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Enrolling by Invitation

NCT Number: NCT07735650

Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver Transplantation

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang-Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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 Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric.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:

  • To determine whether the liver allografts become chimeric in long-term liver transplant recipients.
  • To determine the degree of liver chimerism in long-term liver transplant recipients.
  • To determine whether immunosuppression can be withdrawn based on liver chimerism.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver biopsy

Procedure

Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism.

Immunosuppression withdrawal

Drug

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.

Immunosuppression minimization

Drug

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 outcomes

  1. Percentage of Recipient Cells in the Liver Allograft

    Time frame: 1 year

    Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.

Secondary outcomes

  1. Number of Participants with Successful Complete Immunosuppression Withdrawal

    Time frame: up to 1 year

    The number of enrolled patients who successfully complete the immunosuppression withdrawal protocol and remain immunosuppression-free without experiencing acute cell-mediated rejection.

  2. AST Levels

    Time frame: up to 1 year

    Aspartate aminotransferase (AST) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.

  3. ALT Levels

    Time frame: up to 1 year

    Alanine aminotransferase (ALT) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.

  4. eGFR (Estimated Glomerular Filtration Rate)

    Time frame: At 3 months after immunosuppression withdrawal

    eGFR will be measured to evaluate the improvement of immunosuppressant-related renal adverse effects following drug withdrawal or minimization.

  5. HbA1c (Glycated Hemoglobin)

    Time frame: At 3 months after immunosuppression withdrawal

    HbA1c will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.

  6. Cholesterol Profiles

    Time frame: At 3 months after immunosuppression withdrawal

    Cholesterol profiles will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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