Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2021

Conditions
Liver Transplantation
Interventions
DRUG

Tacrolimus Withdrawal and Everolimus Monotherapy

During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued.

Trial Locations (1)

60611

Northwestern University Comprehensive Transplant Center, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Northwestern University

OTHER