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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004301-41
    Sponsor's Protocol Code Number:P170404J
    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:2018-09-21
    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 number2017-004301-41
    A.3Full title of the trial
    FURosemide Stress Test to predict need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in Intensive Care Units
    Intérêt du Furosémide Stress Test pour prédire le besoin d’épuration extra-rénale dans les nécroses tubulaires aiguës en réanimation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    FURTHER
    A.4.1Sponsor's protocol code numberP170404J
    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 PARIS
    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 supportAP-HP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE-HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI-Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number3301 44 84 17 16
    B.5.5Fax number3301 44 84 17 01
    B.5.6E-mailhouria.mebarek@aphp.fr
    B.Sponsor: 2
    B.1.1Name of SponsorAssistance Publique-Hopitaux de Paris(AP-HP)
    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 supportAP-HP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hopitaux de Paris
    B.5.2Functional name of contact pointDRCI Hopital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1, avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.4CountryFrance
    B.5.6E-mailhouria.mebarek@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 FUROSEMIDE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE RENAUDIN
    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 nameFUROSEMIDE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    FURosemide Stress Test to predict need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in Intensive Care Units
    Intérêt du Furosémide Stress Test pour prédire le besoin d’épuration extra-rénale dans les nécroses tubulaires aiguës en réanimation.
    E.1.1.1Medical condition in easily understood language
    Ischemic acute tubular necrosis (ATN)
    Insuffisance rénale
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001099
    E.1.2Term Acute tubular necrosis
    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 assess FST performance to predict need of RRT in patients with ischemic ATN in ICU : sensitivity
    Dans cette étude d’évaluation de la performance diagnostique du FST, le test sera considéré positif si la diurèse à H2 est inférieure à 200mL. On évaluera la sensibilité du test ainsi défini pour le pronostic rénal dans le cadre d’une IRA par NTA ischémique en réanimation.
    E.2.2Secondary objectives of the trial
    -To assess other performance criteria of FST to predict need of RRT in patients with ischemic ATN in ICU : specificity, predictive positive and negative values
    - To build a ROC with continuous values of two-hour urine output for occurrence of AKIKI criteria
    - To assess FST performance to predict occurrence of effective RRT
    - To assess the same performance indicators for six-hour urine output
    - To compare FST in surgical and medical patients and in oliguric and non oliguric patients
    To assess hemodynamic tolerance of FST
    -Évaluation des paramètres de performance diagnostique du FST (autres que la sensibilité)- Pour les valeurs continues de la diurèse après injection de furosémide, la construction de courbe ROC sera construite par rapport à la référence (critères AKIKI ou décès, à J7), calcul de l’AUC et une étude de seuils sera réalisée
    -Évaluation de la performance diagnostique du FST à H2 pour le pronostic rénal à J7, en prenant cette fois comme référence les EER effectivement réalisées ou le décès, à J7.
    -Évaluer la performance diagnostique du FST mais défini pour la diurèse à H6 pour le pronostic rénal à J7 par rapport aux critères AKIKI ou le décès, à J7.
    -Comparaison des performances du FST dans les sous-groupes des IRA septiques et des IRA post-chirurgicale en fonction du mode de diagnostic de l’IRA (oligurie ou sur l’élévation de la créatininémie).
    -Évaluation de la tolérance hémodynamique du FST
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age over 18 years old
    • Hospitalized in ICU at day of inclusion
    • Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP within 72 hours before inclusion
    • Adequate cardiac output and volemia assessed by cardiac ultrasound, venous saturation in Oxygen (ScVO2) or ΔPP
    • Hemodynamic stabilization : stable norepinephrine dosage (or <20% variations) without vascular filling during the last 3 hours
    • AKI stage I or II in KDIGO classification
    - Patient âgé de plus de 18 ans
    - Hospitalisé en réanimation médicale le jour de l’inclusion
    - Diagnostic de sepsis basé sur la présence d’une infection prouvée ou suspectée ET de l’augmentation du score SOFA de 2 points ou plus par rapport à l’état basal ou patient en post-opératoire de chirurgie cardiaque (chirurgie cardiaque avec circulation extracorporelle dans les 72h)
    - Remplissage adéquat et un débit cardiaque optimisé sur des critères d’échocardiographie trans-thoracique, de saturation veineuse centrale en oxygène (ScVO2) ou de ΔPP
    - Stabilisation hémodynamique : noradrénaline stable au cours des 3 dernières heures (ou variations < 20%) sans nécessité de remplissage vasculaire au cours des 3 dernières heures
    - IRA stade I ou II de la classification KDIGO : Stade I : Créatininémie 1,5 à 1.9 fois la base OU Oligurie < 0,5 ml/kg/h sur 6-12 heures ; stade II : Créatininémie 2 à 2.9 fois la base OU Oligurie < 0,5 ml/kg/h ≥ 12h.
