Active — Not RecruitingNot Applicable

Blood Biomarkers in Pediatric Kidney Transplant Recipients

United States27 participantsStarted 2023-08-21

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Biopsy-proven acute rejection

Timeframe: 7 days from baseline

Clinical resolution of rejection

Timeframe: 8 weeks from baseline

Trial details

NCT IDNCT05477082

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-16

View on ClinicalTrials.gov More Rejection of Kidney Allograft trials