Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis

Aim While darbepoetin alfa ( DA ) can be administered once monthly ( QM ) to maintain haemoglobin ( Hb ) concentrations in anaemic patients with chronic kidney disease not on dialysis ( CKD‐ND ), the QM use of DA for anaemia correction has not been previously investigated. Methods In this randomized, double‐blind, non‐inferiority, active‐controlled study, adult subjects with CKD‐ND , Hb levels <10 g/dL, and not treated with an erythropoiesis‐stimulating agent were randomized 1:1 to receive DA every 2 weeks ( Q 2 W ) or QM for 33 weeks with initial doses of 0.75 μg/kg Q 2 W or 1.5 μg/kg QM . Subjects were treated to target Hb levels of 10–12 g/dL and ≥1 g/dL increase from baseline. The primary end‐point was Hb change between baseline and the evaluation period (weeks 29–33), with a non‐inferiority margin of −0.5 g/dL. Results Three hundred and fifty‐five subjects received ≥1 dose of DA . Mean (95% confidence interval [ CI ]) change in Hb between baseline and the evaluation period was 2.16 (1.98–2.33) g/dL for the Q 2 W group and 1.97 (1.80–2.14) g/dL for the QM group, the mean (95% CI ) difference in Hb change being −0.19 (−0.43 to 0.05) g/dL. Most subjects (97.9% Q 2 W ; 98.1% QM ) achieved a Hb level ≥10.0 g/dL and ≥1.0 g/dL increase in Hb from baseline. Mean DA ( SD ) weekly equivalent doses over the evaluation period were 0.20 (0.23) and 0.27 (0.31) μg/kg per week for the Q 2 W and QM groups, respectively. Safety profiles were similar between groups. Conclusion In subjects with CKD‐ND , QM dosing was non‐inferior to Q 2 W dosing for anaemia correction and had a similar safety profile.