CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02096107
NCT02096107Phase 4Completed
CompareCT.gov

Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients

Medical University of South Carolina·interventional·Posted Mar 26, 2014·Updated Aug 8, 2018

In Brief

A Phase 4 clinical trial evaluating Everolimus and Standard of Care for Graft Dysfunction and Interstitial Fibrosis. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Dysfunction, Interstitial Fibrosis
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 26, 2014
Enrollment StartFeb 1, 2014
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.3 years ago

Interventions

Everolimusdrug

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Standard of Careother

Tacrolimus, mycophenolate mofetil and steroids