Safety and efficacy of Q2W darbepoetin alfa to treat anemia in subjects with chronic kidney disease

A recent study found that darbepoetin alfa dosed every-other-week (Q2W) is safe and efficacious in treating anemia in chronic kidney disease patients. This study was published in the journal, Current medical research and opinion.

This open-label, multicenter, single-arm study included 128 subjects with ESA-naïve chronic kidney disease (CKD), with baseline hemoglobin (Hb) < 11.0 g/dL. Darbepoetin alfa was dosed every-other-week at an initial dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was given from week 1 to week 19. The primary endpoint of the study was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, with the exception of week 1.

Out of 128 subjects, 118 received at least one dose of darbepoetin alfa and 112 of the subjects completed the study, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. The median dose of darbepoetin alfa was 60 microg at week 1 and 80 microg at the time of Hb > or = 11 g/dL.

From the above results, it can be concluded that de novo Q2W darbepoetin alfa was well-tolerated and effective in correcting and maintaining Hb levels in ESA-naïve subjects with CKD who were not undergoing dialysis.