NCT04491552

TruGraf® Long-term Clinical Outcomes Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Transplant Genomics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Detailed description

Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion. Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Patients monitored with TruGraf and TRAC testing	This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.

Timeline

• Start date: 2020-09-09
• Primary completion: 2023-09-01
• Completion: 2023-11-01
• First posted: 2020-07-29
• Last updated: 2022-11-14

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated device study