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    Summary
    EudraCT Number:2019-001510-42
    Sponsor's Protocol Code Number:RC19_0133
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-07-30
    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 number2019-001510-42
    A.3Full title of the trial
    Interest of belatacept as a non-nephrotoxic immunosuppressive treatment in cardiac transplant patients at risk of chronic renal failure.
    Intérêt du belatacept comme traitement immunosuppresseur non néphrotoxique, chez des transplantés cardiaques à risque d’insuffisance rénale chronique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interest of belatacept as a non-nephrotoxic immunosuppressive treatment in cardiac transplant patients at risk of chronic renal failure.
    Intérêt du belatacept comme traitement immunosuppresseur non néphrotoxique, chez des transplantés cardiaques à risque d’insuffisance rénale chronique.
    A.3.2Name or abbreviated title of the trial where available
    BELACOEUR
    A.4.1Sponsor's protocol code numberRC19_0133
    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 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 supportCHU de Nantes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection Recherche, CHU de Nantes
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'ile gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)253482853
    B.5.5Fax number+33(0)253482836
    B.5.6E-mailbp-prom-regl@chu-nantes.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 Nulojix 250mg, poudre pour solution à diluer pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    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 nameBELATACEPT
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    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) 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 No
    D.3.11.9Recombinant medicinal product Yes
    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
    Early graft dysfunction after heart transplant
    Dysfonction précoce du greffon après greffe cardiaque
    E.1.1.1Medical condition in easily understood language
    Early graft dysfunction after heart transplant
    Dysfonction précoce du greffon après greffe cardiaque
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064694
    E.1.2Term Heart graft dysfunction
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to observe a significant improvement in DFG (clearance calculated according to the CKD EPI formula) of 20 ml/min between M3 and M12 post TC, in cardiac transplant patients at risk of CKD, treated with 9 monthly infusions of belatacept associated with a progressive decrease in calcineurin inhibitors.
    L'objectif principal est d'observer une amélioration significative du DFG (clairance calculée selon la formule CKD EPI) de 20 ml/min entre M3 et M12 post TC, chez des transplantés cardiaques à risque d'IRC, traités par 9 perfusions mensuelles de belatacept associé à une diminution progressive des inhibiteurs de calcineurine.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    Demonstrate that if there is a risk of rejection (> grade 2) it is less than 30% during the first year of the heart transplant as found in the literature (non-inferiority criterion)
    Quantify the percentage of patients developing NODAT (New Onset Diabetes After Transplantation) at M3 and M12 post-TC (Estimate).
    Evaluate the mortality specific to M12 post TC (Estimate).
    Evaluate the use of renal replacement therapy between M3 and M12 post-TC.
    Les objectifs secondaires sont :
    Démontrer que s’il existe un risque de rejet (> grade 2) celui-ci est inférieur à 30% au cours de la première année de la transplantation cardiaque comme retrouvé dans la littérature (critère de non-infériorité)
    Quantifier le pourcentage de patients développant un NODAT (New Onset Diabetes After Transplantation) à M3 et M12 post TC (Estimation).
    Evaluer la mortalité spécifique à M12 post TC (Estimation).
    Evaluer le recours à un traitement de suppléance rénale entre M3 et M12 post TC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The inclusion criteria are:
    Cardiac transplant patients for 3 months
    Over 18 years of age
    No DSA at D0 (positive threshold MFI> 2000)
    Having a DFG < 30ml/min calculated according to the formula CKD EPI or a decrease in DFG of more than 50% between the day of the heart transplant and M3, stable for 15 days.
    EBV positive serology
    Having signed the consent after receiving informed information
    Negative pregnancy test for patients of childbearing age, and agreement to use effective contraception throughout the study and 6 weeks after the end of the study
    Having no difficulty in understanding and communicating with the investigator and his representatives
    Beneficiaries of a Social Security scheme
    Les critères d’inclusion sont :
    Patients transplantés cardiaques depuis 3 mois
    Ayant plus de 18 ans
    Ne présentant pas de DSA à J0 (seuil de positivité MFI> 2000)
    Ayant un DFG < 30ml/min calculée selon la formule CKD EPI ou une diminution du DFG de plus de 50% entre le jour de la transplantation cardiaque et M3, stable depuis 15 jours.
    Sérologie EBV positive
    Ayant signé le consentement après avoir reçu une information éclairée
    Test de grossesse négatif pour les patientes en âge de procréer, et accord concernant l’utilisation d’un moyen de contraception efficace tout au long de l’étude et 6 semaines après la fin de l’étude
    N'ayant pas de difficultés pour comprendre et communiquer avec l'investigateur et ses représentants
    Bénéficiant d’un régime de Sécurité Sociale
    E.4Principal exclusion criteria
    The criteria for non-inclusion are:
    2nd heart transplant or other solid organ transplant
    History of rejections
    Cellular or humoral rejection at myocardial biopsy of M3 post TC
    Current viral infection of type CMV, EBV, HCV, HBV.....
    HIV positive serology
    Ongoing participation in another clinical study
    Any clinical condition that the investigator considers incompatible with the conduct of the study under acceptable safety conditions
    Inability of the patient to comply with study procedures
    Pregnant or breastfeeding women
    Person under guardianship, curatorship or safeguard of justice

    Translated with www.DeepL.com/Translator
    Les critères de non-inclusion sont :
    2ème transplantation cardiaque ou autre transplantation d’organe solide
    Antécédents de rejets
    Rejet cellulaire ou humoral à la biopsie myocardique de M3 post TC
    Infection virale actuelle de type CMV, EBV, VHC, VHB….
    Sérologie VIH positive
    Participation en cours à une autre étude clinique
    Tout état clinique que l’investigateur juge incompatible avec le déroulement de l’étude dans des conditions de sécurité acceptable
    Incapacité du patient à respecter les procédures de l’étude
    Femmes enceintes ou allaitantes
    Personne placée sous tutelle, curatelle ou sous sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI at M3 and M12 post HT.
    Dosage de la créatinine plasmatique et calcul de la clairance selon la formule CKD EPI à M3 et M12 post TC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    9 mois
    E.5.2Secondary end point(s)
    - Myocardial biopsies between M3 and M12 post HT
    - Anti-HLA antibody testing according to the habits of heart transplant centres
    - Fasting blood glucose and HBA1C at M3 and M12 post HT
    - Death
    - Number of dialysis sessions between M3 and M12 post HT
    - Biopsies myocardiques entre M3 et M12 post TC
    - Dosage d'anticorps anti-HLA selon les habitudes des centres de transplantation cardiaque
    - Glycémie à jeûn et HBA1C à M3 et M12 post TC
    - Décès
    - Nombre de séances de dialyse entre M3 et M12 post TC
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months
    9 mois
    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 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) 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.8.3 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 concerned4
    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
    LVLS
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state25
    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)
    normal treatment of that condition medical
    Traitement habituel à la condition médicale étudiée
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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