Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.

摘要: BACKGROUND Although an erythropoiesis-stimulating agent (ESA) is most frequently administered intravenously for treatment of anemia in patients with chronic kidney disease who are on dialysis, few studies have compared the efficacy different intravenous (i.v.) dosing schedules. METHODS This multicenter, phase IIIb, open-label, controlled study randomized 289 stable hemodialysis to continue conventional i.v. epoetin alfa or darbepoetin, switch once-weekly at same cumulative weekly starting dose, maintain hemoglobin levels 11.0-13.0 g/dL, and within 1.0 g/dL baseline value. Hemoglobin ESA doses were recorded every 4 weeks 28 weeks. RESULTS fell significantly increased between week (mean 16-28 values) group, group (p< 0.001). The adjusted difference mean groups was 0.73 (greater than threshold therapeutic equivalence 0.5 g/dL). changes from significant all time points (0.36, 0.46, 0.81, 0.87, 0.78, 0.62 0.49 g/dL) 12 dose (718.5, 1,326.5, 1,732.0, 1,839.7 1,959.1 IU/week; p=0.005). maintained target level 78% 84% dosing, 67% 64% those intention-to-treat (p=0.1) per protocol (p=0.016) populations, respectively. CONCLUSIONS did not show regimens.