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NCT01467583 · ClinicalTrials.gov registry record · Phase 4
Fondaparinux in Critically Ill Patients With Renal Failure
A Phase 4 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT01467583: Completed Phase 4 study, sponsored by Wayne State University.
NCT01467583 is a Phase 4 study that has completed, run by Wayne State University. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467583, a Phase 4 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (VTE). Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of \< 30 ml/min, will be safe and effective.
Primary Outcome
Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.
Interventions
- DRUG Fondaparinux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT01467583 record still lists
NCT01467583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Fondaparinux is the first listed.
NCT01467583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467583 about?
NCT01467583 is a clinical study titled "Fondaparinux in Critically Ill Patients With Renal Failure". The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and p...
What is the current status of trial NCT01467583?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2011-11. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01467583?
The interventions under investigation include: Fondaparinux (DRUG).
Who is sponsoring clinical trial NCT01467583?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01467583's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 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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