TruGraf® Testing in High-Risk Kidney Transplant Recipients

Kidney Transplant Rejection Clinical Trial

Official title:

Molecular Biomarkers in Renal Transplant Recipients at Higher Risk of Acute Rejection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04266613
• Other study ID #: TGRP03-US003
• Status: Terminated
• Start date: February 20, 2020
• Est. completion date: June 23, 2021

Study information

• Verified date: August 2021
• Source: Transplant Genomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody >75%.
• 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 at least 30 days post-transplant.

Exclusion Criteria:

• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients who do not meet criteria of high-immune risk.
• Recipients of previous non-renal solid organ and/or islet cell transplantation.
• Infection with HIV.
• Infection with BK.
• Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Diagnostic Test:
• TruGraf® Testing
5 mL collection PAXgene blood sample

Locations

Country	Name	City	State
United States	Houston Methodist Research Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Transplant Genomics, Inc.	The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11. — View Citation

Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Utility of TruGraf Results	Percent of total number of TruGraf results that the PI identified as having clinical utility	1 year
Primary	Correlation of TruGraf Results	Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care	1 year