Status:

UNKNOWN

ddcfDNA in Kidney Transplant Recipients

Lead Sponsor:

Seoul National University Hospital

Collaborating Sponsors:

Samsung Medical Center

Asan Medical Center

Conditions:

Kidney Transplant Rejection

Eligibility:

All Genders

18+ years

Brief 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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 26 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2025

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06013358

Start Date

December 26 2022

End Date

February 1 2025

Last Update

August 28 2023

Active Locations (1)

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Seoul National University Hospital

Seoul, South Korea, 110-744