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    Summary
    EudraCT Number:2012-002856-18
    Sponsor's Protocol Code Number:RB12.079
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-002856-18
    A.3Full title of the trial
    ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial
    A.3.2Name or abbreviated title of the trial where available
    ALCHEMIST
    A.4.1Sponsor's protocol code numberRB12.079
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01848639
    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 Brest
    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 supportFrench health ministry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointAudrey Le Goff-Coquet
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number+33229020089
    B.5.5Fax number+33298223183
    B.5.6E-mailaudrey.legoff-coquet@chu-brest.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 No
    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 nameSpironolactone
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNSpironolactone + Lactose monohydraté (Pharmaceutical INRESA Pharma) + carmin de cochenille (FAGRON Services)
    D.3.9.3Other descriptive namespironolactone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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 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
    end-stage renal failure (ESRF)
    cardiovascular complication
    Insuffisance rénale chronique terminale
    Complication cardiovasculaire
    E.1.1.1Medical condition in easily understood language
    end-stage renal failure
    cardiovascular complication
    Insuffisance rénale chronique terminale
    Complication cardiovasculaire
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007649
    E.1.2Term Cardiovascular disorder
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10050441
    E.1.2Term Chronic renal insufficiency
    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 etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal myocardial infarction (MI), acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or CV-induced death. The primary endpoint will be the time to onset of the first incident
    Déterminer les effets de la spironolactone par comparaison au placebo sur un critère de jugement combiné associant infarctus du myocarde (IDM) non fatal, syndrome coronarien aigu,hospitalisation pour insuffisance cardiaque, accident vasculaire cérébral constitué (AVC) non fatal, ou décès d’origine CV.
    E.2.2Secondary objectives of the trial
    a) cumulative rates of accidents component primary endpoints b) time to onset of death i) from any cause, ii) from a CV event, iii) from a non-CV event; b) time of survival without a major CV event (nonfatal MI,acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation); c) incidence of procedures related to stenosis or vascular access thrombosis for HD; d) incidence of coronary or peripheral revascularizations (including lower limb amputations); e) blood pressure; f) incidence of hyperkalemia> 6 mmol/l; g) estimation of the effect of treatment on quality of life.
    Two ancillary studies are planned and should be funded outside of the budget of the Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique, PHRC 2011, which granted this protocol) : 1) medico-economic study, 2) establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies.
    effets de la spironolactone par comparaison au placebo sur a) les taux cumulé des accidents composant le critère de jugement principal ; b) le délai de survenue de décès i) de toute cause, ii) de cause CV, iii) de cause non CV ; c) le temps de survie sans évènement CV majeur (IDM non fatal,syndrome coronarien aigu, hospitalisation pour insuffisance cardiaque, AVC non fatal, réanimation d’arrêt cardiaque) ; d) l’incidence des procédures liées à une sténose ou à une thrombose de l’accès vasculaire pour HD ; e) l’incidence de revascularisations coronaires ou périphériques (dont amputations des membres inférieurs) ; f) la pression artérielle et sa variabilité inter-visite ; g) l’apparition d’une arythmie complète par fibrillation auriculaire ; h) l’incidence d’hyperkaliémie > 6 mmol/l ; i) la qualité de vie ; j) Réaliser des études de biomarqueurs par la constitution d’une collection biologique ; k) Analyser les données de morbimortalité en post-étude : 3, 5 et 10 ans après l’étude.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women over the age of at least 45 days for IRCT, regardless of the etiology including diabetes, having at least 3 HD sessions per week AND having at least one of the comorbidities, cardiovascular anomalies or risk factor CV following:
    Left ventricular hypertrophy defined by left ventricular mass> 130 g / m2 in men and 100 g / m2 in women, (echocardiography) OR Cornell index (RaVL + SV3)> 28 mm in humans,> 20 mm in women (electrocardiogram), or left ventricular ejection fraction <40%, (echocardiography); QRS wide> 0.14 sec OR Left branch block (electrocardiogram) measured in the 12 months prior to inclusion; diabetes; history of CV disease: coronary artery disease, symptomatic lower extremity arterial disease, renal or carotid artery stenosis> 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF) arrhythmia, current oral anticoagulant therapy for AF indication, valvular prosthesis cardiac or CRP> 5 mg / l for 3 months without documented infectious or neoplastic pathology AND informed written consent.
    Hommes et femmes majeurs, en HD depuis au moins 45 jours pour IRCT quelle que soit l’étiologie dont diabète, ayant au moins 3 séances d’HD par semaine ET présentant au moins l’un des comorbidités, anomalies cardiovasculaires ou facteur de risque CV suivants :
    Hypertrophie ventriculaire gauche définie par une masse ventriculaire gauche >130 g/m2 chez l’homme et 100 g/m2 chez la femme, (échocardiographie) OU Indice de Cornell (RaVL + SV3) >28 mm chez l’homme, > 20 mm chez la femme (électrocardiogramme), OU fraction d’éjection ventriculaire gauche <40%, (échocardiographie) ; QRS large > 0.14 sec OU bloc de branche Gauche (électrocardiogramme) mesurées au cours des douze mois précédent l’inclusion; diabète; antécédent de maladie CV: coronaropathie, artériopathie oblitérante des membres inférieurs symptomatique, sténose artérielle rénale ou carotidienne >50 %, AVC, hospitalisation pour insuffisance cardiaque, arythmie par fibrillation auriculaire (FA) permanente, traitement anticoagulant oral actuel pour indication de FA, prothèse valvulaire cardiaque ou CRP > 5 mg/l depuis 3 mois sans pathologie infectieuse ou néoplasique documentées en cours ET consentement éclairé écrit.
    E.4Principal exclusion criteria
    History of hypersensitivity to spironolactone; galactose intolerance, the Lapp lactase deficiency or malabsorption of glucose or galactose; hyperkalemia > 5.5 mmol / l during the two weeks prior to enrolment, history of unscheduled hemodialysis for hyperkalemia, or hospitalization for hyperkalemia during the last six months; patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately); kidney transplant scheduled within the year; symptomatic interdialytic hypotension; acute systemic disease; uncompensated hypothyroidism, acute hyperthyroidism; any prior or concomitant clinical condition compromising the inclusion, in the discretion of the investigator; cardiac transplant; severe uncontrolled arrhythmia; stroke within 3 months prior to enrolment; acute coronary syndrome within 1 month prior to enrolment; recent (1 month) or planned coronary revascularization with angioplasty; or CV surgery outside the vascular access of the HD recent (3 months) or planned; non menopausal women or without oral contraceptives; pregnancy or planning a pregnancy within 2 years; non compliance; protected adult; SBP > 200 mmHg and/or DBP > 110 mmHg;Any concomitant treatment that can not be stopped by another potassium-sparing diuretic, potassium supplementation, NSAIDs or Cox 2 inhibitors
    antécédent d’hypersensibilité à la spironolactone ; patients présentant une intolérance au galactose, un déficit en lactase de lapp ou un syndrome de malabsorption du glucose ou du galactose ; hyperkaliémie >5.5 mmol/l au cours des deux semaines précédant l’inclusion, antécédent d’hémodialyse non programmée pour hyperkaliémie, ou d’hospitalisation pour hyperkaliémie au cours des six derniers mois ; patient ayant une indication impérative d’une combinaison d’IEC et sartan ou inhibiteur de rénine (chacun d’entre eux étant autorisé séparément); transplantation rénale prévue dans l’année; hypotension symptomatique interdialytique; phase aiguë de maladie systémique; hypothyroïdie non compensée, hyperthyroïdie aiguë; toute condition clinique antérieure ou concomitante compromettant l'inclusion, selon l'appréciation de l'investigateur ; transplantation cardiaque; arythmie sévère non contrôlée; AVC dans les 3 mois précédant l’inclusion; Syndrome coronarien aigu dans le mois précédent l’inclusion; Revascularisation coronaire par angioplastie récente (1 mois) ou prévue ; Chirurgie CV, en dehors des accès vasculaires de l’HD, récente (3 mois) ou prévue; femme en âge de procréer sans dispositif contraceptif efficace ; femme enceinte, allaitante ou ayant un désir de grossesse dans les 2 ans; mauvaise compliance; majeur protégé; PAS >200 mmHg et/ou PAD >110 mmHg ; traitement concomitant ne pouvant être stoppé par un autre diurétique d’épargne potassique, une supplémentation potassique, des AINS ou des inhibiteurs de Cox 2
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the time to onset of the first incident.
    Le critère de jugement principal sera le délai de survenue du premier incident.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the date of the first event or at the end of participation in the patient's test
    A la date du premier évènement ou bien à la fin de participation à l'essai du patient
    E.5.2Secondary end point(s)
    a) cumulative rates of accidents component primary endpoints b) time to onset of death i) from any cause, ii) from a CV event, iii) from a non-CV event; b) time of survival without a major CV event (nonfatal MI,acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation); c) incidence of procedures related to stenosis or vascular access thrombosis for HD; d) incidence of coronary or peripheral revascularizations (including lower limb amputations); e) blood pressure; f) incidence of hyperkalemia> 6 mmol/l; g) estimation of the effect of treatment on quality of life.
    Two ancillary studies are planned and should be funded outside of the budget of the Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique, PHRC 2011, which granted this protocol) : 1) medico-economic study, 2) establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies.
    Les critères d’évaluation secondaires seront : a) les taux cumulés des accidents composant le critère de jugement principal ; b) le délai de survenue de décès i) de toute cause, ii) de cause CV, iii) de cause non CV ; c) le temps de survie sans évènement CV majeur ; d) l’incidence des procédures liées à une sténose ou à une thrombose de l’accès vasculaire pour HD ; e) l’incidence de revascularisations coronaires ou périphériques ; f) la pression artérielle et sa variabilité inter-visite ; g) apparition d’une arythmie complète par fibrillation auriculaire ; h) l’incidence d’hyperkaliémie ; i) l’estimation de l’effet du traitement sur la qualité de vie des patients atteints de cette double pathologie : IRCT en HD et pathologie cardiovasculaire avérée ; j) les résultats des dosages de biomarqueurs ; k) la morbimortalité 3, 5, 10 ans à l’issue de la période de suivi en double insu, sur des données de registres
    E.5.2.1Timepoint(s) of evaluation of this end point
    each visit
    à chaque visite
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 test is the last visit of the last patient monitoring in the protocol.
    La fin de l'essai correspond à la dernière visite du dernier patient suivi dans le protocole.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months1
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 825
    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
    aucun
    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 Decision2015-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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