静脉注射C.E.R.A.可维持曾接受达贝泊汀α治疗的透析患者的血红蛋白水平稳定：III期随机研究STRIATA的结果
Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study.
作者信息
Canaud Bernard, Mingardi Giulio, Braun Johann, Aljama Pedro, Kerr Peter G, Locatelli Francesco, Villa Giuseppe, Van Vlem Bruno, McMahon Alan W, Kerloëguen Cécile, Beyer Ulrich
机构信息
Hôpital Lapeyronie, Service de Nephrologie, Montpellier, France.
出版信息
Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.
BACKGROUND
Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life ( approximately 130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.
METHODS
STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within +/- 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29-36).
RESULTS
Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (-0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.
CONCLUSIONS
Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.
背景
延长促红细胞生成素（ESAs）的给药间隔时间为改善慢性肾脏病（CKD）患者贫血管理的效率提供了契机。然而，延长给药间隔时间使用阿法依泊汀和β-依泊汀时，有效维持血红蛋白（Hb）水平可能具有挑战性。连续促红细胞生成素受体激活剂（C.E.R.A.）具有独特的药理学特性和较长的半衰期（约130小时），允许延长给药间隔时间给药。III期研究结果表明，接受透析的CKD患者每4周给药一次C.E.R.A.可有效维持稳定的Hb水平。
方法
STRIATA（静脉注射C.E.R.A.治疗贫血后在透析中稳定血红蛋白目标）是一项多中心、开放标签的随机III期研究，旨在评估从阿法达贝泊汀（DA）直接转换后每2周（Q2W）静脉注射一次C.E.R.A.维持Hb水平的疗效和安全性。接受每周一次（QW）或Q2W稳定静脉注射DA的成年透析患者被随机分组（1:1），继续其当前的DA治疗方案（n = 156）或接受Q2W静脉注射C.E.R.A.（n = 157），为期52周。调整剂量以将Hb水平维持在基线水平±1.0 g/dl范围内且在10.0至13.5 g/dl之间。主要终点是基线至评估期（第29 - 36周）的平均Hb变化。
结果
大多数患者（>80%）在随机分组前接受QW DA治疗。C.E.R.A.与DA在主要终点的平均（95%CI）差异为0.18 g/dl（-0.05，0.41），在预定义的非劣效性界限内。在维持Hb水平方面，C.E.R.A.在临床上不劣于DA（P < 0.0001）。两种治疗耐受性均良好。
结论
从DA直接转换为Q2W静脉注射C.E.R.A.的血液透析患者成功维持了稳定的Hb水平。
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