ddcfDNA in Kidney Transplant Recipients | NCT06013358

Studies
ddcfDNA in Kidney Transplant Recipients

NCT06013358

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 28, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Kidney Transplant Rejection

Interventions

AlloSeq cfDNA

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2022Actual

Primary Completion Date

Nov 30, 2024Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Aug 22, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2023

Last Update Posted Date

Aug 28, 2023Actual

Name	Class
Samsung Medical Center	OTHER
Asan Medical Center	OTHER
Severance Hospital	OTHER
Korea University Anam Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AlloSeq cfDNA	Genetic	An in vitro diagnostic medical device is employed for predicting damage to and rejection of transplanted organs (kidney, heart, liver, lung) by measuring the ratio of Donor-Derived Cell-Free DNA (dd-cfDNA) to total Cell-Free DNA (cfDNA) extracted from the plasma of patients who have undergone solid organ transplantation. This measurement is carried out using next-generation sequencing methods.

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ara Jo, MD	Contact	82-10-7364-9899		ara501616@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided