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    Summary
    EudraCT Number:2020-000414-16
    Sponsor's Protocol Code Number:APHP-200040
    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:2024-08-27
    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 number2020-000414-16
    A.3Full title of the trial
    Impact of a treatment with angiotensin receptor blocker on outcome after acute kidney injury in patients discharged from the ICU “START-or-NOT trial”.
    A prospective, randomized, double blinded, multicenter study
    Impact d’un traitement par inhibiteur des récepteurs de l’angiotensine 2 sur le pronostic après une insuffisance rénale aigue en réanimation. Étude multicentrique, randomisée, en double aveugle.
    Étude START-or-NOT
    A.4.1Sponsor's protocol code numberAPHP-200040
    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 SponsorAPHP
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
    B.5.2Functional name of contact pointSafiyatou BALDE
    B.5.3 Address:
    B.5.3.1Street Address1, avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33140273601
    B.5.6E-mailsafiyatou.balde@aphp.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 IRBESARTAN EG 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEG LABO - LABORATOIREES EUROGENERICS
    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.3.4Pharmaceutical form Coated tablet
    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 INNIRBESARTAN EG 150 mg
    D.3.9.3Other descriptive nameIRBESARTAN
    D.3.9.4EV Substance CodeSUB08293MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    Acute kidney injury
    Insuffisance rénale
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 26.0
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 impact of the RAASi on cardiovascular and global outcome one year after ICU or acute care discharge in patients who developed an AKI during their ICU stay and totally or partially recovered.
    Évaluer l'impact du traitement par des ARA 2(IRBESARTAN), sur les complications cardiovasculaires, un an après la sortie des soins intensifs chez les patients ayant développé une IRA pendant leur séjour en soins intensifs
    E.2.2Secondary objectives of the trial
    - To evaluate the impact of RAASi initiation on renal outcome after ICU discharge
    - To evaluate the impact of RAASi initiation on new hospitalizations for major cardiovascular events
    - To evaluate the impact of RAASi initiation on potential side effect of the treatment (safety).
    - To identify among the patient's characteristics the factors of response to treatment, including the use of the biological collection built up at inclusion and at the end of the study
    -Évaluer l'impact de l'initiation du traitement par l’IRBESARTAN sur la fonction rénale après la sortie de l'USI
    - Évaluer l'impact du traitement par IRBESARTAN sur les nouvelles hospitalisations pour événements cardiovasculaires majeurs
    - Évaluer la tolérance du traitement par IRBESARTAN
    - Identifier parmi les caractéristiques du patient les facteurs de réponse au traitement.
    - Mise en place d’une collection biologique à l'inclusion et à la fin de l'étude
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient between 18 and 75 years old
    -Met criteria for acute kidney injury during the ICU stay (according to the KDIGO criteria)
    - Within 30 days after ICU discharge and after their renal function has stabilized for at least 48 hours (changes in serum creatinine < 26 micromol/L or < 25%).
    - Signed informed consent
    - Patient affiliated to a Social Security System
    -Women of childbearing potential and men must agree, to use adequate and highly effective contraception, until the end of the research
    -Patient âgé de 18 à 75 ans
    - Patient répondant aux critères d'insuffisance rénale aiguë pendant le séjour en soins intensifs (selon les critères KDIGO)
    -Patient inclus dans les 30 jours suivant la sortie de l'USI et après que sa fonction rénale se soit stabilisée pendant au moins 48 heures (modifications de la créatinine sérique < 26 micromol/L ou < 25 %).
    - Consentement éclairé signé
    - Patient affilié à un régime de sécurité sociale
    -Les femmes en âge de procréer et les hommes doivent utiliser une contraception adéquate et hautement efficace, jusqu'à la fin de la recherche
    E.4Principal exclusion criteria
    Patient treated with ACEi or ARB before ICU admission
    Patient for whom treatment with ACEi or ARB is stronglyrecommended according to the international guidelines at discharge (ie patients with congestive heart failure and persistent dyspnea with LVEF<40%, patients with diabetes mellitus AND [either albuminuria > 300 µg/g creatininuria or hypertension associated with microalbuminuria or hypertension associated with eGFR < 60 ml/min)]
    Hyperkalemia > 5 mmol/L at ICU discharge
    Systolic blood pressure <100 mmHg at ICU discharge
    Patient with severe renal failure, as defined by estimated glomerular filtration rate creatinine clearance < 15 ml/min/1.73m2), requiring renal replacement therapy at ICU discharge
    Oral route impossible.
