Blood Biomarkers in Pediatric Kidney Transplant Recipients | NCT05477082

Studies
Blood Biomarkers in Pediatric Kidney Transplant Recipients

NCT05477082

Sponsor

University of Minnesota

Status

Active, not recruiting

Last Update Posted

Dec 17, 2025Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Rejection of Kidney Allograft

Interventions

Observational group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2023Actual

Primary Completion Date

Nov 16, 2025Actual

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Jul 25, 2022

First Submission Date that Met QC Criteria

Jul 25, 2022

First Posted Date

Jul 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational group	Other	Includes blood draws and data collection only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Pediatric kidney transplant recipients, ages < 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Kizilbash, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States