Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Start Date
9/12/2024
Completion Date
6/30/2030
Summary
This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.
Detailed Description
This study is a multicenter 2:1 randomized nonblinded phase II interventional clinical trial in liver transplant recipients. The primary objective is to determine the safety, efficacy, and tolerability of tacrolimus minimization and eventual withdrawal in conjunction with everolimus monotherapy to preserve renal function. Study subjects will undergo first reduction of tacrolimus with the addition of everolimus. If everolimus is tolerated, subjects will be randomized 2:1 into one of two interventional arms. The first interventional arm will undergo a stepwise reduction of tacrolimus and be on everolimus monotherapy for the remainder of the study. The second interventional arm will remain on the initial reduced tacrolimus dose and everolimus. If subjects prior to randomization are unable to tolerate everolimus, these subjects will be placed in the observational group. These subjects will stop taking everolimus and resume their immunosuppression therapy prior to study enrollment.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Everolimus
Tacrolimus (continued reduction)
Tacrolimus (maintain 50% reduction)
Everolimus
Conditions
Locations
Mayo Clinic Hospital Arizona (Site #: 71144)
Phoenix, Arizona 85054
United States
Ronald Regan at UCLA Medical Center (Site #: 71123)
Los Angeles, California 90095
United States
University of California, San Diego (Site #: 71179)
San Diego, California 92121
United States
University of California, San Francisco (Site #: 71108)
San Francisco, California 94143
United States
Northwestern University (Site #: 71110)
Chicago, Illinois 60611
United States
University of Michigan (Site #: 71154)
Ann Arbor, Michigan 48109
United States
Icahn School of Medicine at Mount Sinai (Site #: 71115)
New York, New York 10029
United States
Duke University Medical Center (Site #: 71139)
Durham, North Carolina 27710
United States
University of Pennsylvania (Site #: 71111)
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh Medical Center (Site #: 71170)
Pittsburgh, Pennsylvania 15260
United States
Baylor Medical Center (Site #: 71153)
Dallas, Texas 75246
United States
Houston Methodist (Site #: 71120)
Houston, Texas 77030
United States