Abstract: TH-PO873
IHOPE: A Randomized, Open-Label, Positive-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Oral Iron Polysaccharide Complex in Patients on Hemodialysis
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Lu, Renhua, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China
- Jin, Haijiao, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China
- Cao, Juan, Taixing People's Hospital, Taixing, China
- Li, Hua, Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, China
- Wang, Xiaoxia, Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Qi, Yinghui, Shanghai Punan Hospital of Pudong NEW District, Shanghai, China
- Li, Qiu, The First People's Hospital of Shuangliu District, Chengdu, Chengdu, China
- Cai, Xudong, Ningbo Traditional Chinese Medicine Hospital, Ningbo, China
- Song, Bin, Deyang People's Hospital, Deyang, China
- Li, Na, Jinan Zhangqiu District People's Hospital, Jinan, China
- Shen, Lianglan, Nantong First People's Hospital, Nantong, China
- Wang, Lili, Shandong Province Qianfoshan Hospital, Jinan, China
- Wang, Xiaoping, Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China
- Ni, Zhaohui, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai, Shanghai, China
Background
The IHOPE study (ChiCTR 2000031166) evaluated the efficacy and safety of iron polysaccharide complex (a novel oral trivalent iron preparation) in individuals receiving hemodialysis (HD) in China.
Methods
IHOPE was a randomized, open-label, positive-controlled, non-inferiority, multicenter study conducted at 12 sites across China. Participants aged 18-75 years who were receiving HD ≥3 months with hemoglobin (Hb) levels ≥100−<130g/L, transferrin saturation (TSAT) ≥20−≤50% or serum ferritin (SF) ≥100−≤500 μg/L, and who had received recombinant human erythropoietin or iron therapy within 12 weeks prior to enrollment, were recruited. Following a 4-week screening period, patients were randomized 1:1 to the experimental group (iron polysaccharide complex 150 mg twice daily orally) or a control group (iron sucrose injection 100 mg 2-weekly IV) for 24 weeks. The primary outcome was the TSAT at 12 weeks of treatment. Secondary outcomes included the TSAT and Hb after 24 weeks of treatment. Safety outcomes included recorded adverse events (AEs) and severe adverse events (SAEs). Non-inferiority for TSAT was assessed using confidence interval methods, with a non-inferiority margin of 7%.
Results
193 adults of mean (SD) age 55.3 (11.66) years were randomized to the experimental group (n = 96) or control group (n = 97); 62.2% were male. At 12 weeks, TSAT in the expertimental group was 32.3% (95% CI 29.39−35.19%) demonstrating non-inferiority to the control group − in whom TSAT was 33.4% (95% CI 30.95−35.77%). At 24 weeks, TSAT values were 29.4% (95% CI 26.71−32.18%) in the experimental group and 32.6% (95% CI 29.68−35.45%) in the control group, again showing non-inferiority. Hb levels at 24 weeks were also comparable between the experimental and control groups (114.6 ± 11.81 g/L vs 117.4 ± 13.89 g/L; P = 0.166). AEs and SAEs were reported in 56.3% and 15.6% of patients, respectively in the experimental arm, and 47.4% and 13.4%, respectively in the control arm, with no new safety concerns identified.
Conclusion
Orally administered iron polysaccharide complex is an effective, well-tolerated treatment, demonstrating non-inferiority to intravenous iron sucrose in managing anemia among Chinese individuals receiving HD.