Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

August 13, 2021 updated by: Transplant Genomics, Inc.
The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine <2.3 mg/dl, <20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (>24 months but < 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-transplant and are undergoing routine management. In Study A, patients will receive testing eight times: Month 2 (at time of surveillance biopsy) 6(at time of surveillance biopsy), 9, 12(at time of surveillance biopsy), 15, 18, 21 and 24(at time of surveillance biopsy) (plus or minus two weeks). Results of the genomic analysis will be considered in determining patient treatment plans and as a molecular guide to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. In Study B, patients who are at least 2 years post transplant up to 5 years post-transplant will receive testing 8 times: Months 3 ,6, 9, 12, 15, 18, 21 and 24 (plus or minus two weeks)from the time of enrollment into the study. Results of the genomic analysis will be considered in determining patient treatment plans and whether any change is needed, such as whether to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. We expect Study A to be completed 24-30months and Study B to be completed in 24-30 months.

Study Type

Observational

Enrollment (Anticipated)

50

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
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic

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

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 are: > 60 days post-transplant (Cohort A); > 2-years post-transplant (Cohort B)

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.
  • Patients that have nephritic 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
Cohort A: Clinical Practice
Subjects more than 60 days post-transplant
Diagnostic test: Diagnostic Test: TruGraf® Testing
5 mL collection PAXgene blood sample
Other Names:
  • Peripheral blood gene expression profiling
Cohort B: Long Term Follow-Up
Subjects who are at least 2 years post transplant up to 5 years post-transplant
Diagnostic test: 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
Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results
Time Frame: 12 months post-transplant
12 months post-transplant
Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results
Time Frame: 24 months post-transplant
24 months post-transplant
Cohort A: Correlation of TruGraf test results with surveillance biopsy
Time Frame: 2 years
2 years
Cohort A and B: Banff pathology
Time Frame: 2 years
Banff pathology will be assessed and compared to TruGraf results.
2 years
Cohort A and B: Renal graft function
Time Frame: 2 years
Renal graft function will be assessed by measuring Estimated Glomerular Filtration Rate (eGFR).
2 years
Cohort A and B: Renal graft function
Time Frame: 2 years
Renal graft function will be assessed by measuring serum creatinine (sCr) levels.
2 years
Cohort A and B: Cost of patient care
Time Frame: 2 years
The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of death
Time Frame: 2 years
2 years
Incidence of graft loss
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Transplant Genomics, Inc.

Collaborators

Scripps Health

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

Helpful Links

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)

April 13, 2020

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TGRP05-US005

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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