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

September 22, 2021 updated by: Transplant Genomics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Subjects Enrolled
Renal transplant recipients who are undergoing routine management
Diagnostic test: TruGraf Testing - Peripheral blood gene expression profiling
5 mL collection PAXgene blood sample
Other Names:
  • Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Utility of TruGraf Results
Time Frame: through study completion, an average of 6 months
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
Time Frame: through study completion, an average of 6 months
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
Time Frame: through study completion, an average of 6 months
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

Collaborators and Investigators

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

Sponsor

Transplant Genomics, Inc.

Collaborators

Duke University

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)

August 19, 2020

Primary Completion (ACTUAL)

May 11, 2021

Study Completion (ACTUAL)

May 11, 2021

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (ACTUAL)

February 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TGRP01-US001

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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