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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Rejection

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 Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: Angela Rose; Phone Number: 9196673507; Email: arose@vericidx.com

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • CHU Grenoble Alpes Health Center
    • Contact: Lionel Rostaing, MD
• Italy
  • Bologna, Italy
    • Recruiting
    • Bologna University
    • Contact: Gaetano LaManna
  • Brescia, Italy
    • Recruiting
    • Brescia University
    • Contact: Federico Alberici
• Spain
  • Barcelona, Spain
    • Recruiting
    • University Hospital Vall d'Hebron, Barcelona
    • Contact: Oriol Bestard
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College Hospital
    • Contact: Theodoros Kasimatis
  • London, United Kingdom
    • Recruiting
    • Guy's Hospital
    • Contact: Paramit Chowdhury
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Scott Benken, Pharm-D
    • Evanston, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Lorenzo Gallon, MD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Daniel Maluf, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford
      • Contact: Milagros Samaniego, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Roslyn Mannon, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Joshua Augustine, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • Recruiting
      • University of Pittsburgh
      • Contact: David Rothstein, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Saed Shawar, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Kidney or kidney/pancreas transplant patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VDX 20-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No