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Omnigraf: Blood Biomarkers in Pediatric Kidney Transplant Recipients

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05477082
Collaborator
(none)
30
Enrollment
1
Location
15.8
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational group

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 27, 2023
Anticipated Study Completion Date :
Dec 27, 2023

Outcome Measures

Primary Outcome Measures

  1. Biopsy-proven acute rejection [7 days from baseline]

    Yes or No assessment

  2. Clinical resolution of rejection [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Sarah Kizilbash, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05477082
Other Study ID Numbers:
  • PEDS-2022-30750
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
acute rejection
kidney transplant
pediatric
biomarker
cell free DNA

Study Results

No Results Posted as of Jul 28, 2022