340
Participants
Start Date
September 12, 2024
Primary Completion Date
June 1, 2027
Study Completion Date
June 1, 2029
Everolimus
"* The first step is the addition of everolimus to participants in this group pre-randomization.~* Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper.~* Participants taking prednisone will taper off prednisone by 6 months post-transplant.~* The second step is tacrolimus minimization and withdrawal to everolimus monotherapy in this group after randomization."
Tacrolimus (continued reduction)
"* Participants randomized in this cohort will have their tacrolimus dose reduced by 50% following randomization.~* They will maintain this daily dose for 4 weeks/1 month (28-30 days). Tacrolimus withdrawal will occur in intervals of 30 days or 4 weeks.~* Each subsequent reduction will be based on LFT stability over the prior time interval before the next reduction"
Tacrolimus (maintain 50% reduction)
\- Participants randomized in this cohort maintain initial reduced dose of Tacrolimus and everolimus for study duration.
Everolimus
"* The first step is the addition of everolimus to participants in the interventional group pre-randomization.~* Participants on a mycophenolate compound will stop taking it within 7 days of initiating everolimus, either by immediate discontinuation or a 7-day taper.~* Participants taking prednisone will taper off prednisone by 6 months post-transplant.~* The second step is to continue on the reduced tacrolimus and everolimus regimen."
RECRUITING
Icahn School of Medicine at Mount Sinai (Site #: 71115), New York
RECRUITING
University of Pittsburgh Medical Center (Site #: 71170), Pittsburgh
RECRUITING
University of Pennsylvania (Site #: 71111), Philadelphia
RECRUITING
Duke University Medical Center (Site #: 71139), Durham
RECRUITING
Northwestern University (Site #: 71110), Chicago
RECRUITING
Baylor Medical Center (Site #: 71153), Dallas
RECRUITING
Mayo Clinic Hospital Arizona (Site #: 71144), Phoenix
RECRUITING
University of California, San Francisco (Site #: 71108), San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
NIH