NCT06013358

ddcfDNA in Kidney Transplant Recipients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
GENETIC	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.

Timeline

• Start date: 2022-12-26
• Primary completion: 2024-11-30
• Completion: 2025-02-01
• First posted: 2023-08-28
• Last updated: 2023-08-28

Locations

1 site across 1 country: South Korea