Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

ABO Blood Type Incompatible Kidney Transplantation
Antibody-mediated Rejection

Clinical Trial Details

NCT number	NCT04541914
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 19, 2020
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02533596` - Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange	N/A
Completed	`NCT04367610` - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Completed	`NCT05021484` - Felzartamab in Late Antibody-Mediated Rejection	Phase 2
Terminated	`NCT02120482` - Combined Apheresis for ABO-incompatible Transplantation - a Pilot Study	N/A
Terminated	`NCT03744910` - Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients	Phase 3
Terminated	`NCT03221842` - Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients	Phase 3
Terminated	`NCT01895127` - Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation	Phase 2
Completed	`NCT02013037` - The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation	Phase 3
Recruiting	`NCT03737136` - Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR	N/A
Recruiting	`NCT05913596` - The Safety and Efficacy of CD38 Monoclonal Antibody Monotherapy for CaAMR in Renal Transplantation	N/A
Withdrawn	`NCT03805178` - Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization	Phase 2
Recruiting	`NCT06112951` - A Prospective Randomized Trial of ECP in Subclinical AMR	N/A
Active, not recruiting	`NCT04897438` - Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection	N/A
Recruiting	`NCT05004493` - Biorepository and Registry for Plasma Exchange Patients
Completed	`NCT04026087` - Subclass of Donor-specific Antibody as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation
Active, not recruiting	`NCT03994783` - Transplant Antibody-Mediated Rejection: Guiding Effective Treatments	Phase 3
Not yet recruiting	`NCT05862766` - Isatuximab in Lung Transplant Recipients	Early Phase 1
Recruiting	`NCT04368962` - DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients
Completed	`NCT03444103` - A Pilot Trial of Clazakizumab in Late ABMR	Phase 2
Recruiting	`NCT05140018` - Incidence, Course and Outcome of ABMR in Kidney Transplantation