Once-monthly continuous erythropoietin receptor activator (CERA) for haemoglobin maintenance in haemodialysis patients with chronic renal anaemia

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dc.authoridsezer, siren/0000-0002-7326-8388
dc.authoridSahin, Idris/0000-0002-8683-3737
dc.authoridDuranay, Murat/0000-0002-2893-4484
dc.authoridcamsari, taner/0000-0001-8293-3688
dc.authoridKiykim, Ahmet/0000-0001-9922-9267
dc.authoridYILDIZ, ALAATTIN/0000-0002-4066-929X
dc.authorwosidDogukan, Ayhan/W-2518-2018
dc.authorwosidsezer, siren/JYQ-2550-2024
dc.authorwosidSahin, Idris/AAS-4390-2020
dc.authorwosidYıldız, Alaattin/AAY-6102-2020
dc.authorwosidDuranay, Murat/HKV-1804-2023
dc.authorwosidcamsari, taner/C-9048-2015
dc.authorwosidKiykim, Ahmet/P-8206-2015
dc.contributor.authorDuman, Neval
dc.contributor.authorUyanik, Abdullah
dc.contributor.authorUnsal, Abdulkadir
dc.contributor.authorSezer, Siren
dc.contributor.authorCamsari, Taner
dc.contributor.authorCirit, Mustafa
dc.contributor.authorYilmaz, Mehmet Emin
dc.date.accessioned2024-06-12T10:51:35Z
dc.date.available2024-06-12T10:51:35Z
dc.date.issued2014
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground. 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 mu g 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.en_US
dc.description.sponsorshipRoche, Turkeyen_US
dc.description.sponsorshipThis study was supported by Roche, Turkey.en_US
dc.identifier.doi10.1093/ckj/sfu079
dc.identifier.issn1753-0784
dc.identifier.issn1753-0792
dc.identifier.issue5en_US
dc.identifier.pmid25504109en_US
dc.identifier.scopus2-s2.0-84928403558en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.urihttps://doi.org/10.1093/ckj/sfu079
dc.identifier.urihttps://hdl.handle.net/20.500.14551/18394
dc.identifier.volume7en_US
dc.identifier.wosWOS:000217845100006en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherOxford Univ Pressen_US
dc.relation.ispartofClinical Kidney Journalen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAnaemiaen_US
dc.subjectDialysisen_US
dc.subjectErythropoietin Receptoren_US
dc.subjectKidney Diseaseen_US
dc.titleOnce-monthly continuous erythropoietin receptor activator (CERA) for haemoglobin maintenance in haemodialysis patients with chronic renal anaemiaen_US
dc.typeArticleen_US

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