Donor-derived cell-free DNA–guided follow-up after kidney transplant
Randomized Controlled Multicenter Trial to Evaluate the Efficacy and Safety of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients
This trial will test whether using a blood test that measures donor-derived cell-free DNA together with clinical data can safely reduce the number of biopsies for adults who received a kidney transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 6 sites (Paris and 5 other locations) |
| Trial ID | NCT06406179 on ClinicalTrials.gov |
What this trial studies
This is a French multicenter randomized trial enrolling 500 adult kidney transplant recipients and comparing dd-cfDNA-guided follow-up to routine biopsy-centered follow-up over the first 18 months after transplant. Patients are randomized at transplantation and have blood collected for dd-cfDNA at scheduled visits (around 3 and 12 months) and as clinically indicated, with one additional research blood sample beyond standard care. Decision support combining dd-cfDNA results and bedside analytics will guide whether to perform invasive biopsies, while paraffin‑embedded biopsy cores and digital slide images will be used for intragraft gene expression profiling in selected cases. The primary aim is to reduce the number of protocol and indication biopsies without increasing missed rejection or graft harm.
Who should consider this trial
Good fit: Adults aged 18 or older receiving a single-organ kidney transplant (living or deceased donor), willing to provide informed consent and attend follow-up at a participating French center are ideal candidates.
Not a fit: Patients with prior multi-organ transplants, those unable to comply with follow-up, or those with medical conditions that in the investigator's view would confound results or increase risk are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could spare many patients from invasive kidney biopsies, lowering complication risk and healthcare costs while enabling more targeted treatment when rejection is detected.
How similar studies have performed: Prior observational and some multicenter studies show dd-cfDNA reliably rises with rejection and can reduce unnecessary biopsies, but randomized multicenter evidence comparing dd-cfDNA-guided care to standard biopsy schedules remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All men and women, age ≥18 years old. * Subject must be a recipient of a non-combined renal transplant from a deceased or living donor. It can be a re transplantation after a graft loss of function or graft rejection * Subject is willing and able to provide signed written informed consent and willing to comply with study procedures * Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: * Subjects who are legally detained in an official institution or under legal protection * Any condition that, in the opinion of the investigator, might interfere with the patient 's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient * History of multi-organ transplant (interference with rejection natural history).
Where this trial is running
Paris and 5 other locations
- Georges Pompidou European Hospital — Paris, France (Active_not_recruiting)
- Hôpital Necker-Enfants Malades — Paris, France (Active_not_recruiting)
- AP-HP - Hôpital Tenon — Paris, France (Active_not_recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- Hopital Saint Louis — Paris, Île-de-France Region, France (Recruiting)
- Hôpital de la Salpêtrière hôpital à Paris — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Lefaucheur, Carmen, PR
- Email: carmenlefaucheur4@gmail.com
- Phone: +33676604946
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.