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NCT05085275 · ClinicalTrials.gov registry record · Phase 3
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
A Phase 3 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, sponsored by USRC Kidney Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 289
- Enrollment target
- 20
- Study locations
NCT05085275: Completed Phase 3 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, sponsored by USRC Kidney Research.
NCT05085275 is a Phase 3 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency that has completed, run by USRC Kidney Research. The registered enrollment target is 289 participants, below the 629-participant average among 14 other Renal Insufficiency, Chronic trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05085275, a Phase 3 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, has completed, sponsored by USRC Kidney Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 289 participants
- Enrollment target
- 20
- Study locations
Study Summary
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
Primary Outcome
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ferric Citrate 1 GM Oral Tablet [AURYXIA]
Study Locations (20)
California
- Balboa Research SMO - Chula Vista
- Balboa Research SMO - El Centro
- Balboa Research SMO - Escondido
- Balboa Research SMO - La Mesa
- Balboa Research SMO - Kearney Mesa - San Diego
Texas
- South Texas Renal Care Group - Live Oak
- South Texas Renal Care Group - San Antonio
- South Texas Renal Care Group - San Antonio
Georgia
- Dialysis Clinic, Inc. - Albany
- Nephrology and Hypertension Specialists, PC - Dalton
Arkansas
- Arkansas Nephrology & Hypertension Clinic - Pine Bluff
Colorado
- Rocky Mountain Kidney Care - Lone Tree
Florida
- Associates in Nephrology - Fort Myers
Indiana
- Major Health Partners - Shelbyville
Missouri
- Kidney Associates of Kansas City - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2024-01-24 |
| Phase | Phase 3 |
What the finished NCT05085275 record still lists
NCT05085275 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 629-participant average among 14 other Renal Insufficiency, Chronic trials with a reported enrollment target (54% lower).
The record links to 7 conditions, with Renal Insufficiency, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05085275 names 20 study sites across 13 states, led by California, Texas, Georgia.
Frequently Asked Questions
What is clinical trial NCT05085275 about?
NCT05085275 is a clinical study titled "Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease". A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
What is the current status of trial NCT05085275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2022-03-30. Estimated completion is 2024-01-24.
What conditions does trial NCT05085275 study?
This clinical trial studies the following conditions: Renal Insufficiency, Chronic, Anemia, Iron Deficiency, Cardiovascular, Hyperphosphatemia, Disease Progression.
What interventions are being tested in trial NCT05085275?
The interventions under investigation include: Placebo (DRUG), Ferric Citrate 1 GM Oral Tablet [AURYXIA] (DRUG).
Who is sponsoring clinical trial NCT05085275?
This trial is sponsored by USRC Kidney Research, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05085275 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05085275's enrollment target sits among peer trials
289 3rd of 14 higher than 12 of 14 other Renal Insufficiency, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Insufficiency, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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