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NCT00311311 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT00311311: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT00311311 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00311311, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
Primary Outcome
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Interventions
- DRUG prednisone
- DRUG tacrolimus
- DRUG sirolimus
- DRUG mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
Why NCT00311311 stopped before completion
NCT00311311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which prednisone is the first listed.
NCT00311311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00311311 about?
NCT00311311 is a clinical study titled "Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients". The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
What is the current status of trial NCT00311311?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2006-04. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00311311?
The interventions under investigation include: prednisone (DRUG), tacrolimus (DRUG), sirolimus (DRUG), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00311311?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00311311's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 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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