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

NCT04267016 | Terminated

• 1 other identifier: TGRP01-US001
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

All Subjects Enrolled

Renal transplant recipients who are undergoing routine management

Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling

Interventions

TruGraf Testing - Peripheral blood gene expression profiling DIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Also known as: Standard of care

All Subjects Enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead
• Duke University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, 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

• Patty West-Thielke, PharmD

  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 6, 2020
• First Posted: February 12, 2020
• Study Start: August 19, 2020
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)