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Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients.
Nephrol Dial Transplant. 2015 Jun; 30(6):1037-46.ND

Abstract

BACKGROUND

Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, sucroferric oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study.

METHODS

In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0-3.0 g/day (2-6 tablets/day; n = 710) or sevelamer 2.4-14.4 g/day (3-18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study.

RESULTS

Overall, 644 patients were available for efficacy analysis (n = 384 sucroferric oxyhydroxide; n = 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 ± 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 ± 0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13-1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide (4.0 ± 1.5) versus sevelamer (10.1 ± 6.6). Patient adherence was 86.2% with sucroferric oxyhydroxide versus 76.9% with sevelamer. Mean serum ferritin concentrations increased over the extension study in both treatment groups, but transferrin saturation (TSAT), iron and hemoglobin concentrations were generally stable. Gastrointestinal-related adverse events were similar and occurred early with both treatments, but decreased over time.

CONCLUSIONS

The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden, compared with sevelamer. Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation.

Authors+Show Affiliations

RWTH University Hospital Aachen, 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 Hospital Queens, Flushing, NY, USA.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.Vifor Pharma, Glattbrugg, Switzerland.NorthShore University Health System University of Chicago Pritzker School of Medicine, Evanston, IL, USA.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25691681

Citation

Floege, Jürgen, et al. "Long-term Effects of the Iron-based Phosphate Binder, Sucroferric Oxyhydroxide, in Dialysis Patients." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 30, no. 6, 2015, pp. 1037-46.
Floege J, Covic AC, Ketteler M, et al. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant. 2015;30(6):1037-46.
Floege, J., Covic, A. C., Ketteler, M., Mann, J. F., Rastogi, A., Spinowitz, B., Chong, E. M., Gaillard, S., Lisk, L. J., & Sprague, S. M. (2015). Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 30(6), 1037-46. https://doi.org/10.1093/ndt/gfv006
Floege J, et al. Long-term Effects of the Iron-based Phosphate Binder, Sucroferric Oxyhydroxide, in Dialysis Patients. Nephrol Dial Transplant. 2015;30(6):1037-46. PubMed PMID: 25691681.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. AU - Floege,Jürgen, AU - Covic,Adrian C, AU - Ketteler,Markus, AU - Mann,Johannes F E, AU - Rastogi,Anjay, AU - Spinowitz,Bruce, AU - Chong,Edward M F, AU - Gaillard,Sylvain, AU - Lisk,Laura J, AU - Sprague,Stuart M, AU - ,, Y1 - 2015/02/16/ PY - 2014/09/04/received PY - 2014/12/24/accepted PY - 2015/2/19/entrez PY - 2015/2/19/pubmed PY - 2015/10/21/medline KW - hemodialysis KW - peritoneal dialysis KW - sucroferric oxyhydroxide SP - 1037 EP - 46 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 30 IS - 6 N2 - BACKGROUND: Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, sucroferric oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. METHODS: In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0-3.0 g/day (2-6 tablets/day; n = 710) or sevelamer 2.4-14.4 g/day (3-18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. RESULTS: Overall, 644 patients were available for efficacy analysis (n = 384 sucroferric oxyhydroxide; n = 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 ± 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 ± 0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13-1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide (4.0 ± 1.5) versus sevelamer (10.1 ± 6.6). Patient adherence was 86.2% with sucroferric oxyhydroxide versus 76.9% with sevelamer. Mean serum ferritin concentrations increased over the extension study in both treatment groups, but transferrin saturation (TSAT), iron and hemoglobin concentrations were generally stable. Gastrointestinal-related adverse events were similar and occurred early with both treatments, but decreased over time. CONCLUSIONS: The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden, compared with sevelamer. Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/25691681/Long_term_effects_of_the_iron_based_phosphate_binder_sucroferric_oxyhydroxide_in_dialysis_patients_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfv006 DB - PRIME DP - Unbound Medicine ER -