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    Summary
    EudraCT Number:2016-000431-40
    Sponsor's Protocol Code Number:UF9672
    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:2016-06-17
    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 number2016-000431-40
    A.3Full title of the trial
    Randomized controlled study evaluating the effect of a biotherapy treatment (anti-RANKL ligand antibody: Denosumab) on bone and vascular metabolism in osteoporotic chronic kidney disease
    Etude contrôlée randomisée, évaluant l'effet d'un traitement par biothérapie (anticorps anti-RANK ligand: Denosumab) sur le métabolisme osseux et vasculaire chez des patientes insuffisantes rénales chroniques (stade5D) ostéoporotiques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled study evaluating the effect of a biotherapy treatment (anti-RANKL ligand antibody: Denosumab) on bone and vascular metabolism in osteoporotic chronic kidney disease
    Etude contrôlée randomisée, évaluant l'effet d'un traitement par biothérapie (anticorps anti-RANK ligand: Denosumab) sur le métabolisme osseux et vasculaire chez des patientes insuffisantes rénales chroniques (stade5D) ostéoporotiques
    A.3.2Name or abbreviated title of the trial where available
    HDENO
    A.4.1Sponsor's protocol code numberUF9672
    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 SponsorHealth Ministry
    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 supportHealth Ministry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Montpellier
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street Address39, avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.6E-maila-fraysse@chu-montpellier.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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 namedenosumab
    D.3.2Product code 55513-710
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient de sexe feminin âgé d'au moins 65 ans
    Patient Insuffisant rénal dialysé à un stade 5 de la maladie rénale et sous traitement de suppléance extra rénale (3 séances par semaine ) depuis au moins 3 mois
    Existence d antecedents de fractures vertebrales
    Patient dont le taux sérique de PTH est compatible avec les recommandations en l'absence de traitement par Cinacalcet
    E.1.1.1Medical condition in easily understood language
    Patient female sex, 65 years or older, chronic kidney disease stage 5, hemodialyzed with extracorporeal treatment for at least 3 months
    History of vertebral fracture
    Patient sexe féminin, 65 ans et plus, insuffisant rénal dialysé, avec traitement de suppléance extra rénale depuis au moins 3 mois
    Existence d’antécédents de fractures vertébrales
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10009119
    E.1.2Term Chronic renal failure
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of denosumab on bone mineral density (femoral T-score) at 24 months in a population of old osteoporotic chronic kidney disease females
    Evaluer l’effet du denosumab sur la densité minérale osseuse (T-score fémoral) à 24 mois dans une population de patientes âgées ostéoporotiques et atteintes d’une maladie rénale chronique stade 5D
    E.2.2Secondary objectives of the trial
    To evaluate the effect of denosumab on bone mineral density evolution (femoral T-score) after 24 months of follow-up
    To evaluate the effect of denosumab on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
    To evaluate the effect of denosumab on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
    To evaluate the effect of denosumab on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
    To evaluate the effect of denosumab on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
    To evaluate the tolerance after 24 months of follow-up
    Evaluer l’effet du denosumab sur l'évolution de la densité minérale osseuse (T-score fémoral) au cours des 24 mois de suivi
    Evaluer l’effet du denosumab sur l'évolution de la densité minérale osseuse (T-score lombaire) au cours des 24 mois de suivi
    Evaluer l’effet du denosumab sur l'évolution des scores de calcifications artérielles coronariennes et de l'aorte abdominale au cours des 24 mois de suivi
    Evaluer l’effet du denosumab sur les paramètres du remodelage osseux (OPG, RANKL, sclérostine, DKK-1), du métabolisme phosphocalcique (FGF23 Ct, Klotho, PTH, 25(OH) vitamine D3, phosphore, calcium, PAL osseuse, ostéocalcine, CTX), de l’inflammation (CRP) au cours des 24 mois de suivi
    Evaluer l’effet du traitement par denosumab sur la morbidité cardiovasculaire (événements cardiovasculaires) et la mortalité au cours des 24 mois de suivi
    Evaluer la tolérance au traitement au cours des 24 mois de suivi
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etude contrôlée randomisée, évaluant l’effet d’un traitement par biothérapie (anticorps anti-RANK ligand: Denosumab) sur le métabolisme osseux et vasculaire chez des patientes insuffisantes rénales chroniques (stade 5D) ostéoporotiques
    E.3Principal inclusion criteria
    Patient female of 65 years or older
    Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
    History of vertebral fracture
    Patient de sexe féminin âgé d'au moins 65 ans
    Patient IRC à un stade 5 de la maladie rénale et sous traitement de suppléance extra-rénale (3 séances par semaine) depuis au moins 3 mois
    Patient présentant une ostéoporose au seuil fracturaire (existence d’un antécédent de fracture vertébrale en se basant sur les critères morphologiques décrits par Lunt et al.)
