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    Summary
    EudraCT Number:2015-002585-23
    Sponsor's Protocol Code Number:ANJ-02-2015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-05
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002585-23
    A.3Full title of the trial
    The effect of 3% NaCl and furosemid on biomarkers and the kidneys managment of sodium and water, vasoactive hormones and GFR in healthy subjects.
    Effekten af 3% NaCl og furosemid på biomarkører og nyrernes behandling af natrium og vand, vasoaktive hormoner, og GFR hos raske forsøgspersoner.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of saline with a high koncentration and furosemide on biomarkers of kidney damage togerther with kidney and circulatory physiology in healthy subjects.
    Effekten af saltvand med høj koncentration og furosemid på biomarkører for nyreskade samt nyre- og kredsløbsfysiologi hos raske forsøgspersoner.
    A.4.1Sponsor's protocol code numberANJ-02-2015
    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 SponsorMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.1.3.4Country
    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 supportMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.5.2Functional name of contact pointAndreas Nygaard Jørgensen
    B.5.3 Address:
    B.5.3.1Street AddressLægårdvej 12C
    B.5.3.2Town/ cityHolstebro
    B.5.3.3Post code7500
    B.5.4Telephone number004578436589
    B.5.6E-mailandrjr@rm.dk
    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 Furix
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFUROSEMIDE
    D.3.9.1CAS number 54-31-9
    D.3.9.4EV Substance CodeSUB07849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 namenatriumklorid/sodium chloride
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN2,9 % SODIUM CHLORIDE
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION
    D.3.9.4EV Substance CodeSUB78176
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number29
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (The effect of flurosemide, together with an infusion of hypertone saline, on the kidneys, using biomarkers)
    Raske forsøgspersoner (ved hjælp af biomarkører ledes efter effekten af flurosemid, under infusion af hyperton natriumklorid, på nyrerne)
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (The effect of the diuretic flurosemide, together with an infusion of high concentration saline, on the kidneys, using biomarkers)
    Raske forsøgspersoner (ved hjælp af biomarkører ledes efter effekten af det vanddrivende stof flurosemid, under infusion af saltvand med høj koncentration, på nyrerne)
    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 18.1
    E.1.2Level SOC
    E.1.2Classification code 10022891
    E.1.2Term Investigations
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of chloride together with flurosemide on the kidneys in a randomized, single-blind, placebo-controlled, cross-over study in healthy subjects, by measuring biomarkers, kidney function and vasoactive hormones.
    At undersøge klorids sammen med flurosemids effekt på nyrerne i et randomiseret, enkeltblindet, placebokontrolleret, overkrydset forsøg hos raske forsøgspersoner, ved måling af biomarkører, nyrefukntion og vasoaktive hormoner.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and Women
    • age 18-40
    • BMI 18,5-30,0 kg/m2
    Fertile women most use safe contraceptives through the trail period, defined as intrauterine devices, abstinens and hormonal contraceptives (birth control pills, contraceptives implants, contraceptives injektion, contraceptives patch, vaginal ring). Excepted are postmenopausal women with no menstruation in at least 12 month before inclusion, surgical sterilization or women with sterilized regular partner.
    • Mænd og kvinder
    • Alder 18-40 år
    • BMI 18,5-30,0 kg/m2
    Fertile kvinder skal anvende sikker antikonception gennem hele forsøgsperioden, defineret som spiral, afholdenhed eller hormonel antikonception (p-piller, implantat, transdermal depotplaster, vaginalring eller depotinjektion). Undtaget herfra er postmenopausale kvinder med udebleven menstruation i mindst 12 måneder før inklusion, kirurgisk steriliserede og kvinder med steriliseret fast partner.
    E.4Principal exclusion criteria
    • Tobacco smoking (Non-smokers in more than 3 months can be included)
    • Medicine- or drug abuse
    • Alcohol abuse >14 units for women >21 units for men
    • Medical treatment (over the counter medication will evaluated whether or not it is grounds for exclusion) within 2 weeks before the trail period starts except contraception.
    • Pregnancy or nursing
    • Neoplastic disorders
    • Significant clinical signs of heart-, lung-, liver-, kidney-,
    endocrine- or brain disorders
    • Clinically significant abnormal findings in screening blood samples, urine sample or ECG
    • Office blood pressure over 140/90 mmHg
    • Donation of blood within 1 month of the first day of investigation.
    • Allergy against compounds in investigational medicine
    • Tobaksrygning (rygestop på over 3 måneder kan inkluderes)
    • Medicin- eller stofmisbrug
    • Alkoholoverforbrug, dvs. >14 genstande/uge for kvinder og >21 genstande/uge for mænd
    • I medicinsk behandling (inkl. Håndkøbsmedicin (paracetamol eller andre præparater som ved lægelig vurdering findes ikke at interferer med projektet godtages)) inden for de sidste to uger før undersøgelsesdagene, fraset antikonception
    • Graviditet eller amning
    • Neoplasi
    • Anamnestiske eller kliniske tegn på betydende hjerte-, lunge-, lever-, nyre-,
    stofskiftesygdomme eller neurologiske lidelser
    • Klinisk betydende afvigelser ved screeningsblodprøver, urinstix eller EKG
    • Konsultationsblodtryk >140/90 mmHg
    • Bloddonation inden for den seneste måned inden første undersøgelsesdag
    • Allergi overfor et af indholdsstofferne i forsøgsmedicinen
    E.5 End points
    E.5.1Primary end point(s)
    Urinary neutrophil gelatinase-associated lipocalin concentration
    urin neutrophil gelatinase-associated lipocalin koncentration
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all subjects have completed and the blood and urine samples have been analyzed.
    Når alle forsøgspersoner er afsluttet og blod- samt urinprøver
    analyseret.
    E.5.2Secondary end point(s)
    Biomakers: u-KIM, u-FABP, TIMP, IGFBP7
    Vasoactive hormones: PRC, p-Ang-II, p-AVP, p-Aldo
    Transport channels: u-AQP2, u-EnaC, u-NCC, u-NK2CC
    Kidney physiology: 51Cr-EDTA-clearance, FENa CH2O, TCO2, p-Cl, u-Cl,
    Hemodynamic: Puls, central and brachial blood pressure
    Biomakør: u-KIM, u-FABP, TIMP, IGFBP7
    Vasoaktive hormoner: PRC, p-Ang-II, p-AVP, p-Aldo
    Transportkanaler: u-AQP2, u-EnaC, u-NCC, u-NK2CC
    Nyrefysiologi: 51Cr-EDTA-clearance, FENa CH2O, TCO2, p-Cl, u-Cl,
    Hæmodynamik: Puls, central og brakial blodtryk
    E.5.2.1Timepoint(s) of evaluation of this end point
    When all subjects have completed and the blood and urine samples have been analyzed.
    Når alle forsøgspersoner er afsluttet og blod- samt urinprøver
    analyseret.
    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 No
    E.6.4Safety Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 27
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state27
    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
    ingen
    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 Decision2016-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-13
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