title: Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study.
abstract: BACKGROUND
  Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life ( approximately 130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.
  
  
  METHODS
  STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within +/- 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29-36).
  
  
  RESULTS
  Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (-0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.
  
  
  CONCLUSIONS
  Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.
authors.affiliation: Hôpital Lapeyronie, Service de Nephrologie, Montpellier, France. b-canaud@chu-montpellier.fr
authors.forename: Bernard
authors.initials: B
authors.lastname: Canaud
authors.forename: Giulio
authors.initials: G
authors.lastname: Mingardi
authors.forename: Johann
authors.initials: J
authors.lastname: Braun
authors.forename: Pedro
authors.initials: P
authors.lastname: Aljama
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kerr
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Villa
authors.forename: Bruno
authors.initials: B
authors.lastname: Van Vlem
authors.forename: Alan W
authors.initials: AW
authors.lastname: McMahon
authors.forename: Cécile
authors.initials: C
authors.lastname: Kerloëguen
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beyer
mesh_terms: D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D001315:Australia; D002170:Canada; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005060:Europe; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007275:Injections, Intravenous; D007674:Kidney Diseases / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins; D006435:Renal Dialysis
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D011092:Polyethylene Glycols