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    Summary
    EudraCT Number:2019-003100-13
    Sponsor's Protocol Code Number:KKSH-154
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-003100-13
    A.3Full title of the trial
    Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention
    Pharmakokinetik von Edoxaban zur Schlaganfallprävention bei Patienten mit fortgeschrittener chronischer Nierenerkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention
    Pharmakokinetik von Edoxaban zur Schlaganfallprävention bei Patienten mit fortgeschrittener chronischer Nierenerkrankung
    A.3.2Name or abbreviated title of the trial where available
    EdoxCKD
    EdoxCKD
    A.4.1Sponsor's protocol code numberKKSH-154
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    B.1.3.4CountryGermany
    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 supportDaiichi Sankyo Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Strasse 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.6E-mailmatthias.girndt@uk-halle.de
    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 Lixiana
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.3Other descriptive nameEDOXABAN
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 RoleComparator
    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 Lixiana
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.3Other descriptive nameEDOXABAN
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Nonvalvular Atrial Fibrillation
    nicht-valvuläres Vorhofflimmern
    E.1.1.1Medical condition in easily understood language
    Nonvalvular Atrial Fibrillation
    nicht-valvuläres Vorhofflimmern
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to analyse the pharmacokinetics (PK) of Edoxaban with reduced dose (30 mg once daily) in CKD patients with Cockcroft-Gault CreaCl 15 - 29 ml/min (group 1) and CKD patients with Cockcroft-Gault CreaCl 30 - 49 ml/min (group 2, experimental groups) each compared to normal dose (60 mg once daily) in patients with Cockcroft-Gault CreaCl ≥ 50 ml/min (group 3, control group).
    Das primäre Ziel ist die Analyse der Pharmakokinetik (PK) von Edoxaban mit reduzierter Dosis (30 mg einmal täglich) bei CKD-Patienten mit Cockcroft-Gault CreaCl 15 - 29 ml/min (Studienarm 1) und CKD-Patienten mit Cockcroft-Gault CreaCl 30 - 49 ml/min (Studienarm 2, experimentelle Gruppen) jeweils im Vergleich zu normaler Dosis (60 mg einmal täglich) bei Patienten mit Cockcroft-Gault CreaCl ≥ 50 ml/min (Studienarm 3, Kontrollgruppe).
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the safety profile of the therapy, regarding (Serious) Adverse events.
    Das sekundäre Ziel ist die Untersuchung der Sicherheit der Therapie, in Hinblick auf (Schwerwiegende) Unerwünsche Ereignisse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients aged 18 - 89 years
    - Non-valvular atrial fibrillation
    - Indication for initiation of oral anticoagulation therapy
    - Cockcroft-Gault CreaCl 15 ml/min or higher
    - CHA2DS2-VASc risk score ≥ 2 (men) or ≥ 3 (women)
    - hospitalisation for reasons other than mere participation in this study
    - Body weight from ≥60 kg to ≤125 kg during screening
    - Written informed consent
    - For women of childbearing potential: consent to the use of highly effective contraception (Pearl Index < 1)
    - For men: consent to the use of condom as an additional contraception
    - Männliche und weibliche Patienten im Alter von 18 - 89 Jahren
    - Nicht-valvuläres Vorhofflimmern
    - Indikation zur Einleitung einer oralen Antikoagulationstherapie
    - Cockcroft-Gault CreaCl 15 ml/min oder höher
    - CHA2DS2-VASc risk score ≥ 2 (Männer) oder ≥ 3 (Frauen)
    - Krankenhausaufenthalt aus anderen Gründen als der bloßen Teilnahme an dieser Studie
    - Körpergewicht von ≥60 kg bis ≤125 kg beim Screening
    - Schriftliche Einwilligung nach Aufklärung
    - Bei gebärfähigen Frauen: Einverständnis zur Anwendung einer hocheffektiven Empfängnisverhütung (Pearl-Index < 1)
    - Bei Männern: Einverständnis zur Anwendung eines Kondoms als zusätzliches Verhütungsmittel
    E.4Principal exclusion criteria
    - Cockcroft-Gault CreaCl < 15ml/min, unstable kidney function and/or need for renal replacement therapy
    - Presence of a functional kidney transplant
    - Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal product
    - Clinically relevant, active bleeding
    - Hepatic Disease associated with coagulopathy and clinically relevant bleeding risk
    - Liver cirrhosis Child-Pugh stage C
    - lesion or condition that may put the patient at significant risk for major bleeding, including but not limited to:
    - Acute or recent (< 1 month) gastrointestinal ulceration,
    - Malignant neoplasms at high risk of bleeding,
    - Recent (< 1 month) brain or spinal injuries,
    - Recent (< 1 month) brain, spinal or ophthalmic surgery,
    - Recent (< 1 month) intracranial hemorrhage,
    - Known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
    - Uncontrolled, severe arterial hypertension
    - Current use (up to 7 days before screening) of NOAC or VKA
    - Simultaneous systemic use of heparin or its derivatives (UFH, low molecular weight heparins, Fondaparinux, etc.) except under special circumstances of switching to oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
    - Simultaneous systemic use of NSAIDs
    - Pregnancy and lactation
    - Co-treatment with one of the P-glycoprotein inhibitors Ciclosporin, Dronedarone, Erythromycin, Ketoconazole within the last 14 days, except for topical use
    - Co-treatment with one of the P-glycoprotein inducers Apalutamid, Carbamazepin, Enzalutamid, Johanniskraut, Letermovir, Phenobarbital, Phenytoin, Pitolisant, Rifampicin within the last 14 days
    - Inability to understand study procedures and to give informed consent
    - Persons who due to judicial or administrative
    arrangement are housed in an institution
    - Simultaneous participation in another interventional study
    - Cockcroft-Gault CreaCl < 15ml/min, instabile Nierenfunktion und/oder Notwendigkeit einer Nierenersatztherapie
    - Vorhandensein eines funktionellen Nierentransplantats
    - Bekannte Überempfindlichkeit gegenüber dem Wirkstoff oder einem der Hilfsstoffe des Prüfpräparats
    - Klinisch relevante, aktive Blutung
    - Lebererkrankung mit Koagulopathie und klinisch relevantem Blutungsrisiko
    - Leberzirrhose Child-Pugh Stadium C
    - Läsion oder Zustand, der den Patienten einem erheblichen Risiko für schwere Blutungen aussetzen kann, einschließlich aber nicht beschränkt auf:
    - Akute oder kürzlich (< 1 Monat) aufgetretene gastrointestinale Ulzerationen,
    - Maligne Neoplasien mit hohem Blutungsrisiko,
    - Kürzlich (< 1 Monat) aufgetretene Hirn- oder Rückenmarksverletzungen,
    - Kürzlich (< 1 Monat) durchgeführte chirurgische Eingriffe an Gehirn, Rückenmark oder Augen,
    - Kürzlich (< 1 Monat) aufgetretene intrakranielle Blutungen,
    - Bekannte oder vermutete Ösophagusvarizen, arteriovenöse Fehlbildungen, Gefäßaneurysmen oder größere intraspinale oder intrazerebrale Gefäßanomalien
    - Unkontrollierte, schwere arterielle Hypertonie
    - Aktuelle Nutzung (bis zu 7 Tage vor dem Screening) von NOAC oder VKA
    - Gleichzeitige systemische Anwendung von Heparin oder seinen Derivaten (UFH, niedermolekulare Heparine, Fondaparinux usw.), außer unter besonderen Umständen bei Umstellung auf orale Antikoagulanzientherapie oder wenn UFH in Dosen verabreicht wird, die zur Aufrechterhaltung eines offenen zentralvenösen oder arteriellen Katheters erforderlich sind
    - Gleichzeitige systemische Anwendung von NSAIDs
    - Schwangerschaft und Stillen
    - Co-Behandlung mit einem der P-Glykoprotein-Inhibitoren Ciclosporin, Dronedaron, Erythromycin, Ketoconazol, innerhalb der letzten 14 Tage, außer bei topischer Anwendung
    - Co-Behandlung mit einem der P-Glykoprotein-Induktoren Apalutamid, Carbamazepin, Enzalutamid, Johanniskraut, Letermovir, Phenobarbital, Phenytoin, Pitolisant, Rifampicin innerhalb der letzten 14 Tage
    - Unfähigkeit, die Studienprozedere zu verstehen und eine Einwilligung nach Aufklärung zu erteilen
    - Personen, die auf gerichtliche oder behördliche
    Anordnung in einer Anstalt untergebracht sind
    - Gleichzeitige Teilnahme an einer anderen interventionellen Studie
    E.5 End points
    E.5.1Primary end point(s)
    Edoxaban AUC0-24 in steady-state (visit 3)

    The visit 3 can already take place from day 5 for patients in group 2 (CreaCl 30 - 49 ml/min) and from day 4 for patients in group 3 (CreaCl ≥ 50 ml/min).
