Pediatric Kidney DiseaseMONITORNCT06761482
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
A study testing monitoring by dd-cfDNA, monitoring by T-Vis and monitoring by dd-cfDNA+ T-Vis in people with Pediatric Kidney Disease and Transplant;Failure,Kidney, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Pediatric Kidney Disease, Transplant;Failure,Kidney
- What is being tested?
- monitoring by dd-cfDNA, monitoring by T-Vis and monitoring by dd-cfDNA+ T-Vis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2026to 22 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Robert Debré Hospital
Paris, 75019
Julien HOGAN, MD, PhD, +331 40 03 21 42, julein.hogan@aphp.fr
About this study
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.
Read the detailed description
MONITOR is an open label multicenter prospective randomized trial of superiority with two active comparators (4 parallel groups 1:1:1:1).
Arm A: monitoring by dd-cfDNA; Arm B: monitoring by T-Vis; Arm C: monitoring by dd-cfDNA+ T-Vis; Comparator arm: Current standard of care based on surveillance biopsies and biological monitoring
Main objectives and primary endpoints :
- To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies. Endpoint: Number of biopsy performed in each arm
- To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
Endpoint: Tacrolimus exposure assessed as the mean of the residual concentration of Tacrolimus between M6 and M24
- Being tested
- monitoring by dd-cfDNA, monitoring by T-Vis, monitoring by dd-cfDNA+ T-Vis
- Keywords
- kidney, transplant, pediatric, rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring by dd-cfDNAProcedure or surgery
monitoring by dd-cfDNA
monitoring by T-VisProcedure or surgery
monitoring by T-Vis
monitoring by dd-cfDNA+ T-VisProcedure or surgery
monitoring by dd-cfDNA+ T-Vis
| Study group | Role | What they receive |
|---|---|---|
| monitoring by dd-cfDNA | Experimental | Not described Receives: Procedure: monitoring by dd-cfDNA |
| monitoring by T-Vis | Experimental | Not described Receives: Procedure: monitoring by T-Vis |
| monitoring by dd-cfDNA and T-Vis | Experimental | Not described Receives: Procedure: monitoring by dd-cfDNA+ T-Vis |
| Current standard of care based on surveillance biopsies and biological monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of kidney allograft during the 2 years post-transplantation
To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies.
Measured: 24 months
Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
Measured: 24 months
Secondary outcomes (5)
Number of participants with adverse events as assessed by CTCAE v4.0 in each group
Adverse events of particular interest will include de novo donor specific antibodies (DSA) formation, clinical rejection, plasma viral replication Cytomegalovirus Virus, Epstein-Barr virus, BK virus.
Measured: 24 months
Cost-utility
Data sources for the latter will include the trial's case report form data for efficacy and resource consumption in terms of ambulatory care, informal care, and productivity losses. It will be complemented by participating hospitals' discharge data to gather information relative to hospital care and its associated costs. The effectiveness criteria will be the number of quality-adjusted life-years (QALYs) gained. QALYs will be derived from patients' responses to the EQ-5D questionnaire
Measured: 24 months
Allograft fibrosis on the surveillance biopsy at 24 months
Measured: 24 months
Allograft function (estimated Glomerular Filtration Rate) at 24 months
Measured: 24 months
Predicted allograft survival until 10 years after evaluation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start22 Jan 2026
- Primary completion22 Jan 2028 (estimated)
- Study completion22 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open label multicenter prospective randomized trial of superiority with two active comparators / 4 groupes : monitoring by dd-cfDNA; monitoring by T-Vis; monitoring by dd-cfDNA+ T-Vis; Current standard of care based on surveillance biopsies and biological monitoring
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien HOGAN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761482
- Sponsor's protocol ID
- APHP230817
- Other IDs
- IDRCB 2024-A01418-39
- Acronym
- MONITOR
- Status last verified
- Nov 2026
- First submitted
- 6 Dec 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06761482
- Acronym / sponsor ID
- MONITOR / APHP230817
- Keywords
- kidney, transplant, pediatric, rejection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 22 Jan 2028 (estimated)
- Study completion
- 22 Jan 2029 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MONITOR is an open label multicenter prospective randomized trial of superiority with two active comparators (4 parallel groups 1:1:1:1).
Arm A: monitoring by dd-cfDNA; Arm B: monitoring by T-Vis; Arm C: monitoring by dd-cfDNA+ T-Vis; Comparator arm: Current standard of care based on surveillance biopsies and biological monitoring
Main objectives and primary endpoints :
- To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies. Endpoint: Number of biopsy performed in each arm
- To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
Endpoint: Tacrolimus exposure assessed as the mean of the residual concentration of Tacrolimus between M6 and M24
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open label multicenter prospective randomized trial of superiority with two active comparators / 4 groupes : monitoring by dd-cfDNA; monitoring by T-Vis; monitoring by dd-cfDNA+ T-Vis; Current standard of care based on surveillance biopsies and biological monitoring
| Arm | Type | Receives |
|---|---|---|
| monitoring by dd-cfDNA | Experimental | Procedure: monitoring by dd-cfDNA |
| monitoring by T-Vis | Experimental | Procedure: monitoring by T-Vis |
| monitoring by dd-cfDNA and T-Vis | Experimental | Procedure: monitoring by dd-cfDNA+ T-Vis |
| Current standard of care based on surveillance biopsies and biological monitoring | No intervention | – |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitoring by dd-cfDNAmonitoring by dd-cfDNA | Procedure or surgery | monitoring by dd-cfDNA |
| monitoring by T-Vismonitoring by T-Vis | Procedure or surgery | monitoring by T-Vis |
| monitoring by dd-cfDNA+ T-Vismonitoring by dd-cfDNA+ T-Vis | Procedure or surgery | monitoring by dd-cfDNA and T-Vis |
Primary outcome
Number of kidney allograft during the 2 years post-transplantation
Time frame: 24 months
To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies.
Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
Time frame: 24 months
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
5 secondary outcomes
Number of participants with adverse events as assessed by CTCAE v4.0 in each group
Time frame: 24 months
Cost-utility
Time frame: 24 months
Allograft fibrosis on the surveillance biopsy at 24 months
Time frame: 24 months
Allograft function (estimated Glomerular Filtration Rate) at 24 months
Time frame: 24 months
Predicted allograft survival until 10 years after evaluation
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien HOGAN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring by dd-cfDNA, monitoring by T-Vis and monitoring by dd-cfDNA+ T-Vis in people with Pediatric Kidney Disease and Transplant;Failure,Kidney, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien HOGAN, MD, PhD (+331 40 03 21 42, julien.hogan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of kidney allograft during the 2 years post-transplantation (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.