TruGraf® Long-term Clinical Outcomes Study

a study on Kidney Transplant Transplants

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Suphamai Bunnapradist

Description

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.

Details

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.

Keywords

Kidney Transplant Rejection, Biomarkers, Subclinical Rejection, Patients monitored with TruGraf and TRAC testing

Eligibility

You can join if…

Open to people ages 18 years and up

  • Written informed consent and HIPAA authorization;
  • At least 18 years of age;
  • Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
  • At least 3-months post-transplant;
  • Stable serum creatinine (per Principal Investigator);
  • Treated with any immunosuppressive regimen, and;
  • Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and

You CAN'T join if...

  • Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
  • Recipient of a previous non-renal solid organ and/or islet cell transplant;
  • Known to be pregnant;
  • Known to be infected with HIV;
  • Known to have Active BK nephropathy;
  • Known to have nephrotic proteinuria (Per Principal Investigator);
  • Participation in other biomarker studies testing clinical utility.

Locations

  • Keck Hospital of USC accepting new patients
    Los Angeles California 90033 United States
  • House of Transplant and Cancer- Riverside Community Hospital accepting new patients
    Riverside California 92501 United States

Lead Scientist at UCLA

  • Suphamai Bunnapradist
    Professor of Clinical, Medicine. Authored (or co-authored) 216 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Transplant Genomics, Inc.
ID
NCT04491552
Study Type
Observational
Participants
Expecting 2000 study participants
Last Updated