Actively Recruiting

Age: 18Years +
All Genders
NCT07415876

Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA

Led by Virginia Commonwealth University · Updated on 2026-02-17

50

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

V

Virginia Commonwealth University

Lead Sponsor

T

Thermo Fisher Scientific, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Kidney transplant rejection remains a significant challenge to long-term graft survival. While histological biopsy continues to be the gold standard for diagnosing rejection, noninvasive biomarkers such as donor-derived cell-free DNA (dd-cfDNA) have gained traction for their ability to detect allograft injury. However, dd-cfDNA may lack sensitivity in certain clinical scenarios particularly in cases of localized immune activation leading to false negatives despite biopsy-confirmed rejection.

CONDITIONS

Official Title

Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing a clinically indicated biopsy
  • Able to provide informed consent
  • Willing to provide a urine sample and allow access to relevant clinical data
  • Biopsy-confirmed rejection with positive histology (retrospective cohort)
  • Donor-derived cell-free DNA less than 1% at time of biopsy (retrospective cohort)
  • Availability of stored urine sample collected at time of biopsy (retrospective cohort)
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to provide informed consent (for prospective enrollment)
  • Pregnant women
  • Prisoners
  • Adults unable to consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

A

Amber Paulus, PhD

CONTACT

G

Gelila Abebe

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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