NCT06761482 Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization
| NCT ID | NCT06761482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Pediatric Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2028-01-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2026-01-22 with a primary completion date of 2028-01-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus). The hypothesis of the study is that the combination of non-invasive biomarkers (Donor-derived cell-free DNA and Virus-specific T cells) will allow both the safe discontinuation of surveillance biopsies and the personalization of the exposure to calcineurin inhibitors among pediatric kidney transplant recipients.
Eligibility Criteria
Inclusion Criteria: * Age less than 21 years old at transplantation * Single renal transplant from a deceased or a living donor. * Absence of pregnancy confirmed by a negative pregnancy test in women in child-bearing period. * Subject and legal guardians are willing and able to provide signed written informed consent and to comply with the study procedures * Patients affiliated to health insurance system including Aide Médicale de l'Etat (AME) Exclusion Criteria: * History of multi-organ transplant (interference with rejection natural history) * No surveillance biopsy planned * Adult patient (or legal guardians) with limited understanding of the French language preventing him from receiving informed information on the protocol
Contact & Investigator
Julien HOGAN, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06761482 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Pediatric Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06761482 currently recruiting?
Yes, NCT06761482 is actively recruiting participants. Contact the research team at julien.hogan@aphp.fr for enrollment information.
Where is the NCT06761482 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06761482 clinical trial?
NCT06761482 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Julien HOGAN, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 170 participants.
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