Duman Neval, Uyanik Abdullah, Unsal Abdulkadir, Sezer Siren, Camsari Taner, Cirit Mustafa, Yilmaz Mehmet Emin, Altun Bülent, Duranay Murat, Yildiz Alaattin, Sahin Idris, Dogukan Ayhan, Ustundag Sedat, Karayaylali Ibrahim, Kahveci Arzu, Sindel Sukru, Kiykim Ahmet Alper, Yenicerioglu Yavuz, Akbas Ertugrul, Ozdener Fatih
Department of Nephrology, Ankara University School of Medicine , Ankara , Turkey.
Department of Nephrology , Ataturk University School of Medicine , Erzurum , Turkey.
Clin Kidney J. 2014 Oct;7(5):464-9. doi: 10.1093/ckj/sfu079. Epub 2014 Jul 29.
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.
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.
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.
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.
本研究旨在根据土耳其当地的临床判断，评估每月一次使用连续促红细胞生成素受体激活剂（CERA）对维持成年慢性肾性贫血透析患者稳定血红蛋白（Hb）水平的疗效和安全性。
这是一项在土耳其20个中心进行的前瞻性、开放标签、单臂、多中心研究。经过4周的筛查期后，接受传统促红细胞生成刺激剂治疗的合格患者转为每月静脉注射CERA，并进入为期16周的CERA剂量滴定期（DTP），随后是为期8周的疗效评估期（EEP）和为期4周的安全性随访。主要终点是在EEP期间Hb浓度在其参考Hb的±1.0 g/dL范围内且在10.0 - 12.0 g/dL范围内保持稳定的患者比例。
共筛查了173例患者，132例进入DTP，84例完成研究。39例患者[46.4%（95%置信区间：35.5 - 57.7%）]维持了稳定的目标Hb浓度。从基线到EEP，时间调整后的平均Hb浓度的平均变化为0.29±1.08 g/dL。EEP期间CERA的平均每月剂量为112.4±76.78 µg，39例患者（36.4%）调整了CERA剂量。11例患者（8.4%）报告了13例与治疗相关的不良事件，最常见的不良事件是感染和寄生虫感染、胃肠道和血管疾病。
在土耳其，每月一次使用CERA可维持慢性肾性贫血透析患者的Hb浓度稳定。研究结果证实了CERA已知的疗效和安全性。
