TruGraf and TRAC In Pediatrics Study (TTIPS)

April 12, 2022 updated by: Transplant Genomics, Inc.

The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation

This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In pediatric renal transplant recipients, subclinical rejection in protocol biopsies is associated with a significantly increased incidence of acute rejection and/or allograft loss at 5 years post-transplant. Currently, TruGraf is the only noninvasive test designed and validated in adult kidney transplant recipients for use in ruling out silent subacute rejection in that has been approved by Medicare as an alternative to surveillance biopsies. The first step to the use of TruGraf in pediatrics is to perform a validation study in children and adolescents. Specifically, if validated in children and adolescents, a TruGraf result would enable a pediatric transplant physician to identify patients in whom no intervention is necessary without the need of a protocol biopsy. Therefore the aim of this study is to examine the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant patients concurrently.

Study Type

Observational

Enrollment (Anticipated)

75

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

  • Canada
      • Vancouver, Canada
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
    • California
      • Los Angeles, California, United States, 90095

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplant pediatric patients age 1 to 18 years old who must be undergoing a protocol biopsy.

Description

Inclusion Criteria:

  • Patients aged 1-≤ 18 years and recipients of either living or deceased donor transplants Undergoing a protocol biopsy at either 3, 6, 12, 24 or 36 months
  • Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels
  • Serum creatinine level at the time of protocol biopsy ≤ 1.7 mg/dl.
  • Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
  • Absence of any systemic or urinary bacterial, viral or fungal infection
  • Absence of significant BK viremia (as determined by the laboratory where the determination is run) at the time of the last clinical determination and at the time of the protocol biopsy
  • Parents or guardians are capable of reading and understanding the Informed Consent document and willing to participate; if appropriate, patient is also able to understand the Informed Consent. If patient is older than 13 years, patient should be able to give Assent as written on Assent Form.
  • For females of child-bearing age, a negative pregnancy test within 6 weeks of the protocol biopsy.

Exclusion Criteria:

  • Refusal to undergo clinical standard-of-care protocol biopsy by either parent/guardian or patient.
  • Inability to obtain adequate tissue on protocol biopsy
  • Current participation in another interventional research study; patients who have completed the drug in another interventional study are eligible if they meet all other inclusion criteria.
  • Serum creatinine at the clinic visit prior to the biopsy is > 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels.
  • Serum creatinine at the time of the protocol biopsy ≥ 1.8 mg/dl. If the patient had a baseline < 1.8, and the creatinine on the day of biopsy is ≥ 1.8, at the discretion of the PI, the patient will be instructed to hydrate for 4 days and a serum creatinine will be obtained at that time. This is standard clinical practice. If the creatinine returns to the baseline (i.e., ≤ 30%) range, the patient will be classified as having stable renal function, while if the patient's serum creatinine does not return to the ≤ 30% range, he/she will be classified as having renal dysfunction
  • Patients who, in the estimation of the investigator, are undergoing "for-cause" biopsies.
  • Presence of any current and active bacterial, viral or fungal infection
  • Presence of BK viremia judged to be significant by the site PI.
  • Presence of BK nephropathy
  • History of PTLD or malignancy
  • Parents / guardians do not understand Informed Consent and / or are unwilling to participate; patient, if of appropriate age, is unwilling to participate
  • Patients manifesting recurrent disease in their transplant (such as FSGS/nephrotic syndrome, C3 Glomeruopathy, MPGN, hyperoxaluria)
  • Abnormal proteinuria as determined by a urinary protein: creatinine ratio of >1.
  • Recipients of multi-organ transplants.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of Biomarkers with protocol biopsy
Time Frame: 1 year
Examination of the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant concurrently.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Time Frame: 1 year
Separately examine the concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
1 year
Compare TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Time Frame: 1 year
Compare the agreement between protocol biopsies and TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
1 year
Relationship between de novo DSA, a normal protocol biopsy and the TruGraf result.
Time Frame: 1 year
Assess the relationship, if any, between the appearance of de novo DSA, a normal protocol transplant biopsy and the TruGraf result.
1 year
Examine TruGraf results and the %CV tacrolimus levels- index of medication nonadherence.
Time Frame: 1 year
Examine the relationship between the TruGraf results and the %CV tacrolimus levels as an index of medication nonadherence.
1 year
Relationship between urinary CXCL10 and subclinical rejection affecting the predictive value of TruGraf.
Time Frame: 1 year
Examine the relationship between urinary CXCL10 and subclinical rejection in this patient cohort to examine whether it improves the performance metrics by improving the negative or positive predictive of TruGraf.
1 year
Examine relationship between ddcfDNA and subclinical rejection
Time Frame: 1 year
Examine the relationship between ddcfDNA and subclinical rejection in this patient cohort
1 year

Collaborators and Investigators

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

Sponsor

Transplant Genomics, Inc.

Collaborators

University of British Columbia
University of California, Los Angeles
University of Alabama at Birmingham

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)

November 30, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TGRP08

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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