Clinical Trial: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Brief Summary: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Detailed Summary:
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
Sponsor: Kaiser Permanente
Current Primary Outcome: Phosphorus Levels [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- IV iron [ Time Frame: 6 months ]Number of doses of IV iron administered after treatment with ferric citrate
- ESA dose [ Time Frame: 6 months ]Mean weekly ESA dose administered 6 months after ferric citrate treatment
- Average pills/day [ Time Frame: 6 months ]Average number of ferric citrate pills/day required to maintain phosphorus control
- Tolerability [ Time Frame: 6 months ]Tolerability of ferric citrate compared to previous binder
Original Secondary Outcome: Same as current
Information By: Kaiser Permanente
Dates:
Date Received: March 1, 2017
Date Started: March 2017
Date Completion: December 2017
Last Updated: March 8, 2017
Last Verified: March 2017