Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
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)
Virginia Commonwealth University
50 participants
Apr 1, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Age ≥18 years
- Undergoing a clinically indicated biopsy
- Able to provide informed consent
- Willing to provide a urine sample and allow access to relevant clinical
- Age ≥18 years
- Biopsy-confirmed rejection (positive histology)
- Donor-derived cell-free DNA\<1% result at time of biopsy
- Availability of stored urine sample collected at time of biopsy
Exclusion Criteria5
- Individuals under 18 years of age
- Individuals unable to provide informed consent (for prospective enrollment)
- Pregnant women
- Prisoners
- Adults unable to consent
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Interventions
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.
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)
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NCT07415876