부산대학교 도서관

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 ( Q2 W) or QM for 33 weeks with initial doses of 0.75 μg/kg Q2 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 Q2 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% Q2 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 Q2 W and QM groups, respectively. Safety profiles were similar between groups. Conclusion In subjects with CKD-ND, QM dosing was non-inferior to Q2 W dosing for anaemia correction and had a similar safety profile. [ABSTRACT FROM AUTHOR]