Department of Internal Medicine IV, Saarland University Medical Centre, Homburg/Saar, Germany.
Curr Med Res Opin. 2010 May;26(5):1083-9. doi: 10.1185/03007991003666652.
C.E.R.A., a continuous erythropoietin receptor activator, offers once-monthly dosing without compromising haemoglobin control. This study was undertaken to examine whether monthly C.E.R.A. using pre-filled syringes maintains stable haemoglobin levels when administered according to local clinical judgement.
RESEARCH, DESIGN AND METHODS: MIRACEL was a prospective, open-label, single-arm, multicentre study performed at 90 nephrology centres in Germany. After a 2-month screening phase, haemodialysis patients receiving epoetin or darbepoetin were converted to monthly intravenous C.E.R.A., with a 5-month titration phase followed by a 2-month evaluation phase.
Clinicaltrials.gov: NCT00413894 RESULTS: Of 661 patients screened, 424 (64.1%) started C.E.R.A. therapy (previous treatment: 72.2% epoetin, 27.8% darbepoetin); 416 were eligible for inclusion in the intent-to-treat population. A mean of two C.E.R.A. dose changes were required during the 7-month treatment period. The primary efficacy variable, haemoglobin within 11-12.5 g/dL or 10-13 g/dL during the evaluation phase, was achieved in 109 (30.8%) and 265 (74.9%) of the 354 evaluable patients, respectively, with no differences observed between patients formerly receiving epoetin or darbepoetin or different dosing frequencies. During the screening, titration and evaluation phases, mean haemoglobin was 11.7 +/- 0.7 g/dL, 11.6 +/- 0.9 g/dL and 11.4 +/- 1.0 g/dL, respectively, and 90.6% (377/416), 70.4% (293/416) and 82.9% (345/416) of patients exhibited < or = 1 g/dL change from phase-specific individual means. C.E.R.A. was well-tolerated with a safety profile similar to that reported in phase III studies.
In this single-arm, open-label, multicentre study, conversion of a large population of haemodialysis patients from epoetin or darbepoetin to monthly C.E.R.A. administration using pre-filled syringes was shown to be practical, convenient and offer good control of haemoglobin levels, regardless of the previous type of therapy or dosing frequency.
C.E.R.A.（一种持续的红细胞生成素受体激动剂）每月一次给药，不影响血红蛋白控制，且无需进行剂量调整。本研究旨在评估在当地临床判断下，使用预充式注射器每月给予 C.E.R.A.治疗能否维持稳定的血红蛋白水平。
MIRACEL 是一项在德国 90 家肾病中心进行的前瞻性、开放标签、单臂、多中心研究。在 2 个月的筛选期后，接受促红细胞生成素或达贝泊汀治疗的血液透析患者转换为每月静脉内 C.E.R.A.治疗，并进行 5 个月的滴定期和 2 个月的评估期。
Clinicaltrials.gov：NCT00413894
在 661 例筛选患者中，424 例（64.1%）开始接受 C.E.R.A.治疗（先前治疗：72.2%接受促红细胞生成素治疗，27.8%接受达贝泊汀治疗）；416 例符合意向治疗人群的纳入标准。在 7 个月的治疗期间，平均需要进行两次 C.E.R.A.剂量调整。主要疗效变量是评估期内血红蛋白处于 11-12.5 g/dL 或 10-13 g/dL 范围内，354 例可评估患者中分别有 109 例（30.8%）和 265 例（74.9%）达到，接受促红细胞生成素或达贝泊汀治疗或不同剂量频率的患者之间无差异。在筛选期、滴定期和评估期，平均血红蛋白分别为 11.7 +/- 0.7 g/dL、11.6 +/- 0.9 g/dL 和 11.4 +/- 1.0 g/dL，90.6%（377/416）、70.4%（293/416）和 82.9%（345/416）的患者与各自的阶段特定个体平均值相比，血红蛋白变化 <或= 1 g/dL。C.E.R.A.具有良好的耐受性，安全性与 III 期研究报告的相似。
在这项单臂、开放标签、多中心研究中，使用预充式注射器将大量血液透析患者从促红细胞生成素或达贝泊汀转换为每月 C.E.R.A.给药，无论先前的治疗类型或剂量频率如何，均切实可行、方便，且能很好地控制血红蛋白水平。
