Status:
UNKNOWN
Molecular Biomarkers in Renal Transplantation Via TruGraf® Test
Lead Sponsor:
Transplant Genomics, Inc.
Collaborating Sponsors:
Scripps Health
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients....
Detailed Description
This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinin...
Eligibility Criteria
Inclusion
- Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
- Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels).
- Kidney transplant patients who are: \> 60 days post-transplant (Cohort A); \> 2-years post-transplant (Cohort B)
Exclusion
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Infection with BK.
- Patients that have nephritic proteinuria (urine protein \>3 gm/day).
Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04398498
Start Date
April 13 2020
End Date
November 30 2022
Last Update
August 19 2021
Active Locations (1)
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1
Scripps Clinic
La Jolla, California, United States, 92037