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 ]

Serum phosphorus levels after treatment with ferric citrate


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