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    Summary
    EudraCT Number:2009-012673-35
    Sponsor's Protocol Code Number:PHAO08-YL/THYMO
    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:2009-05-28
    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 number2009-012673-35
    A.3Full title of the trial
    Etude pharmacocinétique et pharmacodynamique comparant deux posologies différentes de la Thymoglobuline® en transplantation rénale.
    A.3.2Name or abbreviated title of the trial where available
    THYMO
    A.4.1Sponsor's protocol code numberPHAO08-YL/THYMO
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHRU de TOURS
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 THYMOGLOBULINE® 5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME EUROPE BV
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Renal transplantation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038533
    E.1.2Term Renal transplant
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer les paramètres pharmacocinétiques et pharmacodynamiques de 2 posologies d’immunoglobulines anti-thymocytes de lapin (rATG Thymoglobuline®) à la dose standard sur 4 jours ou à dose élevée sur 2 jours, en association avec le MMF, un retrait précoce des corticoïdes et l’introduction retardée du tacrolimus, chez 2 groupes de patients transplantés rénaux.
    E.2.2Secondary objectives of the trial
    * Évaluer l’influence du polymorphisme génétique du récepteur FcγRIIIa sur les paramètres pharmacocinétiques et pharmacodynamiques.
    * Évaluer la tolérance de l’induction par 2 posologies de Thymoglobuline® par :
    • le recours à la dialyse durant la première semaine définissant la reprise retardée de fonction du greffon
    • la créatininémie à J5, une créatininémie supérieure à 250 µmol/L en l’absence de dialyse définissant une reprise lente de fonction rénale
    • l’évolution de la fonction rénale selon Cockroft à 3 mois et à 1 an
    • le taux de rejet aigu sur les 3 premiers mois et à 1 an
    • la survie des patients et des greffons à 1 an
    • l’incidence des infections en particulier à CMV, de la maladie sérique et des syndromes lymphoprolifératifs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient âgé(e) de plus de 18 ans,
    - Première ou seconde transplantation rénale,
    - Patient avec PRA (Panel Reactive Antibody) < 20% et un cross-match négatif
    - Patient pour lequel un suivi d’au moins un an est prévu
    - Patient ayant donné son consentement éclairé et écrit pour participer à l’essai clinique.
    - Patient affilié à la sécurité sociale
    E.4Principal exclusion criteria
    - Patient ayant reçu une induction par Thymoglobuline® ou par un autre ATG lors d’une transplantation antérieure,
    - Patient ayant un poids ≤ 50 kg ou ≥ 85 kg
    - Temps d’ischémie froide avec un risque de reprise retardée de la fonction du greffon (DGF) (c'est-à-dire avec une IF> 24 h)
    - Femme en période d’activité génitale sans contraception efficace,
    - Patient avec greffes d’organes multiples
    - Patient avec une infection active, ou avec une suspicion d’infection par VIH, VHB ou VHC, ou de tuberculose
    - Patient pour lequel est prévue une vaccination dans l'année
    - Patient atteint d’une déficience ne lui permettant pas une bonne compréhension des impératifs de l’essai,
    - Patient sous sauvegarde de justice, sous tutelle ou curatelle,
    - Patient présentant une contre-indication à la Thymoglobuline® (hypersensibilité connue aux protéines de lapin ou à l'un des composants de la préparation)
    E.5 End points
    E.5.1Primary end point(s)
    - Paramètres pharmacocinétiques de la Thymoglobuline® et de la Thymoglobuline® active :
    o concentration totale et active
    o demi-vie d’élimination
    o aire sous la courbe des concentrations en fonction du temps (AUC)
    o Paramètres pharmacocinétiques correspondant à un modèle à 2 compartiments (CLc, CLp, Vc, Vp)

    - Paramètres pharmacodynamiques :
    o Évolution des numérations lymphocytaires : lymphocytes totaux CD4, CD8, CD56, CD19
    o Évolution de l’expression des marqueurs des populations de cellules T régulatrices (Treg): CD4+ CD25+ CD127- FoxP3+
    o Évolution de l’expression des marqueurs des cellules T naïves et mémoires : CD4 CD45 RA, CD4 CD45 RO, CD27, CD62L

    - Polymorphisme génétique :
    o Polymorphisme génétique du récepteur FcγRIIIa
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    2 different doses
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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.1.3Elderly (>=65 years) Yes
    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 state20
    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 Decision2009-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-03
    P. End of Trial
    P.End of Trial StatusOngoing
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