Darbepoetin alfa administered once monthly non-inferior to once every two weeks dosage for anemia correction

According to a recent study, darbepoetin alfa (DA) administered once monthly (QM) to maintain haemoglobin (Hb) concentrations in anaemic patients was non-inferior and with a similar safety profile to DA every 2 weeks (Q2W) in anaemic patients with chronic kidney disease not on dialysis (CKD-ND). The results of this study were published in the journal, Nephrology.

This randomized, non-inferiority, active-controlled, double-blind trial included 355 adult subjects with CKD-ND and having Hb levels <10 g/dL, who were not treated with an erythropoiesis-stimulating agent. These subjects were randomized in a 1:1 ratio to receive initial doses of 0.75 μg/kg DA every 2 weeks (Q2W) or 1.5 μg/kg DA once monthly (QM) for 33 weeks. The primary end-point of the study was the Hb change between baseline and weeks 29-33 (evaluation period), where the non-inferiority margin was -0.5 g/dL.

It was observed that the mean change in Hb between baseline and the evaluation period was 2.16 and 1.97 for the Q2W and QM groups, respectively. 97.9% of the subjects in Q2W and 98.1% subjects in QM group achieved a Hb level ≥10.0 g/dL and ≥1.0 g/dL increase in Hb from baseline. Over weeks 29-33, mean DA (SD) weekly equivalent doses were 0.20 and 0.27 μg/kg per week for the Q2W and QM groups, respectively, with both groups showing similar safety profiles.

Thus, it can be concluded that darbepoetin alfa administered once a month may be non-inferior and having similar safety profile as DA administered every 2 weeks for anemia correction in patients with CKD-ND.