TruGraf® Long-term Clinical Outcomes Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Kidney Transplant Rejection

Clinical Trial Details

NCT number	NCT04491552
Study type	Observational
Source	Transplant Genomics, Inc.
Contact	Isioma Agboli, MD
Phone	510-767-8609
Email	isiomaagboli@eurofins-tgi.com
Status	Recruiting
Phase
Start date	September 9, 2020
Completion date	November 2023

View Details

See also
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