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    Summary
    EudraCT Number:2020-001276-15
    Sponsor's Protocol Code Number:PI2020_843_0027
    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:2020-04-21
    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 number2020-001276-15
    A.3Full title of the trial
    Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.
    La supplémentation à forte dose en vitamine B3 permet-elle de prévenir les évènements rénaux majeurs au cours du choc septique ?
    Étude randomisée contrôlée multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.
    La supplémentation à forte dose en vitamine B3 permet-elle de prévenir les évènements rénaux majeurs au cours du choc septique ?
    Étude randomisée contrôlée multicentrique
    A.3.2Name or abbreviated title of the trial where available
    VITAKI
    A.4.1Sponsor's protocol code numberPI2020_843_0027
    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 Amiens-Picardie
    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 Amiens-Picardie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, CHU Amiens-Picardie
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.6E-mailmattoug.salah@chu-amiens.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 VITAMINE PP AGUETTANT 500 mg/5 mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    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 nameNicotinamide 500 mg
    D.3.4Pharmaceutical form 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 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 injection
    D.8.4Route of administration of the placeboIntracavernous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    adverse kidney events during septic shock
    évènements rénaux majeurs au cours du choc septique
    E.1.1.1Medical condition in easily understood language
    adverse kidney events during septic shock
    évènements rénaux majeurs au cours du choc septique
    E.1.1.2Therapeutic area Not possible to specify
    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
    to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care
    de montrer la supériorité de la supplémentation en Nicotinamide par rapport au groupe placebo, chez les patients présentant un choc septique admis en réanimation.
    E.2.2Secondary objectives of the trial
    - Increase in the number of days living without extra-renal treatment on day 30.
    - Reduction in the incidence of major renal adverse events at day 90 (MAKE 90).
    - Reducing the length of hospital stay in intensive care.
    - The good tolerance of Nicotinamide to the doses used in the study.
    - Evaluation of the efficacy of Nicotinamide supplementation as a function of the urinary quinolonate/ tryptophan ratio on day 0 and day 1
    - Augmentation du nombre de jour vivant sans épuration extra-rénale à J30.
    - Réduction de l’incidence des évènements indésirables rénaux majeurs à J90 (MAKE 90).
    - La réduction de la durée d’hospitalisation en réanimation.
    - La bonne tolérance du Nicotinamide aux doses employées dans l’étude.
    - Evaluation de l’efficacité de la supplémentation en Nicotinamide en fonction du ratio quinolonate/tryptophane urinaire à J0 et J1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
    Patient adulte admis en réanimation pour la prise en charge d’un état de choc septique définie par l’association d’un sepsis et du besoin de drogues vasopressives pour maintenir une PAM ≥ 65 mm Hg et d’un taux de Lactates > 2 mmol/l (18mg/dl) malgré un remplissage adéquat.
    E.4Principal exclusion criteria
    Presence of inclusion criteria for more than 24 hours
    Immediate indication to start renal replacement therapy at the time of randomization: Hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with pH <7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis.
    Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism)
    Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient.
    Moribund patient (estimated survival less than 24 hours)
    Patient who are not expected to survive to day 30 due to terminal-stage disease (terminal respiratory or heart failure, Child C cirrhosis, uncontrolled cancer)
    Resuscitated cardiac arrest
    Présence des critères d’inclusion depuis plus de 24 heures
    Indication immédiate à débuter une épuration extra-rénale au moment de la randomisation : Hyperkaliémie>6,5 mmol/l, acidose métabolique avec pH<7,15 non contrôlés par le traitement médical, œdème pulmonaire aigu résistant aux diurétiques ou de l’accumulation d’un toxique nécessitant une dialyse.
    Indication formelle a une supplémentation en Nicotinamide selon le médecin en charge (ex : pellagre, dénutrition profonde, éthylisme sévère.)
    Patient insuffisant rénal chronique sévère (clairance < 30 ml/min) dans les 3 mois précédant la survenue de l’état de choc ou transplanté rénal.
    Patient moribond (survie estimée à moins de 24 heures)
    Patient dont la survie à J30 est peu probable en raison de comorbidités évoluées (insuffisance respiratoire ou cardiaque terminale, cirrhose Child C, cancer non contrôlé)
    Arrêt cardio-respiratoire récupéré
    E.5 End points
    E.5.1Primary end point(s)
    the proportion of patients meeting one or more criteria for MAKE30: in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine on day 30
    Critère composite évalué à J30 comportant : la mortalité hospitalière toute cause confondue, la mise en route d’une épuration extrarénale ou la persistance d’un taux de créatinine sérique ≥2 fois la créatinine de base.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 30
    Jour 30
    E.5.2Secondary end point(s)
    - The reduction in the incidence of moderate to severe AKI defined as stage 2 and 3 of the KDIGO 2012 classification.
    - The increase in the number of days living without renal replacement therapy (censored at death or at day 30).
    - Reduction of the incidence of major renal adverse events at J90 (MAKE 90).The reduction of the intensive care unit length of stay.
    - liver toxicity, checked on day 1, Day2, day 3 and day 7 (transaminases, bilirubin, alkaline phosphatase, gamma-glutamyl-transferase), nausea, vomiting, headache, flushing, facial erythema.
    - Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1.
    French - La définition de l’insuffisance rénale modérée à sévère correspondant aux stades 2 et 3 de la classification KDIGO 2012.
    - La durée d’hospitalisation : définie par le délai entre la date d’admission et la sortie pour les sujets sortis vivants de la réanimation.
    - Le nombre de jour vivant sans épuration extra rénale censuré au décès ou à J30.
    - Le MAKE 90 est un critère composite évalué à J90 comportant : le décès toute cause confondue, la mise en route d’une épuration extrarénale ou la persistance d’un taux de créatinine sérique ≥2 fois la créatinine de base.
    - Tolérance hépatique, contrôlée à J1, J2, J3 et J7 (transaminases, bilirubine, phosphatase alcaline, gamma-GT), nausée, vomissements, céphalées, bouffées congestives, érythème facial.
    - Critère de jugement principal en fonction du Ratio quinolonate/tryptophane urinaire à J0 et J1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 0, 1, 2, 3, 7, 30 and day 90
    jour 0, 1, 2, 3, 7, 30 et jour 90
    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) 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 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 concerned13
    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 months39
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    unconscious patient
    patient inconscient
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state310
    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
    Néant
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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