    Patient dont le taux sérique de PTH est compatible avec les recommandations (2 à 9 fois la normale du laboratoire) en l’absence de traitement par Cinacalcet
    E.4Principal exclusion criteria
    Cinacalcet treatment
    Substitutive hormonal treatment
    Calcium phosphate balance (PTH, 25(OH) vitamin D3, Calcium, phosphate) outside the KDIGO guidelines
    Hypersensibility to active substance or one of excipients of Prolia®
    Traitement par Cinacalcet
    Traitement hormonal substitutif
    Bilan phosphocalcique (PTH, 25(OH) vitamine D3, Calcium, phosphate) en dehors des recommandations KDIGO:
    -PTH entre 2 et 9 fois la limite supérieure du laboratoire. En raison de la non standardisation des méthodes, les valeurs d’exclusion doivent être calculées pour chaque centre.
    - Les valeurs de calcium et phosphate d’exclusion sont:
    Ca <2.15 ou >2.55 mmol/L
    PO4 <0.9 ou >1.4 mmol/L
    Les patientes seront exclues si leur taux de 25(OH) vitamine D3 est < à 30 ng/mL
    Suspicion de bas remodelage osseux (os adynamique) (PTH inférieure à 2 fois la normale du laboratoire et phosphatase alcaline osseuse inférieure à 10 µg/L)
    Hypersensibilité à la substance active ou à l'un des excipients du Prolia®
    E.5 End points
    E.5.1Primary end point(s)
    Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
    Variation relative de la DMO fémorale après 24 mois de suivi (T-score évalué par ostéodensitométrie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 0, month 24
    mois 0, mois 24
    E.5.2Secondary end point(s)
    - Relative variation of femoral bone mineral density after 12 months of follow-up and evolution during the 24 months of follow-up
    - Relative variation of lumbar bone mineral density after 12 and 24 months of follow-up and evolution during the 24 months of follow-up
    - Evolution of coronary calcification scores at 12 and 24 months of follow-up
    - Evolution of abdominal aorta calcification scores at 12 and 24 months of follow-up
    - Variation of parameters of bone remodelling, calcium phosphorus metabolism and inflammation at 6, 12, 18 et 24 months of follow-up
    - Morbi-mortality at 24 months of follow-up
    - Adverse events occuring during the entire study
    - Variation relative de la DMO fémorale à 12 mois de suivi et évolution au cours des 24 mois de suivi.
    - Variation relative de la DMO lombaire à 12 et 24 mois de suivi et évolution au cours des 24 mois de suivi.
    - Evolution des scores de calcifications artérielles coronariennes à 12 et 24 mois de suivi.
    - Evolution des scores de calcifications de l’aorte abdominale à 12 mois et 24 mois de suivi.
    - Variation des paramètres du remodelage osseux, du métabolisme phosphocalcique et de l’inflammation à 6, 12, 18 et 24 mois de suivi.
    - Morbi-mortalité à 24 mois de suivi.
    - Evénements indésirables survenus tout au long de l'étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 0, 6, 12, 18, 24
    mois 0, 6, 12, 18, 24
    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) 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 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.8.2.4Number 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 concerned7
    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
    The end of the study will correspond to the last visit of the last subject undergoing the trial
    La fin de l'étude correspond à la dernière visite du dernier patient inclus dans l'étude
    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 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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    None
    Non
    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 Decision2016-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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