PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients) (PIONEER)

November 13, 2025 updated by: Transplant Genomics, Inc.

Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients

This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring.

Approximately 15 U.S. sites

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All subjects who meet the inclusion criteria and none of the exclusion criteria will be eligible to participate. As the study is non-interventional, no protocol-mandated treatment or management plan will be imposed. In the absence of a universally ac-cepted paradigm for post-transplant monitoring with molecular diagnostics, participat-ing sites will be encouraged to follow their usual practice, supplemented where ap-propriate by the suggested TruGraf and TRAC™ algorithms.

To evaluate both the prognostic performance and the clinical utility of these bi-omarkers, a hybrid analytic framework will be used. Biomarker results will be made available to clinicians in real time, and investigators will prospectively record whether each result led to a change in clinical management. Natural History Subgroup: Test-ing events in which both TruGraf® and TRAC results are double-negative and no change in management occurred. Analyses will be anchored at the test-event level to avoid immortal time bias. This subgroup will be used to evaluate the safety and true negative predictive value (NPV) of a double-negative result, including the incidence of biopsy-proven acute rejection (BPAR) within 30 days.

• Real-World Use Subgroup: Testing events in which biomarker results prompt-ed a change in clinical management (e.g., change in immunosuppression, for-cause biopsy, or enhanced monitoring). By definition, any action following a test result places the event in this subgroup, irrespective of whether the bi-omarker result was double-negative or abnormal. Because clinical actions can alter subsequent risk trajectories, analyses in this subgroup will account for treatment-confounder feedback using causal modeling strategies (e.g., marginal structural models, target trial emulation).

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Study population- Post kidney transplant subjects 18 and older at leas 30 days post surgery will undergo TruGraf, TRAC and TRAC-ID biomarker testing at Mo 1,4,7,10,12,16,20 and 24.

Description

Inclusion Criteria:

  • Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.
  • At least 18 years of age at the time of screening.
  • Enrollment begins 30 days prior to transplant till day 29 post-transplantation.
  • Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.
  • Receiving any immunosuppressive regimen.
  • Able and willing to comply with all study procedures, as assessed by the Investigator.
  • Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care

Exclusion Criteria:

History of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.

  • History of dual or en-bloc kidney transplants.
  • Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.
  • Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.
  • History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.
  • History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natural History Subgroup
Diagnostic test: There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
Investigators will prospectively record whether each results led to a change in clinical management. Participating sites will be encouraged to follow their usual practice, supplemented where appropriate by the suggested TruGraf and TRAC™ TRAC ID algorithms
• Real-World Use Subgroup
Diagnostic test: There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
Investigators will prospectively record whether each results led to a change in clinical management. Participating sites will be encouraged to follow their usual practice, supplemented where appropriate by the suggested TruGraf and TRAC™ TRAC ID algorithms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring
Time Frame: 24 Months post transplant

The primary endpoint is a composite at 24-months post-transplant, defined as the occurrence of any of the following events:

• Biopsy-proven acute rejection (BPAR) on any for-cause biopsy between Month 1 to Month 24 (local read).

OR

• De novo Class I or Class II DSA detected at Month 12 or Month 24 (centrally read).

OR • Decline in eGFR ≥20% from Month 3 to Month 24, calculated using the CKD-EPI creatinine-based equation.

OR

• Three or more abnormal TruGraf and TRAC results between Months 1 and 24
24 Months post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.
Time Frame: Month 3 to Mo 24 post transplant
Actions taken based on tests results TruGraf, TRAC/TRAC-ID
Month 3 to Mo 24 post transplant
To asses the safety of a double negative TruGraf/TRAC result
Time Frame: Month 3 to Mo 24 post transplant
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Month 3 to Mo 24 post transplant
To explore the impact of biomarker -informed clinical decision-making on outcomes such as BPAR, estimated glomerular filtration rate (eGFR) trajectory, and immunosuppressive adjustments
Time Frame: Month 3 to Mo 24 post transplant
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Month 3 to Mo 24 post transplant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory objective: Evaluate the utility of serial TRAC-ID assays to monitor viral or systemic infections and guide safe adjustments of immunosuppression
Time Frame: Mont 3- Mo 24
TRAC-ID results will be available for Investigators
Mont 3- Mo 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transplant Genomics, Inc.

Collaborators

Medical University of South Carolina
University of California, Los Angeles
Northwestern University
Georgetown University
The Cleveland Clinic
Duke University
Weill Medical College of Cornell University
University of Washington
University of Utah
Virginia Commonwealth University
AdventHealth
University of Nebraska
The Methodist Hospital Research Institute
East Carolina University
Erie County Medical Center
Keck School of Medicine USC

Investigators

  • Study Director: Isioma Agboli, MD, Transplant Genomics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TGRP20_PIONEER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results and Statistical analysis will be shared with PI's and Internal steering committee for Journal publications. It will become available upon publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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