TruGraf® Long-term Clinical Outcomes Study

November 10, 2022 updated by: Transplant Genomics, Inc.
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.

Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Banner University Medical Center Tucson
        • Contact:
    • California
      • Fresno, California, United States, 93720
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90033
      • Riverside, California, United States, 92501
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
      • San Francisco, California, United States, 94109
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Illinois
      • Chicago, Illinois, United States, 60208
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois-Chicago Medical Center
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Hospital and Clinic
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis-Knighton Medical Center
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02215
      • Springfield, Massachusetts, United States, 01107
        • Recruiting
        • Renal and Transplant Associates of New England
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Health Sciences Center
        • Contact:
    • New York
      • Bronx, New York, United States, 10467
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center
        • Contact:
      • Rochester, New York, United States, 14618
      • Rochester, New York, United States, 14642
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Vidant Medical Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84132
      • Salt Lake City, Utah, United States, 84115
    • Virginia
      • Falls Church, Virginia, United States, 22042
      • Richmond, Virginia, United States, 23298
    • Washington

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

This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at least one year from the time of transplant. Approximately 2000 subjects will be enrolled.

Description

Inclusion Criteria:

  • Written informed consent and HIPAA authorization;
  • At least 18 years of age;
  • Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
  • At least 3-months post-transplant;
  • Stable serum creatinine (per Principal Investigator);
  • Treated with any immunosuppressive regimen, and;
  • Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and

Exclusion Criteria:

  • Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
  • Recipient of a previous non-renal solid organ and/or islet cell transplant;
  • Known to be pregnant;
  • Known to be infected with HIV;
  • Known to have Active BK nephropathy;
  • Known to have nephrotic proteinuria (Per Principal Investigator);
  • Participation in other biomarker studies testing clinical utility.

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
Patients monitored with TruGraf and TRAC testing
Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection.
Diagnostic test: Patients monitored with TruGraf and TRAC testing
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.
Time Frame: Baseline to month 24
Baseline to month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First occurrence of biopsy proven acute rejection (on a for cause biopsy)
Time Frame: Baseline to month 24
Baseline to month 24
First occurrence of clinically treated acute rejection
Time Frame: Baseline to month 24
Baseline to month 24
Proteinuria
Time Frame: Baseline to month 24
defined by a spot urine protein-creatinine ratio > 0.5
Baseline to month 24
TruGraf results
Time Frame: Baseline to month 24
The proportion of TruGraf not-TX results
Baseline to month 24
TRAC results
Time Frame: Baseline to month 24
The proportion of TRAC results > 0.69
Baseline to month 24
Clinical Utility of TruGraf and TRAC in clinical decision making
Time Frame: Baseline to month 24
Percent of total number of TruGraf results that the PI identified as having clinical utility
Baseline to month 24
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
Time Frame: Baseline to month 24
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
Baseline to month 24
Proportion of subjects with graft loss
Time Frame: Baseline to month 24
defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period
Baseline to month 24
Graft survival
Time Frame: Baseline to month 24
calculated from the date of kidney transplantation until data of graft loss
Baseline to month 24
Proportion of subjects with death-censored graft loss
Time Frame: Baseline to month 24
defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored
Baseline to month 24
Percent subject death period
Time Frame: Baseline to month 24
Subject death from any cause at any time
Baseline to month 24
Subject survival
Time Frame: Baseline to month 24
calculated from date of kidney transplantation until date of patient death
Baseline to month 24
Estimated GFR
Time Frame: Baseline to month 24
calculated using the MDRD 4-variable equation
Baseline to month 24

Collaborators and Investigators

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

Sponsor

Transplant Genomics, Inc.

Investigators

  • Principal Investigator: Patty W. Thielke, PharmD, 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)

September 9, 2020

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TGRP06

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

Yes

product manufactured in and exported from the U.S.

Yes

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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