Blood Biomarkers in Pediatric Kidney Transplant Recipients

NCT05477082 | Active Not Recruiting

• 1 other identifier: PEDS-2022-30750
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rejection of Kidney Allograft

Keywords

acute rejection; kidney transplant; pediatric; biomarker; cell free DNA

Outcome Measures

Primary Outcomes (2)

• Biopsy-proven acute rejection

  Yes or No assessment

  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

  8 weeks from baseline

Interventions

Observational group OTHER

Includes blood draws and data collection only

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Sarah Kizilbash, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: August 21, 2023
• Primary Completion: November 16, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)