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    Summary
    EudraCT Number:2019-001340-22
    Sponsor's Protocol Code Number:CathLockTrialHD
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-001340-22
    A.3Full title of the trial
    A prospective, randomized, multicenter trial to compare a Taurolock™
    based lock solution to a Citrate and Citrate/Urokinase based lock
    solution in tunneled hemodialysis catheters for the prevention of
    bacteremia and dysfunction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of different lock Solutions (i.e. medicine that prevents dysfunktion of central venuos catheter in hemodialysis patients) regarding catheter related infections (i.e. blood poisioning due to bacteria)
    A.3.2Name or abbreviated title of the trial where available
    CathLock Trial Dialysis
    A.4.1Sponsor's protocol code numberCathLockTrialHD
    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 SponsorUniverstitätsklinikum St.Pölten
    B.1.3.4CountryAustria
    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 supportUniversitätsklinikum St.Pölten
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum St.Pölten
    B.5.2Functional name of contact pointDepartment of Internal Medicine 1
    B.5.3 Address:
    B.5.3.1Street AddressDunantplatz 1
    B.5.3.2Town/ citySt.Pölten
    B.5.3.3Post code3100
    B.5.3.4CountryAustria
    B.5.4Telephone number+432742900412141
    B.5.6E-mailinterne1@stpoelten.lknoe.at
    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 Actosolv
    D.2.1.1.2Name of the Marketing Authorisation holderEumedica N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameActosolv
    D.3.2Product code Actosolv
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIn vitro use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNActosolv
    D.3.9.1CAS number 9039-53-6
    D.3.9.2Current sponsor codeUrokinase
    D.3.9.3Other descriptive nameUROKINASE
    D.3.9.4EV Substance CodeSUB05055MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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
    Patients requiring hemodialysis with a CVC due to renal failure of any cause. Aim of this study is to investigate different CVC lock Solutions.
    E.1.1.1Medical condition in easily understood language
    Patients who require hemodialysis due to renal failure will be included in this study. Hemodialysis patients require a central venous catheter for their treatment.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Aim of this study is to evaluate a CLS regime of Citrate, a CLS
    regime of citrate combined with Urokinase and a Taurolodine-based CLS
    regarding catheter-related bloodstream infections and catheter dysfunctions
    Protocol_Locksolutions_Dialysis Page 7/26 Version 1.1.


    Primary outcome variable:
    § Total number of CRBSI
    E.2.2Secondary objectives of the trial
    § Total number of catheter dysfunctions
    § Rate of catheter removal or exchange due to dysfunctions
    § Rate of necessity of catheter rescue with Alteplase
    § Rate of infections per 1000 catheter days
    § Rate of catheter exchange due to infections
    § Survival without any CRBSI
    § Hospitalization (number and days of hospitalization)
    § Cost analysis (incl. medication, hospitalization)
    § Use of antibiotics (number of episodes and days)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    § Male or female older than 18 years
    § Requirement for hemodialysis using a tunneled dialysis catheter
    § Willingness and ability to comply with the protocol
    § Signed informed consent
    E.4Principal exclusion criteria
    § Children aged less than 18 years
    § Any systemic infection prior 7 days before catheter insertion
    § Positive blood culture in previous 7 days before catheter
    insertion
    § Heparin induced thrombocytopenia and/or contraindication for
    anticoagulation (recent or planned surgery, thrombocytopenia <
    70G/l, bleeding disorder)
    § Allergy or hypersensitivity against study drug or devices
    § Any disease considered relevant for proper performance of the
    study or risks to the patient, at the discretion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variables:
    § Total number of CRBSI
    E.5.1.1Timepoint(s) of evaluation of this end point
    until occurence of first CRBSI, maximum of 24 months,
    E.5.2Secondary end point(s)
    Secondary outcome variables:
    § Total number of catheter dysfunctions
    § Rate of catheter removal or exchange due to dysfunctions
    § Rate of necessity of catheter rescue with Alteplase
    § Rate of infections per 1000 catheter days
    § Rate of catheter exchange due to infections
    § Survival without any CRBSI
    § Hospitalization (number and days of hospitalization)
    § Cost analysis (incl. medication, hospitalization)
    § Use of antibiotics (number of episodes and days)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints will be documented during the observation period, which is until first occurrence of CRBSI or a maximum of 24 months
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 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 state240
    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)
    All patients will be continuously treated within the respective institution. Treatment will be continued after trial has ended.
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
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