ddcfDNA in Kidney Transplant Recipients

August 22, 2023 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Recipients with de novo DSA positivity post-kidney transplantation maintaining stable renal function

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diagnostic accuracy of subclinical ABMR
Time Frame: 10 years within kidney transplantation
10 years within kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SNUH-ddcfDNA-KT-V1.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplant Rejection

Clinical Trials on AlloSeq cfDNA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe