Expanding Liver Transplant Immunosuppression Minimization Via Everolimus (CTOT-43)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject and/or legal guardian must be able to understand and provide informed consent
• Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo)
• Estimated glomerular filtration rate \>=30 ml/min/1.73m\^2 at enrollment using the CKD-EPI 2021 equation
• Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids
• Female subjects of childbearing potential with negative pregnancy test upon study entry
• All subjects of reproductive potential agreeing to use contraception for the duration of the study
• Previous vaccination or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, zoster (if \>=19 years old), and 2019-nCoV (COVID-19) as outlined in the DAIT Vaccination Guideline
Locations
United States
Arizona
Mayo Clinic Hospital Arizona (Site #: 71144)
RECRUITING
Phoenix
California
University of California, San Francisco (Site #: 71108)
RECRUITING
San Francisco
Illinois
Northwestern University (Site #: 71110)
RECRUITING
Chicago
North Carolina
Duke University Medical Center (Site #: 71139)
RECRUITING
Durham
New York
Icahn School of Medicine at Mount Sinai (Site #: 71115)
RECRUITING
New York
Pennsylvania
University of Pennsylvania (Site #: 71111)
RECRUITING
Philadelphia
University of Pittsburgh Medical Center (Site #: 71170)
RECRUITING
Pittsburgh
Texas
Baylor Medical Center (Site #: 71153)
RECRUITING
Dallas
Contact Information
Primary
Tracia Debnam, MS
Tracia.debnam@nih.gov
301-761-7414
Time Frame
Start Date:2024-09-12
Estimated Completion Date:2029-06-01
Participants
Target number of participants:340
Treatments
Experimental: Interventional Group 1
Participants in this group will slowly reduce their dose of tacrolimus and continue everolimus as their only immunosuppression medication.
Experimental: Interventional Group 2
Participants in this group will continue to take reduced Tacrolimus and Everolimus IS regimen.
No_intervention: Observational Group
Participants in this group could not tolerate the addition of everolimus. These participants will not be randomized.~* Participants in this group will stop taking everolimus.~* Participants in this group will resume taking their tacrolimus +/- mycophenolate compound and prednisone immunosuppression regimen.