Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.
University of Alberta
Summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
Description
There is a need for better screening of kidney transplant patients for rejection. Patients with kidney transplants are routinely tested (creatinine, urine protein, histology and donor specific antibody (DSA) as standard of care to detect rejection, but these tests are not adequate. Rejection is often missed by these tests (false negatives) and other processes such as acute kidney injury can produce false-positive results. Moreover, histology has a high interobserver disagreement diagnosing rejection, and cannot accurately assess acute injury. A definitive molecular assessment of rejection and…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study. Exclusion Criteria: * Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.
Interventions
- Diagnostic TestMMDx
Portion of kidney transplant indication biopsy
- Diagnostic TestProspera
Transplant patient blood sample
- Diagnostic TestHLA antibody
Transplant patient blood sample
Locations (31)
- Tampa General HospitalTampa, Florida
- University of Maryland School of MedicineBaltimore, Maryland
- The Johns Hopkins University, School of MedicineBaltimore, Maryland
- Detroit Medical Center, Harper University Hospital of Wayne State UniversityDetroit, Michigan
- Henry Ford HospitalDetroit, Michigan
- Barnes-Jewish Hospital, Washington University at St. LouisSt Louis, Missouri