Department of Internal Medicine IV, Saarland University Medical Centre, Kirrbergerstrasse, Homburg/Saar, Germany.
MVZ Davita Rhein-Ruhr, Düsseldorf, Germany.
Nephrol Dial Transplant. 2017 Feb 1;32(2):279-287. doi: 10.1093/ndt/gfw418.
It is unknown whether early intervention with low-dose erythropoiesis-stimulating agents (ESAs) in non-anaemic patients delays progression of chronic kidney disease (CKD).
In a single-blind, 24-month trial, adults with estimated glomerular filtration rate (eGFR) 30–59 mL/min/1.73 m2 and either Type 2 diabetes mellitus or previous kidney transplantation were randomized to low-dose continuous erythropoiesis receptor activator (CERA; monthly dose 30–75 µg; n = 115) or placebo (n = 120). The primary endpoint was the annual change in eGFR (abbreviated Modification of Diet in Renal Disease formula).
Mean (standard deviation) eGFR was 40.7 (9.8) mL/min/1.73 m2 versus 39.8 (9.2) mL/min/1.73 m2 at baseline for CERA and placebo, respectively, and 39.0 (11.6) g/dL versus 39.7 (10.6) g/dL at the final visit. The median (interquartile range) annual reduction in eGFR was 0.5 (−2.2, 3.8) mL/min/1.73 m2 with CERA versus 0.4 (−2.0, 3.2) mL/min/1.73 m2 with placebo (P = 0.657). No significant difference in the annual change in eGFR was observed between treatment groups in the subpopulations with Type 2 diabetes or kidney transplant. Adverse events with a suspected relation to study drug occurred in 22.0% and 16.2% of patients randomized to CERA or placebo, respectively, and adverse events led to study drug discontinuation in 11.0% and 8.5% of patients.
Patients with moderate CKD and Type 2 diabetes or previous kidney transplantation showed stable renal function that was unaffected by administration of low-dose ESA. In addition, there was no clinically meaningful effect of 2-year low-dose ESA treatment on albuminuria, an important surrogate marker of kidney injury.
目前尚不清楚在非贫血患者中早期使用低剂量促红细胞生成素刺激剂（ESA）是否会延缓慢性肾脏病（CKD）的进展。
在一项为期 24 个月的单盲试验中，肾小球滤过率（eGFR）估计值为 30-59 mL/min/1.73 m2 的成年人，患有 2 型糖尿病或既往接受过肾移植，被随机分配至低剂量持续红细胞生成素受体激动剂（CERA；每月剂量 30-75 µg；n=115）或安慰剂（n=120）组。主要终点是 eGFR 的年变化（缩写为肾脏病饮食改良公式）。
CERA 和安慰剂组的平均（标准差）eGFR 分别为 40.7（9.8）mL/min/1.73 m2和 39.8（9.2）mL/min/1.73 m2，基线时分别为 39.0（11.6）g/dL和 39.7（10.6）g/dL。最后一次就诊时。CERA 组 eGFR 的中位（四分位距）年下降幅度为 0.5（-2.2，3.8）mL/min/1.73 m2，安慰剂组为 0.4（-2.0，3.2）mL/min/1.73 m2（P=0.657）。在 2 型糖尿病或肾移植亚组中，两组间 eGFR 的年变化无显著差异。分别有 22.0%和 16.2%接受 CERA 或安慰剂治疗的患者发生疑似与研究药物相关的不良事件，分别有 11.0%和 8.5%的患者因不良事件而停止使用研究药物。
患有中度 CKD 的 2 型糖尿病或既往接受过肾移植的患者肾功能稳定，不受低剂量 ESA 治疗的影响。此外，2 年低剂量 ESA 治疗对白蛋白尿（肾脏损伤的重要替代标志物）没有明显的临床意义。
