Nephrology Center, Gartenstrasse 8, 40822, Mettmann, Germany,
Clin Drug Investig. 2013 Oct;33(10):699-706. doi: 10.1007/s40261-013-0091-z.
Correction of low hemoglobin (Hb) levels is associated with improved survival and greater quality of life in dialysis patients, but frequent administration of erythropoiesis stimulating agent (ESA) therapy is unsatisfactory for peritoneal dialysis patients.
The objective of this study was to assess Hb stability in an unselected population of maintenance peritoneal dialysis patients receiving once-monthly treatment with C.E.R.A., a continuous erythropoietin receptor activator.
In a prospective, non-interventional, single-arm study at 33 Germany dialysis centers, peritoneal dialysis patients with or without ESA treatment prior to study entry received once-monthly treatment with C.E.R.A. Hb stability was assessed by the proportion of patients for whom all measured Hb values during months 6-8 (the evaluation phase) were within the range 11-12, 11-13, 10-12 or 11-12.5 g/dL.
220 patients received at least one dose of C.E.R.A. During the evaluation phase, 185 patients provided ≥1 Hb measurement (efficacy population) and 162 patients provided ≥2 Hb measurements (the modified efficacy population). The mean (SD) time between C.E.R.A. doses was 28.2 (7.2) days and mean (SD) C.E.R.A. dose was 109 (57) μg per application. Mean (SD) Hb level was 11.1 (1.4) g/dL at baseline and 11.5 (1.3) g/dL at the end of the study (modified efficacy population). The primary efficacy variable, all measured Hb values in the range 11-12 g/dL, was 18.4 % (34/185) and 14.8 % (24/162) in the efficacy and modified efficacy populations, respectively. The mean (SD) maximum intra-individual fluctuation in Hb level was 0.56 (0.50) g/dL in the efficacy population and 0.58 (0.49) g/dL in the modified efficacy population, with maximum intra-individual fluctuation ≤1 g/dL in 85.4 % (158/185) and 83.3 % (135/162) of patients, respectively. No adverse drug reactions were reported during the study.
In this large population of maintenance peritoneal dialysis patients, once-monthly administration of C.E.R.A. achieved a high degree of Hb stability and was well-tolerated.
纠正低血红蛋白（Hb）水平与透析患者的生存改善和生活质量提高有关，但频繁给予促红细胞生成素刺激剂（ESA）治疗并不令人满意。
本研究旨在评估在接受每月一次 C.E.R.A.（一种持续红细胞生成素受体激活剂）治疗的未选择的维持性腹膜透析患者中，Hb 的稳定性。
在 33 家德国透析中心进行的一项前瞻性、非干预性、单臂研究中，无论是否在研究入组前接受 ESA 治疗，腹膜透析患者每月接受一次 C.E.R.A.治疗。通过在第 6-8 个月（评估期）期间所有测量的 Hb 值在 11-12、11-13、10-12 或 11-12.5 g/dL 范围内的患者比例，评估 Hb 的稳定性。
220 名患者至少接受了一剂 C.E.R.A.治疗。在评估期内，185 名患者提供了≥1 次 Hb 测量值（疗效人群），162 名患者提供了≥2 次 Hb 测量值（改良疗效人群）。C.E.R.A.剂量之间的平均（SD）时间为 28.2（7.2）天，平均（SD）C.E.R.A.剂量为每次应用 109（57）μg。基线时的平均（SD）Hb 水平为 11.1（1.4）g/dL，研究结束时为 11.5（1.3）g/dL（改良疗效人群）。主要疗效变量，疗效人群中所有测量的 Hb 值在 11-12 g/dL 范围内为 18.4%（34/185），改良疗效人群中为 14.8%（24/162）。疗效人群中 Hb 水平的最大个体内波动的平均值（SD）为 0.56（0.50）g/dL，改良疗效人群中为 0.58（0.49）g/dL，最大个体内波动在 1 g/dL 以内的患者分别为 85.4%（158/185）和 83.3%（135/162）。研究期间未报告任何药物不良反应。
在本大规模维持性腹膜透析患者人群中，每月一次给予 C.E.R.A.可实现 Hb 的高度稳定性且耐受性良好。
