Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Personalization of Immunosuppression
Official title: Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Run by Assistance Publique - Hôpitaux de Paris · NCT06761482 · Data updated 2026-11-12
This study tests whether non-invasive biomarkers can guide care in kids with kidney transplants to reduce biopsies and tailor immunosuppressive drug exposure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 21 Years |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | January 22, 2026 |
| Main results expected | January 22, 2028 |
| Study ends | January 22, 2029 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06761482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric kidney transplant recipients (<21 years) with a single kidney transplant and in whom surveillance biopsies are planned.
✕Probably not a fit
Patients for whom biomarker-guided monitoring is not feasible or who do not have access to required assays may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
MONITOR is an open-label, multicenter, prospective randomized trial comparing four approaches to monitoring pediatric kidney transplant patients. It evaluates whether donor-derived cell-free DNA and virus-specific T cells can safely replace surveillance biopsies and allow personalized tacrolimus exposure. Participants are randomized to dd-cfDNA alone, T-Vis alone, both biomarkers, or current standard biopsy-based monitoring. Primary goals are to reduce biopsy numbers and lower tacrolimus exposure where possible. Eligibility includes children under 21 with a single renal transplant and insured status in France.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive biopsies and minimize exposure to immunosuppressive drugs.
How similar studies have gone: Other studies using non-invasive biomarkers for transplant monitoring have shown promise, but this trial tests a combined, randomized approach in pediatrics.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Robert Debré Hospital
Paris, France Recruiting
Study contacts
- Principal investigator: Julien HOGAN, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Julien HOGAN, MD, PhD
- Email: julien.hogan@aphp.fr
- Phone: +331 40 03 21 42
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.