ddcfDNA in Kidney Transplant Recipients

Seoul National University

Status: Enrolling

Conditions: Kidney Transplant Rejection

Treatments: Genetic: AlloSeq cfDNA

Study type: Observational

Funder types: Other

Identifiers

NCT06013358

SNUH-ddcfDNA-KT-V1.4

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.