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
Recruiting
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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

Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Amber Paulus
[email protected]
Gelila Abebe
[email protected]
(804) 628-4969
Gaurav Gupta (PRINCIPAL_INVESTIGATOR)

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By research site
Virginia Commonwealth University· Richmond, VA

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