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NCT00369382 · ClinicalTrials.gov registry record · Phase 4
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
A Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT00369382: Completed Phase 4 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00369382 is a Phase 4 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 121 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369382, a Phase 4 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.
Primary Outcome
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m\^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved rena
Interventions
- DRUG sirolimus
- DRUG cyclosporine or tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
What the finished NCT00369382 record still lists
NCT00369382 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which sirolimus is the first listed.
NCT00369382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369382 about?
NCT00369382 is a clinical study titled "Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients". The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunct...
What is the current status of trial NCT00369382?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2006-09. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00369382?
The interventions under investigation include: sirolimus (DRUG), cyclosporine or tacrolimus (DRUG).
Who is sponsoring clinical trial NCT00369382?
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 NCT00369382's enrollment target sits among peer trials
121 669th of 2000 higher than 1,328 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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