Background: Patients with end-stage renal disease requiring hemodialysis are frequently treated with epoetin alfa (recombinant human erythropoietin, rHuEPO) for anemia. The aim of this study was to determine whether successful management of anemia could be maintained by changing the dosing schedule of epoetin alfa from 2 or 3 times per week to once-weekly administration via not only the subcutaneous (s.c.) but also the intravenous (i.v.) route.
Methods: Patients included in the study had hemodialysis for > 12 months, treatment with epoetin for > or = 6 months and adequate iron stores. The study consisted of a pre-study period (12 weeks), Phase I (4 weeks, patients continued prestudy regimen), Phase II (12 weeks, once-weekly i.v. or s.c. regimen with dose adjustments permitted to maintain target hemoglobin (Hb) concentrations) and Phase III (4 weeks, once-weekly i.v. or s.c. regimen without dose adjustments).
Results: The study was completed by 203 patients (per-protocol population: i.v. group, n = 115, s.c. group, n = 88). In the majority of patients (69.4% overall: i.v. group, 67.0%, s.c. group, 72.7%), the individual Phase I Hb concentrations were maintained within +/-1.0 g/dl (+/-10 g/l) during Phase III. In 79.3% of the patients (i.v. group, 75.7%, s.c. group, 84.1%), a stable Hb concentration (decrease of < or = 1 g/dl (< or = 10 g/l)) was maintained without statistically significant dose adjustments (82.4+/-33.8 - 86.8+/-42.1 IU/kg body weight/week). Hb concentrations decreased from 11.57+/-0.83 g/dl(115.7+/-8.3 g/l) in Phase I to 11.39+/-1.09 g/dl (113.9+/-10.9 g/l) in Phase III (p < 0.05) in the entire group. The weekly dose of epoetin alfa required to maintain the individual target Hb concentrations changed from 85.1+/-34.6 IU/kg in Phase I to 92.1+/-45.1 IU/kg in Phase III in the entire population (p <0.05).
Conclusions: With once-weekly administration of epoetin alfa, Hb concentrations can be maintained in the majority of stable hemodialysis patients, and only minimal dose adjustments are required.