Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
United States340 participantsStarted 2024-09-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
✕. Active unresolved systemic viral, bacterial, fungal, or parasitic infection requiring oral or intravenous anti-infective therapy
✕. History of autoimmune liver disease including autoimmune hepatitis, primary sclerosing cholangitis, and/or primary biliary cirrhosis, or other contraindications to drug withdrawal
✕
What they're measuring
1
Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2
Timeframe: From Visit 2 to Visit 9 (12 months post-liver transplant)
2
Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2
Timeframe: From Visit 2 to Visit 9 (12 months post-liver transplant)
Trial details
NCT IDNCT06280950
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)