Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial
Introduction: Renal anemia is a common complication among patients with non-dialysis chronic kidney disease (ND-CKD), and there remains an unmet need for more efficient and convenient daily oral medications to improve patient outcomes. This study aimed to evaluate the efficacy and safety...
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| Format: | Article |
| Language: | English |
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Karger Publishers
2025-01-01
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| Series: | Kidney Diseases |
| Online Access: | https://karger.com/article/doi/10.1159/000543193 |
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| author | Xin-Ling Liang Ren-Wei Huang Jian-Teng Xie Yan-Ning Zhang Yi-Nan Li Xiao-Nong Chen Tian-Jun Guan Hua Zhou Ping Fu Yun-Hua Liao Hui Xu Ai-Cheng Yang Hong-Wen Zhao Zi-Chen Liu Li-Li Yang Xue-Qing Yu |
| author_facet | Xin-Ling Liang Ren-Wei Huang Jian-Teng Xie Yan-Ning Zhang Yi-Nan Li Xiao-Nong Chen Tian-Jun Guan Hua Zhou Ping Fu Yun-Hua Liao Hui Xu Ai-Cheng Yang Hong-Wen Zhao Zi-Chen Liu Li-Li Yang Xue-Qing Yu |
| author_sort | Xin-Ling Liang |
| collection | DOAJ |
| description |
Introduction: Renal anemia is a common complication among patients with non-dialysis chronic kidney disease (ND-CKD), and there remains an unmet need for more efficient and convenient daily oral medications to improve patient outcomes. This study aimed to evaluate the efficacy and safety of enarodustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, in treating anemia for ND-CKD patients. Methods: This phase 3 study was conducted at 48 centers across China, enrolling 156 ND-CKD patients. Participants were randomly randomized in a 2:1 ratio to receive either enarodustat or placebo for an initial 8-week double-blind period, followed by a 16-week open-label period during which all patients received enarodustat. Results: The primary endpoint was the mean change in hemoglobin (Hb) levels from baseline to the average level during weeks 7–9. Secondary endpoints focused on Hb concentration or treatment pattern, while exploratory endpoints assessed iron metabolism-related parameters. The mean (±SD) change in Hb levels from baseline to weeks 7–9 was 15.99 (±9.46) g/L in the enarodustat group, compared to -0.14 (±8.08) g/L in the placebo group, resulting in a mean difference of 16.00 (±1.54) g/L (p < 0.001). During weeks 7–9, 85.3% of patients in the enarodustat group achieved Hb levels =100 g/L with 86.0% maintaining this level during weeks 21–25. In the first 4 weeks, the Hb increased by 11.82 (±9.56) g/L in the enarodustat group. By week 9, the mean change in hepcidin level was -42.94 (±37.56) ng/mL in the enarodustat group, compared to +4.58 (±33.34) ng/mL in the placebo group. Enarodustat also improved other iron-related parameters and reduced the need for iron supplements. The safety profile of enarodustat was well tolerable with adverse events comparable to those of the placebo. Conclusion: Enarodustat effectively corrected renal anemia with a manageable safety profile. Its once-daily oral administration offers convenience that may enhance the adherence. Enarodustat shows the potential as a promising therapy for anemic patients with ND-CKD. |
| format | Article |
| id | doaj-art-7a04b706fecc42e4800360c8eca24458 |
| institution | DOAJ |
| issn | 2296-9357 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Karger Publishers |
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| series | Kidney Diseases |
| spelling | doaj-art-7a04b706fecc42e4800360c8eca244582025-08-20T03:09:48ZengKarger PublishersKidney Diseases2296-93572025-01-01111496210.1159/000543193Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 TrialXin-Ling Lianghttps://orcid.org/0000-0002-6764-9571Ren-Wei HuangJian-Teng XieYan-Ning ZhangYi-Nan LiXiao-Nong ChenTian-Jun GuanHua ZhouPing FuYun-Hua LiaoHui XuAi-Cheng YangHong-Wen ZhaoZi-Chen LiuLi-Li YangXue-Qing Yuhttps://orcid.org/0000-0001-8624-744X Introduction: Renal anemia is a common complication among patients with non-dialysis chronic kidney disease (ND-CKD), and there remains an unmet need for more efficient and convenient daily oral medications to improve patient outcomes. This study aimed to evaluate the efficacy and safety of enarodustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, in treating anemia for ND-CKD patients. Methods: This phase 3 study was conducted at 48 centers across China, enrolling 156 ND-CKD patients. Participants were randomly randomized in a 2:1 ratio to receive either enarodustat or placebo for an initial 8-week double-blind period, followed by a 16-week open-label period during which all patients received enarodustat. Results: The primary endpoint was the mean change in hemoglobin (Hb) levels from baseline to the average level during weeks 7–9. Secondary endpoints focused on Hb concentration or treatment pattern, while exploratory endpoints assessed iron metabolism-related parameters. The mean (±SD) change in Hb levels from baseline to weeks 7–9 was 15.99 (±9.46) g/L in the enarodustat group, compared to -0.14 (±8.08) g/L in the placebo group, resulting in a mean difference of 16.00 (±1.54) g/L (p < 0.001). During weeks 7–9, 85.3% of patients in the enarodustat group achieved Hb levels =100 g/L with 86.0% maintaining this level during weeks 21–25. In the first 4 weeks, the Hb increased by 11.82 (±9.56) g/L in the enarodustat group. By week 9, the mean change in hepcidin level was -42.94 (±37.56) ng/mL in the enarodustat group, compared to +4.58 (±33.34) ng/mL in the placebo group. Enarodustat also improved other iron-related parameters and reduced the need for iron supplements. The safety profile of enarodustat was well tolerable with adverse events comparable to those of the placebo. Conclusion: Enarodustat effectively corrected renal anemia with a manageable safety profile. Its once-daily oral administration offers convenience that may enhance the adherence. Enarodustat shows the potential as a promising therapy for anemic patients with ND-CKD.https://karger.com/article/doi/10.1159/000543193 |
| spellingShingle | Xin-Ling Liang Ren-Wei Huang Jian-Teng Xie Yan-Ning Zhang Yi-Nan Li Xiao-Nong Chen Tian-Jun Guan Hua Zhou Ping Fu Yun-Hua Liao Hui Xu Ai-Cheng Yang Hong-Wen Zhao Zi-Chen Liu Li-Li Yang Xue-Qing Yu Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial Kidney Diseases |
| title | Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial |
| title_full | Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial |
| title_fullStr | Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial |
| title_full_unstemmed | Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial |
| title_short | Enarodustat for the Treatment of Anemia in Chinese Patients with Non-Dialysis Chronic Kidney Disease: A Phase 3 Trial |
| title_sort | enarodustat for the treatment of anemia in chinese patients with non dialysis chronic kidney disease a phase 3 trial |
| url | https://karger.com/article/doi/10.1159/000543193 |
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