Dataset Information

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.

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.

SUBMITTER: Liu J

PROVIDER: S-EPMC10794965 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Liu Jun J Zuo Li L Walpen Sebastian S Bernard Laurence L Marty Matthieu M Enoiu Milica M

Nephron 20230720 1

<h4>Introduction</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 37473746

Similar Datasets

Project description:Rationale & objectiveHigh pill burden associates with reduced phosphate-binder adherence among dialysis patients, contributing to elevated serum phosphorus levels. We compared the real-world effectiveness of sucroferric oxyhydroxide (SO) versus other phosphate binders in hemodialysis patients over 2 years.Study designRetrospective cohort study.Setting & participantsAdult in-center hemodialysis patients prescribed 2 years of uninterrupted SO therapy (maintenance SO; n = 222) compared with patients who discontinued SO therapy (discontinued SO; n = 596) within 90 days of first prescription and switched to other phosphate binder(s) for 2 years.ExposuresPhosphate binders.OutcomesAchievement of serum phosphorus levels ≤ 5.5 mg/dL, pill burden, and hospitalizations.Analytical approachComparisons were made quarterly (Q1-Q8) between maintenance SO and discontinued SO using Poisson and mixed-effects linear regression.ResultsPatients achieving serum phosphorus levels ≤ 5.5 mg/dL increased from baseline in maintenance SO (46 [20.7%] to a maximum of 104 [46.8%; P < 0.001]) and discontinued SO (96 [16.1%] to a maximum of 201 [33.7%]; P < 0.001). 100 (45%) maintenance SO patients achieved target serum phosphorus levels at Q8 with 3.1 fewer pills per day from baseline (7.5 to 4.4 pills per day; P < 0.001), and 190 (31.9%) discontinued SO patients achieved serum phosphorus levels ≤ 5.5 mg/dL at Q8 with pill burden unchanged (9.1 to 9.3 pills per day; P = 0.3). Among all patients during 2 years, mean serum phosphorus levels decreased by -0.66 mg/dL and -0.45 mg/dL (maintenance SO vs discontinued SO; P = 0.014), and mean pill burden decreased in maintenance SO (8.5 to 5.1 pills per day; P < 0.001), but not in discontinued SO (11.6 to 10.9 pills per day; P = 0.2). The serum phosphorus level decrease with SO was confirmed in a sensitivity analysis including patients with SO therapy for 2 or fewer years. Compared with discontinued SO, maintenance SO patients had 35.6 fewer hospitalizations per 100 patient-years (incidence rate ratio, 0.75 [95% CI, 0.58-0.96]).LimitationsNo data for treatment indication, tolerance, or adherence.ConclusionsPatients maintained on SO therapy were more likely to achieve target serum phosphorus levels, use 50% fewer phosphate-binder pills per day, and have fewer hospital admissions than patients switched to treatment with other binders.

Dataset Information

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

Methods

Results

Conclusion

Publications

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.

Similar Datasets

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