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    Clinical Trial Results:
    Prevention of Aortic Stenosis Pilot Trial

    Summary
    EudraCT number
    		 2015-000704-25
    Trial protocol
    		 GB  
    Global end of trial date
    11 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    		 Study paper

    Trial information

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    Trial identification
    Sponsor protocol code
    PASP01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN17365679
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 N/A: N/A
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    David Wald, Queen Mary University of London, 0044 02078826298, d.s.wald@qmul.ac.uk
    Scientific contact
    David Wald, Queen Mary University of London, 0044 02078826298, d.s.wald@qmul.ac.uk
    Sponsor organisation name
    Queen Mary University of london
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Prof D Wald, Queen Mary University of London, 0044 207 882 7279, d.s.wald@qmul.ac.uk
    Scientific contact
    Prof D Wald, Queen Mary University of London, 0044 207 882 7279, d.s.wald@qmul.ac.uk
    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
    02 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the within-person differences in serum phosphate after taking sevelamer at 2.4g/day and 7.2g/day compared with placebo.
    Protection of trial subjects
    The trial was designed to minimise inconvenience to patients in terms of the number of visits they needed to make to the study centre and interns of managing the pill burden
    Background therapy
    		 N/A
    Evidence for comparator
    		 A matching placebo was used.
    Actual start date of recruitment
    15 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    10
    From 65 to 84 years
    60
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2017 and June 2018 patients were recruited from 2 UK centres in London (St Bartholomews Hospital and Guys & St Thomas;s Hospital).

    Pre-assignment
    Screening details
    		 All patients had mild to moderate Aortic stenosis defined as peak velocity of trans aortic valve blood flow between 2.0 and 4.0m/s. They were not eligible if they were pregnant or breast feeding, allergic to sevelamer, had a history of hypophosptanemia, bowel obstruction, locates intolerance, required phosphate binding drugs or other interacting

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Randomised schedule produced independently of clinical investigators. Active and matching placebo packaged independently. Allocation sequence concealed from investigators and subjects and analysis's.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 sevelamer
    Arm description
    		 Sevelamer (800mg) taken with food at meal times up to a maximum of 2.4g per day for 6 weeks Sevelamer (2.4g) taken with food at meal times up to a maximum of 7.2g per day for 6 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevelamer
    Investigational medicinal product code
    PRD1627600-1627608
    Other name
    Sevelamer Carbonate
    Pharmaceutical forms
    Film-coated tablet and gastro-resistant granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg tablets, one with each meal up to 2.4g per day for 6 weeks orally

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    PLACEBO of Sevelamer carbonate 800 mg Film-coated tablets
    Investigational medicinal product code
    N/a
    Other name
    Pharmaceutical forms
    Film-coated tablet and gastro-resistant granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching Placebo - 3 times daily with food; each regimen lasted 6 weeks

    Number of subjects in period 1
    		sevelamer Placebo
    Started
    72
    72
    Completed
    61
    61
    Not completed
    11
    11
         Too many Pills
    -
    4
         Adverse event, non-fatal
    7
    7
         Too many Pills
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 72 72
    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
        median (full range (min-max))
    		 65 (35 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 53 53

    End points

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    End points reporting groups
    Reporting group title
    sevelamer
    Reporting group description
    		 Sevelamer (800mg) taken with food at meal times up to a maximum of 2.4g per day for 6 weeks Sevelamer (2.4g) taken with food at meal times up to a maximum of 7.2g per day for 6 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Primary: Change in serum phosphate concentration

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    End point title
    		 Change in serum phosphate concentration [1]
    End point description
    To determine the within-person differences in serum phosphate concentration after taking sevelamer at 2.4g/day and 7.2g/day compared with placebo.
    End point type
    Primary
    End point timeframe
    pre and post study treatment periods
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The System does not accept the data being entered- this is blank. Full data attached in study document
    End point values
    		 sevelamer Placebo
    Number of subjects analysed
    61
    61
    Units: mg/Dl
        number (not applicable)
    61
    61
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Through our the study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The System does not accept the data being entered- this is blank. Full data attached in study document

    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.
    None reported
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    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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