Skip to main content
OpenTrials
Completed

NCT Number: NCT04541914

Diagnostic Efficacy of Molecular Diagnostic Method for AMR in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ABO Blood Type Incompatible Kidney Transplantation Antibody-mediated Rejection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-gene classification model

Diagnostic Test

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

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

    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)

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

    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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.