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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 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00166712
The ClinicalTrials.gov registry entry for NCT00166712 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00166712 reports 0 study locations.
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.
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