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One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis.
Nephrol Dial Transplant. 2017 Nov 01; 32(11):1918-1926.ND

Abstract

Background

Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population.

Methods

The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total.

Results

In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (sucroferric oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, sucroferric oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with sucroferric oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with sucroferric oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with sucroferric oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with sucroferric oxyhydroxide and nausea, vomiting and constipation with sevelamer.

Conclusions

Sucroferric oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.

Authors+Show Affiliations

RWTH University Hospital Aachen, Germany.Gr.T. Popa University of Medicine and Pharmacy, Iasi, Romania.Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.Munich General Hospital, Munich, Germany.University of California, Los Angeles, CA, USA.New York-Presbyterian Hospital Queens, Flushing, NY, USA.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, IL, USA.

Pub Type(s)

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

Language

eng

PubMed ID

28339993

Citation

Floege, Jürgen, et al. "One-year Efficacy and Safety of the Iron-based Phosphate Binder Sucroferric Oxyhydroxide in Patients On Peritoneal Dialysis." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 32, no. 11, 2017, pp. 1918-1926.
Floege J, Covic AC, Ketteler M, et al. One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis. Nephrol Dial Transplant. 2017;32(11):1918-1926.
Floege, J., Covic, A. C., Ketteler, M., Mann, J., Rastogi, A., Spinowitz, B., Rakov, V., Lisk, L. J., & Sprague, S. M. (2017). One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 32(11), 1918-1926. https://doi.org/10.1093/ndt/gfw460
Floege J, et al. One-year Efficacy and Safety of the Iron-based Phosphate Binder Sucroferric Oxyhydroxide in Patients On Peritoneal Dialysis. Nephrol Dial Transplant. 2017 Nov 1;32(11):1918-1926. PubMed PMID: 28339993.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - One-year efficacy and safety of the iron-based phosphate binder sucroferric oxyhydroxide in patients on peritoneal dialysis. AU - Floege,Jürgen, AU - Covic,Adrian C, AU - Ketteler,Markus, AU - Mann,Johannes, AU - Rastogi,Anjay, AU - Spinowitz,Bruce, AU - Rakov,Viatcheslav, AU - Lisk,Laura J, AU - Sprague,Stuart M, PY - 2016/08/25/received PY - 2016/12/09/accepted PY - 2017/3/25/pubmed PY - 2018/5/19/medline PY - 2017/3/25/entrez KW - chronic kidney disease KW - hemodialysis KW - peritoneal dialysis KW - phosphate binder KW - sevelamer carbonate KW - sucroferric oxyhydroxide SP - 1918 EP - 1926 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 32 IS - 11 N2 - Background: Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (sucroferric oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, sucroferric oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with sucroferric oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with sucroferric oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with sucroferric oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with sucroferric oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/28339993/One_year_efficacy_and_safety_of_the_iron_based_phosphate_binder_sucroferric_oxyhydroxide_in_patients_on_peritoneal_dialysis_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfw460 DB - PRIME DP - Unbound Medicine ER -