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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04727788
Other study ID # VDX 20-1001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 21, 2021
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Verici Dx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 550
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Grenoble Alpes Health Center Grenoble
Italy Bologna University Bologna
Italy Brescia University Brescia
Spain University Hospital Vall d'Hebron, Barcelona Barcelona
United States University of Maryland Baltimore Maryland
United States University of Illinois at Chicago Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Henry Ford Detroit Michigan
United States Northwestern University Evanston Illinois
United States Vanderbilt University Medical Center Nashville Tennessee
United States University of Nebraska Medical Center Omaha Nebraska
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Verici Dx

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) early acute rejection occurring within first 6 months, including borderline ACR baseline
Primary 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
Primary 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
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