Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis

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

doi:10.1016/j.ekir.2025.03.017

Randomized, Positive-Controlled Study on the Efficacy and Safety of Oral Polysaccharide-Iron Complex Therapy in Patients on Hemodialysis

Kidney Int Rep. 2025 Mar 17;10(6):1742-1749. doi: 10.1016/j.ekir.2025.03.017. eCollection 2025 Jun.

Authors

Renhua Lu^{1

2

3

4}, Haijiao Jin^{1

2

3

4}, Juan Cao⁵, Hua Li⁶, Xiaoxia Wang⁷, Yinghui Qi⁸, Qiu Li⁹, Xudong Cai¹⁰, Bin Song¹¹, Na Li¹², Lianglan Shen¹³, Li Wang¹⁴, Xiaoping Wang¹⁵, Zhaohui Ni^{1

2

3

4}

Affiliations

¹ Department of Nephrology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² Molecular Cell Laboratory for Kidney Disease, Shanghai, China.
³ Shanghai Peritoneal Dialysis Research Center, Shanghai, China.
⁴ Uremia Diagnosis and Treatment Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
⁵ Taixing People's Hospital, Taixing, China.
⁶ Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁷ Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
⁸ Shanghai Punan Hospital of Pudong New District, Shanghai, China.
⁹ The First People's Hospital of Shuangliu District, Chengdu, China.
¹⁰ Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, China.
¹¹ Deyang People's Hospital, Deyang, China.
¹² Jinan Zhangqiu District People's Hospital, Jinan, China.
¹³ Nantong First People's Hospital, Nantong, China.
¹⁴ Shandong Province Qianfoshan Hospital, Jinan, China.
¹⁵ Central Hospital Affiliated to Shandong First Medical University, Jinan, China.

Abstract

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.

Keywords: hemodialysis; oral iron supplements; renal anemia.