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
Observational

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-001108
Category
Nephrology
Contact
NAKUL DATTA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04491552
For detailed technical eligibility, visit ClinicalTrials.gov.