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|Title:||Darbepoetin Alfa once monthly corrects Anaemia in patients with chronic kidney disease not on dialysis||Authors:||Roger, Simon D ;Kolmakova, Elena ;Fung, Maple ;Malecki, Robert ;Vinhas, Jose ;Dellanna, Frank ;Thomas, Mark ;Manamley, Nick ;Ferenczi, Sandor||Issue Date:||May-2014||Source:||Volume 19, Issue 5, pp. 266-274||Journal title:||Nephrology||Abstract:||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 mug/kg Q2W or 1.5 mug/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) mug/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.||URI:||https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/246||DOI:||10.1111/nep.12214||Pubmed:||http://www.ncbi.nlm.nih.gov/pubmed/24506498||ISSN:||1440-1797||Publicaton type:||Journal Article||Keywords:||Kidney Disease
|Study or Trial:||Randomized Controlled Clinical Trial/Controlled Clinical Trial|
|Appears in Collections:||Renal Medicine|
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