This trial is a multi-center, prospective, open label, non-controlled, nonrandomized, interventional cohort study in which 60 adult recipients of liver allografts will undergo gradual immunosuppression withdrawal. Liver recipients greater than 6 years post-transplant or greater than 3 years posttransplant and age greater than 50 years at time of screening will undergo liver biopsy and blood sampling before initiation of immunosuppression withdrawal. Participants may initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with a CNI and a mycophenolate compound. Eligible participants will undergo immunosuppressive withdrawal according to a pre-specified algorithm (see section 3.1.3) with the goal of achieving complete discontinuation of immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal. Participants will undergo protocol biopsies at 1 and 3 years following drug discontinuation. Successfully weaned participants who remain rejection-free will undergo 3 years of followup after the last dose of immunosuppression. Participants who develop biopsyconfirmed or presumed rejection will resume immunosuppression and will undergo 3-5 years of follow-up. Study investigators and participants will remain blinded to the results of tolerance biomarkers for individual participants until the end of the study. The tolerance biomarker results will be evaluated as a group once the primary endpoint is reached. Participants will be enrolled by a consortium of US transplant sites. A parallel study with a harmonized clinical and mechanistic protocol is planned for a similar number of participants at EU sites.
|Effective start/end date||2/1/15 → 1/31/22|
- Benaroya Research Institute at Virginia Mason (FY19ITN158//5UM1AI109565-06)
- National Institute of Allergy and Infectious Diseases (FY19ITN158//5UM1AI109565-06)
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