Using donor-derived DNA and immune cells to predict kidney transplant rejection
Integration of Donor-derived Cell-free DNA With HLA-DR+TNFR2+ Regulatory T Cell in the Prediction of Acute Rejection and Graft Function After Kidney Transplantation
This study is testing if measuring certain DNA and immune cells from kidney donors can help predict if a kidney transplant will be rejected by the recipient's body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05084768 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the prediction of acute rejection in kidney transplant recipients by analyzing donor-derived cell-free DNA (dd-cfDNA) and regulatory T cells (Tregs). The study will evaluate how levels of dd-cfDNA and specific Treg populations correlate with acute rejection events, particularly focusing on their predictive capabilities for both high and low severity rejections. By identifying these biomarkers, the study seeks to enable non-invasive monitoring of transplant health, potentially leading to timely interventions that could enhance long-term graft survival.
Who should consider this trial
Good fit: Ideal candidates for this study are adult kidney transplant candidates or recipients.
Not a fit: Patients under 18, those undergoing multi-organ transplants, or those with HIV or HCV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of kidney transplant rejection, improving patient outcomes and graft longevity.
How similar studies have performed: Other studies have shown promise in using dd-cfDNA for predicting transplant rejection, but this specific integration of dd-cfDNA with Treg analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult kidney transplant candidates/recipients Exclusion Criteria: * Age less than 18 * Multi-organ transplants * Kidney transplant candidates/recipients with HIV * Kidney transplant candidates/recipients with HCV
Where this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Minh-Tri Nguyen, MD PhD — Loma Linda University
- Study coordinator: Ryan Evans, CCRP
- Email: rlevans@llu.edu
- Phone: 9095583870
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.