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ddcfDNA in Kidney Transplant Recipients

ddcfDNA in Kidney Transplant Recipients

Non Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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.

Study details
    Kidney Transplant Rejection

NCT06013358

Seoul National University Hospital

20 August 2025

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