ddcfDNA in Kidney Transplant Recipients

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06013358

Collaborator

Samsung Medical Center (Other), Asan Medical Center (Other), Severance Hospital (Other), Korea University Anam Hospital (Other)

200

Enrollment

Location

25.2

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection	Genetic: AlloSeq cfDNA

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 26, 2022

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Outcome Measures

Primary Outcome Measures

diagnostic accuracy of subclinical ABMR [10 years within kidney transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Severance Hospital
Korea University Anam Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06013358

Other Study ID Numbers:

SNUH-ddcfDNA-KT-V1.4

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 28, 2023