NCT03079869

Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Detailed description

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

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Ferric Citrate	One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-09-14
• Completion: 2019-09-14
• First posted: 2017-03-15
• Last updated: 2022-01-13
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study