Renal prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis-stimulating agent: a multicenter open-label randomized controlled study
Renal prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis-stimulating agent: a multicenter open-label randomized controlled study
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对红细胞生成刺激剂低反应性贫血的慢性肾病患者服用依泊汀β聚乙二醇实现的不同目标血红蛋白水平的肾脏预后：一项多中心开放标签随机对照研究
DOI：
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发表时间：
2021
影响因子：
2.3
通讯作者：
H. Hirakata
中科院分区：
文献类型：
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作者：
K. Tsuruya;Terumasa Hayashi;Hiroyasu Yamamoto;H. Hase;S. Nishi;K. Yamagata;M. Nangaku;T. Wada;Y. Uemura;Y. Ohashi;H. Hirakata
没有证据表明慢性肾脏病（CKD）伴促红细胞生成素（ESA）反应性低下患者的靶血红蛋白水平是否合适。因此，我们对非透析依赖性CKD （NDD-CKD）患者进行了一项随机对照研究，比较强化治疗和保守治疗维持血红蛋白水平的结果。这是一项在89家机构进行的多中心、开放标签、随机、平行组研究。在NDD-CKD患者中，esa低反应性肾性贫血患者被随机分为强化治疗组和保守治疗组，强化治疗组在目标血红蛋白水平为11 g/dL或更高的情况下给予促生成素- pegol；保守治疗组在入组时维持血红蛋白水平（±1 g/dL）。主要终点是发生第一次肾脏复合事件的时间，定义为：(1)过渡到肾脏替代治疗（透析或肾移植）；(2)估计肾小球滤过率（eGFR）降至6.0 mL/min/1.73 m2以下；或(3)eGFR降低30%或更多。次要终点是肾功能（eGFR变化率）、心血管（CV）事件和安全性。2012年8月至2015年12月，共登记385例患者，其中362例符合入选标准。两组患者肾脏存活率和CV事件发生率无显著差异。然而，三种类型肾脏复合事件的发生率有差异。在伴有ESA低反应性肾性贫血的NDD-CKD患者中，积极给药ESA并没有明显延长肾脏生存期，也没有导致CV事件发生率的显著差异。
There is no evidence regarding appropriate target hemoglobin levels in chronic kidney disease (CKD) patients with an erythropoiesis-stimulating agent (ESA)-hyporesponsiveness. Therefore, we conducted a randomized controlled study in non-dialysis dependent CKD (NDD-CKD) patients with ESA-hyporesponsiveness, comparing results of intensive versus conservative treatment to maintain hemoglobin levels. This was a multicenter, open-label, randomized, parallel-group study conducted at 89 institutions. Among NDD-CKD patients, those with ESA-hyporesponsive renal anemia were randomly assigned to an intensive treatment group, to which epoetin beta pegol was administered with target hemoglobin level of 11 g/dL or higher, or conservative treatment group, in which the hemoglobin levels at enrollment (within ± 1 g/dL) were maintained. The primary endpoint was the time to the first kidney composite event defined as (1) transition to renal replacement therapy (dialysis or renal transplantation); (2) reduction of estimated glomerular filtration rate (eGFR) to less than 6.0 mL/min/1.73 m2; or (3) reduction of eGFR by 30% or more. Secondary endpoints were kidney function (change rate in eGFR), cardiovascular (CV) events, and safety. Between August 2012 and December 2015, 385 patients were registered, and 362 patients who met the eligibility criteria were enrolled. There was no significant difference in kidney survival or in CV events between the two groups. However, the incidences of the 3 types of kidney composite events tended to differ. In NDD-CKD patients with ESA-hyporesponsive renal anemia, the aggressive administration of ESA did not clearly extend kidney survival or result in a significant difference in the incidence of CV events.
影响因子：
19.6
作者：
Szczech, Lynda A.;Barnhart, Huiman X.;Inrig, Jula K.;Reddan, Donal N.;Sapp, Shelly;Califf, Robert M.;Patel, Uptal D.;Singh, Ajay K.
通讯作者：
Singh, Ajay K.