PROTOCOL SUMMARY~Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 Real World Experience Study from Kaiser Permanente Southern California~Short Title: FeCitrate~Protocol Number: KP FeCitrate~Study Phase: 4~Study Site(s): Los Angeles Kaiser Sunset Medical Center~Number of Subjects: 55~Study Arms: 1~Indication: Hyperphosphatemia in end stage renal disease~Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a real world environment~Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).~Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.~Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate~Statistical Methods: Not powered to detect statistical significance
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 Real World Experience Study from Kaiser Permanente Southern California