NCT06280950 · National Institute of Allergy and Infectious Diseases (NIAID)
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
(ELIMINATE)
What this study is about
This is a study to determine the safety, effectiveness, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus treatment given alone to preserve renal function. Two hundred - seventy (270) subjects will be randomly assigned 2:1 into one of two groups between 2-3 months post-transplant.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject and/or legal guardian must be able to understand and provide informed consent 2. Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo) 3. Estimated glomerular filtration rate \>=30 ml/min/1.73m\^2 at enrollment using the CKD-EPI 2021 equation 4. Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids 5. Female subjects of childbearing potential with negative pregnancy test upon study entry 6. All subjects of reproductive potential agreeing to use contraception for the duration of the study 7. 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 2. Act
Where
- Phoenix, Arizona
- San Francisco, California
- Chicago, Illinois
- New York, New York
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations