Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

Seoul National University

Status: Completed

Conditions: ABO Blood Type Incompatible Kidney Transplantation; Antibody-mediated Rejection

Treatments: Diagnostic Test: 5-gene classification model

Study type: Interventional

Funder types: Other

Identifiers

NCT04541914

20030871109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Validation group

Experimental group

Description:

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)

Treatment:

Diagnostic Test: 5-gene classification model