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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Retrospective (Kidney Transplant recipients) There will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled
  • Other: Retrospective Cohort Enrollment
    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 (Kidney Transplant recipients) There will be 30 Prospective (Kidney Transplant recipients) subjects enrolled
  • Other: Prospective Cohort Enrollment
    Subjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy

Recruiting Locations

Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23298
Contact:
Amber Paulus
Amber.Paulus@vcuhealth.org

More Details

Status
Recruiting
Sponsor
Virginia Commonwealth University

Study Contact

Amber Paulus, PhD
(804) 628-4969
amber.Paulus@vcuhealth.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.