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Active, not recruitingNCT05477082OmnigrafUpdated Dec 17, 2025

Blood Biomarkers in Pediatric Kidney Transplant Recipients

An observational study in Rejection of Kidney Allograft, sponsored by University of Minnesota. Active, not recruiting at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
Up to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rejection of Kidney Allograft

Keywords

  • acute rejection
  • kidney transplant
  • pediatric
  • biomarker
  • cell free DNA
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
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

Inclusion criteria

  • Kidney transplant recipients
  • Participants undergoing a for-cause kidney biopsy to rule out graft rejection
  • Ages 21 years and less

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Interventions

  • OtherObservational group

    Includes blood draws and data collection only

06

What researchers measure

Primary outcomes

  1. Biopsy-proven acute rejection

    Yes or No assessment

    Time frame: 7 days from baseline

  2. 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

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05477082
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 28, 2022
Start date
Aug 21, 2023
Primary completion
Nov 16, 2025
Completion
Nov 1, 2026 (estimated)
Last update
Dec 17, 2025

Study contacts

Sarah Kizilbash, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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