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Clinical Trial
. 2020;144(9):428-439.
doi: 10.1159/000507258. Epub 2020 Jun 25.

Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study

Adrian C Covic  1 , Stuart M Sprague  2 , Anjay Rastogi  3 , Markus Ketteler  4 , Sebastian Walpen  5 , Amandine Perrin  6 , Jürgen Floege  7
Affiliations
Clinical Trial

Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study

Adrian C Covic et al. Nephron. 2020.

Abstract

Introduction: Control of hyperphosphatemia in patients on dialysis remains a major challenge.

Objective: This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial.

Methods: Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled.

Results: Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (-2.89 vs. -0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765-0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328-0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937-0.992) as significant predictors of uncontrolled sP.

Conclusion: This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.

Keywords: Chronic kidney disease; Dialysis; Phosphate binder; Sevelamer carbonate; Sucroferric oxyhydroxide.

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Conflict of interest statement

A.C.C. has received consultancy fees or lecture fees from Vifor Pharma, Fresenius Medical Care, and Amgen. S.M.S. has received consultancy fees from OPKO, Vifor Pharma, Amgen, Fresenius Medical Care, Litholink Corp, and NPS Pharma and research funding from Abbott, Amgen, and Shire. A.R. has received consultancy fees from Fresenius Medical Care and Vifor Pharma and lecture and consultancy fees from Sanofi, Cytochroma/OPKO Health, Vifor Pharma, Satellite Healthcare, and Deltanoid. M.K. has received consulting fees or lecture fees from Vifor Pharma, Fresenius Medical Care, Amgen, AbbVie, Medice, Mitsubishi Pharma, Sanofi, and Shire. S.W. and A.P. are both employees of Vifor Pharma. J.F. has received consulting fees or lecture fees from AbbVie, Amgen, Chugai, Fresenius Medical Care, Sanofi, Shire, and Vifor Pharma.

Figures

Fig. 1
Fig. 1
Concentrations and changes from baseline in mean (SD) serum phosphorus (a), mean (SD) iPTH (b), and median (25th/75th percentile) FGF-23 (c) for sP-controlled patients and sP-uncontrolled patients (main analysis set, N = 497). a *p < 0.001 compared with sP-uncontrolled patients (baseline-adjusted ANOVA testing). Values are mean ± SD. aWeek 0 in initial phase 3 study. bExtension study week 28 result. sP, serum phosphorus. b *p < 0.001 compared with sP-uncontrolled patients (baseline-adjusted ANOVA testing). Values are mean ± SD. aWeek 0 in initial phase 3 study. bDefined as extension study week 28 result. iPTH, intact parathyroid hormone; sP, serum phosphorus. c *p < 0.05, **p < 0.001 compared with sP-uncontrolled patients (baseline-adjusted generalized linear model on rank data). Values are median (±25th/75th percentiles). aWeek 0 in initial phase 3 study. bDefined as extension study week 28 result. FGF-23, fibroblast growth factor-23; sP, serum phosphorus.
Fig. 2
Fig. 2
Supporting analysis of concentrations and changes from baseline in mean (SD) serum phosphorus (a), mean (SD) iPTH (b), and median (25th/75th percentile) FGF-23 (c) for sP-controlled and sP-uncontrolled patients (supporting analysis set, N = 569). a *p < 0.001 compared with sP-uncontrolled (baseline-adjusted ANOVA). Values are mean ± SD. aWeek 0 in initial phase 3 study. bDefined as extension study week 28 result. sP, serum phosphorus. b *p < 0.01, **p < 0.001 compared with sP-uncontrolled (baseline-adjusted ANOVA). Values are mean ± SD. aWeek 0 in initial phase 3 study. bDefined as extension study week 28 result. iPTH, intact parathyroid hormone; sP, serum phosphorus. c *p < 0.001 compared with sP-uncontrolled patients (baseline-adjusted generalized linear model on rank data). Values are median (±25th/75th percentiles). aWeek 0 in initial phase 3 study. bDefined as extension study week 28. FGF-23, fibroblast growth factor-23; sP, serum phosphorus.
Fig. 3
Fig. 3
Comparison of maximum daily phosphate binder dose administered to sP-controlled and sP-uncontrolled patients in the sucroferric oxyhydroxide (a) and sevelamer carbonate (b) groups (main analysis set, N = 497). sP, serum phosphorus.
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