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A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat''s Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia 期刊论文

编号：

03B1A7E7AA07D62E5E4E7380DC7C381C
作者：

Ma, Jie#^[1]Yang, Xiangdong^[2];Xiao, Xiaoyan^[2];Sun, Changyou^[3];Zhang, Qinghong^[4];Wang, Caili^[5];Xu, Yan^[6];Zhao, Jianrong^[7,10];Yang, Aicheng^[8,11];Cheng, Hong^[9,12];Chen, Menghua^[13];Chen, Wenli^[14];Zheng, Zhihua^[15,18,23];Shi, Yongjun^[16];Zhao, Zhanzheng^[17];Yang, Zhenhua;Yang, Lin^[19];Yao, Li^[20];Zhong, Xiaoshi^[21];Deng, Yilan^[22];Xiong, Zuying;Yang, Xiaoping^[24];Zhang, Chunjiang^[24];Xie, Weiji^[25];Yin, Aiping^[26];Zhou, Hua^[27];Bi, Weihong^[28];Li, Wenbin^[29];Wang, Junxia^[30];Li, Suhua;Yin, Yuanyuan;Li, Xuemei*^[1]
语种：

英文
期刊：

AMERICAN JOURNAL OF NEPHROLOGY ISSN：0250-8095 2026 年 ; 2026 MAR 5
收录：
关键词：

Desidustat Anemia Chronic kidney disease Treatment Safety Hemoglobin
摘要：

Introduction: This phase III trial assessed desidustat''s efficacy and safety compared with placebo for the treatment of anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD). Methods: A multicenter, randomized, double-blind trial enrolled 152 NDD-CKD patients with anemia (101 desidustat, 51 placebo). Primary endpoint: hemoglobin (Hb) change from baseline to weeks 7-9. Secondary endpoints included Hb response rate (>= 100 g/L), time to target Hb, and target Hb maintenance (100-120 g/L). Safety evaluated treatment-emergent adverse events (TEAEs). Exploratory endpoints analyzed Hb dynamics (weeks 21-25) and serum hepcidin levels (baseline-week 53). Results: After 9 weeks of treatment, desidustat increased Hb level from 89.18 g/L to 105.66 g/L, whereas placebo decreased from 89.41 g/L to 88.51 g/L, with a mean difference of 17.52 g/L (95% confidence interval [CI]: 14.35-20.68) in the full analysis set. And in the per protocol set, desidustat increased Hb level from 88.86 g/L to 105.62 g/L, and placebo declined from 89.37 g/L to 87.57 g/L, with a mean difference of 18.39 g/L (95% CI: 15.39-21.39). Hb response rates were 85.15% vs. 23.53% (p < 0.001). Median time to target Hb was 30 days with desidustat vs. 0 days with placebo (p < 0.001). By week 9, desidustat maintained Hb within target range 51.68% of the time vs. 10.24% for placebo (p < 0.001). TEAE incidence was comparable between groups. During weeks 21-25, Hb rose further (desidustat: +21.26 g/L; placebo: +26.63 g/L). Serum hepcidin decreased sharply in desidustat by week 9 (-67.43 ng/mL vs. -6.38 ng/mL; placebo), though placebo showed delayed reduction by week 25 - levels equalized by week 53. Conclusion: Desidustat significantly improved Hb levels and accelerated anemia correction in NDD-CKD patients versus placebo, with comparable safety.
推荐引用方式
GB/T 7714：

Ma Jie,Yang Xiangdong,Xiao Xiaoyan, et al. A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat''s Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia [J].AMERICAN JOURNAL OF NEPHROLOGY,2026.
APA：

Ma Jie,Yang Xiangdong,Xiao Xiaoyan,Sun Changyou,&Li Xuemei.(2026).A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat''s Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia .AMERICAN JOURNAL OF NEPHROLOGY.
MLA：

Ma Jie, et al. "A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat''s Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia" .AMERICAN JOURNAL OF NEPHROLOGY(2026).
入库时间：

6/3/2026 9:27:27 AM
更新时间：

6/4/2026 7:17:38 AM

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