TruGraf Long-term Clinical Outcomes Study

  • STATUS
    Recruiting
  • End date
    Nov 5, 2023
  • participants needed
    2000
  • sponsor
    Transplant Genomics, Inc.
Updated on 5 May 2021

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.

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 timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf and TRACin 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.

Details
Condition Renal Transplant Rejection, Kidney Transplant Rejection
Treatment Patients monitored with TruGraf and TRAC testing
Clinical Study IdentifierNCT04491552
SponsorTransplant Genomics, Inc.
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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