    Pregnancy
    Breast feeding
    Patients chronically treated with Aliskiren
    Known hypersensitivity to the active substance or to one of its excipients and in particular to lactose
    Patients with a contraindication to treatment with Irbesartan
    Patients treated with diuretic, alpha-blocker, or NSAIDs
    -Patient traité par ACEi ou ARA avant son admission en réanimation
    - Patient pour lequel un traitement par ACEi ou ARA est fortement recommandé selon les recommandations internationales à la sortie (c'est-à-dire patients atteints d'insuffisance cardiaque congestive et dyspnée persistante avec FEVG < 40 %, patients atteints de diabète sucré ET [soit albuminurie > 300 µg/g créatininurie ou hypertension associée à une microalbuminurie ou à une hypertension associée à un DFGe < 60 ml/min)]
    - Hyperkaliémie > 5 mmol/L à la sortie des soins intensifs
    - Tension artérielle systolique <100 mmHg à la sortie des soins intensifs
    - Patient présentant une insuffisance rénale sévère, telle que définie par un taux de filtration glomérulaire estimé, une clairance de la créatinine < 15 ml/min/1,73 m²), nécessitant une dialyse à la sortie de l'USI
    - Impossibilité de prise du traitement par voie orale.
    -Grossesse
    -Allaitement maternel
    - Patient traité de manière chronique par Aliskiren
    - hypersensibilité connue à la substance active ou à l'un de ses excipients et notamment au lactose
    - patient présentant une contre-indication au traitement par IRBESARTAN
    - Patient traités par diurétiques, alpha-bloquants ou AINS
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective: To evaluate the impact of the RAASi on cardiovascular and global outcome one year after ICU or acute care discharge in patients who developed an AKI during their ICU stay and totally or partially recovered.
    Primary outcome: The primary endpoint of the trial is MACE (major adverse cardiovascular events), i.e. a composite outcome composed of all-cause mortality and all unscheduled hospital readmission for cardiovascular events (acute heart failure, stroke, acute coronary syndrome) during the year following ICU discharge.
    Composite composé de la mortalité toutes causes confondues et de toutes les réadmissions hospitalières non programmées pour événements cardiovasculaires (insuffisance cardiaque aiguë, accident vasculaire cérébral, syndrome coronarien aigu) au cours de l'année suivant la sortie de l'Unité de Soins intensifs
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year + 15 days
    End of research visit
    A un an plus ou moins 15 jours de la fin de l'étude.
    E.5.2Secondary end point(s)
    - Albuminuria>0.3 g/day one year after ICU discharge
    - Occurrence of chronic kidney disease one year after ICU discharge defined as eGFR <60 ml/min/1.73m2
    - Decrease of estimated glomerular filtration from baseline to one year after enrollment.
    -change in Chronic kidney disease staging one year after enrollment.
    - New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization
    - Hyperkalemia >6 mmol/L
    -Death
    - Biological collection built up at inclusion and at the end of the study
    - Albuminurie > 0,3 g/jour, un an après la sortie de l'USI
    - Survenue d'une maladie rénale chronique un an après la sortie de l'USI définie comme un DFGe < 60 ml/min/1,73 m2
    - Diminution de la filtration glomérulaire, de la baseline à un an après inclusion
    -modification du stade de la maladie rénale chronique un an après l’inclusion.
    - Nouvel épisode d'insuffisance rénale aiguë (selon les critères KDIGO) nécessitant une hospitalisation
    - Hyperkaliémie > 6 mmol/L
    -Décès
    - Collection biologique constituée à l'inclusion et à la fin de l'étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Endpoint assessment at one year.
    le critère d'évaluation sera fait à un an.
    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) 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.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Dernière visite du dernier patient inclus
    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 months31
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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 Decision2021-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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