Urinary CXCL10 to detect 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)
We will test whether measuring urinary CXCL10 helps detect acute rejection in kidney transplant patients whose donor-derived cell-free DNA is low.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT07415876 on ClinicalTrials.gov |
What this trial studies
Prospective and retrospective cohorts of adult kidney transplant recipients will be enrolled at Virginia Commonwealth University to compare urinary CXCL10 levels with biopsy-confirmed rejection and simultaneous dd-cfDNA results. The retrospective arm includes patients with biopsy-proven rejection, dd-cfDNA <1% at the time of biopsy, and stored urine samples, while the prospective arm enrolls adults undergoing a clinically indicated biopsy who can provide urine and consent. Urine CXCL10 concentrations will be measured and correlated with Banff histology, donor-specific antibodies, and CXCR3+ T cell markers to see if CXCL10 identifies rejection missed by low dd-cfDNA. The study combines noninvasive urine testing with existing biopsy and dd-cfDNA data to determine diagnostic value.
Who should consider this trial
Good fit: Adults (≥18) who are kidney transplant recipients undergoing a clinically indicated biopsy or with biopsy-confirmed rejection and available urine samples, and who can provide informed consent, are ideal candidates.
Not a fit: Patients under 18, pregnant women, prisoners, those unable to consent, or patients without available urine samples (or whose rejection is already clearly detected by other reliable tests) may not receive benefit from participation.
Why it matters
Potential benefit: If successful, urinary CXCL10 could provide a noninvasive way to detect acute rejection missed by low dd-cfDNA, enabling earlier treatment to protect the transplant.
How similar studies have performed: Prior work, including a 2021 study by Arnau et al., showed urinary CXCL10 correlates with Banff scores and donor-specific antibodies and can distinguish T-cell and antibody-mediated rejection, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Prospective Inclusion Criteria: * 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 Retrospective Inclusion Criteria: * 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 Criteria (applies to both arms): * Individuals under 18 years of age * Individuals unable to provide informed consent (for prospective enrollment) * Pregnant women * Prisoners * Adults unable to consent
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Gaurav Gupta, MD — Virginia Commonwealth University
- Study coordinator: Amber Paulus, PhD
- Email: amber.Paulus@vcuhealth.org
- Phone: (804) 628-4969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.