Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000334-17
    Sponsor's Protocol Code Number:TRACK_001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-000334-17
    A.3Full title of the trial
    Treatment of cardiovascular disease with low Rivaroxaban in Advanced Chronic Kidney Disease - TRACK trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of heart and blood vessel disease (cardiovascular disease) with
    low dose blood thinner (low rivaroxaban) in people with advanced kidney
    disease or receiving dialysis (advanced chronic kidney disease)
    A.3.2Name or abbreviated title of the trial where available
    TRACK
    A.4.1Sponsor's protocol code numberTRACK_001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03969953
    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 SponsorThe George Institute of Global Health
    B.1.3.4CountryAustralia
    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 supportNational Health and Medical Research Council
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportMinistère de la Santé (Ministry of Health)
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe George Institute of Global Health
    B.5.2Functional name of contact pointTRACK Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressLevel 5, 1 King St
    B.5.3.2Town/ cityNewtown
    B.5.3.3Post code2042
    B.5.3.4CountryAustralia
    B.5.4Telephone number0061280524511
    B.5.6E-mailtracktrial@georgeinstitute.org.au
    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 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 nameRivaroxaban
    D.3.2Product code BAY 59-7939
    D.3.4Pharmaceutical form 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 INNRivaroxaban
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Improvement of cardiovascular outcomes in patients with advanced
    chronic kidney disease.
    E.1.1.1Medical condition in easily understood language
    Heart and blood vessel disease
    Kidney disease
    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
    To determine whether low dose rivaroxaban (2.5mg twice daily),
    compared to placebo, significantly reduces the risk of a composite
    outcome of Cardio vascular (CV) death, non-fatal myocardial infarction,
    stroke or peripheral arterial disease events, in patients with chronic
    kidney disease stages 4 or 5 or dialysis-dependent kidney failure, and an
    elevated CV risk
    E.2.2Secondary objectives of the trial
    To determine whether, in people with CKD stages 4 or 5 kidney failure or
    dialysis and an elevated CV risk, low dose rivaroxaban compared to
    placebo reduces the risk of CV death, all cause death risk, risk of
    individual components of composite outcomes, and risk of venous
    thromboembolism.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TRACK - French Ancillay Study (FRANCE ONLY)
    We will measure a) plasma PTX2, a novel partner for FX and b) plasma
    concentrations of the innovative antagonist of TGF-β signaling (CD109).
    We will also evaluate their association with Mineralocorticoid-receptordependent
    NGAL and galectin-3 fibrotic biomarkers (which role is being
    studied in depth by Inserm U1116 including P. Rossignol).
    E.3Principal inclusion criteria
    1. Age ≥18 years,
    2. Kidney failure on haemodialysis or peritoneal dialysis, or CKD stage 4
    or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement
    therapy,
    3. Elevated CV risk, defined by at least one of the following:
    a. History of CAD or PAD or non-haemorrhagic non-lacunar stroke,
    or
    b. Diabetes mellitus, or
    c. Age ≥65 years.
    E.4Principal exclusion criteria
    1. Mechanical/prosthetic heart valve (does not include bioprosthetic
    valves that do not require therapeutic anticoagulation),
    2. Indication for, or contraindication to, anticoagulant therapy,
    3. High bleeding risk including any coagulopathy,
    4. Lesion or condition considered to be a significant risk of major
    bleeding,
    5. Major bleeding episode in the 30 days prior to study enrolment, or any
    active and clinically significant bleeding,
    6. Current treatment with P2Y12 inhibitors/adenosine diphosphate
    (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor)
    or phosphodiesterase inhibitors (dipyridamole), where the treating
    physician or patient does not wish to stop these medications,
    7. Concurrent treatment with strong inhibitors of combined CYP3A4 and
    P-glycoprotein; or strong inducers of CYP3A4,
    8. Any stroke within 1 month prior to enrolment,
    9. Any previous history of a haemorrhagic or lacunar stroke,
    10. Severe heart failure with known ejection fraction <30% or NYHA
    class III or IV symptoms,
    11. History of hypersensitivity or known contraindication to rivaroxaban,
    12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP
    ≥110 mm Hg) at the time of screening,
    13. Haemoglobin <90 g/L, or platelet count <100 x 109/L,
    14. Significant liver disease (defined as Child-Pugh Class B or C) or ALT
    >3 times upper normal limit,
    15. Kidney transplant recipients with a functioning allograft, or
    scheduled for living-donor kidney transplant surgery,
    16. All countries except Europe: Pregnancy or intention to become
    pregnant or breast-feeding; Europe only: Women who are not in a
    postmenopausal state, where postmenopausal is defined as no menses
    for 12 months without alternative medical causes,
    17. Inability to understand or comply with the requirements of the
    study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is a composite of cardiovascular death,
    non-fatal myocardial infarction, stroke, or peripheral artery disease
    event.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable
    E.5.2Secondary end point(s)
    1. 3-point MACE (cardiovascular death, non-fatal myocardial infarction,
    or stroke),
    2. All-cause death,
    3. Composite of all-cause death, non-fatal myocardial infarction, or
    stroke,
    4. Composite of all-cause death, non-fatal myocardial infarction, or
    stroke, or peripheral artery disease event,
    XML File Identifier: DVFg7GynzItyp0fYxDU9ITtN89M=
    Page 12/21
    5. Individual components of the composite outcomes,
    6. Net-clinical-benefit outcome (a composite outcome of cardiovascular
    death, non-fatal myocardial infarction, stroke, PAD events, fatal
    bleeding, or symptomatic bleeding into a critical organ),
    7. Venous thromboembolism.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    India
    Malaysia
    Saudi Arabia
    Singapore
    Taiwan
    Tunisia
    France
    Germany
    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
    This is an event-driven trial. The trial will continue until a total of 515
    participants experience a primary endpoint event. The expected
    maximum duration of follow-up will be approximately 5 years from the
    recruitment of the first participant. All participants will remain in the
    trial even if they permanently discontinue the study medication or
    commence dialysis therapy or change the dialysis modality (except
    where the participant withdraws consent) or undergo kidney
    transplantation.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 2000
    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
    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 Decision2023-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 02:49:22 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA