TruGraf and TRAC In Pediatrics Study

NCT05335538 | Unknown

• 1 other identifier: TGRP08
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Kidney Transplant Rejection

Keywords

Biomarkers; Subclinical Rejection; Biopsy

Outcome Measures

Primary Outcomes (1)

• Concordance of Biomarkers with protocol biopsy

  Examination of the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant concurrently.

  1 year

Secondary Outcomes (6)

• 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

  1 year

• Relationship between de novo DSA, a normal protocol biopsy and the TruGraf result.

  1 year

• Examine TruGraf results and the %CV tacrolimus levels- index of medication nonadherence.

  1 year

• Relationship between urinary CXCL10 and subclinical rejection affecting the predictive value of TruGraf.

  1 year

Interventions

Patients monitored with TruGraf and TRAC testing DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Refusal to undergo clinical standard-of-care protocol biopsy by either parent/guardian or patient.
• Inability to obtain adequate tissue on protocol biopsy
• 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.

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead
• University of Alabama at Birmingham: collaborator
• University of British Columbia: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

RECRUITING

British Columbia Children's Hospital

Vancouver, Canada

RECRUITING

Related Publications (62)

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Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

Study Officials

• Patty West-Thielke, PharmD

  Transplant Genomics

  STUDY DIRECTOR

Central Study Contacts

Cortney Miller, PhD

CONTACT

5107753326; cortneymiller@eurofins-tgi.com

Isioma Agboli, MD

CONTACT

15107678609; isiomaagboli@eurofins-tgi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: November 30, 2021
• Primary Completion: December 30, 2022
• Study Completion: March 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)