Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

NCT04541914 | Completed

• 1 other identifier: 20030871109
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ABO Blood Type Incompatible Kidney Transplantation; Antibody-mediated Rejection

Keywords

molecular diagnostic method; diagnostic efficacy; accommodation

Outcome Measures

Primary Outcomes (1)

• The value by logistic regression equation using peripheral blood marker on the 7th day after ABOiKT for prediction of antibody-mediated rejection

  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 Outcomes (1)

• The value by logistic regression equation using peripheral blood marker on the 5th or 10th day after ABOiKT for prediction of antibody-mediated rejection

  the 5th or 10th day after ABO-incompatible kidney transplantation

Study Arms (1)

Validation group

EXPERIMENTAL

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

Interventions

5-gene classification model DIAGNOSTIC_TEST

Peripheral blood marker-based molecular diagnostic method for AMR in ABOiKT

Validation group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Jeon HJ, Lee JG, Kim K, Jang JY, Han SW, Choi J, Ryu JH, Koo TY, Jeong JC, Lee JW, Ishida H, Park JB, Lee SH, Ahn C, Yang J. Peripheral blood transcriptome analysis and development of classification model for diagnosing antibody-mediated rejection vs accommodation in ABO-incompatible kidney transplant. Am J Transplant. 2020 Jan;20(1):112-124. doi: 10.1111/ajt.15553. Epub 2019 Aug 26.

  PMID: 31373158 BACKGROUND

Study Officials

• Jaeseok Yang, M.D., Ph.D

  Transplantation Center, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: May 19, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)