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    Summary
    EudraCT Number:2012-004368-23
    Sponsor's Protocol Code Number:20121005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-25
    Trial results View 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 number2012-004368-23
    A.3Full title of the trial
    Feasible strategy for preventing blood clots in critically ill patients with acute kidney Injury
    Forebyggelse af Blodpropper hos patienter med akut nyresvigt på Intensiv-afdeling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of blood clots in patients with acute kidney injury
    Forebyggelse af Blodpropper hos patienter med akut nyresvigt på Intensiv-afdeling
    A.3.2Name or abbreviated title of the trial where available
    F.B.I.
    F.B.I.
    A.4.1Sponsor's protocol code number20121005
    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 SponsorOdense University Hospital
    B.1.3.4CountryDenmark
    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 supportOdense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointOdense University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post codeDK 5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4565413947
    B.5.6E-mailPalle.Toft@ouh.regionsyddanmark.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 Klexane®
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis Denmark A/S
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparin sodium
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameENOXAPARIN
    D.3.9.4EV Substance CodeSUB21316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 150
    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 Yes
    D.3.11.13.1Other medicinal product typeEnoxaparin natrium
    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
    venous thromboembolism
    Venøs tromboembolisme
    E.1.1.1Medical condition in easily understood language
    blood clot
    blodprop i de dybe vener
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To reduce the incidence of venous thromboembolism(VTE) among patients on continuous renal replacement therapy (CRRT) by using 1 mg/kg enoxaparin, versus the standard dose of 40 mg enoxaparin.
    At vurdere om forekomsten af venøs tromboembolisme (VTE) blandt intensivpatienter i kontinuerlig dialysebehandling reduceres ved brug af optimeret dosis enoxaparin på 1 mg/kg versus den sædvanlige dosis på 40 mg.
    E.2.2Secondary objectives of the trial
    To show that falling neutrophil gelatinase-associated lipocalin (NGAL) levels and urine volumes > 200 ml are predictive of renal recovery. In addition to examine the difference in anti-Xa activity, LOS, ventilator free days, bleeding, mortality, filter lifespan, and incidence of other venous thrombosis and HIT between the 2 groups.
    Der måles NGAL og urinvolumen som prognostisk faktorer for renal recovery. Desuden vuderes:kateterrelateret trombe og alle øvrige VTE,
    anti-Xa aktiviteten, blødning (større og mindre),dialysefilterlevetid,
    heparininduceret trombocytopeni,varigheden af opholdet på intensivafdeling og hospital,varigheden af mekanisk ventilation og mortalitet for begge grupper.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who develop acute kidney injury, and who need CRRT
    Weight 45 - 150 kg
    Age ≥18 years
    Informed consent
    Legemsvægt mellem 45 og 150 kg
    Alder ≥18
    Patienter som udvikler akut nyresvigt, og som kræver behandling med kontinuerlig dialyse (CRRT)
    Informeret samtykke
    E.4Principal exclusion criteria
    Major trauma
    Need for therapeutic anticoagulation
    Contraindication to heparin(allergy, HIT)
    Pregnancy
    Life-support limitation
    Uncontrolled hypertension(bp > 180/110) i ≥12 timer
    Cerebral haemorrhage , acute gastrointestinal bleeding
    Severe thrombocytopenia (platelet count <50 × 109/l)
    International Normalized Ratio or activated partial thromboplastin time ≥2 times the upper limit of normal
    Chronic renal failure, or acute-on-chronic
    Allergi over for enoxaparin, andre lavmolekylære hepariner, heparin, eller benzylalkohol
    Gravide patienter
    Patienter kendt fra tidligere med heparininduceret trombocytopeni (HIT)
    Akut gastrointestinal ulceration eller blødning, cerebral blødning eller stort traume
    Patienter som er udsigtsløs syge
    Ureguleret hypertension (blodtryk > 180/110) i ≥12 timer
    Positiv blødningsundersøgelse/ -anamnese (fra journalnotat, hvis patienten er bevidstløs )
    Alvorlige koagulationsforstyrrelser (trombocyttal <50 × 109/l, International Normalized Ra-tio eller activated partial thromboplastin time ≥2 gange øvre normal grænse )
    Brug af brilique/ plavix /marevan/terapeutisk dosis af enoxaparin eller lignende præparater
    Kronisk nyresvigt eller akut-on-kronisk nyresvigt

