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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04727788
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : October 6, 2021
Information provided by (Responsible Party):
Verici Dx

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
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.

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Study Type : Observational
Estimated 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 : March 21, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 months ]
    clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy

Biospecimen Retention:   Samples With DNA
whole blood, urine, tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Kidney or kidney/pancreas transplant patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04727788

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Contact: Angela Rose 9196673507

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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Scott Benken, Pharm-D         
Northwestern University Recruiting
Evanston, Illinois, United States, 60611
Contact: Lorenzo Gallon, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Daniel Maluf, MD         
United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact: Milagros Samaniego, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Roslyn Mannon, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joshua Augustine, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Saed Shawar, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Nicolae Leca, MD         
CHU Grenoble Alpes Health Center Recruiting
Grenoble, France
Contact: Lionel Rostaing, MD         
Bologna University Recruiting
Bologna, Italy
Contact: Gaetano LaManna         
Brescia University Recruiting
Brescia, Italy
Contact: Federico Alberici         
University Hospital Vall d'Hebron, Barcelona Recruiting
Barcelona, Spain
Contact: Oriol Bestard         
United Kingdom
Guy's Hospital Not yet recruiting
London, United Kingdom
Contact: Paramit Chowdhury         
King's College Hospital Not yet recruiting
London, United Kingdom
Contact: Theodoros Kasimatis         
Sponsors and Collaborators
Verici Dx
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Principal Investigator: Michael J Donovan, PhD, MD Verici Dx
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Responsible Party: Verici Dx Identifier: NCT04727788    
Other Study ID Numbers: VDX 20-1001
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No