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ddcfDNA in Kidney Transplant Recipients

NCT06013358 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-08-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2024-11-30
Completion
2025-02-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013358 on ClinicalTrials.gov