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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07415876
Status
Completed

Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retrospective Cohort Enrollment — OTHER
    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.
  • Prospective Cohort Enrollment — OTHER
    Subjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy

Study Details

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.

Key Dates

First listed
Feb 17, 2026
Start date
Jun 4, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
20 participants (actual)

Arms

  • Arm: Retrospective (Kidney Transplant recipients)
    There will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled
  • Arm: Prospective (Kidney Transplant recipients)
    There will be 30 Prospective (Kidney Transplant recipients) subjects enrolled

Primary Outcome Measure

Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients [ Time Frame: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

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By research site
Virginia Commonwealth University· Richmond, VA

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