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

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

Renhua Lu  1   2   3   4 , Haijiao Jin  1   2   3   4 , Juan Cao  5 , Hua Li  6 , Xiaoxia Wang  7 , Yinghui Qi  8 , Qiu Li  9 , Xudong Cai  10 , Bin Song  11 , Na Li  12 , Lianglan Shen  13 , Li Wang  14 , Xiaoping Wang  15 , Zhaohui Ni  1   2   3   4
Affiliations

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

Renhua Lu et al. Kidney Int Rep. .

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.

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Figures

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Graphical abstract
Figure 1
Figure 1
Patient flow chart. D, day; V, visit.
Figure 2
Figure 2
Primary and secondary efficacy end points in the treatment (n = 96) and control (n = 97) groups. (a) Mean transferrin saturation (TSAT) at week 12 (95% CI). (b) TSAT levels at week 24 (95% CI). (c) Hemoglobin levels at week 12 (P = 0.18). (d) High-sensitivity C-reactive protein (HsCRP) levels at week 12 (95% CI, P = 0.628). (e) Hemoglobin levels at week 24 (P = 0.166). (f) HsCRP levels at week 24 (95% CI, P = 0.495). (g) Serum ferritin levels at week 12 (∗∗∗P < 0.001). (h) Serum ferritin levels at week 24 (∗∗∗P < 0.001). CI, confidence interval.
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References

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