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Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide.
Nephrol Dial Transplant. 2017 Aug 01; 32(8):1330-1338.ND

Abstract

BACKGROUND

Sucroferric oxyhydroxide is a non-calcium, iron-based phosphate binder indicated for the treatment of hyperphosphataemia in adult dialysis patients. This post hoc analysis of a randomized, 24-week Phase 3 study and its 28-week extension was performed to evaluate the long-term effect of sucroferric oxyhydroxide on iron parameters.

METHODS

A total of 1059 patients were randomized to sucroferric oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer carbonate ('sevelamer') 2.4-14.4 g/day (n = 349) for up to 52 weeks. The current analysis only included patients who completed 52 weeks of continuous treatment (n = 549). Changes in iron-related parameters and anti-anaemic product use during the study were measured.

RESULTS

Some changes in iron-related parameters across both treatment groups were observed during the first 24 weeks of the study, and to a lesser extent with longer-term treatment. There were small, but significantly greater increases in mean transferrin saturation (TSAT) and haemoglobin levels with sucroferric oxyhydroxide versus sevelamer during the first 24 weeks (change in TSAT: +4.6% versus +0.6%, P = 0.003; change in haemoglobin: +1.6 g/L versus -1.1 g/L, P = 0.037). Mean serum ferritin concentrations also increased from Weeks 0 to 24 with sucroferric oxyhydroxide and sevelamer (+119 ng/mL and +56.2 ng/mL respectively; no statistically significant difference between groups). In both treatment groups, ferritin concentrations increased to a greater extent in the overall study population [>70% of whom received concomitant intravenous (IV) iron], compared with the subset of patients who did not receive IV iron therapy during the study. The pattern of anti-anaemic product use was similar in both treatment groups, with a trend towards higher use of IV iron and erythropoiesis-stimulating agents with sevelamer.

CONCLUSIONS

Initial increases in some iron-related parameters were observed in both treatment groups but were more pronounced with sucroferric oxyhydroxide. These differences between treatment groups with respect to changes in iron parameters are likely due to minimal iron absorption from sucroferric oxyhydroxide.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27342579

Citation

Covic, Adrian C., et al. "Iron-related Parameters in Dialysis Patients Treated With Sucroferric Oxyhydroxide." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 32, no. 8, 2017, pp. 1330-1338.
Covic AC, Floege J, Ketteler M, et al. Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrol Dial Transplant. 2017;32(8):1330-1338.
Covic, A. C., Floege, J., Ketteler, M., Sprague, S. M., Lisk, L., Rakov, V., & Rastogi, A. (2017). Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 32(8), 1330-1338. https://doi.org/10.1093/ndt/gfw242
Covic AC, et al. Iron-related Parameters in Dialysis Patients Treated With Sucroferric Oxyhydroxide. Nephrol Dial Transplant. 2017 Aug 1;32(8):1330-1338. PubMed PMID: 27342579.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. AU - Covic,Adrian C, AU - Floege,Jürgen, AU - Ketteler,Markus, AU - Sprague,Stuart M, AU - Lisk,Laura, AU - Rakov,Viatcheslav, AU - Rastogi,Anjay, PY - 2015/12/21/received PY - 2016/05/18/accepted PY - 2016/6/28/pubmed PY - 2018/3/3/medline PY - 2016/6/26/entrez KW - chronic kidney disease KW - dialysis KW - iron KW - phosphate binder KW - sucroferric oxyhydroxide SP - 1330 EP - 1338 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 32 IS - 8 N2 - BACKGROUND: Sucroferric oxyhydroxide is a non-calcium, iron-based phosphate binder indicated for the treatment of hyperphosphataemia in adult dialysis patients. This post hoc analysis of a randomized, 24-week Phase 3 study and its 28-week extension was performed to evaluate the long-term effect of sucroferric oxyhydroxide on iron parameters. METHODS: A total of 1059 patients were randomized to sucroferric oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer carbonate ('sevelamer') 2.4-14.4 g/day (n = 349) for up to 52 weeks. The current analysis only included patients who completed 52 weeks of continuous treatment (n = 549). Changes in iron-related parameters and anti-anaemic product use during the study were measured. RESULTS: Some changes in iron-related parameters across both treatment groups were observed during the first 24 weeks of the study, and to a lesser extent with longer-term treatment. There were small, but significantly greater increases in mean transferrin saturation (TSAT) and haemoglobin levels with sucroferric oxyhydroxide versus sevelamer during the first 24 weeks (change in TSAT: +4.6% versus +0.6%, P = 0.003; change in haemoglobin: +1.6 g/L versus -1.1 g/L, P = 0.037). Mean serum ferritin concentrations also increased from Weeks 0 to 24 with sucroferric oxyhydroxide and sevelamer (+119 ng/mL and +56.2 ng/mL respectively; no statistically significant difference between groups). In both treatment groups, ferritin concentrations increased to a greater extent in the overall study population [>70% of whom received concomitant intravenous (IV) iron], compared with the subset of patients who did not receive IV iron therapy during the study. The pattern of anti-anaemic product use was similar in both treatment groups, with a trend towards higher use of IV iron and erythropoiesis-stimulating agents with sevelamer. CONCLUSIONS: Initial increases in some iron-related parameters were observed in both treatment groups but were more pronounced with sucroferric oxyhydroxide. These differences between treatment groups with respect to changes in iron parameters are likely due to minimal iron absorption from sucroferric oxyhydroxide. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/27342579/Iron_related_parameters_in_dialysis_patients_treated_with_sucroferric_oxyhydroxide_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfw242 DB - PRIME DP - Unbound Medicine ER -