Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

PHASE2RecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

September 12, 2024

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2029

Conditions
Liver Transplant
Interventions
DRUG

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."

DRUG

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"

DRUG

Tacrolimus (maintain 50% reduction)

\- Participants randomized in this cohort maintain initial reduced dose of Tacrolimus and everolimus for study duration.

DRUG

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."

Trial Locations (8)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai (Site #: 71115), New York

15260

RECRUITING

University of Pittsburgh Medical Center (Site #: 71170), Pittsburgh

19104

RECRUITING

University of Pennsylvania (Site #: 71111), Philadelphia

27710

RECRUITING

Duke University Medical Center (Site #: 71139), Durham

60611

RECRUITING

Northwestern University (Site #: 71110), Chicago

75246

RECRUITING

Baylor Medical Center (Site #: 71153), Dallas

85054

RECRUITING

Mayo Clinic Hospital Arizona (Site #: 71144), Phoenix

94143

RECRUITING

University of California, San Francisco (Site #: 71108), San Francisco

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH