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Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
Sponsor: Virginia Commonwealth University
Summary
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.
Official title: Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-04
Completion Date
2027-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Retrospective Cohort Enrollment
Subjects for this cohort will be selected from existing research database and criteria include: hx of kidney transplantation, clinically indicated biopsy, positive histology, \<1% circulating donor-derived cell-free DNA (dd-cfDNA) result at the time of biopsy, and Availability of frozen urine samples.
Prospective Cohort Enrollment
Subjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy
Locations (1)
Virginia Commonwealth University
Richmond, Virginia, United States