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NCT00166712 · ClinicalTrials.gov registry record · Phase 4
A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression
A Phase 4 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00166712: Clinical Trial Phase 4 study, sponsored by Northwestern University.
NCT00166712 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00166712, a Phase 4 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to alemtuzumab administration to limit cytokine release syndrome in association with this monoclonal antibody, and continued for the first two days post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in addition, either tacrolimus (Tac) or sirolimus. After six months, patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF. Individuals in this arm of the study who do not experience acute rejection, and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to sirolimus + MMF) will be weaned to MMF monotherapy. Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
Primary Outcome
The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.
Interventions
- DRUG Sirolimus
- DRUG Alemtuzumab
- DRUG Mycophenolate mofetil (MMF)
- DRUG Tacrolimus (TAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-04 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
Why NCT00166712 stopped before completion
NCT00166712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00166712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00166712 about?
NCT00166712 is a clinical study titled "A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression". This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to al...
What is the current status of trial NCT00166712?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-04. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00166712?
The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Mycophenolate mofetil (MMF) (DRUG), Tacrolimus (TAC) (DRUG).
Who is sponsoring clinical trial NCT00166712?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00166712's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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