ddcfDNA in Kidney Transplant Recipients

NCT06013358 | Unknown

• 1 other identifier: SNUH-ddcfDNA-KT-V1.4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of subclinical ABMR

  10 years within kidney transplantation

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Severance Hospital: collaborator
• Korea University Anam Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Central Study Contacts

Ara Jo, MD

CONTACT

82-10-7364-9899; ara501616@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: December 26, 2022
• Primary Completion: November 30, 2024
• Study Completion: February 1, 2025
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)