title: C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial.
abstract: OBJECTIVE
  This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis.
  
  
  METHODS
  In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb +/-1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation.
  
  
  RESULTS
  Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated.
  
  
  CONCLUSIONS
  Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.
authors.affiliation: Department of Renal Medicine, King's College Hospital, Bessemer Road, London, SE5 9RS, UK. iain.macdougall@kch.nhs.uk
authors.forename: Iain C
authors.initials: IC
authors.lastname: Macdougall
authors.forename: Rowan
authors.initials: R
authors.lastname: Walker
authors.forename: Robert
authors.initials: R
authors.lastname: Provenzano
authors.forename: Fernando
authors.initials: F
authors.lastname: de Alvaro
authors.forename: Harold R
authors.initials: HR
authors.lastname: Locay
authors.forename: Paul C
authors.initials: PC
authors.lastname: Nader
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Frank C
authors.initials: FC
authors.lastname: Dougherty
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beyer
mesh_terms: D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology*; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins
chemical_list: D006397:Hematinics; D011994:Recombinant Proteins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D011092:Polyethylene Glycols