Actively Recruiting
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-04
340
Participants Needed
8
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject and/or legal guardian must be able to understand and provide informed consent
- Adult (age 18 years or older) recipient of first liver transplant alone
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m² or higher at enrollment
- Currently treated with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry
- All subjects of reproductive potential agree to use contraception during the study
- Previous vaccination or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, zoster (if 19 years or older), and COVID-19 as outlined in the DAIT Vaccination Guideline
You will not qualify if you...
- Unable or unwilling to give written informed consent or comply with the study protocol
- Active unresolved systemic infection requiring oral or intravenous treatment
- History of autoimmune liver disease or other contraindications to drug withdrawal
- History of non-hepatic autoimmune disease requiring current or future systemic immunosuppression outside the study
- History of hepatic artery or portal vein thrombosis after transplant
- History of recurrent cirrhosis after liver transplantation
- Chronic use of systemic glucocorticoids, biological immunomodulatory therapy, or other immunosuppressants outside the study protocol
- History of hepatitis B or C infection with detectable viral PCR at enrollment
- History of any prior organ transplant
- History of two or more biopsy-proven acute cellular rejection episodes, or one or more moderate to severe rejection episodes, or antibody-mediated rejection
- Current treatment with any mTOR-inhibitor agent
- Contraindication to everolimus treatment including open wounds, high urine protein:creatinine ratio, significant low blood counts, high triglycerides, or other specified conditions
- Abnormal liver function tests above specified limits at study entry
- Pregnant at enrollment or planning pregnancy during the study
- Participation in another clinical trial that interferes with this study
- Received live attenuated vaccine within two months of enrollment
- Current diagnosed mental illness or drug/alcohol abuse affecting compliance or data quality
- Other medical problems posing additional risks or interfering with study compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Mayo Clinic Hospital Arizona (Site #: 71144)
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of California, San Francisco (Site #: 71108)
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University (Site #: 71110)
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai (Site #: 71115)
New York, New York, United States, 10029
Actively Recruiting
5
Duke University Medical Center (Site #: 71139)
Durham, North Carolina, United States, 27710
Actively Recruiting
6
University of Pennsylvania (Site #: 71111)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
University of Pittsburgh Medical Center (Site #: 71170)
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
8
Baylor Medical Center (Site #: 71153)
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
T
Tracia Debnam, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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