Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study

NCT06761482 | Not Yet Recruiting

• 2 other identifiers: APHP230817IDRCB 2024-A01418-39
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Kidney Disease; Transplant;Failure,Kidney

Keywords

kidney; transplant; pediatric; rejection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Secondary Outcomes (5)

• Number of participants with adverse events as assessed by CTCAE v4.0 in each group

  24 months

• Cost-utility

  24 months

• Allograft fibrosis on the surveillance biopsy at 24 months

  24 months

• Allograft function (estimated Glomerular Filtration Rate) at 24 months

  24 months

• Predicted allograft survival until 10 years after evaluation

  10 years

Study Arms (4)

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

Interventions

monitoring by dd-cfDNA PROCEDURE

monitoring by dd-cfDNA

monitoring by dd-cfDNA

monitoring by T-Vis PROCEDURE

monitoring by T-Vis

monitoring by T-Vis

monitoring by dd-cfDNA+ T-Vis PROCEDURE

monitoring by dd-cfDNA+ T-Vis

monitoring by dd-cfDNA and T-Vis

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Julien HOGAN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien HOGAN, MD, PhD

CONTACT

+331 40 03 21 42; julien.hogan@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

FR (1)