Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT03079869
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2017-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Sponsor:
Kaiser Permanente
Organization:
Study Overview
Official Title:
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11035 | OTHER | Kaiser Permanente Southern California IRB | View |