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NCT00086346 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 607
- Enrollment target
NCT00086346: Clinical Trial Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00086346 is a Phase 3 study that was terminated before completion, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 607 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086346, a Phase 3 study, was terminated before completion, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 607 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
Primary Outcome
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is \>90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Interventions
- DRUG Sirolimus (Rapamune)
- DRUG Cyclosporine or Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 607 participants |
| Start Date | 2002-12 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
Why NCT00086346 stopped before completion
NCT00086346 is an interventional study that assigns participants to a tested intervention. The registered 607 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus (Rapamune) is the first listed.
NCT00086346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00086346 about?
NCT00086346 is a clinical study titled "Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients". The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
What is the current status of trial NCT00086346?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 607 participants. The study started on 2002-12. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00086346?
The interventions under investigation include: Sirolimus (Rapamune) (DRUG), Cyclosporine or Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT00086346?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086346's enrollment target sits among peer trials
607 605th of 2000 higher than 1,395 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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