Clincosm LogoSign in Get a demo

TruGraf® Testing in High-Risk Kidney Transplant Recipients

Sponsor
Transplant Genomics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04266613
Collaborator
The Methodist Hospital Research Institute (Other)
19
Enrollment
1
Location
16.1
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: TruGraf® Testing

Study Design

Study Type:
Observational
Actual Enrollment :
19 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Molecular Biomarkers in Renal Transplant Recipients at Higher Risk of Acute Rejection
Actual Study Start Date :
Feb 20, 2020
Actual Primary Completion Date :
Jun 23, 2021
Actual Study Completion Date :
Jun 23, 2021

Arms and Interventions

Arm Intervention/Treatment
All Subjects Enrolled

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Utility of TruGraf Results [1 year]

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

    2. Correlation of TruGraf Results [1 year]

      Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Houston Methodist Research Institute Houston Texas United States 77210

    Sponsors and Collaborators

    • Transplant Genomics, Inc.
    • The Methodist Hospital Research Institute

    Investigators

    • Study Director: John Holman, MD, Transplant Genomics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Transplant Genomics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04266613
    Other Study ID Numbers:
    • TGRP03-US003
    First Posted:
    Feb 12, 2020
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 1, 2021