Clinical trial NCT04727788: Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
Official title: Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Transplant Rejection
Lead sponsor: Verici Dx
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney or kidney/pancreas transplant patients

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Individual Recipients of living or deceased donor kidney transplant
2. Age: ≥ 18 ≤ 80
3. The subject must be able to comprehend and sign an approved informed consent form

Exclusion Criteria:

1. Recipients of multiple organ transplant, except kidney-pancreas multiple transplant
2. Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
3. HIV or Hepatitis C positive patients
4. Persons who are known to be pregnant

Primary outcomes:
measure: Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR)
timeFrame: baseline
measure: Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR
timeFrame: 6 months
measure: Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Grenoble
country: France
facility: CHU Grenoble Alpes Health Center
city: Bologna
country: Italy
facility: Bologna University
city: Brescia
country: Italy
facility: Brescia University
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron, Barcelona
Study officials:
affiliation: Verici Dx
name: Michael J Donovan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: