Dec 14, 2017 - compared with use of sevelamer carbonate (SEV) in dialysis patients. Methods: 1059 patients were randomized to SFOH (1.0-3.0 g/day) or SEV ...
Nephrology Dialysis Transplantation 30 (Supplement 3): iii195–iii204, 2015 doi:10.1093/ndt/gfv176.21
CHRONIC KIDNEY DISEASE. ANAEMIA FP397
POST HOC ANALYSIS OF IRON INDICES IN DIALYSIS PATIENTS WITH LOWER VS HIGHER BASELINE FERRITIN IN A PHASE 3 STUDY OF SUCROFERRIC OXYHYDROXIDE
Adrian Covic1, Stuart Sprague2, Markus Ketteler3, Anjay Rastogi4, Bruce Spinowitz5, Viatcheslav Rakov6, Jaco Botha7 and Jürgen Flöge8 1 Gr.T. Popa University of Medicine and Pharmacy, Department of Internal Medicine, Iași, Romania, 2NorthShore University Health System, Division of Nephrology and Hypertension, Evanston, IL, 3Coburg Clinic and KfH-Dyalisis Center, Department of Nephrology and Clinical Immunology, Coburg, Germany, 4 UCLA, Department of Medicine, Los Angeles, CA, 5New York Hospital of Queens, Department of Medicine, Flushing, NY, 6Vifor Pharma Ltd., Global Medical Affairs, Glattbrugg, Switzerland, 7Vifor Pharma Ltd., statistics, Glattbrugg, Switzerland, 8University Hospital Aachen, Department of Nephrology and Clinical Immunology, Aachen, Germany Introduction and Aims: A post hoc analysis of data from a randomized, open-label, Phase 3 study evaluated the effect of use of the iron-based phosphate binder sucroferric oxyhydroxide (SFOH; VELPHORO®) on iron indices by baseline ferritin levels compared with use of sevelamer carbonate (SEV) in dialysis patients. Methods: 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. Results: 549 patients completed the extension study (i.e., 52 weeks’ continuous treatment). Changes in mean iron indices stratified by baseline ferritin quartiles for both treatment groups are shown in the Table. Among patients with lower baseline ferritin levels, there was a trend for greater changes in iron indices from baseline to Week 52 with SFOH versus SEV, with significantly greater increases in TSAT levels observed in the SFOH group. Among patients with baseline ferritin levels in the upper quartile, changes in iron indices were less pronounced in both treatment groups. Conclusions: Changes in iron indices in patients with lower baseline ferritin levels appeared more pronounced with SFOH vs SEV, likely due to low iron absorption with SFOH. In patients with higher baseline ferritin levels, no such differences were noted, indicating that iron uptake associated with SFOH use is self-limiting at higher baseline levels. There was no indication for a risk of iron overload with SFOH. Previous analyses have demonstrated that increases in iron parameters observed during the study were primarily driven by concomitant IV iron use.
© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
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