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    Clinical Trial Results:
    apixaban in end -stage renal disease

    Summary
    EudraCT number
    		 2015-003132-12
    Trial protocol
    		 BE  
    Global end of trial date
    24 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2021
    First version publication date
    03 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    s57150
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03456648
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Bjorn Meijers, UZ Leuven, 32 16342409, bjorn.meijers@uzleuven.be
    Scientific contact
    Bjorn Meijers, UZ Leuven, 32 16342409, bjorn.meijers@uzleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to determine inter-dialytic pharmacokinetics of Apixaban
    Protection of trial subjects
    Patients were under direct supervision of a (para-)medic during the first 24 hours after administration of the IMP
    Background therapy
    		 Maintenance hemodialysis (hemodiafiltration not allowed) three times/ week During study period regional citrate anticoagulation with a calcium-containing dialysate was used
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients treated with maintenance hemodialysis by the dialysis unit of the university hospitals Leuven. Patients were recruited between 09-09-2016 and 12-04-2018

    Pre-assignment
    Screening details
    		 Inclusion criteria - Patients aged 18 to 85 years - Maintenance (dialysis vintage >3 months) thrice weekly hemodialysis Exclusion criteria - Treated with oral vitamin K antagonists - Recent (< 4 weeks prior to informed consent) major surgery - Recent (< 4 weeks prior to informed cons severe bleeding episode requiring blood transfusion

    Period 1
    Period 1 title
    Single dose PD (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High Dose predialysis
    Arm description
    		 apixaban 5 mg pre-dialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Apixaban 5 mg

    Arm title
    		 low dose predialysis
    Arm description
    		 Apixaban 2.5 mg pre-dialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Apixaban 2.5 mg

    Arm title
    		 High dose post-dialysis
    Arm description
    		 Apixaban 5 mg post-dialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Apixaban 5 mg taken after the hemodialysis session

    Arm title
    		 Low dose post-dialysis
    Arm description
    		 Apixaban 2.5 mg post-dialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Apixaban 2.5 mg

    Number of subjects in period 1
    		High Dose predialysis low dose predialysis High dose post-dialysis Low dose post-dialysis
    Started
    6
    6
    6
    6
    Completed
    6
    6
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    High Dose predialysis
    Reporting group description
    		 apixaban 5 mg pre-dialysis

    Reporting group title
    low dose predialysis
    Reporting group description
    		 Apixaban 2.5 mg pre-dialysis

    Reporting group title
    High dose post-dialysis
    Reporting group description
    		 Apixaban 5 mg post-dialysis

    Reporting group title
    Low dose post-dialysis
    Reporting group description
    		 Apixaban 2.5 mg post-dialysis

    Reporting group values
    		 High Dose predialysis low dose predialysis High dose post-dialysis Low dose post-dialysis Total
    Number of subjects
    		 6 6 6 6 24
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 71.7 (63 to 85) 59.3 (33 to 85) 72.8 (66 to 84) 70.5 (64 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 3 4 10
        Male
    		 4 5 3 2 14

    End points

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    End points reporting groups
    Reporting group title
    High Dose predialysis
    Reporting group description
    		 apixaban 5 mg pre-dialysis

    Reporting group title
    low dose predialysis
    Reporting group description
    		 Apixaban 2.5 mg pre-dialysis

    Reporting group title
    High dose post-dialysis
    Reporting group description
    		 Apixaban 5 mg post-dialysis

    Reporting group title
    Low dose post-dialysis
    Reporting group description
    		 Apixaban 2.5 mg post-dialysis

    Primary: AUC (0-48h)

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    End point title
    		 AUC (0-48h)
    End point description
    Area under the curve (AUC) from intake until 48 hours after intake
    End point type
    Primary
    End point timeframe
    Single dose AUC 0-48 h
    End point values
    		 High Dose predialysis low dose predialysis High dose post-dialysis Low dose post-dialysis
    Number of subjects analysed
    6
    6
    6
    6
    Units: ng/mL/h
        median (full range (min-max))
    2792.1 (1750 to 3788)
    1159 (563 to 1938)
    3817.6 (1243 to 5604)
    2214.2 (479 to 4411)
    Statistical analysis title
    		 overall difference AUC
    Statistical analysis description
    Kruskall-Wallis (non-parametric ANOVA)
    Comparison groups
    High Dose predialysis v low dose predialysis v High dose post-dialysis v Low dose post-dialysis
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0186 [2]
    Method
    		 ANOVA
    Parameter type
    		 Kruskall-Wallis distribution of variance
    Point estimate
    0.019
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.011
         upper limit
    		 0.026
    Variability estimate
    Standard deviation
    Dispersion value
    0.008
    Notes
    [1] - Kruskall-Wallis (non-parametric ANOVA)
    [2] - overall difference

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days after administration of IMP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    9
    Reporting groups
    Reporting group title
    High Dose predialysis
    Reporting group description
    		 apixaban 5 mg pre-dialysis

    Reporting group title
    low dose predialysis
    Reporting group description
    		 Apixaban 2.5 mg pre-dialysis

    Reporting group title
    High dose post-dialysis
    Reporting group description
    		 Apixaban 5 mg post-dialysis

    Reporting group title
    Low dose post-dialysis
    Reporting group description
    		 Apixaban 2.5 mg post-dialysis

    Serious adverse events
    		 High Dose predialysis low dose predialysis High dose post-dialysis Low dose post-dialysis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Hepatobiliary disorders
    Liver function test increased
    Additional description: subacute liver failure
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
    Additional description: severe upper respiratory tract infection requiring hospitalization
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Inflammation
    Additional description: inflammation requiring hospitalization
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 High Dose predialysis low dose predialysis High dose post-dialysis Low dose post-dialysis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    Hepatobiliary disorders
    liver function test abnormal
    Additional description: Mild elevation of liver function tests
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Single centre, single dose pharmacodynamics study
    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.

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