigan; Satellite Healthcare, Mountain View, California; Tufts Medical Center, Boston, Massachusetts; Washington University School of Medicine, St. Louis, Missouri; ^|| Brigham and Womens’ Hospital, Boston, Massachusetts; and ^¶ AMAG Pharmaceuticals, Inc., Lexington, Massachusetts

Correspondence: Dr. Louis Brenner, AMAG Pharmaceuticals, Inc., 100 Hayden Avenue, Lexington, MA 02421. Phone: 617-498-3325; Fax: 617-812-5971; E-mail: lbrenner{at}amagpharma.com

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 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.