title: Once-monthly continuous erythropoietin receptor activator (CERA) for haemoglobin maintenance in haemodialysis patients with chronic renal anaemia.
abstract: BACKGROUND
  This study was conducted to evaluate the efficacy and safety of once-monthly continuous erythropoietin receptor activator (CERA) for maintenance of stable haemoglobin (Hb) levels in adult chronic renal anaemia patients on dialysis according to local clinical judgment in Turkey.
  
  
  METHODS
  This was a prospective, open-label, single-arm, multi-centre study conducted in 20 centres in Turkey. After a 4-week screening period, eligible patients receiving conventional erythropoiesis-stimulating agents were converted to monthly intravenous CERA and entered a 16-week CERA dose-titration period (DTP) followed by an 8-week efficacy evaluation period (EEP) and a 4-week safety follow-up. The primary endpoint was the proportion of patients whose Hb concentration remained stable within ±1.0 g/dL of their reference Hb and within the range of 10.0-12.0 g/dL during the EEP.
  
  
  RESULTS
  A total of 173 patients were screened, 132 entered the DTP and 84 completed the study. Thirty-nine patients [46.4% (95% confidence interval: 35.5-57.7%)] maintained stable target Hb concentrations. The mean change in time-adjusted average Hb concentration was 0.29 ± 1.08 g/dL between baseline and the EEP. The mean CERA monthly dose was 112.4 ± 76.78 µg during the EEP, and the CERA dose was adjusted in 39 patients (36.4%). Eleven patients (8.4%) reported 13 treatment-related adverse events, the most frequent adverse events being infections and infestations, gastrointestinal and vascular disorders.
  
  
  CONCLUSIONS
  Once-monthly CERA maintains stable Hb concentrations in chronic renal anaemia patients on dialysis in Turkey. The study results confirm the known efficacy and safety profile of CERA.
authors.affiliation: Department of Nephrology, Ankara University School of Medicine , Ankara , Turkey.
authors.forename: Neval
authors.initials: N
authors.lastname: Duman
authors.affiliation: Department of Nephrology , Ataturk University School of Medicine , Erzurum , Turkey.
authors.forename: Abdullah
authors.initials: A
authors.lastname: Uyanik
authors.affiliation: Nephrology Clinic , Sisli Etfal Research and Training Hospital , Istanbul , Turkey.
authors.forename: Abdulkadir
authors.initials: A
authors.lastname: Unsal
authors.affiliation: Department of Nephrology , Baskent University School of Medicine , Ankara , Turkey.
authors.forename: Siren
authors.initials: S
authors.lastname: Sezer
authors.affiliation: Department of Nephrology , Dokuz Eylul University School of Medicine , Izmir , Turkey.
authors.forename: Taner
authors.initials: T
authors.lastname: Camsari
authors.affiliation: Nephrology Clinic , Izmir Ataturk Research and Training Hospital , Izmir , Turkey.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Cirit
authors.affiliation: Department of Nephrology , Dicle University School of Medicine , Diyarbakir , Turkey.
authors.forename: Mehmet Emin
authors.initials: ME
authors.lastname: Yilmaz
authors.affiliation: Department of Nephrology , Hacettepe University School of Medicine , Ankara , Turkey.
authors.forename: Bülent
authors.initials: B
authors.lastname: Altun
authors.affiliation: Nephrology Clinic , Ankara Research and Training Hospital , Ankara , Turkey.
authors.forename: Murat
authors.initials: M
authors.lastname: Duranay
authors.affiliation: Department of Nephrology , Istanbul University Istanbul School of Medicine , Istanbul , Turkey.
authors.forename: Alaattin
authors.initials: A
authors.lastname: Yildiz
authors.affiliation: Department of Nephrology , Inonu University School of Medicine , Malatya , Turkey.
authors.forename: Idris
authors.initials: I
authors.lastname: Sahin
authors.affiliation: Department of Nephrology , Firat University School of Medicine , Elazig , Turkey.
authors.forename: Ayhan
authors.initials: A
authors.lastname: Dogukan
authors.affiliation: Department of Nephrology , Trakya University School of Medicine , Edirne , Turkey.
authors.forename: Sedat
authors.initials: S
authors.lastname: Ustundag
authors.affiliation: Department of Nephrology , Cukurova University School of Medicine , Adana , Turkey.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Karayaylali
authors.affiliation: Department of Nephrology , Marmara University School of Medicine , Istanbul , Turkey.
authors.forename: Arzu
authors.initials: A
authors.lastname: Kahveci
authors.affiliation: Department of Nephrology , Gazi University School of Medicine , Ankara , Turkey.
authors.forename: Sukru
authors.initials: S
authors.lastname: Sindel
authors.affiliation: Department of Nephrology , Mersin University School of Medicine , Mersin , Turkey.
authors.forename: Ahmet Alper
authors.initials: AA
authors.lastname: Kiykim
authors.affiliation: Department of Nephrology , Adnan Menderes University School of Medicine , Aydin , Turkey.
authors.forename: Yavuz
authors.initials: Y
authors.lastname: Yenicerioglu
authors.affiliation: Roche Pharmaceuticals Medical Department, Istanbul , Turkey.
authors.forename: Ertugrul
authors.initials: E
authors.lastname: Akbas
authors.affiliation: Roche Pharmaceuticals Medical Department, Istanbul , Turkey.
authors.forename: Fatih
authors.initials: F
authors.lastname: Ozdener
keywords: anaemia; dialysis; erythropoietin receptor; kidney disease