Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients

Rush

Status: Withdrawn

Conditions: Kidney Rejection Transplant; Kidney Transplant; Transplant;Failure,Kidney

Study type: Observational

Funder types: Other

Identifiers

NCT05811468

22060707

Details and patient eligibility

About

This study will compare the performance of Gene Expression Profile (GEP)/ Donor derived cell free deoxyribonucleic acid (dd-cfDNA) tests, to the following tests: Molecular Microscope (MMDx) and histopathology (study of changes in tissues caused by disease) in their ability to diagnose (exactly identify) various types of injury within the transplanted kidney.

Full description

This study will evaluate the performance of the blood-based assays like gene expression panel (GEP), and donor derived cell free DNA (dd-cfDNA) against tissue-based assays like molecular microscope (MMDX) and histopathology in their ability to more accurately detect presence of rejection among kidney transplant recipients deemed at higher than usual risk for immunologic injury i.e., rejection.

Furthermore, the study should shed light on the ability of the different blood- based assays to accurately discern between the different types of rejection (early cellular versus humoral) against such confirmed by histopathology and molecular microscope.

The study will also shed light on the ability of these noninvasive biomarkers to be utilized as a tool of immunomodulation in addition to studying their ability to accurately confirm presence of adequately treated rejection among the recipients of kidney transplant.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing a for cause biopsy due to ongoing or suspected "injury" of the allograft.
• Patients will be between 3 months and 7 years post-transplant episode.
• Recipients of both cadaveric and living donor renal transplant are considered eligible.

Exclusion criteria

• No multi organ transplant recipients will be included.
• Pregnancy
• HIV positive recipients
• Recipients of kidney transplant from an identical sibling
• Patients with active and biopsy proven BK nephropathy