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.