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)
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.
• 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