Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection

Study Overview
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Brief Summary
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Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.

Detailed Description
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The study is correlative and observational and will involve collecting clinical and pathological data along with blood, biopsy tissue and urine during standard routine scheduled medical visits for transplant preparation or monitoring. The blood will be used for next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of three Verici Dx sequencing immune-phenotype signature risk score tests. The research biopsy tissue and urine are for secondary or exploratory objectives. To allow comparison with current accepted standard approaches to identify kidney transplant injury or rejection, digital images of stained tissue sections taken from surveillance or for-cause biopsy tissue will be evaluated in a central pathology laboratory for the purposes of this study. Enrolled subjects will continue in the study for 24 months during which the planned validation of the acute clinical and subclinical rejection tests will complete after 6 months of follow-up; subjects will be followed to 24 months for the validation of the Verici Dx blood-based fibrosis risk prognostic test. After 24 months, patients will be followed through ANZDATA and UNOS registry data for later development of fibrosis or for graft loss or death.

Official Title
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Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection

Conditions
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Kidney Transplant Rejection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual Recipients of living or deceased donor kidney transplant Age: ≥ 18 ≤ 80 The subject must be able to comprehend and sign an approved informed consent form Exclusion Criteria: Recipients of multiple organ transplant, except kidney-pancreas multiple transplant Subjects who are currently participating in a therapeutic clinical trial for transplant rejection HIV or Hepatitis C positive patients Persons who are known to be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) | early acute rejection occurring within first 6 months, including borderline ACR | baseline | 
| Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR | clinical or subclinical acute rejection 3 months post transplant including borderline ACR, acute cell-mediated rejection as confirmed by histologic evidence on biopsy | 6 months | 
| Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss | clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy | 24 months |