Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

Antibody-mediated Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04541914
• Other study ID #: 20030871109
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ABO Blood Type Incompatible Kidney Transplantation
• Antibody-mediated Rejection

Intervention

Diagnostic Test:
• 5-gene classification model
Peripheral blood marker-based molecular diagnostic method for AMR in ABOiKT

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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 acco — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The value by logistic regression equation using peripheral blood marker on the 5th or 10th 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 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