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Blood Biomarkers in Pediatric Kidney Transplant Recipients

NCT ID: NCT05477082

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-21

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rejection of Kidney Allograft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational group

Includes blood draws and data collection only

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Kizilbash, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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PEDS-2022-30750

Identifier Type: -

Identifier Source: org_study_id