Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients

University of Minnesota1 site in 1 country27 target enrollmentAugust 21, 2023

ConditionsRejection of Kidney Allograft

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rejection of Kidney Allograft
Sponsor: University of Minnesota
Enrollment: 27
Locations: 1
Primary Endpoint: Biopsy-proven acute rejection
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.

Registry

clinicaltrials.gov

Start Date

August 21, 2023

End Date

November 1, 2026

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Kidney transplant recipients
•Participants undergoing a for-cause kidney biopsy to rule out graft rejection
•Ages 21 years and less

Exclusion Criteria

•Participants who have opted out of research
•Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
•Participants, 18 years and older, who are illiterate and cannot read.
•Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
•Participants, 18 years and older, who do not speak English
•Participants who are pregnant as confirmed by medical records