TruGraf® Testing in High-Risk Kidney Transplant Recipients

NCT04266613 | Terminated

• 1 other identifier: TGRP03-US003
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• Clinical Utility of TruGraf Results

  Percent of total number of TruGraf results that the PI identified as having clinical utility

  1 year

• 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

Study Arms (1)

All Subjects Enrolled

High immune risk transplant recipients who are undergoing routine management under current standard of care

Diagnostic Test: TruGraf® Testing

Interventions

TruGraf® Testing DIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Also known as: Peripheral blood gene expression profiling

All Subjects Enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients with high immune risk who are undergoing routine management

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77210, United States

Location

Related Publications (2)

• 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.

  PMID: 30979456 BACKGROUND

• 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.

  PMID: 30979457 BACKGROUND

Study Officials

• John Holman, MD

  Transplant Genomics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 20, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)