    E.4Principal exclusion criteria
    • Chronic Kidney Disease with glomerular filtration rate ≤ 30 ml/mn/1,73m2
    • Obstructive AKI
    • AKI stage III in KDIGO classification
    • Known allergy to loop diuretics
    • Contraindications to Furosemide
    • Previous AKI during the same hospitalization
    • Pregnancy or breastfeeding women
    • Subject under a legal protective measure
    • No affiliation to a social regime or CMU
    - Insuffisance rénale chronique avec débit de filtration glomérulaire estimé par la formule MDRD ≤ 30 ml/mn/1,73m2
    - IRA obstructive (définie par la présence d’un obstacle sur les voies urinaires recherché systématiquement en cas d’insuffisance rénale aigue)
    - IRA stade 3 de KDIGO
    - Allergie connue aux diurétiques de l’anse

    - Ayant déjà eu un épisode d’IRA au cours de l’hospitalisation
    - Femme enceinte ou allaitante
    - Majeurs protégés (tutelle, curatelle, mesure de sureté)
    - Refus de participation exprimé par les membres de la famille ou par la personne de confiance s’ils sont présents
    - Pas d’affiliation à un régime de sécurité sociale ou CMU
    E.5 End points
    E.5.1Primary end point(s)
    In this study of diagnostic performance of FST, its result will be considered as positive if two-hour urine output after Furosemide injection is < 200 mL

    The sensitivity of FST will be calculated in relation with the following criteria : occurence of least one of RRT criteria (AKIKI study) or death within seven days
    Sensibilité du FST (positif si diurèse inférieure à 200mL à H2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    In this study of diagnostic performance of FST, its result will be considered as positive if two-hour urine output after Furosemide injection is < 200 mL
    le test sera considéré positif si la diurèse à H2 est inférieure à 200mL. On évaluera la sensibilité du test ainsi défini pour le pronostic rénal dans le cadre d’une IRA par NTA ischémique en réanimation.
    E.5.2Secondary end point(s)
    To assess other performance criteria of FST to predict need of RRT in patients with ischemic ATN in ICU : specificity, predictive positive and negative values
    - To build a ROC with continuous values of two-hour urine output for occurrence of AKIKI criteria
    - To assess FST performance to predict occurrence of effective RRT
    - To assess the same performance indicators for six-hour urine output
    - To compare FST in surgical and medical patients and in oliguric and non oliguric patients
    To assess hemodynamic tolerance of FST
    - Évaluation des paramètres de performance diagnostique du FST (autres que la sensibilité) : spécificité (Sp), rapport de vraisemblance (RVP, RVN), valeurs prédictifs (VPP, VPN) par rapport au même critère de référence.
    - Pour les valeurs continues de la diurèse après injection de furosémide, la construction de courbe ROC sera construite par rapport à la référence (critères AKIKI ou décès, à J7), calcul de l’AUC et une étude de seuils sera réalisée
    - Évaluation de la performance diagnostique du FST à H2 pour le pronostic rénal à J7, en prenant cette fois comme référence les EER effectivement réalisées ou le décès, à J7. L’aire sous la courbe pour les valeurs continues de la diurèse sera calculée par rapport à cette référence, ainsi que l’AUC et l’une étude de seuils sera realisée.
    - Évaluer la performance diagnostique du FST mais défini pour la diurèse à H6 pour le pronostic rénal à J7 par rapport aux critères AKIKI ou le décès, à J7.
    - Comparaison des performances du FST dans les sous-groupes des IRA septiques et des IRA post-chirurgicale en fonction du mode de diagnostic de l’IRA (oligurie ou sur l’élévation de la créatininémie).
    - Évaluation de la tolérance hémodynamique du FST
    E.5.2.1Timepoint(s) of evaluation of this end point
    H6 or 7 days
    H6 ou 7 jours
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned2
    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
    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 months
    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.1.3Elderly (>=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 state70
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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