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    Summary
    EudraCT Number:2010-019574-33
    Sponsor's Protocol Code Number:BRD 09/7-D
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-09
    Trial results View 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 number2010-019574-33
    A.3Full title of the trial
    Etude prospective, multicentrique, randomisée, en double-aveugle, contrôlée à groupes parallèles, visant à évaluer la balance bénéfice-risque du sevrage progressif d'un inhibiteur de la calcineurine (Tacrolimus) chez des patients transplantés depuis plus de 4 ans et cliniquement sélectionnés
    A.3.2Name or abbreviated title of the trial where available
    Arrêt du Tacrolimus en transplantation rénale
    A.4.1Sponsor's protocol code numberBRD 09/7-D
    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 SponsorCHU de Nantes
    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 Prograf 0,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma
    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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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.IMP: 2
    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 Prograf 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma
    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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transplantation rénale
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer le bénéfice du sevrage du Tacrolimus (Prograf) sur la fonction rénale des patients un an après la fin de la période de sevrage
    E.2.2Secondary objectives of the trial
    - Déterminer les taux de rejet chronique et de rejet aigu prouvés par biopsie ainsi que les taux de rejet cortico-résistant ;
    - Evaluer les taux de survie des patients et des greffons ;
    - Déterminer l’apparition d’anticorps anti-HLA donneur spécifiques et non donneur spécifiques ;
    - Déterminer l'apparition de lésions histologiques de rejet aigu ou chronique humoral ou cellulaire infraclinique ;
    - Déterminer l'apparition ou l'aggravation de lésions histologiques de fibrose interstitielle et atrophie tubulaire inflammatoire ;
    - Evaluer les conséquences du sevrage du Tacrolimus (Prograf) sur les effets indésirables liés à l’effet immunosuppresseur (occurrence de cancers et d’infections) et ceux liés directement à la molécule elle-même (hypertension, hyperlipidémie, hyperglycémie) ;
    - Déterminer les bénéfices de la procédure de sevrage du Tacrolimus (Prograf) sur la qualité de vie des patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Etude des biomarqueurs sanguins phénotypiques et transcriptionnels (version n°2 du 26/07/2010) dont l'objectif est d'explorer uné série de biomarqueurs sanguins phénotypiques et transcriptionnels associés au risque immunologique.

    - Etude du score composite (version n°2 du 26/07/2010) dont le but est de construire un score composite biologique et clinique comme outil pronostic du risque de rejet post-greffe et de sélection des patients éligibles à une procédure de sevrage du Tacrolimus.
    E.3Principal inclusion criteria
    - Homme ou femme d’âge compris entre 18 et 70 ans (inclus)
    - Ayant reçu une greffe de donneur décédé
    - Première allogreffe rénale depuis au moins 4 ans et moins de 10 ans
    - Présentant une fonction rénale stable, c’est-à-dire présentant une créatininémie avec une variation de ± 25 % de la valeur moyenne de l’année avant inclusion
    - Traité avec du Tacrolimus (Prograf) en association avec du MPA (Cellcept ou Myfortic) +/- stéroïdes (entre 5 et 10 mg par jour)
    - Patient ayant donné son consentement éclairé
    - Patient assuré social
    - Patiente (en âge de procréer) ayant une contraception efficace
    - Débit de filtration glomérulaire (DFG) défini par le dosage de la cystatine C >= 40 ml/min/1,73m2
    - Protéinurie ≤ 0,5 g/jour
    - Patient présentant des taux sériques de Tacrolimus compris entre 5 -10 ng/ml à chacun des dosages réalisés au cours des 6 derniers mois (bornes incluses)
    - Patient présentant des taux sériques de MPA (Cellcept ou Myfortic) supérieurs >= 30 ng/ml
    - Sans anticorps anti-HLA au moment de l’inclusion, vérifié au moyen de techniques très sensibles (Luminex HD)
    - Absence de signe histologique de rejet aigu ou chronique humoral ou cellulaire infraclinique sur la biopsie du greffon rénal selon la dernière classification de Banff 2009
    E.4Principal exclusion criteria
    - Patient âgé de moins de 18 ans ou de plus de 70 ans
    - Transplantation d’un rein de donneur vivant
    - Transplanté depuis moins de 4 ans et plus de 10 ans
    - Patient re-transplanté
    - Transplantation de plusieurs organes
    - Patient non traité par du Tacrolimus en traitement d’entretien
    - Taux sériques de Tacrolimus du patient < 5 ou > 10 ng/ml
    - Taux sériques du MPA du patient < 30 ng/ml
    - Patient traité avec d’autres médicaments immunosuppresseurs que Tacrolimus (Prograf), MPA (Cellcept ou Myfortic) et stéroïdes
    - Patient ne présentant pas une fonction stable du greffon à l’inclusion (c’est-à-dire : variation de la créatininémie > 25 % de la valeur moyenne de l’année avant l’inclusion dans l’étude), avec un DFG défini par le dosage de la cystatine C < 40 ml/min/1,73m2 au moment de l’inclusion
    - Patient présentant une protéinurie > 0,5 g à l’entrée dans l’étude
    - Patient présentant des anticorps anti-HLA à l’entrée dans l'étude
    - Patient non-observant
    - Présence de signe histologique de rejet aigu ou chronique humoral ou cellulaire infraclinique sur la biopsie du greffon rénal selon la dernière classification de Banff 2009
    - Antécédents de troubles lymphoprolifératifs
    - Diagnostic d'une pathologie maligne dans les 5 ans précédant l'inclusion
    - Données hématologiques significativement anormales d’un point de vue clinique, telles que déterminées par l'investigateur, pour l'hématocrite, l'hémoglobine, la numération des leucocytes ou des plaquettes
    - Données de biochimie sanguine significativement anormales d’un point de vue clinique, telles que déterminées par l'investigateur
    - Abus significatif de drogue ou d’alcool au moment de l’inclusion, déterminé par l’investigateur
    - Patient séropositif aux anticorps de l’hépatite C ou à l’antigène de surface de l’hépatite B (HbsAg), ou infection VIH
    - Participation à une étude clinique dans les 3 mois précédents
    - Grossesse, allaitement
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de jugement sera l’amélioration de la fonction rénale à un an après arrêt/sevrage complet du Tacrolimus (Prograf) évaluée par la mesure du débit de filtration glomérulaire (DFG) calculé par le dosage de la cystatine C selon l’équation de Le Bricon. Le DFG sera comparé entre les dates J-30 et J480 (1 an après la fin du sevrage).
    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 Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months35
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state106
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Information précisée dans le protocole
    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 Decision2010-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-20
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