Blood Biomarkers in Pediatric Kidney Transplant Recipients

N/AActive Not RecruitingNCT05477082

University of Minnesota27 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rejection of Kidney Allograft

Interventions

Observational groupOTHER

Includes blood draws and data collection only

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Biopsy-proven acute rejection

Yes or No assessment

Time frame: 7 days from baseline

Clinical resolution of rejection

Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine

Time frame: 8 weeks from baseline

Data from ClinicalTrials.gov

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