ddcfDNA in Kidney Transplant Recipients

Seoul National University Hospital200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Kidney Transplant Rejection

Interventions

AlloSeq cfDNAGENETIC

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

diagnostic accuracy of subclinical ABMR

Time frame: 10 years within kidney transplantation

Central Contacts

Ara Jo, MD

CONTACT

82-10-7364-9899 ara501616@gmail.com

Data from ClinicalTrials.gov

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