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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-26

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transplant;Failure,Kidney Kidney Transplant Kidney Rejection Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No