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

Pilot Study to Evaluate the Correlation Between Peripheral Gene Expression Profile Testing, Tissue-based Gene Expression Profiling, Donor Derived Cell Free DNA, and Histopathology Among High-risk Kidney Transplant Recipients

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05811468

Enrollment

Registered

2023-04-13

Start date

2023-09-26

Completion date

2025-05-30

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Rejection Transplant, Kidney Transplant, Transplant;Failure,Kidney

Keywords

Gene expression profile, Molecular microscope, Donor derived cell free DNA, Kidney biopsy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.

Countries

United States

Outcome results