TruGraf® Testing in High-Risk Kidney Transplant Recipients

August 26, 2021 updated by: Transplant Genomics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77210
        • Houston Methodist Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Utility of TruGraf Results
Time Frame: 1 year
Percent of total number of TruGraf results that the PI identified as having clinical utility
1 year
Correlation of TruGraf Results
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transplant Genomics, Inc.

Collaborators

The Methodist Hospital Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TGRP03-US003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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