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NCT07415876 | RECRUITING | Kidney Transplant Rejection


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

Virginia Commonwealth University

Brief 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.

Condition or disease

Kidney Transplant Rejection

Intervention/treatment

Retrospective Cohort Enrollment

Prospective Cohort Enrollment

Detailed Description:

One promising biomarker is CXCL10 (C-X-C motif chemokine ligand 10), a chemokine induced by interferon-γ that plays a central role in recruiting CXCR3+ T cells during immune responses. A 2021 study by Arnau et al. found that urinary CXCL10 levels were significantly associated with Banff scores of acute graft injury and donor-specific antibodies, and could discriminate both T-cell-mediated and antibody-mediated rejection in kidney transplant recipients, identifying CXCL10 as a promising candidate non-invasive biomarker for monitoring allograft rejection.

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
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)
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT07415876


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Locations


RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

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