Monitoring kidney transplant rejection using blood DNA analysis
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
This study is testing whether a new blood test that looks at DNA from the donor can help kidney transplant patients and their doctors better understand if the transplant is being rejected without needing painful biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06026592 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of donor-derived cell-free DNA (dd-cfDNA) as a non-invasive diagnostic tool to monitor kidney transplant rejection. Researchers aim to quantify epigenetic signatures in the blood of kidney transplant patients to predict and characterize graft dysfunction. By analyzing the evolution of renal-specific cell-free DNA before and after transplantation, the study seeks to improve upon traditional methods that rely on invasive biopsies and non-specific markers. The goal is to enhance the accuracy of graft monitoring and reduce the need for invasive procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for a kidney transplant due to end-stage renal failure.
Not a fit: Patients who are under legal protective measures or those not eligible for kidney transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more accurate method for monitoring kidney transplant rejection, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using cell-free DNA as a biomarker for transplant rejection, suggesting that this approach may be a meaningful advancement in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * With end-stage renal failure * Summoned for a kidney transplant at Pitié Salpêtrière Hospital * Having been informed of the study and not objecting to the study having given free and informed written consent for the genetic analysis * Benefiting from a social security scheme (excluding AME) Exclusion Criteria: Under legal protective measures (curatorship or guardianship, under judicial safeguard).
Where this trial is running
Paris, Île-de-France Region
- Pitié-Salpétriêre Hospital — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Sarah Dr DROUIN, MD-PhD
- Email: sarah.drouin@aphp.fr
- Phone: +33 1 42 17 71 73
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.