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NCT02661295 · ClinicalTrials.gov registry record · Phase 4
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
A Phase 4 study, sponsored by Winthrop University Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT02661295: Clinical Trial Phase 4 study, sponsored by Winthrop University Hospital.
NCT02661295 is a Phase 4 study that was terminated before completion, run by Winthrop University Hospital. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02661295, a Phase 4 study, was terminated before completion, sponsored by Winthrop University Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Primary Outcome
Percent change in total cholesterol (mg/dl) from Baseline to Month 6.
Interventions
- DRUG Ferric Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 4 |
Why NCT02661295 stopped before completion
NCT02661295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Ferric Citrate is the first listed.
NCT02661295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02661295 about?
NCT02661295 is a clinical study titled "A Study of Ferric Citrate to Improve Inflammation and Lipid Levels". The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based ph...
What is the current status of trial NCT02661295?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2015-07. Estimated completion is 2018-03-15.
What interventions are being tested in trial NCT02661295?
The interventions under investigation include: Ferric Citrate (DRUG).
Who is sponsoring clinical trial NCT02661295?
This trial is sponsored by Winthrop University Hospital, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02661295's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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