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NCT00189202 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00189202: Completed Phase 2 study, sponsored by University of Michigan.
NCT00189202 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00189202, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes. This study will evaluate: 1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities, 2. Decreased rates of metabolic complications such as post-transplant diabetes, 3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
Primary Outcome
To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2004-08 |
| Est. Completion | 2008-07-01 |
| Phase | Phase 2 |
What the finished NCT00189202 record still lists
NCT00189202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT00189202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00189202 about?
NCT00189202 is a clinical study titled "Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans". African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and com...
What is the current status of trial NCT00189202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-08. Estimated completion is 2008-07-01.
What interventions are being tested in trial NCT00189202?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00189202?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00189202's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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