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Clinical Trials in Italy / NCT04727788
Active, not recruiting Observational

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

NCT04727788 · tracked via the Priya Life Science Italy tracker
Sponsor
Verici Dx
Phase
Observational
Started
2021-03-21
Last updated
2025-11-20

Condition(s) studied

Kidney Transplant Rejection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
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

Primary outcome measure(s)

  • Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) — baseline
    early acute rejection occurring within first 6 months, including borderline ACR
  • 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
  • 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

Trial sites (13)

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

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
PRObiotics for KIdney Transplantation Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04727788 on ClinicalTrials.gov ↗ ← All trials in Italy