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

Withdrawn

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

• Registration Number: NCT05811468
• Lead Sponsor: Rush University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-13
• Study Start: 2023-09-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify the number of rejection cases detected by histopathology and MMDX as reported by respective pathology laboratories/ pathologists	Through study completion, an average of 1 year	Measure the number of rejections in the kidney allograft detected by histopathology and MMDX as invasive tests and ascertain concordance of those results with blood based non invasive assays.
Quantify the number of rejections in the kidney allograft detected via non invasive blood- based testing as reflected in abnormal laboratory readout of GEP value and dd-CFDNA fraction.	Through study completion, an average of 1 year	The number of rejections in the kidney allograft detected via blood- based non invasive testing will be measured and compared to the number of rejection cases detected by histopathology and MMDX to ascertain accuracy of blood based assays to detect rejection among kidney transplant recipients

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States