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    Summary
    EudraCT Number:2018-003232-80
    Sponsor's Protocol Code Number:2017-71
    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:2018-10-25
    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 number2018-003232-80
    A.3Full title of the trial
    RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over Trial
    RENACTIF : Réduction par la N-AcétylCystéine d’un mécanisme Thrombotique dans l’Insuffisance rénale : Essai randomisé, en double aveugle, contrôlé-placebo, cross-over
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over Trial
    RENACTIF : Réduction par la N-AcétylCystéine d’un mécanisme Thrombotique dans l’Insuffisance rénale : Essai randomisé, en double aveugle, contrôlé-placebo, cross-over
    A.3.2Name or abbreviated title of the trial where available
    RENACTIF
    RENACTIF
    A.4.1Sponsor's protocol code number2017-71
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03636932
    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 SponsorASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    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 supportASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI 80 RUE BROCHIER
    B.5.3.2Town/ cityMARSEILLE
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number491382747+33
    B.5.5Fax number491381479+33
    B.5.6E-mailpromotion.interne@ap-hm.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 HIDONAC 5 g/25 ml
    D.2.1.1.2Name of the Marketing Authorisation holderZAMBON FRANCE S.A.
    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 nameN-AcetylCysteine
    D.3.2Product code N-AcetylCysteine
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLCYSTEINE
    D.3.9.2Current sponsor codeACETYLCYSTEINE
    D.3.9.3Other descriptive nameACETYLCYSTEINE
    D.3.9.4EV Substance CodeSUB05229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Kidney Disease
    maladie rénale chronique
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    maladie rénale chronique
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary objective is to compare the effect of N-acetylcysteine (NAC) intravenously administered at each dialysis session (2gram on 3 dialysis sessions per week) to placebo on circulating tissue factor (FT) levels in patients with Chronic Kidney Disease on chronic terminal in hemodialysis after 4 weeks of treatment. The objective is to show a 33% decrease in circulating FT levels in the NAC group compared to the control group
    L’objectif principal est de comparer l’effet que la N-acétylcystéine (NAC) administrée par voie intra veineuse à chaque séance de dialyse (2grammes sur les 3 séances de dialyse par semaine) par rapport au placebo sur les taux de facteur tissulaire (FT) circulant chez les patients insuffisants rénaux chroniques terminaux en hémodialyse chronique après 4 semaines de traitement. l'objectif est de montrer une diminution de 33% du facteur tissulaire circulant dans le groupe NAC comparé au groupe contrôle.
    E.2.2Secondary objectives of the trial
    To compare pro-coagulant activity and plasma tissue factor expression between the two groups
    To compare the rate of erythrocyte GSH between the two groups
    To compare the expression of circulating tissue factor after a hemodialysis session between the two groups
    Comparer l’activité pro coagulante et l'expression du facteur tissulaire plasmatique entre les deux groupes
    Comparer le taux de GSH érythrocytaire entre les deux groupes
    Comparer l’expression du facteur tissulaire circulant après une séance d’hémodialyse entre les deux groupes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult subjects of both sexes aged 18 years and over
    Affiliated subjects or beneficiaries of a social security scheme
    Hemodialysis patients regardless of the etiology of their renal insufficiency for more than three months on a cycle of three sessions per week
    Hemodialysis patients at least four hours per dialysis session
    Patients with a weight of more than 40kg
    Subjects capable of giving informed consent, agreeing to participate in the study and having signed a consent
    Patient able to understand a written questionnaire
    Sujets adultes des deux sexes âgés de 18 ans ou plus
    Sujets affiliés ou bénéficiaires d’un régime de Sécurité Sociale
    Patients hémodialysés quel que soit l’étiologie de leur insuffisance rénale depuis plus de trois mois sur un cycle de trois séances par semaine
    Patients hémodialysés au minimum quatre heures par séance de dialyse
    Patients avec un poids de plus de 40kg
    Sujets capable de donner leur consentement éclairé, acceptant de participer à l’étude et ayant signé un consentement
    Patient capable de comprendre un questionnaire écrit
    E.4Principal exclusion criteria
    Pregnant or lactating women
    Persons deprived of their liberty or hospitalized without consent
    Majors under legal protection or unable to express their consent Possibility of recovery of renal function
    Chronic progressive infection that may affect their thrombotic risk: progressive neoplasia, anticoagulant treatment prescribed for less than 1 month
    Patients with a weight under 40 kg
    Patient not able to express his consent
    Patient taking AVK-type oral anticoagulants outside anticoagulation during the session.
    Patient with a known allergy to the active molecule or an excipient
    Femmes enceintes ou allaitantes
    Personnes privées de liberté ou hospitalisées sans consentement
    Majeurs sous protection légale ou hors d’état d’exprimer leur consentement Possibilité de récupération d’une fonction rénale
    Infection chronique évolutive pouvant influer sur leur risque thrombotique : néoplasie évolutive, traitement anticoagulant prescrit depuis moins de 1 mois
    Patients avec un poids de moins de 40 kg
    Patient non apte à exprimer son consentement
    Patient prenant des anticoagulants oraux type AVK en dehors de l’anticoagulation lors de la séance.
    Patient ayant une allergie connue à la molécule active ou à un de ses excipients
    E.5 End points
    E.5.1Primary end point(s)
    The circulating tissue factor is measured by ELISA test from the plasma from a blood sample of a 4.5ml citrate tube. The objective of this measure will be to observe a reduction of one third of the rate between the beginning of the treatment and the end of the treatment being 4 weeks. Plasma Circulating Tissue Factor Levels are correlated with Cardiovascular Mortality
    La mesure du facteur tissulaire circulant s’effectue par test ELISA à partir du plasma provenant d’un prélèvement sanguin d’un tube citraté de 4,5ml. L’objectif de cette mesure sera d’observer une diminution d’un tiers du taux entre le début du traitement et la fin du traitement soit 4 semaines. Les taux plasmatiques de facteur tissulaire circulant sont corrélés avec la mortalité cardio-vasculaire
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mois
    E.5.2Secondary end point(s)
    The measurement of the tissue coagulant activity test is carried out by activated factor X generation test (fluorometric measurement) from citrated plasma (one tube). measuring the effectiveness of treatment on leukocyte tissue factor, involved in the thrombosis process.
    La mesure du test d’activité pro coagulante du facteur tissulaire s’effectue par test de génération de facteur X activé (mesure fluorimétrique) à partir de plasma citraté (un tube). mesure de l'éfficacité du traitement sur le facteur tissulaire leucocytaire, impliqué dans le processus de thrombose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months
    4 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 Yes
    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 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 Yes
    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 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
    the last visit of the last subject
    la dernière visite du dernier sujet
    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 months12
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    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)
    Whash out of 1 month, then resumption of treatment in the normal condition of the disease
    Période sans traitement de 1 mois, puis reprise du traitement dans les conditions normales de la maladie
    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 Decision2018-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-04
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