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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04727788
• Other study ID #: VDX 20-1001
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

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