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.
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.
Study Type
OBSERVATIONAL
Enrollment
130
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC Liver results will be utilized in conjunction with standard of care assessments to determine patient management in the study arm.
Immunosuppression reduction
Percent of subjects in each arm achieving at least 50% reduction from baseline total immunosuppressant (non-corticosteroid) dose at 6 months
Time frame: 6-months
Immunosuppressant trough
Immunosuppressant trough levels at 6 months post transplant
Time frame: 6-months
Median and mean IS trough
Median and mean change in IS trough levels from baseline to 6 months
Time frame: 6-months
monotherapy immunosuppression
Percent of patients achieving monotherapy immunosuppression
Time frame: 1 year
clinical utility
Percent and total number of TruGraf Liver and TRAC Liver results that the PI identified as having clinical utility (Utility).
Time frame: 1 year
Liver testing workflow
Percent and total number of eligible patients for whom the PI was able to complete the entire TruGraf Liver and TRAC Liver testing workflow (Feasibility).
Time frame: 1 year
CKD score
Progression of CKD score managed by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria from a scale of GI (normal kidney) to G5 (kidney failure)
Time frame: 1 year
BPAR for-cause biopsy
Incidence of biopsy proven acute rejection on a for cause biopsy at months 6 and 12
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Time frame: 1 year
Acute rejection
Incidence of clinically treated acute rejection at months 6 and 12
Time frame: 1 year
eGFR timepoints
eGFR at months 6 and 12
Time frame: 1 year
eGFR timepoint range
eGFR change from baseline to months 6 and 12
Time frame: 1 year
Slope of eGFR
Slope of eGFR from baseline to months 6 and 12
Time frame: 1 year
eGFR decline or progression of CKD
Risk factors for eGFR decline or progression of CKD score
Time frame: 1 year
Infections
Incidence of grade 3 or greater infections at months 6 and 12
Time frame: 1 year
SF-36 scores
Change in SF-36 scores from baseline to 6 months and end of study (SF 36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: 1 year