Status:
UNKNOWN
TruGraf® Long-term Clinical Outcomes Study
Lead Sponsor:
Transplant Genomics, Inc.
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Brief 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 Om...
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 timepo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04491552
Start Date
September 9 2020
End Date
November 1 2023
Last Update
November 14 2022
Active Locations (36)
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1
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724
2
Fresno Nephrology Medical Group
Fresno, California, United States, 93720
3
Scripps Memorial Hospital La Jolla
La Jolla, California, United States, 92037
4
Keck Hospital of USC
Los Angeles, California, United States, 90033