Darbepoetin alfa is a unique genetically engineered
glycoprotein with a three-fold longer terminal half-life than recombinant human
erythropoietin (rHuEPO). The objective of this study was to determine if
darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen is an effective and safe alternative for treating renal
anemia in patients undergoing dialysis. A total of 1,008 French
hemodialysis and
peritoneal dialysis patients receiving stable rHuEPO
therapy by either the intravenous (i.v., N = 217) or subcutaneous (s.c., N = 791) route were switched to
darbepoetin alfa given by the same route of administration at a reduced dosing frequency. Patients receiving rHuEPO once weekly (N = 248, 25%) were switched to
darbepoetin alfa every two weeks, and those receiving rHuEPO two or three times weekly (N = 760, 75%) were switched to
darbepoetin alfa once weekly. The doses of
darbepoetin alfa were titrated to maintain
hemoglobin concentration in the target range of 10.0 to 13.0 g/dl for up to 24 weeks. The primary endpoint was the change in
hemoglobin between baseline and the evaluation period (weeks 21-24). Adjusted (for covariates that might influence
hemoglobin response) mean change in
hemoglobin from baseline to the evaluation period was not clinically significant: +0.11 g/dl (95% CI: -0.30; 0.52). An i.v./s.c. dose ratio of 0.96 (95% CI: 0.86; 1.06) at evaluation confirms previous findings that
darbepoetin alfa dose requirements were not different for the s.c. and i.v. routes. At the end of the evaluation period, more than 98% of patients successfully maintained
hemoglobin within the target range and at their
darbepoetin alfa assigned dosing frequency.
Darbepoetin alfa was well tolerated with a safety profile consistent with that observed in previous
darbepoetin alfa studies.
Darbepoetin alfa administered at a reduced dosing frequency relative to the prior rHuEpo regimen effectively maintains
hemoglobin in the target range in dialysis patients with renal
anemia.