title: C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis.
abstract: BACKGROUND
  No previous randomized controlled studies have been reported examining de novo, once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a randomized multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients.
  
  
  METHODS
  Patients were randomized (1:1) to receive either 1.2 μg/kg C.E.R.A. Q4W or darbepoetin alfa QW/Q2W during a 20-week correction period and an 8-week evaluation period. Two primary end points were assessed: the haemoglobin (Hb) response rate and the change in average Hb concentration between baseline and evaluation.
  
  
  RESULTS
  The Hb response rate for C.E.R.A. was 94.1%, significantly higher than the protocol-specified 60% response rate [95% confidence interval (CI): 89.1, 97.3; P < 0.0001] and comparable with darbepoetin alfa (93.5%; 95% CI: 88.4, 96.8; P < 0.0001). C.E.R.A. Q4W was non-inferior to darbepoetin alfa QW/Q2W, with similar mean Hb changes from baseline of 1.62 g/dL and 1.66 g/dL, respectively. Patients receiving C.E.R.A. showed a steady rise in Hb, with fewer patients above the target range during the first 8 weeks compared with darbepoetin alfa [39 patients (25.8%) versus 72 patients (47.7%); P < 0.0001]. Adverse event rates were comparable between the treatment groups.
  
  
  CONCLUSIONS
  C.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients.
authors.affiliation: Department of Renal Medicine, Gosford Hospital, Gosford, Australia. sroger@nsccahs.health.nsw.gov.au
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Rainer P
authors.initials: RP
authors.lastname: Woitas
authors.forename: Maurice
authors.initials: M
authors.lastname: Laville
authors.forename: Sheldon W
authors.initials: SW
authors.lastname: Tobe
authors.forename: Robert
authors.initials: R
authors.lastname: Provenzano
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Golper
authors.forename: Prajej
authors.initials: P
authors.lastname: Ruangkanchanasetr
authors.forename: Ho Yung
authors.initials: HY
authors.lastname: Lee
authors.forename: Kwan-Dun
authors.initials: KD
authors.lastname: Wu
authors.forename: Michal
authors.initials: M
authors.lastname: Nowicki
authors.forename: Agnes
authors.initials: A
authors.lastname: Ladanyi
authors.forename: Alberto
authors.initials: A
authors.lastname: Martínez-Castelao
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beyer
authors.forename: Frank C
authors.initials: FC
authors.lastname: Dougherty
mesh_terms: D000368:Aged; D000740:Anemia / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000097:blood* / Q000150:complications
chemical_list: D006454:Hemoglobins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D011092:Polyethylene Glycols