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Clinical trial

The Efficacy of Donor-derived Cell-free DNA as a Biomarker for Subclinical Antibody-mediated Rejection in de Novo Anti-HLA DSA-positive Recipients Who Maintain Stable Renal Function After Kidney Transplantation

ID
Name
SNUH-ddcfDNA-KT-V1.4
Description
The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation. This will be achieved through the measurement of donor-derived cell-free DNA. The utility of donor-derived cell-free DNA will be validated based on histological findings using Receiver Operating Characteristics (ROC) curve analysis.
Trial arms
Trial start
2022-12-26
Estimated PCD
2024-11-30
Trial end
2025-02-01
Status
Recruiting
Treatment
AlloSeq cfDNA
An in vitro diagnostic medical device is employed for predicting damage to and rejection of transplanted organs (kidney, heart, liver, lung) by measuring the ratio of Donor-Derived Cell-Free DNA (dd-cfDNA) to total Cell-Free DNA (cfDNA) extracted from the plasma of patients who have undergone solid organ transplantation. This measurement is carried out using next-generation sequencing methods.
Size
200
Primary endpoint
diagnostic accuracy of subclinical ABMR
10 years within kidney transplantation
Eligibility criteria
Inclusion Criteria: * Recipients aged 18 and above * Patients with de novo DSA positivity post-kidney transplantation and stable renal function: De novo HLA DSAs encompass both class I and class II, with Mean Fluorescence Intensity (MFI) greater than 1000. Stable renal function is defined as serum creatinine variation of less than 15% compared to the last 6 months. * Patients with detected de novo HLA-DSAs but did not undergo histological examinations. Exclusion Criteria: * Multi-organ transplant recipients * Recipients with positive preformed DSAs * ABO-incompatible transplant recipients * Pediatric recipients under 18 years old at the time of transplantation * Recipients lost to follow-up observation * atients already subjected to histological examinations due to positive De novo HLA-DSAs.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-08-28

1 organization

1 product

1 indication

Organization
Seoul National University Hospital
Product
AlloSeq
Indication
Kidney Transplant Rejection