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    Clinical Trial Results:
    Role of different phosphate binders on absorption of vitamin K, metabolism of matrix γ-carboxy-glutamaat (Gla) proteïne (MGP).

    Summary
    EudraCT number
    		 2013-003949-41
    Trial protocol
    		 NL  
    Global end of trial date
    01 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2022
    First version publication date
    09 Apr 2022
    Other versions
    Summary report(s)
    		 main document

    Trial information

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    Trial identification
    Sponsor protocol code
    36810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VU medical center
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands, 1081HV
    Public contact
    Martijn Stolk, VU medical Center, 0031 204449322, m.stolk@vumc.nl
    Scientific contact
    Martijn Stolk, VU medical Center, 0031 204449322, m.stolk@vumc.nl
    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
    23 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in intestinal tract end thereby cause different level of calcification. Level of calcification will be measured by dp-ucMGP which is used as markers for vascular calcification. Because of the fact that ucMGP en dp-ucMGP are vitamin K dependant PIVKA-II will be measured as well. Better insight in mechanisms of vascular calcification under different circumstance can lead to therapeutic options which inhibit calcification and benefit survival of dialysis patients
    Protection of trial subjects
    The blood work during a dialysis sessions was monitored more frequently. There was no extra pain since the blood was drawn during dialysis.
    Background therapy
    		 No additional products were used.
    Evidence for comparator
    		 There is evidence that lanthanumcarbonate does bind fat soluble vitamins in vivo. this was the reason to compare this drug with calcium carbonate.
    Actual start date of recruitment
    01 Jan 2014
    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
    Netherlands: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    6
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In three Dutch dialysis centers (Noord West Ziekenhuisgroep location Alkmaar, Diapriva Amsterdam, Elyse clinic Amstelveen) hemodialysis patients were enrolled. Enrollment of patients started in October 2014 and the study follow up ended in September 2018

    Pre-assignment
    Screening details
    		 Clinically stable adult (age > 18 years) hemodialysis patients with a life expectancy of more than six months were screened.

    Period 1
    Period 1 title
    baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    there was no blinding implemented

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 lantahnum carbonate
    Arm description
    		 start with use of lantahnum carbonate
    Arm type
    		 Experimental

    Investigational medicinal product name
    lanthanum carbonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Soluble tablet
    Routes of administration
    Oral use
    Dosage and administration details
    three times a day 1000 mg for eight weeks

    Arm title
    		 calcium carbonate
    Arm description
    		 start with calcium carbonate use
    Arm type
    		 Experimental

    Investigational medicinal product name
    calciumcarbonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    three times a day 1000 mg for eight weeks

    Number of subjects in period 1
    		lantahnum carbonate calcium carbonate
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 12 12
    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
    65,4
    Units: years
        arithmetic mean (standard deviation)
    		 65 ( 11 ) -
    Gender categorical
    gender
    Units: Subjects
        Female
    		 4 4
        Male
    		 8 8
    baseline
    At inclusion, we captured data on age, medical history, dialysis vintage, medication, blood pressure and laboratory data. Every two weeks serum calcium, phosphate and albumin levels were measured.
    Units: depending on the variable
        arithmetic mean (standard deviation)
    		 1914 ( 651 ) -
    Subject analysis sets

    Subject analysis set title
    baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    baseline

    Subject analysis sets values
    		 baseline
    Number of subjects
    12
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    65,4
    Units: years
        arithmetic mean (standard deviation)
    65 ( 11 )
    Gender categorical
    gender
    Units: Subjects
        Female
    4
        Male
    8
    baseline
    At inclusion, we captured data on age, medical history, dialysis vintage, medication, blood pressure and laboratory data. Every two weeks serum calcium, phosphate and albumin levels were measured.
    Units: depending on the variable
        arithmetic mean (standard deviation)
    1914 ( 651 )

    End points

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    End points reporting groups
    Reporting group title
    lantahnum carbonate
    Reporting group description
    		 start with use of lantahnum carbonate

    Reporting group title
    calcium carbonate
    Reporting group description
    		 start with calcium carbonate use

    Subject analysis set title
    baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    baseline

    Primary: dp-uc-MGP

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    End point title
    		 dp-uc-MGP
    End point description
    Primary end point was the difference in dp-ucMGP and PIVKA-II after 8 weeks of treatment between LC and CC.
    End point type
    Primary
    End point timeframe
    Primary end point was the difference in dp-ucMGP and PIVKA-II after 8 weeks of treatment between LC and CC.
    End point values
    		 lantahnum carbonate calcium carbonate
    Number of subjects analysed
    6
    6
    Units: dp-uc-MGP
    arithmetic mean (standard deviation)
        difference between dp-uc-MGP
    20 ( 0 )
    5 ( 0 )
    Attachments
    		 baseline
    laboratory parameters
    Statistical analysis title
    		 difference in dp-uc-MGP between
    Statistical analysis description
    difference in dp-uc-MGP between the groups after 8 weeks of treatment
    Comparison groups
    lantahnum carbonate v calcium carbonate
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.9 [2]
    Method
    		 lineair mixed model
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - cross over study, the patients that completed at least one period of 8 weeks of treatment with a binder were analysed.
    [2] - not significant

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 patients got admitted to the hospital, however the admission was not a side effect of the medication.
    Adverse event reporting additional description
    1 patient got admitted with galbladder problems and other one with pneumonia.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ABR formulier
    Dictionary version
    1
    Reporting groups
    Reporting group title
    lanthanumcarbonate
    Reporting group description
    		 One patient with gall bladder problems got admitted. The study medication was not a causative factor.

    Reporting group title
    calciumcarbonate
    Reporting group description
    		 One patient gor admitted for pneumonia. This was not due to the use of the study medication

    Serious adverse events
    		 lanthanumcarbonate calciumcarbonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 lanthanumcarbonate calciumcarbonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    Hepatobiliary disorders
    gall bladder problems
    Additional description: patients was admitted for gall bladder problems, these were unrelated to the study medication
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    Additional description: Admittance for pneumonia. study medication was not a causative factor.
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    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.
    the number of patients that completed the trial was very small.
    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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