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    Clinical Trial Results:
    Investigate the differences between treating Chronic Kidney Disease - Mineral and Bone Disorder with an iron-containing phosphate binder or a calcium-containing phosphate binder in Chronic Kidney Disease stage 3-5.

    Summary
    EudraCT number
    		 2017-002095-10
    Trial protocol
    		 DK  
    Global end of trial date
    14 Nov 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MV-2-2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medicinsk forskning
    Sponsor organisation address
    Lægårdvej 12, Holstebro, Denmark, 7500
    Public contact
    Marie Houmaa Vrist, Universitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, +45 78436585, Jesper.Noergaard.Bech@vest.rm.dk
    Scientific contact
    Marie Houmaa Vrist, Universitetsklinik for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, +45 78436585, Jesper.Noergaard.Bech@vest.rm.dk
    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
    09 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate whether treatment with an iron- or calcium-containing phosphate binder can affect differently the results from 18F-NaF PET/CT, bALP, osteocalcin, FGF23 og OPG/RANKL ratio. Differences in the stiffness of blood vessel assessed with applanation tonometry. Finally, we investigate changes in calcium score (TBR) and iron status
    Protection of trial subjects
    Blood samples every second week
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2018
    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
    Denmark: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    15
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Deltagerne er rekrutterret til ambulatoriet nyremedicisk Dagafsnit, holstebro Regionshospital, danmark

    Pre-assignment
    Screening details
    		 30-80 years and CKD stage 3-5d

    Period 1
    Period 1 title
    Behandlingsperiode 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Velphoro
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velphoroo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder.

    Arm title
    		 Unikalk basic
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Unikalk basic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder.

    Number of subjects in period 1
    		Velphoro Unikalk basic
    Started
    13
    13
    Completed
    8
    9
    Not completed
    5
    4
         Consent withdrawn by subject
    2
    1
         Physician decision
    -
    2
         Adverse event, non-fatal
    3
    -
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Behandlingsperiode 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Velphoro
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velphoro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder.

    Arm title
    		 unikalk
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Unikalk basic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment with SO or CC aimed to reduce p-phospate to < 1.8 mmol/L (CC up to 3600 mg/day; SO up to 3000 mg/day). However, if dose escalation did not reduce phosphate levels < 1.8 mmol/L, and the phosphate levels remained stable, further dose escalations were not performed. Treatment periods were 8 weeks however, if phosphorus level was not stable, the treatment was continued, though maximum 15 weeks. The treatment periods were separated by at minimum of a 2-week washout period. A run-in period of 2 weeks was applied if the patient already was treated with a phosphate binder.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Resultaterne fra de deltager der ikke har gennemført begge behandlingsperioder er ikke analyseret og derfor er baseline mest repræsentativt uden disse for at se om grupperne er ens
    Number of subjects in period 2 [2]
    		Velphoro unikalk
    Started
    9
    8
    Completed
    7
    7
    Not completed
    2
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Protocol deviation
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: En deltager bliver inkluderet men ønsker allerede inden han er randomiseret alleligevel ikke deltagelse.

    Baseline characteristics

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

    Reporting group title
    unikalk
    Reporting group description
    		 -

    Reporting group values
    		 Velphoro unikalk Total
    Number of subjects
    		 9 8 17
    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 (standard deviation)
    		 61 ± 4.2 64 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    		 2 4 6
        Male
    		 7 4 11

    End points

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    End points reporting groups
    Reporting group title
    Velphoro
    Reporting group description
    		 -

    Reporting group title
    Unikalk basic
    Reporting group description
    		 -
    Reporting group title
    Velphoro
    Reporting group description
    		 -

    Reporting group title
    unikalk
    Reporting group description
    		 -

    Primary: Ki (lumbal)

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    End point title
    		 Ki (lumbal) [1]
    End point description
    End point type
    Primary
    End point timeframe
    end of study
    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: Der er ikke valgt statistiske analyser, da data fra dette projekt er kombineret med et lignende projekt for at opnå brugbare resultater. Dette vil blive publiceret i en kommende artikel.
    End point values
    		 Velphoro unikalk
    Number of subjects analysed
    7
    7
    Units: ml/min-1/ml-1
        arithmetic mean (standard deviation)
    0.027 ± 0.01
    0.030 ± 0.01
    No statistical analyses for this end point

    Secondary: osteocalcin

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    End point title
    		 osteocalcin
    End point description
    End point type
    Secondary
    End point timeframe
    end of study
    End point values
    		 Velphoro unikalk
    Number of subjects analysed
    7
    7
    Units: ug/L
        arithmetic mean (standard deviation)
    149 ± 180
    134 ± 174
    No statistical analyses for this end point

    Secondary: bALP

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    End point title
    		 bALP
    End point description
    End point type
    Secondary
    End point timeframe
    end of study
    End point values
    		 Velphoro unikalk
    Number of subjects analysed
    7
    7
    Units: µg/l
        arithmetic mean (standard deviation)
    17.13 ± 6.4
    22.8 ± 11.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Fra første scanning til 48 timer efter sidste scanning
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Velphoro
    Reporting group description
    		 -

    Serious adverse events
    		 Velphoro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Velphoro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 22 (31.82%)
    Gastrointestinal disorders
    kvalme, opkast, forstoppelse eller mavesmerter
         subjects affected / exposed
    7 / 22 (31.82%)
         occurrences all number
    7

    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.
    Resultaterne fra dette studie vil blive publiseret sammen med da fra et tilsvarende studie med dialysepatienter, så antallet af deltager bliver højere og studiet dermed opnår nok power.
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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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