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)

What this Trial Is About

Kidney transplant rejection poses a major challenge to keeping transplanted kidneys functioning long-term. Researchers are studying noninvasive biomarkers to improve detection of rejection compared to traditional biopsy methods. This trial focuses on urinary CXCL10, a chemokine involved in immune response, to see if it can better detect acute rejection in kidney transplant patients, especially when donor-derived cell-free DNA (dd-cfDNA) levels are low. This observational study is sponsored by Virginia Commonwealth University and aims to enhance monitoring of transplant health. The study will enroll two groups of kidney transplant recipients: 20 retrospective subjects selected from existing databases who have biopsy-confirmed rejection with low dd-cfDNA and available frozen urine samples, and 30 prospective subjects who have recently undergone a clinically indicated biopsy and can provide urine samples. Researchers will compare urinary CXCL10 levels to dd-cfDNA to assess its accuracy for detecting acute rejection. They will also evaluate the stability of CXCL10 under different shipping conditions to determine if ambient transport affects test reliability. Participants will provide urine samples and clinical data for analysis. The study will monitor outcomes up to five years, including loss of follow-up, graft loss, or death. Researchers will assess urinary CXCL10 concentration changes, potential sample degradation, and explore the feasibility of cost-effective shipping methods. This study involves no investigational treatment, focusing on sample analysis and data collection to improve diagnostic tools for kidney transplant rejection.

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