Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001087-28
    Sponsor's Protocol Code Number:RC31/19/0511
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-001087-28
    A.3Full title of the trial
    Anti-IL6 receptor antibodies to reduce allo-sensitization post allograft nephrectomy ; a pilot phase II study
    Réduire le risque d'allo-immunisation post ablation du greffon rénal par utilisation d'un anticorps anti-IL6 récepteur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti-IL6 receptor antibodies to reduce allo-sensitization post allograft nephrectomy
    Réduire le risque d'allo-immunisation après l'ablation du greffon rénal par utilisation d'un anticorps anti-IL6 récepteur
    A.3.2Name or abbreviated title of the trial where available
    RAIPONS
    RAIPONS
    A.4.1Sponsor's protocol code numberRC31/19/0511
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Toulouse
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU Toulouse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Toulouse
    B.5.2Functional name of contact pointCLINICAL RESEARCH ASSISTANT
    B.5.3 Address:
    B.5.3.1Street AddressHôtel-Dieu 2 rue Viguerie TSA 80035
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number561778490+33
    B.5.5Fax number561778411+33
    B.5.6E-maildaguzan.c@chu-toulouse.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name RoActemra
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRoActemra
    D.3.4Pharmaceutical form Solution for injection in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    Intravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    kidney transplantation
    Patient nécessitant une ablation du greffon après greffe rénale
    E.1.1.1Medical condition in easily understood language
    greffe rénale
    graft nephrectomy
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029116
    E.1.2Term Nephrectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the rate of serious infectious complication rate at 1 year post graft nephrectomy
    d’évaluer le taux de complications infectieuses graves suite à la néphrectomie dans la première année post geste dans une cohorte prospective de patients traités par Tocilizumab
    E.2.2Secondary objectives of the trial
    Complications other than infectious complications, Occurrence of allo-sensitization at one year post graft nephrectomy
    Les objectifs secondaires sont d'évaluer d'une part l'ensemble des complications post ablation du greffon, ainsi qu'une évaluation de l'efficacité du traitement pour réduire l'allo-immunisation à 1 an de la néphrectomie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult recipients, affiliated to the social security, requiring a graft nephrectomy, with a project to retransplantation
    - Patients ≥18 ans,
    - affilié à un régime de sécurité sociale
    - nécessitant une ablation du greffon après greffe rénale
    - redevable d’une réinscription sur liste de greffe rénale
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur.
    E.4Principal exclusion criteria
    combined transplantations, PRA >20%. Patient under protective measures, Rituximab used for immunosuppression induction Previous transplants not removed, Active infectious complications at graft nephrectomy, need for immunosuppressive treatments after graft nephrectomy, Participation to another interventional studies using Rituximab, polyclonal antibodies, Eucizumab, or Tocilizumab. adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision, pregnancy or breastfeeding.
    - Greffes multiples (combinées ou séquentielles)
    - greffon rénal antérieur toujours en place
    - nécessité de maintien d’un traitement immunosuppresseur post ablation du greffon
    - allergie ou hypersensibilité au Tocilizumab
    - Infection active au moment de la néphrectomie
    - utilisation de rituximab, ou de Tocilizumab dans l’année précédant la transplantectomie
    - Participation à un protocole de recherche clinique utilisant un traitement par Rituximab, Eculizumab, ou un Inhibiteur de la C1 estérase
    - sous mesures de protection juridique (tutelle, curatelle ou sous sauvegarde de justice)
    - PRA supérieur à 20%
    - Patiente enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    We hypothetize that Tocilizumab is usefull to prevent allo-sensitization post graft nephrectomy. We propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of infectious complications following early and late graft nephrectomy, with a treatment by Tocilizumab.
    l'objectif principal est d’évaluer le taux de complications infectieuses graves suite à la néphrectomie dans la première année post geste dans une cohorte prospective de patients traités par Tocilizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year post graft nephrectomy
    1 an post néphrectomie
    E.5.2Secondary end point(s)
    Complications other than infectious complications, Occurrence of allo-sensitization at one year post graft nephrectomy
    - La sécurité hors complications infectieuses graves à un an de la néphrectomie, mesurée par :
    • La survenue de complications post néphrectomie
    • La survenue de décès
    • La survenue d’hospitalisations
    • La survenue de complications chirurgicales
    • La survenue de complications infectieuses (légères et modérées)
    -L’efficacité du traitement, mesurée par le taux d'immunisation à un an post néphrectomie
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year post graft nephrectomy
    1 an post néphrectomie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 23:04:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA