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    Summary
    EudraCT Number:2011-003184-29
    Sponsor's Protocol Code Number:PHAO2011-YL/ADEQUATE
    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:2011-09-19
    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 number2011-003184-29
    A.3Full title of the trial
    Impact sur l’efficacité et la tolérance entre 4 mois et 12 mois post-transplantation de 2 valeurs de concentrations résiduelles cibles d’Advagraf® chez des patients transplantés rénaux de novo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact sur l'efficacité et la tolérance entre 4 mois et 12 mois d'une réduction de moitié de la dose quotidienne d'Advagraf® chez des patients transplantés rénaux
    A.3.2Name or abbreviated title of the trial where available
    ADEQUATE
    A.4.1Sponsor's protocol code numberPHAO2011-YL/ADEQUATE
    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 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 supportMonetary support by Astellas
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Tours
    B.5.2Functional name of contact pointDirection de la Recherche
    B.5.3 Address:
    B.5.3.1Street Address2 boulevard Tonellé
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37044 CEDEX 9
    B.5.3.4CountryFrance
    B.5.4Telephone number330247474747
    B.5.5Fax number330247478204
    B.5.6E-mailrecherche.clinique@chu-tours.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 ADVAGRAF
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS
    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 nameADVAGRAF
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) No
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ADVAGRAF
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS
    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 nameADVAGRAF
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) No
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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
    TRANSPLANTATION RENALE DE NOVO
    E.1.1.1Medical condition in easily understood language
    TRANSPLANTATION RENALE
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    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
    Evaluer la fonction rénale à 1 an post-transplantation rénale, et son évolution, chez des patients ayant eu une réduction de moitié de leur dose quotidienne d’Advagraf® à 4 mois post-transplantation en comparaison avec les patients dont la dose n’a pas été divisée.
    E.2.2Secondary objectives of the trial
    Evaluer et comparer les 2 groupes de traitement:
    - histologie de la biopsie de routine à un an post-transplantation (M12) (Banff 2009),
    - fibrose estimée par lecture numérique à 1 an post-transplantation,
    - métabolisme du glucose à M12 et son évolution par rapport à celle de M4,
    - complications à BKV et CMV à 1 an post-transplantation et évolution depuis M4,
    - alloimmunisation anti-HLA par la méthode Luminex® à M3 et M12,
    - fréquence globale des épisodes de rejet aigu au cours des 12 mois post-transplantation,
    - rejets aigus prouvés par biopsie (Banff 2009) : fréquence globale de rejet aigu, incidence et délai d’apparition du premier rejet aigu et du premier rejet aigu résistant aux corticostéroïdes, et sévérité des rejets aigus,
    - évolution des différents paramètres de la fonction rénale
    - survie du greffon et du patient à un an, tolérance (clinique et biologique) et incidence des effets indésirables d’intérêt particulier [dyslipidémie, hypertension artérielle].
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adulte âgé de 18 à 70 ans
    - Acceptant de donner, après information, leur consentement éclairé par écrit
    - Nécessitant une première transplantation rénale
    - Transplantation d’un rein d’un donneur décédé ou vivant (non HLA-identique) avec compatibilité ABO
    - Absence de DSA positif en Luminex® indépendamment de la MFI
    - Cross match T négatif en cytotoxicité
    E.4Principal exclusion criteria
    Transplantation combinée
    Bi-greffe rénale
    Allogreffe rénale antérieure
    - Antécédents de greffe autre que rénale
    - Donneur à coeur non-battant
    - Patient avec un IMC supérieur à 30
    - Pathologie hépatique sévère définit par un profil hépatique anormal (ASAT, ALAT ou bilirubine totale > 3 x LSN) au bilan de sélection
    - Infection sévère en cours lors de la sélection,
    E.5 End points
    E.5.1Primary end point(s)
    La fonction rénale estimée par le débit de filtration glomérulaire (DFG) estimé par la formule MDRD 4 (Modification Diet in Renal Disease)
    E.5.1.1Timepoint(s) of evaluation of this end point
    M4, M6 et M12 post-transplantation
    E.5.2Secondary end point(s)
    a) pourcentage de fibrose du greffon, par mesure numérique de la fibrose par analyse des images,
    b) métabolisme du glucose,
    c) complications à BKV et à CMV (recherche par PCR)
    d) présence de DSA et si positif identification des Ac-anti-HLA
    e) rejet aigu,
    f) rejet aigu prouvé par biopsie
    g) survie du greffon
    h) survie du patient
    i) Protéinurie sur 24h
    j) rapport protéinurie/créatininurie
    k) recours à la dialyse
    l) évaluation de la tolérance
    m) recherche des EI d’intérêt particulier
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) M12
    b) M4, M6 et M12
    c) M3, M4 et M12
    d) M3 et M12
    e) à chaque visite et en fin d'essai (M12)
    f) à chaque visite et en fin d'essai (M12)
    g) à chaque visite et en fin d'essai (M12)
    h) à chaque visite et en fin d'essai (M12)
    i) M4 et M12
    j) à chaque visite et en fin d'essai (M12)
    k) à chaque visite et en fin d'essai (M12)
    l) à chaque visite et en fin d'essai (M12)
    m) à chaque visite et en fin d'essai (M12)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    maintien du patient à la dose au moment de la randomisation (4ème mois post-transplantation)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    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 state246
    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 Decision2011-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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