TruGraf for Graft Rejection

Overseen By Sameera Rizvi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Repeat transplant, Multi organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

471 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to improve how doctors identify liver issues in individuals who have undergone a liver transplant. It aims to develop a new, non-invasive test using a machine learning tool called TruGraf, which checks blood for signs of liver damage instead of requiring a biopsy. Participants in this study will have already had or will soon have a liver biopsy as part of their regular care. Those who have had a liver transplant and are scheduled for a biopsy might find this trial suitable. As a Phase 2 trial, this research focuses on evaluating the effectiveness of the new test in an initial, smaller group, offering participants a chance to contribute to advancements in non-invasive liver monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that TruGraf is safe for liver transplant patients?

A previous study demonstrated that TruGraf is safe for kidney transplant patients. This simple blood test checks gene activity to identify problems with transplanted organs. TruGraf has approval for use with kidney transplants, indicating it is generally well-tolerated in those cases. Although specific safety data for liver transplants is lacking, its approval for kidney transplants suggests potential safety for the liver as well. However, results can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TruGraf trial because it explores a new way to diagnose liver graft pathology that doesn't solely rely on traditional liver biopsy methods. Unlike the standard of care, which requires invasive procedures to evaluate the health of a liver transplant, TruGraf aims to provide insights through non-invasive techniques. This approach could offer a simpler, less painful, and potentially more efficient way to monitor liver transplant patients, reducing the need for frequent biopsies and improving overall care.

What evidence suggests that TruGraf is effective for identifying liver damage in transplant patients?

Studies have shown that TruGraf effectively detects signs of organ damage in transplant patients. It examines gene activity in the blood to identify changes that might indicate problems with the transplanted liver. Research indicates that TruGraf can spot potential issues without requiring an invasive biopsy. Previous findings suggest that this test offers a reliable, non-invasive method to monitor liver health in transplant patients. Overall, TruGraf holds promise as a tool to rule out liver damage.

Who Is on the Research Team?

Mamatha Bhat, MD

Principal Investigator

UHN

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to agree to participate in the study.

I will have a liver biopsy soon or had one in the last 48 hours.

I have received a liver transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Blood samples are collected from liver transplant patients for TruGraf testing and comparison with biopsy results

36 months

Follow-up

Participants are monitored for safety and effectiveness of the non-invasive diagnostic tool

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TruGraf

How Is the Trial Designed?

Group I: Liver Transplant patient will be undergoing liver graft biopsy. Experimental Treatment 1 Intervention

Liver transplant patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Transplant Genomics, Inc.

Industry Sponsor

Trials

16

Recruited

4,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06557564

NCT06557564 | Diagnosis of Graft Pathology by TruGraf

Patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent. Exclusion Criteria: Repeat transplant ...

2.

transplantgenomics.com

transplantgenomics.com/our-tests/

Post-Transplant Rejection Test

TruGraf Kidney is the first and only non-invasive biomarker test approved for coverage and validated for surveillance of stable kidney transplant recipients.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06061341

NCT06061341 | TruGraf Liver Gene Expression Serial Test

Monitoring for graft health post-transplant typically relies upon measurements of immunosuppression drug levels, serum liver enzyme testing, clinical symptoms ...

4.

ldh.la.gov

ldh.la.gov/assets/medicaid/MCPP/11.2.21/1163_HBL_GENE.00058_2021_07_01_V5_AC_ju_ks_DRFT_RC.pdf

Medical Policy

In 2020, Levitsky and colleagues conducted a discovery and validation study of TruGraf liver by performing a retrospective cohort analysis of 75 ...

5.

app.trialscreen.org

app.trialscreen.org/trials/diagnosis-graft-pathology-trugraf-study-nct06557564

Diagnosis of Graft Pathology by TruGraf

Participation in this study may help develop a non-invasive tool for diagnosing liver graft diseases, which could ultimately reduce the need for invasive ...