FERRIC CITRATE (FC) AS A PHOSPHATE BINDER IN. PERITONEAL DIALYSIS (PD). Negoi Dana1, Jamie P Dwyer2, Julia B Lewis2, Kausik Umanath3, ...
Nephrology Dialysis Transplantation 30 (Supplement 3): iii257–iii275, 2015 doi:10.1093/ndt/gfv180.42
DIALYSIS. PERITONEAL DIALYSIS - 1 FP590
FERRIC CITRATE (FC) AS A PHOSPHATE BINDER IN PERITONEAL DIALYSIS (PD)
Negoi Dana1, Jamie P Dwyer2, Julia B Lewis2, Kausik Umanath3, Stephen Z Fadem4, Robert Niecestro5, Desiree DeWaal1, Erwin Aguilar6, Mohammed Sika2, Mark Koury7, Yoram Yagil8 and for the Collaborative Study Group2 1 University of Vermont Medical Center, Nephrology, Burlington, VT, 2Vanderbilt University Medical Center, Nephrology, Nashville, TN, 3Henry Ford Hospital, Nephrology, Detroit, MI, 4Baylor College of Medicine, Nephrology, Houston, TX, 5 Collaborative Study Group, Nephrology, Pocono Pines, PA, 6Louisiana State University, Nephrology, New Orleans, LA, 7Vanderbilt University Medical Center, Hematology/Oncology, Nashville, TN, 8Ben-Gurion University, Nephrology, Beer Sheba, Israel Introduction and Aims: Ferric citrate was recently approved in the U.S. for the treatment of hyperphosphatemia in dialysis patients. This approval was based primarily on a study in 441 dialysis patients, fourteen of which were on PD, the rest on hemodialysis. Because published data on the use of FC in PD are scarce, we analyzed the efficacy of FC in the subset of PD patients in this study. Methods: The study design was a three-period, multicenter, randomized, open-label safety and efficacy trial. The first period consisted of a 2-week washout, the second period incorporated a 52-week randomized, open-label, active control (AC) and the third period was comprised of a 4-week, randomized, placebo control (PC). We provide the descriptive analyses of the subset of PD subjects, relating to the efficacy of FC. Results: During the second 52-week active control period of the study, 11/14 of the PD patients were treated with FC while 3/11 were randomized to AC (sevelamer carbonate and/or calcium acetate). Eight subjects continued to the third period of the study, in which 3/8 were randomized to FC, while 5/8 to placebo. The results of the second period of the study are shown in table 1 and of the third period in table 2.
Over 52 weeks of treatment, FC achieved a similar decrease in serum phosphorus levels as AC. In parallel, FC but not AC achieved an increase in ferritin levels and in TSAT. Consequently, in subjects treated with FC, cumulative ESA dose over 52 weeks was lower compared to AC, IV iron usage tended to be lower than in AC and Hgb levels remained stable but fell in AC. Conclusions: These results suggest that in PD patients, similar to what was reported in patients on hemodialysis, FC is an effective phosphate binder that increases in parallel iron stores and that may decrease the need for IV iron usage and for ESA, while maintaining stable Hgb levels.
© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
