ddcfDNA in Kidney Transplant Recipients

Kidney Transplant Rejection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013358
• Other study ID #: SNUH-ddcfDNA-KT-V1.4
• Status: Recruiting
• Start date: December 26, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: Ara Jo, MD
• Phone: 82-10-7364-9899
• Email: ara501616[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Genetic:
• AlloSeq cfDNA
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Korea University Anam Hospital, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of subclinical ABMR		10 years within kidney transplantation