Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03079869
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 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
Study:
NCT03079869
Study Brief:
Protocol Section:
NCT03079869