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New treatment option for Liver Transplant
Official title Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
ClinicalTrials.gov ID: NCT06280950
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, being studied as a potential treatment for liver transplant.
Also referred to as Zortress.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people of childbearing potential with negative pregnancy test upon study entry
You likely can't join if
- 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...
- History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol
- History post-transplant of Hepatic Artery Thrombosis or Portal Vein Thrombosis.
- History of recurrent cirrhosis after liver transplantation.
See the full eligibility 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 people of childbearing potential with negative pregnancy test upon study entry
- All people 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
- 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
- History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol
- History post-transplant of Hepatic Artery Thrombosis or Portal Vein Thrombosis.
- History of recurrent cirrhosis after liver transplantation.
- Chronic use of systemic glucocorticoids, biological immunomodulatory therapy, or other immunosuppressive agents other than per study protocol
- History of hepatitis B or C virus infection with detectable viral PCR at enrollment
- History of prior organ transplantation (liver or other type)
- History of \>= 2 biopsy-proven acute cellular rejection episodes of any severity, \>=1 moderate to severe rejection episode (histologically defined or requiring lymphodepletion therapy), or \>= 1 antibody- mediated...
- Active treatment with any mTOR-inhibitor agent (everolimus, sirolimus)
- Contraindication to treatment with everolimus (open wound or wound infection; urine protein: creatinine ratio \> 0.5; significant pancytopenia (any of the following: WBC \ 1000 mg/dL; other per PI)
- Abnormal liver function tests on study entry: Total Bilirubin (TB)\>1.5 mg/dL and Direct Bilirubin (DB) \>1.0 mg/dL, Alkaline Phosphatase (AP) \>200 U/L, and Alanine Aminotransaminase (ALT)\>60 U/L
- Pregnant on enrollment or plan to become pregnant during the study period
- Participation in another clinical trial that would interfere with this study's procedures and intervention:
- Use of investigational biologic or drug (within 8 weeks of study enrollment)
- Additional blood collection that would exceed research blood draw limits
- Any other procedure or intervention, in the investigator's opinion would interfere with this study
- Received live attenuated vaccine(s) within 2 months of enrollment
- Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements...
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Francisco, California, United States; Chicago, Illinois, United States; New York, New York, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.