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

Nephron. 2024;148(1):22-33. doi: 10.1159/000531869. Epub 2023 Jul 20.

Abstract

Introduction: This study aimed to investigate the efficacy and safety of sucroferric oxyhydroxide (SFOH) versus 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 was non-inferiority analysis of change in sP from baseline to week 12. Secondary endpoints included sP over time and safety.

Results: 415 patients were screened; 286 were 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) versus -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. The SFOH group achieved target sP (1.13-1.78 mmol/L) earlier than the 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 weeks of 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.

Keywords: Chronic kidney disease; Hyperphosphataemia; Phosphate binder; Sucroferric oxyhydroxide.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase III

MeSH terms

  • Adult
  • Chelating Agents / adverse effects
  • China
  • Drug Combinations
  • Ferric Compounds / adverse effects
  • Humans
  • Hyperphosphatemia* / drug therapy
  • Hyperphosphatemia* / etiology
  • Phosphorus
  • Renal Dialysis
  • Sevelamer / adverse effects
  • Sucrose*

Substances

  • Sevelamer
  • sucroferric oxyhydroxide
  • Ferric Compounds
  • Phosphorus
  • Chelating Agents
  • Drug Combinations
  • Sucrose

Associated data

  • ClinicalTrials.gov/NCT03644264

Grants and funding

This study (ClinicalTrials.gov Identifier: NCT03644264) was supported by Vifor Fresenius Medical Care Renal Pharma Ltd.