Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Kidney Transplant Rejection Clinical Trial

Official title:

A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04267016
• Other study ID #: TGRP01-US001
• Status: Terminated
• Start date: August 19, 2020
• Est. completion date: May 11, 2021

Study information

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

Clinical Trial Summary

This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. 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: 26
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 >90 days (+/- 2 weeks) post-transplant will be included in this study

Exclusion Criteria:

• 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 nephropathy.
• Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Diagnostic Test:
• TruGraf Testing - Peripheral blood gene expression profiling
5 mL collection PAXgene blood sample

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Transplant Genomics, Inc.	Duke University

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	through study completion, an average of 6 months
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.	through study completion, an average of 6 months
Primary	Feasibility of TruGraf Testing	Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow	through study completion, an average of 6 months