Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: liver biopsy, Immunosuppression withdrawal, Immunosuppression minimization.
- Who it may be relevant to
- Registry conditions: Liver Transplantation, Liver Transplantation in Long-term. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
Overview
The goal of this clinical trial is to learn whether liver parenchyma chimerism can represent a chievement of operational tolerance in liver transplantation recipients. The researchers will examine the degree of parenchyma chimerism. The participants will withdraw or minimize their immunosuppression to avoid the adverse effects of immunosuppressants.
Detailed description
After liver transplantation, immunosuppression should be induced or maintained to prevent acute cell-mediated rejection or chronic antibody-mediated rejection.All these immunosuppressive agents have various adverse effects including nephrotoxicity, neurotoxicity, hyperglycemia, hypertension, bone marrow suppression, gastrointestinal disturbance, etc. We examine the liver specimen from long-term liver transplant recipients with stable liver function. The liver showed chimeric change of the liver. Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric. The specific aims of this study are:
1. To determine whether the liver allografts become chimeric in long-term liver transplant recipients. 2. To determine the degree of liver chimerism in long-term liver transplant recipients. 3. To determine whether immunosuppression can be withdrawn based on liver chimerism.
Based on the degree of chimeric change of the liver grafts, immunosuppression withdrawal can be conducted in this study and find out the indicator of immunosuppression withdrawal in liver transplantation setting.
Interventions
- Procedure liver biopsy
Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism. - Drug Immunosuppression withdrawal
For patients with an STR $\\ge$ 75% percentile cutoff, half dose of the immunosuppressive regimen is decreased for the first two months. If liver function is unaltered, immunosuppression is totally withdrawn at the 3rd month. - Drug Immunosuppression minimization
For patients with STR \> 15% but not reaching the 75% percentile cutoff, the immunosuppressive regimen is decreased by 1/3 at the first two months. If liver function is unaltered, it is further decreased to 1/2 of the original dose.
Primary outcome measures
- Percentage of Recipient Cells in the Liver Allograft [Time frame: 1 year]
Secondary outcome measures (6)
- Number of Participants with Successful Complete Immunosuppression Withdrawal [Time frame: up to 1 year]
- AST Levels [Time frame: up to 1 year]
- ALT Levels [Time frame: up to 1 year]
- eGFR (Estimated Glomerular Filtration Rate) [Time frame: At 3 months after immunosuppression withdrawal]
- HbA1c (Glycated Hemoglobin) [Time frame: At 3 months after immunosuppression withdrawal]
- Cholesterol Profiles [Time frame: At 3 months after immunosuppression withdrawal]
Eligibility criteria
Inclusion criteria
- a. The patients had liver transplantation, either deceased liver or liver donor, for ≥ 5 years.
b. Age ≥ 20 years old. c. The patients have stable liver function, and do not have clinical suspicious of acute cell-mediated rejection within 1 year.
d. Sign the informed consent. e. Platelet ≥ 80000/mm3. f. INR ≤ 1.4 g. AST and ALT ≤ 1.5X h. Albumin ≥ 3.5gm/dl. i. Total bilirubin < 1.5mg/dl. j. ECOG ≤ 2
Exclusion criteria
- a. Liver transplantation less than 5 years b. Abnormal liver function AST and ALT > 1.5X c. Severe infection d. De novo malignancy e. Disagree to have liver biopsy. f. ECOG > 2
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Chang-Gung Memorial Hospital — Taoyuan
Identifiers
NCT: NCT07735650 · 202402038A3