    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of proximal leg deep-vein thrombosis(DVT) detected on ≥3 days after randomization; or pulmonary embolus(PE) diagnosed on computed tomography (CT) of the chest or at autopsy.
    Det primære effektmål er dokumenteret VTE påvist ved bilateral CUS af proksimale underekstremiteter på ≥3. dage efter randomisering eller CT scanning af lunger eller ved obduktion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will be assessed daily for clinical signs of VTE. Bilateral proximal leg venous compression ultrasound (CUS)will be conducted on the 1st,3rd and 7th day of inclusion. CUS will then be repeated on a weekly basis, or if DVT is clinically suspected. CT chest and echocardiography will only be performed on clinical suspicion of PE.
    Alle patienter får daglig gennemgået bedside klinisk vurdering af VTE. Andre interventioner omfatter bilateral venøs kompression ultralyd (CUS) af proksimale underekstremiteter på konventionel steder på 1.dag af hver patients inklusion. Gentages på dag 3. og dag 7., og derefter ugentlig eller ved mistanke om DVT.Mistanke om lungeemboli (PE) vil blive evalueret med ekkokardiografi og spiral CT angiografi hos patienterne.

    E.5.2Secondary end point(s)
    Secondary outcomes include all other DVT, anti-Xa activity, bleeding(major and minor), filter lifespan, heparin-induced thrombocytopenia (HIT), length of stay on the intensive care unit, hospital length of stay, ventilator days, and death. We will monitor NGAL levels to determine whether NGAL can be used as a prognostic factor for renal recovery.
    Sekundære effektmål er: kateterrelateret trombe og alle øvrige VTE, anti-Xa aktiviteten, blødning (større og mindre), dialysefilterlevetid, HIT, varigheden af opholdet på intensivafdeling og hospital, varigheden af mekanisk ventilation og mortalitet. Der måles NGAL og urinvolumen som prognostisk faktorer for renal recovery.

    E.5.2.1Timepoint(s) of evaluation of this end point
    All patients will be assessed daily for clinical signs of bleeding or VTE.

    Baseline anti-Xa levels will be measured. Peak and trough anti-Xa levels will be measured on day 3 and thereafter once per week.

    NGAL will be measured at baseline, and again during CRRT-free intervals.
    Alle patienter får daglig gennemgået bedside klinisk vurdering af blødning og VTE.

    Anti-Xa måles ved baseline, og derefter på dag 3. og 1x ugentligt: ved 3-5 timer efter dagens enoxaparin dosis = peak anti-Xa
    ved 20 timer efter dagens enoxaparin dosis = dale anti-Xa

    Biomarkører plasma og urin NGAL ved baseline og ved dialyse pause.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    forskellige doser af enoxaparin
    different doses of the same drug
    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 concerned3
    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
    However an interim analysis will be performed to decide whether the trial should continue after enrollment of the first 133 patients.
    Sidst besøg, sidste patient. En interimanalyse af dataene vil blive udført for at undersøge, om forsøget skal fortsætte, efter at de første 67 patienter har været indskrevet i hver deres gruppe.
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-10-25. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Many of our critically ill patients have impaired consciousness, and in these patients we will seek informed consent from the next of kin and the GP.
    Hos de bevidsthedsslørede patienter, hvor deres fysiske/mentale tilstand gør det umuligt at opnå informeret samtykke, søges stedfortrædendes samtykke. Hvis de pårørende er til stede, søges almindeligt stedfortrædende samtykke hos dem.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state266
    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
    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 Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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