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Active, Not Recruiting

NCT Number: NCT05477082

Blood Biomarkers 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Rejection of Kidney Allograft

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Group

Other

Includes blood draws and data collection only

Primary outcomes

  1. Biopsy-proven acute rejection

    Time frame: 7 days from baseline

    Yes or No assessment

  2. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: Omnigraf

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 28, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.