Clinical trial NCT04541914: Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ABO Blood Type Incompatible Kidney Transplantation
Antibody-mediated Rejection
Keywords: molecular diagnostic method
diagnostic efficacy
accommodation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The value by logistic regression equation using peripheral blood marker on the 7th day after ABOiKT for prediction of antibody-mediated rejection
timeFrame: the 7th day after ABO-incompatible kidney transplantation
Secondary outcomes:
measure: The value by logistic regression equation using peripheral blood marker on the 5th or 10th day after ABOiKT for prediction of antibody-mediated rejection
timeFrame: the 5th or 10th day after ABO-incompatible kidney transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Transplantation Center, Seoul National University Hospital
name: Jaeseok Yang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.