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

NCT04727788 | Active Not Recruiting

• 1 other identifier: VDX 20-1001
• Study Type: observational
• Target: 550
• Locations: 4 countries
• Sites: 13

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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney or kidney/pancreas transplant patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verici Dx: lead

Study Sites (13)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Northwestern University

Evanston, Illinois, 60611, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

CHU Grenoble Alpes Health Center

Grenoble, France

Location

Bologna University

Bologna, Italy

Location

Brescia University

Brescia, Italy

Location

University Hospital Vall d'Hebron, Barcelona

Barcelona, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine, tissue

Study Officials

• Michael J Donovan, PhD, MD

  Verici Dx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 21, 2021
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); IT (2); FR (1); ES (1)