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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 is a Phase 4 study that was terminated before completion, run by Winthrop University Hospital. The registered enrollment target is 38 participants.
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.
Interventions
- DRUG Ferric Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02661295
The ClinicalTrials.gov registry entry for NCT02661295 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winthrop University Hospital, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ferric Citrate is the first listed.
NCT02661295 reports 0 study locations.
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.
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