ddcfDNA in Kidney Transplant Recipients
Recruiting
- Conditions
- Kidney Transplant Rejection
- Registration Number
- NCT06013358
- Lead Sponsor
- Seoul National University Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diagnostic accuracy of subclinical ABMR 10 years within kidney transplantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of