Article A Randomized Comparison of Ferumoxytol and Iron Sucrose for Treating Iron Deficiency Anemia in Patients

Background and objectives Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia. Design, setting, participants, & measurements In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1.02 g ferumoxytol (23510-mg injections) or 1.0 g iron sucrose administered as either a slow injection or infusion (10 doses for dialysis patients and 5 doses for nondialysis patients). Inclusion criteria included hemoglobin,11.0 g/dl, transferrin saturation,30%, and eGFR,60 ml/min per 1.73 m2 or a diagnosis of underlying CKD (e.g., nephropathy or nephritis). The primary end point was change in hemoglobin from baseline to week 5. Results In total, 162 patients were randomized. Demographics were balanced between the treatment groups. Adverse event profiles of the two regimens were fairly similar: overall adverse events, 48 % ferumoxytol versus 65 % iron sucrose; related adverse events, 10 % ferumoxytol versus 16 % iron sucrose; and adverse events leading to study discontinuation, 1 % ferumoxytol versus 5 % iron sucrose. Rates of serious adverse events and relate