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Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study.
Nephron. 2020; 144(9):428-439.N

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.

Authors+Show Affiliations

Nephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Iași, Romania, accovic@gmail.com.NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA.Division of Nephrology, University of California, Los Angeles, California, USA.Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.Department of Medical Affairs, Vifor Pharma, Glattbrugg, Switzerland.Department of Biometrics, Vifor Pharma, Glattbrugg, Switzerland.Division of Nephrology, RWTH University Hospital Aachen, Aachen, Germany.

Pub Type(s)

Clinical Trial, Phase III
Controlled Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

32585670

Citation

Covic, Adrian C., et al. "Characteristics of Patients Who Achieve Serum Phosphorus Control On Sucroferric Oxyhydroxide or Sevelamer Carbonate: a Post Hoc Analysis of a Phase 3 Study." Nephron, vol. 144, no. 9, 2020, pp. 428-439.
Covic AC, Sprague SM, Rastogi A, et al. Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study. Nephron. 2020;144(9):428-439.
Covic, A. C., Sprague, S. M., Rastogi, A., Ketteler, M., Walpen, S., Perrin, A., & Floege, J. (2020). Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study. Nephron, 144(9), 428-439. https://doi.org/10.1159/000507258
Covic AC, et al. Characteristics of Patients Who Achieve Serum Phosphorus Control On Sucroferric Oxyhydroxide or Sevelamer Carbonate: a Post Hoc Analysis of a Phase 3 Study. Nephron. 2020;144(9):428-439. PubMed PMID: 32585670.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study. AU - Covic,Adrian C, AU - Sprague,Stuart M, AU - Rastogi,Anjay, AU - Ketteler,Markus, AU - Walpen,Sebastian, AU - Perrin,Amandine, AU - Floege,Jürgen, Y1 - 2020/06/25/ PY - 2019/09/16/received PY - 2020/03/14/accepted PY - 2020/6/26/pubmed PY - 2021/8/28/medline PY - 2020/6/26/entrez KW - Chronic kidney disease KW - Dialysis KW - Phosphate binder KW - Sevelamer carbonate KW - Sucroferric oxyhydroxide SP - 428 EP - 439 JF - Nephron JO - Nephron VL - 144 IS - 9 N2 - 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. SN - 2235-3186 UR - https://www.unboundmedicine.com/medline/citation/32585670/Characteristics_of_Patients_Who_Achieve_Serum_Phosphorus_Control_on_Sucroferric_Oxyhydroxide_or_Sevelamer_Carbonate:_A_post_hoc_Analysis_of_a_Phase_3_Study_ L2 - https://www.karger.com?DOI=10.1159/000507258 DB - PRIME DP - Unbound Medicine ER -