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.
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
75
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.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUCLA Mattel Children's Hospital
Los Angeles, California, United States
RECRUITINGBritish Columbia Children's Hospital
Vancouver, Canada
RECRUITINGConcordance 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.
Time frame: 1 year
Concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Separately examine the concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Time frame: 1 year
Compare TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Compare the agreement between protocol biopsies and TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Time frame: 1 year
Relationship between de novo DSA, a normal protocol biopsy and the TruGraf result.
Assess the relationship, if any, between the appearance of de novo DSA, a normal protocol transplant biopsy and the TruGraf result.
Time frame: 1 year
Examine TruGraf results and the %CV tacrolimus levels- index of medication nonadherence.
Examine the relationship between the TruGraf results and the %CV tacrolimus levels as an index of medication nonadherence.
Time frame: 1 year
Relationship between urinary CXCL10 and subclinical rejection affecting the predictive value of TruGraf.
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.
Time frame: 1 year
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Examine relationship between ddcfDNA and subclinical rejection
Examine the relationship between ddcfDNA and subclinical rejection in this patient cohort
Time frame: 1 year