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
Sponsors and collaborators
Virginia Commonwealth University
Lead sponsor
Thermo Fisher Scientific, Inc
Collaborator