Dec 14, 2017 - VELPHORO®) and sevelamer carbonate (SEV) in dialysis patients with hyperphosphataemia. Methods: In this Phase 3 study, 1059 patients ...
Nephrology Dialysis Transplantation 30 (Supplement 3): iii195–iii204, 2015 doi:10.1093/ndt/gfv176.7
CHRONIC KIDNEY DISEASE. ANAEMIA FP383
POST HOC ANALYSIS OF IV IRON AND ESA USE OVER 1 YEAR IN A PHASE 3 STUDY OF SUCROFERRIC OXYHYDROXIDE
Adrian Covic1, Stuart Sprague2, Markus Ketteler3, Bruce Spinowitz4, Anjay Rastogi5, Viatcheslav Rakov6, Jaco Botha7 and Jürgen Flöge8 1 ‘Gr. T. Popa’ University of Medicine and Pharmacy, Nephrology, Iași, Romania, 2 NorthShore University Health System, Division of Nephrology and Hypertension, Evanston, IL, 3Coburg Clinic and KfH-Dyalisis Center, Department of Nephrology and Clinical Immunology, Coburg, Germany, 4New York Hospital of Queens, Department of Medicine, Flushing, NY, 5UCLA, Department of Medicine, Los Angeles, CA, 6Vifor Pharma Ltd., Global Medical Affairs, Glattbrugg, Switzerland, 7 Vifor Pharma Ltd., statistics, Glattbrugg, Switzerland, 8University Hospital Aachen, Department of Nephrology and Clinical Immunology, Aachen, Germany Introduction and Aims: This post hoc analysis evaluated intravenous (IV) iron and erythropoiesis stimulating agent (ESA) use during a randomized, open-label, Phase 3 study of the iron-based phosphate binder sucroferric oxyhydroxide (SFOH; VELPHORO®) and sevelamer carbonate (SEV) in dialysis patients with hyperphosphataemia. Methods: In this Phase 3 study, 1059 patients were randomized to SFOH (1.0-3.0 g/ day) or SEV (2.4-14.4 g/day) for 12 weeks’ dose titration plus 12 weeks’ maintenance. Eligible patients enrolled in a 28-week extension study. Concomitant use of IV iron and ESA was permitted. Results: In total, 549 patients completed the extension study (i.e., 52 weeks’ continuous treatment). Percentages of patients receiving IV iron or ESA over the course of the study are shown in the Table. During the first 12 weeks of the study, concomitant use of IV iron and ESAs increased from baseline in both treatment groups. After Week 12, the percentage of patients receiving IV iron decreased in both treatment groups, with a trend toward lower IV iron use in the SFOH group, compared with the SEV group. From Week 12 until the end of the study (Week 52), ESA use was significantly lower in the SFOH group, compared with the SEV group. Conclusions: A trend towards lower use of antianaemic products was observed among patients receiving SFOH versus those receiving SEV. ESA use was significantly lower with SFOH versus SEV from Week 12 onwards. Overall, these trends in antianaemic product use reflect changes in iron parameters observed during the study, with differences between the treatment groups likely due to low iron uptake in patients treated with SFOH. Furthermore, country-specific trends in clinical practice (e.g. use of concomitant IV iron) have to be considered. There was no indication for a risk of iron overload with SFOH over year of treatment.
© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
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