title: An open-label study of darbepoetin alfa administered once monthly for the maintenance of haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis.
abstract: OBJECTIVE
  To demonstrate the efficacy and safety of once-monthly (QM) darbepoetin alfa administration in maintaining haemoglobin (Hb) 11.0-13.0 g dL(-1) in subjects with chronic kidney disease (CKD) not receiving dialysis and previously treated with darbepoetin alfa every other week (Q2W).
  
  
  METHODS
  This open-label study enrolled subjects > or =18 years of age who had glomerular filtration rate > or =15 and < or =60 mL min(-1)/1.73 m(2), had Hb 11.0-13.0 g dL(-1), and were receiving Q2W darbepoetin alfa.
  
  
  METHODS
  Subjects were switched to QM darbepoetin alfa therapy for 28 weeks; the QM dose was titrated to maintain Hb levels. Primary end-point: proportion of subjects maintaining Hb > or =11.0 g dL(-1) during the final 8 weeks of the study (evaluation phase). Secondary end-points: Hb concentration during evaluation, darbepoetin alfa dose during the study, adverse events, laboratory parameters, and blood pressure.
  
  
  RESULTS
  The study enrolled 152 subjects (female 52%, white 64%). Mean Hb > or =11.0 g dL(-1) during evaluation was achieved by 76% of the 150 subjects who received at least one dose of darbepoetin alfa [95% confidence interval (CI): 68%, 83%]. Mean (SD) Hb during evaluation was 11.71 (0.92) g dL(-1). Eighty-five per cent of 129 subjects who completed the study (95% CI: 78%, 91%) had Hb > or =11.0 g dL(-1) during evaluation. The dose of darbepoetin alfa over the study period was median (95% CI) 124.4 mug (106.2, 140.0). Darbepoetin alpha administered QM was well tolerated in study subjects.
  
  
  CONCLUSIONS
  Darbepoetin alpha administered QM maintained Hb in study subjects with CKD not receiving dialysis.
authors.affiliation: Division of Nephrology, Ohio State University, Columbus, OH 43210, USA. anil.agarwal@osumc.edu
authors.forename: A K
authors.initials: AK
authors.lastname: Agarwal
authors.forename: M R
authors.initials: MR
authors.lastname: Silver
authors.forename: J E
authors.initials: JE
authors.lastname: Reed
authors.forename: R K
authors.initials: RK
authors.lastname: Dhingra
authors.forename: W
authors.initials: W
authors.lastname: Liu
authors.forename: N
authors.initials: N
authors.lastname: Varma
authors.forename: C
authors.initials: C
authors.lastname: Stehman-Breen
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000740:Anemia / Q000150:complications / Q000188:drug therapy; D002908:Chronic Disease; D003115:Colony-Stimulating Factors / Q000008:administration & dosage* / Q000009:adverse effects; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D003115:Colony-Stimulating Factors; D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D007501:Iron