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

Sponsor
Verici Dx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04727788
Collaborator
(none)
414
Enrollment
14
Locations
33.3
Anticipated Duration (Months)
29.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    414 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection
    Actual Study Start Date :
    Mar 21, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) [baseline]

      early acute rejection occurring within first 6 months, including borderline ACR

    2. Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR [6 months]

      clinical or subclinical acute rejection 3 months post transplant including borderline ACR, acute cell-mediated rejection as confirmed by histologic evidence on biopsy

    3. Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss [24 months]

      clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Illinois at Chicago Chicago Illinois United States 60612
    2 Northwestern University Evanston Illinois United States 60611
    3 University of Maryland Baltimore Maryland United States 21201
    4 Henry Ford Detroit Michigan United States 48202
    5 University of Nebraska Medical Center Omaha Nebraska United States 68198
    6 Cleveland Clinic Cleveland Ohio United States 44195
    7 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    8 University of Washington Seattle Washington United States 98195
    9 CHU Grenoble Alpes Health Center Grenoble France
    10 Bologna University Bologna Italy
    11 Brescia University Brescia Italy
    12 University Hospital Vall d'Hebron, Barcelona Barcelona Spain
    13 Guy's Hospital London United Kingdom
    14 King's College Hospital London United Kingdom

    Sponsors and Collaborators

    • Verici Dx

    Investigators

    • Principal Investigator: Michael J Donovan, PhD, MD, Verici Dx

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Verici Dx
    ClinicalTrials.gov Identifier:
    NCT04727788
    Other Study ID Numbers:
    • VDX 20-1001
    First Posted:
    Jan 27, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 6, 2021