Expanding Liver Transplant Immunosuppression Minimization Via Everolimus (NCT06280950)
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus (CTOT-43)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (22 items).
Location: Mayo Clinic Hospital Arizona (Site #: 71144) — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- 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 rejection episode
- Active treatment with any mTOR-inhibitor agent (everolimus, sirolimus)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Mayo Clinic Hospital Arizona (Site #: 71144) — Phoenix, Arizona
- University of California, San Francisco (Site #: 71108) — San Francisco, California
- Northwestern University (Site #: 71110) — Chicago, Illinois
- Icahn School of Medicine at Mount Sinai (Site #: 71115) — New York, New York
- Duke University Medical Center (Site #: 71139) — Durham, North Carolina
- University of Pennsylvania (Site #: 71111) — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center (Site #: 71170) — Pittsburgh, Pennsylvania
- Baylor Medical Center (Site #: 71153) — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (301) 761-7414
Email: Tracia.debnam@nih.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Liver Transplant
- EVR and EPO for Liver Transplant Tolerance — San Francisco, California
- Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue — Cleveland, Ohio
- Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool — Boston, Massachusetts
- US National OCS Liver Perfusion (OLP) Registry — Birmingham, Alabama
- Liver Transplantation With Tregs at MGH — Boston, Massachusetts
- Proteogenomic Monitoring and Assessment of Liver Transplant Recipients — Chicago, Illinois
Explore by condition: All Liver Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.