title: Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis.
abstract: OBJECTIVE
  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 μg/kg Q2W 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 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) μg/kg per week for the Q2W and QM groups, respectively. Safety profiles were similar between groups.
  
  
  CONCLUSIONS
  In subjects with CKD-ND, QM dosing was non-inferior to Q2W dosing for anaemia correction and had a similar safety profile.
authors: Renal Research, Gosford, Australia.
authors: Simon D
authors: SD
authors: Roger
authors: Elena
authors: E
authors: Kolmakova
authors: Maple
authors: M
authors: Fung
authors: Robert
authors: R
authors: Malecki
authors: José
authors: J
authors: Vinhas
authors: Frank
authors: F
authors: Dellanna
authors: Mark
authors: M
authors: Thomas
authors: Nick
authors: N
authors: Manamley
authors: Sándor
authors: S
authors: Ferenczi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D001315:Australia; D015415:Biomarkers / Q000097:blood; D000068256:Darbepoetin alfa; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005060:Europe; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis; D013997:Time Factors; D016896:Treatment Outcome; D015854:Up-Regulation; D055815:Young Adult
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa
keywords: anaemia; chronic kidney failure; darbepoetin alfa; haemoglobin; randomized controlled trial