Supplementary Material for: Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer carbonate in Chinese dialysis patients with hyperphosphataemia: A randomised, open-label, multicentre, 12-week phase III study

Introduction: This study aimed to investigate the efficacy and safety of sucroferric oxyhydroxide (SFOH) vs sevelamer carbonate in controlling serum phosphorus (sP) in adult Chinese dialysis patients with hyperphosphataemia (sP >1.78 mmol/L). Methods: Open-label, randomised (1:1), active-controlled, parallel group, multicentre, phase III study of SFOH and sevelamer at starting doses corresponding to 1,500 mg iron/day and 2.4 g/day, respectively, with 8-week dose titration and 4-week maintenance (NCT03644264). Primary endpoint: non-inferiority analysis of change in sP from baseline to Week 12. Secondary endpoints: sP over time and safety. Results: 415 patients screened; 286 enrolled and randomised (142 and 144 to SFOH and sevelamer, respectively). Mean (SD) baseline sP: 2.38 (0.57) and 2.38 (0.52) mmol/L, respectively. Mean (SD) change in sP from baseline to Week 12: –0.71 (0.60) vs –0.63 (0.52) mmol/L, respectively; difference (sevelamer minus SFOH) in least squares means (95% CI): 0.08 mmol/L (–0.02, 0.18) with the lower limit of 95% CI above the non-inferiority margin of –0.34 mmol/L. SFOH group achieved target sP (1.13–1.78 mmol/L) earlier than sevelamer group (56.5% vs 32.8% at Week 4) and with a lower pill burden (mean 3.7 vs 9.1 tablets/day over 4-week maintenance, respectively). Safety and tolerability of SFOH was consistent with previous studies and no new safety signals were observed. Conclusion: SFOH effectively reduced sP from baseline and was non-inferior to sevelamer after 12 weeks of treatment but had a lower pill burden in Chinese dialysis patients with hyperphosphataemia; SFOH benefit–risk profile is favourable in Chinese patients.