Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06013358
Status:
UNKNOWN
Last Update Posted:
2023-08-28
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ddcfDNA in Kidney Transplant Recipients
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: