title: Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naïve to erythropoiesis-stimulating agents.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naïve to erythropoiesis-stimulating agent (ESA) therapy.
  
  
  METHODS
  This was an open-label, multicenter, single-arm study enrolling ESA-naïve CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL. Q2W darbepoetin alfa treatment was initiated at a dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was administered from week 1 to week 19.
  
  
  METHODS
  The primary endpoint was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, except in week 1. Hb levels, darbepoetin alfa dose, and safety were also assessed.
  
  
  RESULTS
  Of the 128 subjects who received at least one dose of darbepoetin alfa and of the subjects who completed the study, 118 (92%) and 112 (97%), respectively, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. Median darbepoetin alfa dose at week 1 and at the time of achieving a Hb > or = 11 g/dL were 60 and 80 microg, respectively. Darbepoetin alfa was well-tolerated, and short-term adverse events were consistent with those expected in CKD subjects.
  
  
  CONCLUSIONS
  This study demonstrates that de novo Q2W darbepoetin alfa was effective in correcting and maintaining Hb levels in ESA-naïve subjects with CKD who were not receiving dialysis. Study limitations, including lack of a control arm for the study and multiple race information for subjects, must be considered in interpreting the results.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT00112008.
authors.affiliation: Case Western Reserve University School of Medicine at MetroHealth Medical Center, Cleveland, OH, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Silver
authors.forename: R
authors.initials: R
authors.lastname: Geronemus
authors.forename: M
authors.initials: M
authors.lastname: Krause
authors.forename: C Y
authors.initials: CY
authors.lastname: Chen
authors.forename: R
authors.initials: R
authors.lastname: Kewalramani
authors.forename: C
authors.initials: C
authors.lastname: Stehman-Breen
mesh_terms: D000368:Aged; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007501:Iron / Q000008:administration & dosage; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged
chemical_list: D004921:Erythropoietin; D000068256:Darbepoetin alfa; D007501:Iron