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NCT02096107 · ClinicalTrials.gov registry record · Phase 4
Novartis Everolimus Transition
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT02096107: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT02096107 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02096107, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
Primary Outcome
Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen. The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is
Interventions
- OTHER Standard of Care
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-05 |
| Phase | Phase 4 |
What the finished NCT02096107 record still lists
NCT02096107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02096107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02096107 about?
NCT02096107 is a clinical study titled "Novartis Everolimus Transition". Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
What is the current status of trial NCT02096107?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2014-02. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02096107?
The interventions under investigation include: Standard of Care (OTHER), Everolimus (DRUG).
Who is sponsoring clinical trial NCT02096107?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02096107's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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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