Open
Actively Recruiting
TruGraf® Long-term Clinical Outcomes Study
About
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 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.
Study Type
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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 Criteria:
- 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.
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Study Stats
Protocol No.
21-001108
Category
Genitourinary Disorders
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood