Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2022-12-26
2025-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
NCT05084768
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection
NCT04897438
Donor Derived Cell-free DNA and Rejection of Kidney Allografts
NCT05995379
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
NCT06026592
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance
NCT04566055
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Severance Hospital
OTHER
Korea University Anam Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SNUH-ddcfDNA-KT-V1.4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.