Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Sandy Feng, MD
Headshot of Sandy Feng
Sandy Feng

Description

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.

Official Title

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus (CTOT-43)

Details

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.

Keywords

Liver Transplant, Liver, Transplant, Everolimus, Tacrolimus, Tacrolimus (continued reduction), Tacrolimus (maintain 50% reduction)

Eligibility

Locations

  • UCSF (Site #: 71108) accepting new patients
    San Francisco California 94143 United States
  • Mayo Clinic Hospital Arizona (Site #: 71144) accepting new patients
    Phoenix Arizona 85054 United States

Lead Scientist at UCSF

  • Sandy Feng, MD
    Dr. Sandy Feng is a transplant surgeon who performs liver, kidney and pancreas transplants. In her research, Feng studies transplantation tolerance, a transplant recipient's ability to maintain normal organ function with minimal or no use of immunosuppressive drugs.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT06280950
Phase
Phase 2 Liver Transplant Research Study
Study Type
Interventional
Participants
Expecting 340 study participants
Last Updated