CLINESE-Centro de Nefrologia de Sergipe, Brazil Medserv, Sao Paulo, Brazil.
Int Urol Nephrol. 2013 Oct;45(5):1355-64. doi: 10.1007/s11255-012-0272-3. Epub 2012 Sep 19.
C.E.R.A. is a continuous erythropoietin receptor activator with characteristics that permit a once-monthly schedule of administration for the maintenance treatment for chronic kidney disease (CKD) patients. The main objective of this study was to assess the maintenance of Hb concentration with once-monthly intravenous and/or subcutaneous C.E.R.A. therapy in Latin American dialysis patients with chronic renal anemia previously treated with epoetin alfa s.c or i.v 1-3 times per week.
This was a single-arm, open-label, multicenter, 32-week study of anemic patients with CKD previously treated with epoetin alfa sc or iv 1-3 times per week. After a 4-week screening period, during which mean Hb levels were maintained between 10.5 and 12.5 g/dL on their previous erythropoiesis stimulating agent, eligible patients entered a 16-week C.E.R.A. dose titration period followed by a 4-week efficacy evaluation period (EEP) and a 28-week safety follow-up. The starting dose of C.E.R.A. was based on the previous dose of epoetin alfa. Doses of C.E.R.A. were then adjusted to maintain Hb levels within ±1.0 g/dL of the reference concentration and between 10.5 and 12.5 g/dL. The Hb reference concentration was defined as the mean of all Hb levels during screening. The primary end point was the proportion of patients maintaining a mean Hb concentration (g/dL) within ±1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the EEP.
A total of 163 patients from 27 centers in Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, and Venezuela entered the treatment period and 102 completed the prescribed course of C.E.R.A. Forty-five patients (43.7 %) maintained a mean Hb concentration within ±1 g/dL of their reference Hb value and between 10.5 and 12.5 g/dL during the EEP. The median monthly dose remained constant at 120 μg during the titration period and during the EEP. On the average, there were only 2.3 dose changes per patient in 28 weeks of treatment, covering 7 C.E.R.A. scheduled administrations. 53 % of all dose changes were dose decreases, 47 % increases. A total of 10 AEs and 4 SAEs were considered to be related to the study treatment.
Once-monthly C.E.R.A. treatment effectively maintains stable Hb concentrations in patients with chronic renal anemia undergoing dialysis with a good safety and tolerability profile.
C.E.R.A. 是一种持续的促红细胞生成素受体激活剂，具有可每月给药一次的特性，适用于慢性肾脏病 (CKD) 患者的维持治疗。本研究的主要目的是评估拉丁美洲透析患者在接受每周皮下或静脉注射促红素 1-3 次的慢性肾性贫血治疗后，使用每月一次的静脉内和/或皮下 C.E.R.A. 治疗维持血红蛋白 (Hb) 浓度的情况。
这是一项在先前每周皮下或静脉注射促红素 1-3 次治疗的贫血慢性肾脏病患者中进行的、单次、开放标签、多中心、32 周研究。在 4 周的筛选期后，患者接受了 16 周的 C.E.R.A. 剂量滴定期，随后进行了 4 周的疗效评估期（EEP）和 28 周的安全性随访。C.E.R.A. 的起始剂量基于先前的促红素剂量。然后调整 C.E.R.A. 的剂量，以维持 Hb 水平在参考浓度的±1.0 g/dL 范围内，并且在 10.5-12.5 g/dL 之间。参考浓度定义为筛选期所有 Hb 水平的平均值。主要终点是在 EEP 期间，维持 Hb 浓度平均值（g/dL）在参考 Hb 浓度的±1 g/dL 范围内，并且在 10.5-12.5 g/dL 之间的患者比例。
共有来自阿根廷、巴西、智利、哥伦比亚、厄瓜多尔、墨西哥、秘鲁、乌拉圭和委内瑞拉的 27 个中心的 163 名患者进入了治疗期，其中 102 名患者完成了 C.E.R.A. 的规定疗程。在 EEP 期间，45 名患者（43.7%）的平均 Hb 浓度维持在参考 Hb 值的±1 g/dL 范围内，并且在 10.5-12.5 g/dL 之间。在滴定期和 EEP 期间，每月的中位剂量保持在 120 μg 不变。在 28 周的治疗中，平均每个患者有 2.3 次剂量调整，覆盖了 7 次 C.E.R.A. 计划给药。所有剂量调整中，53%为剂量减少，47%为剂量增加。共有 10 例不良事件（AE）和 4 例严重不良事件（SAE）被认为与研究治疗相关。
每月一次的 C.E.R.A. 治疗可有效维持透析慢性肾性贫血患者的稳定 Hb 浓度，具有良好的安全性和耐受性。
