Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver Transplantation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: liver biopsy, Immunosuppression withdrawal, Immunosuppression minimization.
- Кому может быть актуально
- Состояния в реестре: Liver Transplantation, Liver Transplantation in Long-term. Базовые параметры: от 20 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
Обзор
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.
Подробное описание
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 Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric.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 To determine whether immunosuppression can be withdrawn based on liver chimerism.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.
Вмешательства
- Процедура liver biopsy
Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism. - Препарат 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. - Препарат 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.
Первичные конечные точки
- Percentage of Recipient Cells in the Liver Allograft [Срок оценки: 1 year]
Вторичные конечные точки (6)
- Number of Participants with Successful Complete Immunosuppression Withdrawal [Срок оценки: up to 1 year]
- AST Levels [Срок оценки: up to 1 year]
- ALT Levels [Срок оценки: up to 1 year]
- eGFR (Estimated Glomerular Filtration Rate) [Срок оценки: At 3 months after immunosuppression withdrawal]
- HbA1c (Glycated Hemoglobin) [Срок оценки: At 3 months after immunosuppression withdrawal]
- Cholesterol Profiles [Срок оценки: At 3 months after immunosuppression withdrawal]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Тайвань · 1 центр
- Chang-Gung Memorial Hospital — Taoyuan
Идентификаторы
NCT: NCT07735650 · 202402038A3