Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis
Introduction: The IHOPE study evaluated the efficacy and safety of oral iron polysaccharide complex versus i.v. iron in Chinese patients on hemodialysis (HD). Methods: This randomized, open-label, noninferiority trial enrolled adults (aged 18–75 years) on maintenance HD (MHD) with hemoglobin of 100...
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Elsevier
2025-06-01
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| Series: | Kidney International Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024925001603 |
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| author | Renhua Lu Haijiao Jin Juan Cao Hua Li Xiaoxia Wang Yinghui Qi Qiu Li Xudong Cai Bin Song Na Li Lianglan Shen Li Wang Xiaoping Wang Zhaohui Ni |
| author_facet | Renhua Lu Haijiao Jin Juan Cao Hua Li Xiaoxia Wang Yinghui Qi Qiu Li Xudong Cai Bin Song Na Li Lianglan Shen Li Wang Xiaoping Wang Zhaohui Ni |
| author_sort | Renhua Lu |
| collection | DOAJ |
| description | Introduction: The IHOPE study evaluated the efficacy and safety of oral iron polysaccharide complex versus i.v. iron in Chinese patients on hemodialysis (HD). Methods: This randomized, open-label, noninferiority trial enrolled adults (aged 18–75 years) on maintenance HD (MHD) with hemoglobin of 100 to 130 g/l, transferrin saturation (TSAT) of 20% to 50%, or serum ferritin of 100 to 500 μg/l. Patients were randomized 1:1 to receive oral iron polysaccharide complex (150 mg twice daily) or i.v. iron sucrose (100 mg biweekly) for 24 weeks. The primary outcome was TSAT at 12 weeks. Noninferiority margin was set at 7% with significance at 0.05. Results: Among 193 participants (mean age: 55.3 years, 62.2% male), 12-week TSAT was 32.3% (95% CI: 29.39%–35.19%) in the oral group versus 33.4% (95% CI: 30.95%–35.77%) in the i.v. group, demonstrating noninferiority. At 24 weeks, TSAT remained noninferior (29.4% vs. 32.6%), and hemoglobin levels were comparable (114.6 vs. 117.4 g/l; P = 0.166). Adverse events occurred in 51.0% of oral and 47.4% of i.v. group patients, with serious adverse events in 14.6% and 13.4%, respectively. Conclusion: Oral iron polysaccharide complex demonstrated noninferiority to i.v. iron sucrose for maintaining iron status in patients on HD, with comparable safety profiles. |
| format | Article |
| id | doaj-art-79d7bdf271714067a9d233eb6e276513 |
| institution | OA Journals |
| issn | 2468-0249 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj-art-79d7bdf271714067a9d233eb6e2765132025-08-20T02:06:06ZengElsevierKidney International Reports2468-02492025-06-011061742174910.1016/j.ekir.2025.03.017Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on HemodialysisRenhua Lu0Haijiao Jin1Juan Cao2Hua Li3Xiaoxia Wang4Yinghui Qi5Qiu Li6Xudong Cai7Bin Song8Na Li9Lianglan Shen10Li Wang11Xiaoping Wang12Zhaohui Ni13Department of Nephrology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Molecular Cell Laboratory for Kidney Disease, Shanghai, China; Shanghai Peritoneal Dialysis Research Center, Shanghai, China; Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Nephrology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Molecular Cell Laboratory for Kidney Disease, Shanghai, China; Shanghai Peritoneal Dialysis Research Center, Shanghai, China; Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaTaixing People's Hospital, Taixing, ChinaSir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaTongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaShanghai Punan Hospital of Pudong New District, Shanghai, ChinaThe First People's Hospital of Shuangliu District, Chengdu, ChinaNingbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, ChinaDeyang People's Hospital, Deyang, ChinaJinan Zhangqiu District People's Hospital, Jinan, ChinaNantong First People's Hospital, Nantong, ChinaShandong Province Qianfoshan Hospital, Jinan, ChinaCentral Hospital Affiliated to Shandong First Medical University, Jinan, ChinaDepartment of Nephrology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Molecular Cell Laboratory for Kidney Disease, Shanghai, China; Shanghai Peritoneal Dialysis Research Center, Shanghai, China; Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Correspondence: Zhaohui Ni, Department of Nephrology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160, Pujian Road, Shanghai, China.Introduction: The IHOPE study evaluated the efficacy and safety of oral iron polysaccharide complex versus i.v. iron in Chinese patients on hemodialysis (HD). Methods: This randomized, open-label, noninferiority trial enrolled adults (aged 18–75 years) on maintenance HD (MHD) with hemoglobin of 100 to 130 g/l, transferrin saturation (TSAT) of 20% to 50%, or serum ferritin of 100 to 500 μg/l. Patients were randomized 1:1 to receive oral iron polysaccharide complex (150 mg twice daily) or i.v. iron sucrose (100 mg biweekly) for 24 weeks. The primary outcome was TSAT at 12 weeks. Noninferiority margin was set at 7% with significance at 0.05. Results: Among 193 participants (mean age: 55.3 years, 62.2% male), 12-week TSAT was 32.3% (95% CI: 29.39%–35.19%) in the oral group versus 33.4% (95% CI: 30.95%–35.77%) in the i.v. group, demonstrating noninferiority. At 24 weeks, TSAT remained noninferior (29.4% vs. 32.6%), and hemoglobin levels were comparable (114.6 vs. 117.4 g/l; P = 0.166). Adverse events occurred in 51.0% of oral and 47.4% of i.v. group patients, with serious adverse events in 14.6% and 13.4%, respectively. Conclusion: Oral iron polysaccharide complex demonstrated noninferiority to i.v. iron sucrose for maintaining iron status in patients on HD, with comparable safety profiles.http://www.sciencedirect.com/science/article/pii/S2468024925001603hemodialysisoral iron supplementsrenal anemia |
| spellingShingle | Renhua Lu Haijiao Jin Juan Cao Hua Li Xiaoxia Wang Yinghui Qi Qiu Li Xudong Cai Bin Song Na Li Lianglan Shen Li Wang Xiaoping Wang Zhaohui Ni Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis Kidney International Reports hemodialysis oral iron supplements renal anemia |
| title | Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis |
| title_full | Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis |
| title_fullStr | Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis |
| title_full_unstemmed | Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis |
| title_short | Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis |
| title_sort | randomized positive controlled study on the efficacy and safety of oral polysaccharide iron complex therapy in patients on hemodialysis |
| topic | hemodialysis oral iron supplements renal anemia |
| url | http://www.sciencedirect.com/science/article/pii/S2468024925001603 |
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