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

Summary

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

Conditions

• Immunosuppression Management
• Biomarkers / Blood
• Subclinical Rejection
• Biopsy
• Kidney Transplant Rejection

Interventions

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

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• Keck School of Medicine USC

  collaborator UNKNOWN

• Weill Medical College of Cornell University

  collaborator OTHER

• Erie County Medical Center

  collaborator OTHER

• East Carolina University

  collaborator OTHER

• AdventHealth

  collaborator OTHER

• Transplant Genomics, Inc.

  lead INDUSTRY

Principal Investigators

• Isioma Agboli, MD · Transplant Genomics

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-20

Primary Completion

2028-12-31

Completion

2029-03-31