Using donor-derived DNA to predict kidney transplant rejection
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
This study is testing if measuring donor DNA in the blood can help predict kidney transplant rejection in patients who have stable kidney function but show signs of certain antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06013358 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict occurrences of subclinical Antibody-Mediated Rejection (ABMR) in kidney transplant recipients who are de novo DSA-positive and have stable renal function. The approach involves measuring donor-derived cell-free DNA (ddcfDNA) and validating its utility through histological findings using Receiver Operating Characteristics (ROC) curve analysis. By focusing on patients with specific HLA DSA positivity, the study seeks to enhance monitoring and potentially improve outcomes for kidney transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult kidney transplant recipients who are de novo DSA-positive and have stable renal function.
Not a fit: Patients who have undergone multi-organ transplants or have preformed DSAs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of kidney transplant rejection, allowing for timely interventions.
How similar studies have performed: Other studies have shown promise in using donor-derived cell-free DNA for monitoring transplant rejection, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Ara Jo, MD
- Email: ara501616@gmail.com
- Phone: 82-10-7364-9899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.