Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD

IF 5.7 2区医学 Q1 UROLOGY & NEPHROLOGY

Kidney International Reports Pub Date : 2025-03-01 DOI:10.1016/j.ekir.2024.12.002

Jianteng Xie , Aicheng Yang , Hongyu Qiu , Xiaomei Peng , Wanhong Lu , Xiangyang Huang , Qinkai Chen , Aimin Zhong , Shuifu Tang , Qin Wang , Chuan Li , Liangliang He , Xiaohong Jia , Anran Ma , Fan Wang , Xueqing Yu

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Abstract

Introduction

Pegmolesatide has been recently approved for treating anemia in chronic kidney disease (CKD) patients in China. We presented the results of the pivotal study conducted in patients with nondialysis-dependent (NDD)-CKD with anemia.

Methods

This randomized, active-controlled, open-label, noninferiority phase 3 study was conducted across 38 centers in China. Eligible patients were randomly assigned to receive subcutaneous injection of pegmolesatide in the upper arm once every 4 weeks or epoetin alfa weekly or biweekly, with doses adjusted to maintain hemoglobin (Hb) level of 100 to 120 g/l. The primary outcome was the mean change in Hb level from the baseline during the efficacy evaluation period. Noninferiority of pegmolesatide to epoetin alfa was established if the lower limit of the 2-sided 95% confidence interval (CI) was ≥ −10 g/l.

Results

A total of 173 patients received at least 1 dose of pegmolesatide (115 patients) or epoetin alfa (58 patients). During the efficacy evaluation period, the mean change in Hb from baseline level was 19.2 g/l in the pegmolesatide group and 15.4 g/l in the epoetin alfa group with a between-group difference of 3.8 g/l (95% CI: 0.7–6.9). The incidence of adverse events (AEs) and serious AEs (SAEs) were similar between groups, with hypertension being the most reported AE related to the study drug. No drug-related hypersensitivity reactions or fatal events were observed.

Conclusion

Pegmolesatide demonstrated comparable efficacy to epoetin alfa in elevating and maintaining Hb levels in patients with NDD-CKD with anemia without new safety concerns (ClinicalTrials.gov identifier: NCT03903809).

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吡莫塞肽治疗非透析性CKD患者贫血的随机试验

pegmolesatide最近在中国被批准用于治疗慢性肾脏疾病（CKD）患者的贫血。我们介绍了在非透析依赖(NDD)-CKD合并贫血患者中进行的关键研究结果。这项随机、主动对照、开放标签、非劣效性的3期研究在中国的38个中心进行。符合条件的患者被随机分配接受上臂皮下注射pegmolesatide，每4周一次，或每周一次或每两周一次，剂量调整以维持血红蛋白（Hb）水平为100至120 g/l。主要结果是在疗效评估期间Hb水平从基线的平均变化。如果双侧95%置信区间（CI）的下限≥−10 g/l，则pegmolesatide对epoetin α具有非劣效性。结果173例患者接受了至少1剂培莫塞肽（115例）或依生成素（58例）治疗。在疗效评估期间，聚莫塞肽组Hb较基线水平的平均变化为19.2 g/l， eppoetin α组Hb较基线水平的平均变化为15.4 g/l，组间差异为3.8 g/l （95% CI: 0.7-6.9）。不良事件（AE）和严重AE （SAEs）的发生率在两组之间相似，高血压是与研究药物相关的最多的AE。未观察到药物相关的超敏反应或致命事件。pemolesatide在NDD-CKD合并贫血患者中升高和维持Hb水平的疗效与epoetin alfa相当，且无新的安全性问题（ClinicalTrials.gov临床试验号：NCT03903809）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Kidney International Reports Medicine-Nephrology

CiteScore

7.70

自引率

3.30%

发文量

1578

审稿时长

8 weeks

期刊介绍： Kidney International Reports, an official journal of the International Society of Nephrology, is a peer-reviewed, open access journal devoted to the publication of leading research and developments related to kidney disease. With the primary aim of contributing to improved care of patients with kidney disease, the journal will publish original clinical and select translational articles and educational content related to the pathogenesis, evaluation and management of acute and chronic kidney disease, end stage renal disease (including transplantation), acid-base, fluid and electrolyte disturbances and hypertension. Of particular interest are submissions related to clinical trials, epidemiology, systematic reviews (including meta-analyses) and outcomes research. The journal will also provide a platform for wider dissemination of national and regional guidelines as well as consensus meeting reports.