Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

May 13, 2025 updated by: Jaeseok Yang, Seoul National University Hospital

Diagnostic Efficacy of Peripheral Blood Marker-based Molecular Diagnostic Method for Antibody-mediated Rejection (AMR) in ABO Blood Type Incompatible Kidney Transplant (ABOiKT)

The purpose of this study is to determine whether the peripheral blood marker-based molecular diagnostic method developed in the previous study can differentiate and predict accommodation and antibody-mediated rejection (AMR) in ABO blood type incompatible kidney transplant (ABOiKT) patients who are prospectively recruited.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our research team retrospectively analyzes biomarkers that distinguish accommodation and acute antibody-mediated rejection through transcriptomic analysis of peripheral blood in patients with ABO blood type incompatibility kidney transplantation at Seoul National University Hospital. Through this, a classification model was developed to distinguish accommodation and antibody-mediated rejection using peripheral blood marker at the time of the protocol biopsy on the 10th day after renal transplantation, and recently reported as a new peripheral blood marker-based molecular diagnostic method. On the 10th day after surgery, transcriptomic analysis through RNA-seq was performed using samples of peripheral blood from 18 patients with accommodation and 10 patients with antibody-mediated rejection confirmed by protocol biopsy. The candidate genes were validated in the discovery set and another independent training set through quantitative real-time polymerase chain reaction (PCR). Finally, a 5-gene classification model including COX7A2L, CD69, CD14, CFD, and FOXJ3 was developed through logistic regression analysis.

To evaluate the diagnostic effectiveness (sensitivity, specificity) for the peripheral blood marker-based molecular diagnostic method by prospectively recruiting patients with ABO blood type incompatible kidney transplantation is needed. And, it is necessary to evaluate the effectiveness of whether the peripheral blood marker-based molecular diagnostic method can predict antibody-mediated rejection or accommodation as a result of protocol biopsy that will be performed on the 10th day after transplantation - peripheral blood samples collected earlier than the 10th day (day 5 and day 7) after ABO blood type incompatible kidney transplantation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ABO blood group incompatible kidney transplant patients
  • Patients who consent to written consent
  • Patients over 19 years of age

Exclusion Criteria:

  • Pregnant patients
  • Patients with a history of drug abuse within the last 6 months
  • Psychiatric disease history (major depression, bipolar disorder, schizophrenia, etc.)
  • Patients who do not want to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Validation group
Evaluation for diagnostic efficacy of peripheral blood marker-based molecular diagnostic method for antibody-mediated rejection (AMR) in ABO blood type incompatible kidney transplant (ABOiKT)
Diagnostic test: 5-gene classification model
Peripheral blood marker-based molecular diagnostic method for AMR in ABOiKT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The value by logistic regression equation using peripheral blood marker on the 7th day after ABOiKT for prediction of antibody-mediated rejection
Time Frame: the 7th day after ABO-incompatible kidney transplantation
To evaluate whether the value by logistic regression equation using peripheral blood marker-based molecular diagnostic method on the 7th day after ABOiKT can predict antibody-mediated rejection from the protocol kidney biopsy results on the 10±2 day after ABOiKT (If the probability value of a sample is higher than 0.5, it is classified as accommodation. Samples with values <0.5 are classified as antibody-mediated rejection by this diagnostic method)
the 7th day after ABO-incompatible kidney transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The value by logistic regression equation using peripheral blood marker on the 5th or 10th day after ABOiKT for prediction of antibody-mediated rejection
Time Frame: the 5th or 10th day after ABO-incompatible kidney transplantation
To evaluate whether the value by logistic regression equation using peripheral blood marker-based molecular diagnostic method on the 5th or 10th day after ABOiKT can predict antibody-mediated rejection from the protocol kidney biopsy results on the 10±2 day after ABOiKT (If the probability value of a sample is higher than 0.5, it is classified as accommodation. Samples with values <0.5 are classified as antibody-mediated rejection by this diagnostic method)
the 5th or 10th day after ABO-incompatible kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jaeseok Yang, M.D., Ph.D, Transplantation Center, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20030871109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe