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TruGraf® Long-term Clinical Outcomes Study

About

Brief Summary

This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have 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 1-year post-transplant (+/- 2 months);
  • Stable serum creatinine (current serum creatinine < 2.3 mg/dl, < 20% increase compared to the average of the previous 3 serum creatinine levels);
  • Treated with any immunosuppressive regimen, and;
  • Selected by provider to undergo TruGraf® and TRAC™ testing as part of post-transplant care; and
  • Has Medicare Part B coverage.

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 BK nephropathy;
  • Known to have nephrotic proteinuria (urine protein > 3 gm/day).

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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.