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

作者：Roger Simon D; Kolmakova Elena; Fung Maple; Malecki Robert; Vinhas Jose; Dellanna Frank; Thomas Mark; Manamley Nick; Ferenczi Sandor^*

来源：Nephrology, 2014, 19(5): 266-274.

DOI：10.1111/nep.12214

• haemoglobin
• chronic kidney failure
• anaemia
• darbepoetin alfa
• randomized controlled trial

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 (Q2W) or QM for 33 weeks with initial doses of 0.75 mu g/kg Q2W or 1.5 mu g/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 Q2W 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% Q2W; 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) mu g/kg per week for the Q2W and QM groups, respectively. Safety profiles were similar between groups.
Conclusion
In subjects with CKD-ND, QM dosing was non-inferior to Q2W dosing for anaemia correction and had a similar safety profile.

• 出版日期2014-5