ddcfDNA in Kidney Transplant Recipients

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06013358

Enrollment

200

Registered

2023-08-28

Start date

2022-12-26

Completion date

2025-02-01

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection

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.

Interventions

GENETICAlloSeq 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

South Korea

Contacts

Primary ContactAra Jo, MD

ara501616@gmail.com82-10-7364-9899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026