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Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial

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机构： [1]Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China. [2]The Department of Nephrology, The First Affiliated Hospital of Xiamen University, Xiamen, China. [3]The Department of Nephrology, General Hospital of Northern Theater Command, Shengyang, China. [4]The Department of Nephrology, The Second People's Hospital of Yibin, Yibin, China. [5]The Department of Nephrology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China. [6]The Department of Nephrology, Liuzhou Worker's Hospital, Liuzhou, China. [7]The Department of Nephrology, The First Affiliated Hospital of Soochow University, Suzhou, China. [8]The Department of Blood Purification, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China. [9]The Department of Nephrology, West China Hospital of Sichuan University, Chengdu, China. [10]The Institute of Nephrology, Zhongda Hospital Southeast University, Nanjing, China. [11]The Department of Nephrology, The Second Hospital of HeBei Medical University, Shijiazhuang, China. [12]The Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, China. [13]The Department of Nephrology, Siping Central People's Hospital, Siping, China. [14]The Department of Nephrology, The Second People's Hospital of Hefei, Hefei, China. [15]The Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. [16]The Department of Nephrology, Jilin Province People's Hospital, Changchun, China. [17]The Department of Nephrology, Cangzhou People's Hospital, Cangzhou, China. [18]The Department of Nephrology, The First Bethune Hospital of Jilin University, Changchun, China. [19]The Department of Nephrology, General Hospital of Ningxia Medical University, Yinchuang, China. [20]The Department of Nephrology, People's Hospital of Jiangxi Province, Nanchang, China. [21]The Department of Nephrology, Lanzhou University Second Hospital, Lanzhou, China. [22]The Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [23]The Department of Nephrology, Shengjing Hospital of China Medicine University, Shengyang, China. [24]The Department of Nephrology, Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH), Chengdu, China. [25]The Department of Nephrology, LinYi People's Hospital, Linyi, China. [26]The Department of Nephrology, Hwamei Hospital, University of Chinese Academy of Sciences, China. [27]The Department of Nephrology, Wuyi Hospital of T.C.M, Jiangmen City (Affiliated Jiangmen TCM Hospital of Jinan University), China. [28]The Department of Nephrology, The Second Norman Bethune Hospital of Jilin University, Changchun, China. [29]The Department of Nephrology, The First Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. [30]The Department of Nephrology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. [31]The Department of Nephrology, Shanghai Fengxian Center Hospital, Shanghai, China. [32]The Department of Nephrology, Tong Ren Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China. [33]The Department of Nephrology, Tianjin Medical University General Hospital, Tianjin, China. [34]The Department of Nephrology, Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China. [35]The Department of Nephrology, Guangzhou First People's Hospital, Guangzhou, China. [36]The Department of Nephrology, The First Hospital of Qiqihar, Qiqihar, China. [37]The Department of Nephrology, The First Affiliated Hospital/The First Clinical Medicine School of Guangdong Pharmaceutical University, Guangzhou, China. [38]The Department of Nephrology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China. [39]The Department of Nephrology, The Second Xiangya Hospital of Central South University, Changsha, China. [40]The Department of Nephrology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. [41]Hansoh Pharmaceutical Group Co, Ltd, Shanghai, China.

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关键词： Anemia Chronic kidney disease Dialysis Epoetin alfa Pegmolesatide

摘要：

Pegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist, is being evaluated as an alternative to epoetin alfa for treating anemia of chronic kidney disease (CKD) in Chinese dialysis patients. There is a critical need for a long-acting, cost-effective erythropoiesis-stimulating agent that does not produce EPO antibodies.A randomized, open-label, active-comparator, non-inferiority phase three trial was conducted at 43 dialysis centers in China between May 17th, 2019, and March 28th, 2022. Eligible patients aged 18-70 years were randomly assigned (2:1) to receive pegmolesatide once every four weeks or epoetin alfa one to three times per week, with doses adjusted to maintain a hemoglobin level between 10.0 and 12.0 g/dL. The primary efficacy endpoint was the mean change in hemoglobin level from baseline to the efficacy evaluation period in the per-protocol set (PPS) population. Non-inferiority of pegmolesatide to epoetin alfa was established if the lower limit of the two-sided 95% confidence interval for the between-group difference was ≥ -1.0 g/dL. Safety assessment included adverse events and potential anaphylaxis reactions. This trial is registered at ClinicalTrials.gov, NCT03902691.Three hundreds and seventy-two patients were randomly assigned to the pegmolesatide group (248 patients) or the epoetin alfa group (124 patients). A total of 347 patients (233 in the pegmolesatide group and 114 in the epoetin alfa group) were included in the PPS population. In the PPS, the mean change (standard deviation, SD) in hemoglobin level from baseline to the efficacy evaluation period was 0.07 (0.92) g/dL in the pegmolesatide group and -0.22 (0.97) g/dL in the epoetin alfa group. The between-group difference was 0.29 g/dL (95% confidence interval: 0.11-0.47), verifying non-inferiority of pegmolesatide to epoetin alfa. Adverse events occurred in 231 (94%) participants in the pegmolesatide group and in 110 (89%) in the epoetin alfa group. Hypertension was the most common treatment-related adverse event. No fatal cases of anaphylaxis or hypotension were reported.Monthly subcutaneously injection of pegmolesatide was as effective and safe as conventional epoetin alfa administrated one to three times a week in treating anemia in Chinese dialysis patients.The study was supported by Hansoh Medical Development Group.© 2023 The Authors.

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出版当年[2022]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

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出版当年[2021]版：

Q1 MEDICINE, GENERAL & INTERNAL

最新[2023]版：

Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 9.6 最新[2023版] 9.9 最新五年平均 17.033 出版当年[2021版] 16.564 出版当年五年平均 0 出版前一年[2020版] 15.1 出版后一年[2022版]

第一作者：

第一作者机构： [1]Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China.

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通讯作者：

通讯机构： [1]Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China. [*1]Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China.

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Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial

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