title: C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks.
abstract: OBJECTIVE
  This Phase III study examined the efficacy and safety of C.E.R.A., a continuous erythropoietin receptor activator, given once every 2 weeks (Q2W) via subcutaneous or intravenous injection using pre-filled syringes, for maintaining hemoglobin (Hb) levels in patients with chronic kidney disease (CKD) on dialysis who converted directly from epoetin therapy.
  
  
  METHODS
  Patients (n = 336) were randomized 1:1 to continue epoetin at their current dose, route and administration interval (once to three times weekly (QW-TIW)), or receive C.E.R.A. Q2W by the same route as previous epoetin treatment for 36 weeks. Dosage was adjusted to maintain patients' Hb within +/-1.0 g/dl of baseline value and within 10.0-13.5 g/dl. Primary endpoint was mean change in Hb between baseline and the evaluation period (weeks 29-36).
  
  
  RESULTS
  Mean change in Hb for C.E.R.A. and epoetin was 0.088 and -0.030 g/dl, respectively (endpoint Hb 11.93 and 11.86 g/dl, respectively). Analysis showed that C.E.R.A. was as effective as epoetin in maintaining Hb (p < 0.0001), and was well tolerated. The administration route had no impact on primary endpoint.
  
  
  CONCLUSIONS
  Q2W C.E.R.A. administered using pre-filled syringes effectively maintains stable control of Hb in patients on dialysis who convert directly from epoetin QW-TIW.
authors.affiliation: Division of Nephrology, New York Hospital Queens, Nephrology Associates, Flushing, NY 11355, USA. bss9001@nyp.org
authors.forename: Bruce
authors.initials: B
authors.lastname: Spinowitz
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Coyne
authors.forename: Charmaine E
authors.initials: CE
authors.lastname: Lok
authors.forename: Mario
authors.initials: M
authors.lastname: Fraticelli
authors.forename: Maher
authors.initials: M
authors.lastname: Azer
authors.forename: Sanjay
authors.initials: S
authors.lastname: Dalal
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Villa
authors.forename: Steven
authors.initials: S
authors.lastname: Rosansky
authors.forename: Helena
authors.initials: H
authors.lastname: Adamis
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beyer
mesh_terms: D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007275:Injections, Intravenous; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000379:methods*; D013594:Syringes; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D011092:Polyethylene Glycols; D000068817:Epoetin Alfa