    Edoxaban AUC0-24 im steady-state (Visite 3)

    Für Patienten im Studienarm 2 (CreaCl 30 - 49 ml/min) kann Visite 3 bereits ab Tag 5 und für Patienten im Studienarm 3 (CreaCl ≥ 50 ml/min) ab Tag 4 erfolgen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 6 of study therapy

    Optional: from day 5 for patients in group 2 (CreaCl 30 - 49 ml/min) and from day 4 for patients in group 3 (CreaCl ≥ 50 ml/min)
    Tag 6 der Studientherapie

    Optional: ab Tag 5 für Patienten im Studienarm 2 (CreaCl 30 - 49 ml/min) und ab Tag 4 für Patienten im Studienarm 3 (CreaCl ≥ 50 ml/min)
    E.5.2Secondary end point(s)
    - Pharmacokinetic parameters of Edoxaban and the active M4 metabolites
    - Adverse Events, Serious Adverse Events, Bleeding Events
    - Pharmakokinetische Parameter von Edoxaban und dem aktiven M4-Metaboliten
    - Unerwünschte Ereignisse, Schwerwiegende unerwünschte Ereignisse, Blutungsereignisse
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 1 (visit 1), 6 (visit 3, optional for group 2 from day 5 and for group 3 grom day 4) and 14 (visit 4): pharmacokinetic parameters of Edoxaban and the active M4 metabolites
    - Throughout the entire study therapy, day 1 to 14: adverse events, serious adverse events, bleeding events
    - Tag 1 (Visite 1), 6 (Visite 3, optional für Studienarm 2 ab Tag 5 und für Studienarm 3 ab Tag 4) und 14 (Visite 4): pharmakokinetische Parameter von Edoxaban und dem aktiven M4-Metaboliten
    - Während der gesamten Studientherapie, Tag 1 bis 14: unerwünschte Ereignisse, schwerwiegende unerwünschte Ereignisse, Blutungsereignisse
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 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 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 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
    Letzte Studienvisite des letzten Patienten
    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 months1
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state72
    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)
    Further treatment after completion of the trial will not differ from the expected normal treatment of that condition and is the responsibility of the attending physician at the trial site. Since Edoxaban is approved for the prophylaxis of stroke and peripheral embolism in patients with atrial fibrillation in the entire renal function spectrum which may be included here, further treatment with this substance by the after-care physician is recommended.
    Die Weiterbehandlung nach Beendigung der Studie wird sich nicht von der erwarteten, normalen Therapie der Erkrankung unterscheiden und obliegt dem behandelnden Arzt an der Prüfstelle. Da Edoxaban für die Prophylaxe von Schlaganfall und peripherer Embolie bei Patienten mit Vorhofflimmern im gesamten Nierenfunktionsspektrum das hier eingeschlossen werden kann, zugelassen ist, wird eine Weiterbehandlung mit dieser Substanz durch den nachbetreuenden Arzt empfohlen.
    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 Decision2020-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-31
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