Blood Biomarkers in Pediatric Kidney Transplant Recipients (Omnigraf)

December 9, 2025 updated by: University of Minnesota

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric kidney transplant recipients, ages < 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopsy-proven acute rejection
Time Frame: 7 days from baseline
Yes or No assessment
7 days from baseline
Clinical resolution of rejection
Time Frame: 8 weeks from baseline
Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine
8 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Sarah Kizilbash, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Actual)

November 16, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEDS-2022-30750

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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