A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf Liver and TRAC Liver Testing as Part of Standard of Care: Optimizing Liver ImmunoSuppression (TRU-IMMUNO)
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 主要终点
- Immunosuppression reduction
研究概览
简要总结
This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide immunosuppression management.
详细描述
This study will provide TruGraf Liver and TRAC liver tests to one group of transplant providers early after liver transplantation to clarify if the Trugraf Liver and TRAC Liver results can complement their immunosuppression minimization strategies to avoid complications and reduce the occurrence of acute rejection. The ability to decrease IS will be compared to the group that does not receive the test results.
Subjects will be randomized into 2 groups: one will receive Trugraf/TRAC Liver testing and the other will not. Subjects in the biomarker arm will have TruGraf Liver and TRAC Liver testing at study enrollment (1-2 months post-liver transplant) and thereafter every month for 6 months. Subjects will also have Trugraf Liver and TRAC Liver testing at months 9 and 12 following transplantation (7-8 and 10-11 months post baseline). The TruGraf and TRAC Liver results will be used in the biomarker arm in conjunction with all other clinical parameters available to guide decisions related to immunosuppression changes. There are no protocol mandated immunosuppression changes. Subjects in the standard of care arm will not have biomarkers available for decisions related to immunosuppression changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Recipient of a primary or subsequent deceased-donor or living donor liver transplantation.
- •Normal liver function tests at the time of or within 2 weeks of the baseline visit, defined by Total Bilirubin (TB) ≤1.5 mg/dL and Direct Bilirubin (DB) <0.5 mg/dL, Alkaline Phosphatase (AP) ≤200 U/L, and Alanine Transaminase (ALT) ≤60 U/L (males) ≤36 U/L (females).
- •Between 1-2 months post-liver transplantation
排除标准
- •Inability or unwillingness to provide informed consent.
- •Recipients of previous hepatic or non-hepatic solid organ transplantation
- •History of ≥2 mild or moderate rejections or 1 severe rejection prior to enrollment defined by BANFF 2016 criteria
- •History of autoimmune liver disease
- •Listed for repeat liver transplantation
- •Infection with HIV
- •Active HBV or HCV viremia (patients with undetectable virus can be included)
结局指标
主要结局
Immunosuppression reduction
时间窗: 6-months
Percent of subjects in each arm achieving at least 50% reduction from baseline total immunosuppressant (non-corticosteroid) dose at 6 months
次要结局
- Immunosuppressant trough(6-months)
- Median and mean IS trough(6-months)
- Liver testing workflow(1 year)
- Infections(1 year)
- monotherapy immunosuppression(1 year)
- clinical utility(1 year)
- CKD score(1 year)
- BPAR for-cause biopsy(1 year)
- Acute rejection(1 year)
- eGFR timepoints(1 year)
- eGFR timepoint range(1 year)
- Slope of eGFR(1 year)
- SF-36 scores(1 year)
- eGFR decline or progression of CKD(1 year)