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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Individuals under 18 years of age

Individuals unable to provide informed consent (for prospective enrollment)

Pregnant women

Prisoners

Trial design

Treatments tested in this trial

  • Retrospective Cohort Enrollment
  • Prospective Cohort Enrollment

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

Thermo Fisher Scientific, Inc

Collaborator