TRU-IMMUNO: Optimizing Liver Immunosuppression

Transplant Genomics

Status: Unknown

Conditions: Liver Transplant Rejection

Treatments: Diagnostic Test: Patients monitored with TruGraf and TRAC Liver testing

Study type: Observational

Funder types: Industry

Identifiers

NCT05335551

TGRP09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

130 participants in 2 patient groups

Patients monitored with TruGraf/TRAC Liver testing

Description:

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 postbaseline) The TruGraf and TRAC Liver results will be used in the biomarker arm in conjunction with all other clinical parameters available to guide decisions of the Principal Investigator and Sub-Investigators related to immunosuppression management. changes.

Treatment:

Diagnostic Test: Patients monitored with TruGraf and TRAC Liver testing

Patients not monitored with TruGraf/TRAC Liver testing

Description:

Patients in control/ stamdard of care arm will have immusuppresion reduction based on the clinical judgement and management of the Principal Investigator and Sub-Investigators.