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    Clinical Trial Results:
    A randomized, prospective, double-blind, comparative placebo-controlled study of intravenous iron isomaltoside 1000 (Monofer®) administered by infusions to iron-deficient blood donors

    Summary
    EudraCT number
    		 2012-001529-28
    Trial protocol
    		 DK  
    Global end of trial date
    23 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Dec 2017
    First version publication date
    07 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P-Monofer-BD-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01895231
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pharmacosmos A/S
    Sponsor organisation address
    Roervangsvej 30, Holbaek, Denmark, DK-4300
    Public contact
    Clinical trial disclosure desk, Pharmacosmos A/S, Pharmacosmos A/S, +45 59485935, trial@pharmacosmos.com
    Scientific contact
    Clinical trial disclosure desk, Pharmacosmos A/S, Pharmacosmos A/S, +45 59485935, trial@pharmacosmos.com
    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 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo in first-time female donors with p-ferritin below 60 µg/L. The safety objective of the study is to evaluate the safety of IV iron isomaltoside 1000 compared to placebo.
    Protection of trial subjects
    The protocol and amendments were approved by local ethics committees/Institutional Review Boards and competent authorities. The trial was conducted in accordance with good clinical practice and the Declaration of Helsinki. Informed consent was obtained in writing prior to any trial-related activities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2013
    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
    Denmark: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    85
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were screened in the period 07 June 2013 to 30 June 2016. The trial took place at one site in Denmark.

    Pre-assignment
    Screening details
    		 Women aged ≥ 18 years, who were first time blood donors and had a p-ferritin concentration < 60 ng/mL were able to participate in the trial after having signed the informed consent form.

    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
    Blinding implementation details
    Randomisation, preparation, and connection of infusions were handled by personnel otherwise unrelated to the trial. Infusion bags and disposables were non-transparent. In order to ensure that, the infusion bags and all visible disposables will be wrapped in aluminium foil by the personnel unrelated to the trial. All used material will be removed by the same person without revealing the infused fluid. The monitor performing data monitoring and site management (except IMP handling) was blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A, iron isomaltoside
    Arm description
    		 1000 mg iron isomaltoside was administered as a single IV infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron isomaltoside
    Investigational medicinal product code
    ATC code: B03AC
    Other name
    Monofer, Monover, Monofar, Monoferro
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg iron isomaltoside was administered as a single IV infusion. Iron isomaltoside is available as a dark brown, non-transparent aqueous solution for injection/infusion containing 100 mg iron/mL with pH between 5.0 and 7.0.

    Arm title
    		 Group B, placebo
    Arm description
    		 A 100 ml 0.9 % sodium chloride solution was used as an IV placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects in the placebo group received saline (0.9 % sodium chloride) as a single dose infusion of 100 mL.

    Number of subjects in period 1
    		Group A, iron isomaltoside Group B, placebo
    Started
    43
    42
    Completed
    40
    36
    Not completed
    3
    6
         Consent withdrawn by subject
    1
    -
         Protocol non-compliance
    -
    1
         Could not draw blood samples due to tiny veins.
    1
    -
         Adverse event, non-fatal
    -
    1
         Pregnancy
    -
    1
         Lost to follow-up
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A, iron isomaltoside
    Reporting group description
    		 1000 mg iron isomaltoside was administered as a single IV infusion.

    Reporting group title
    Group B, placebo
    Reporting group description
    		 A 100 ml 0.9 % sodium chloride solution was used as an IV placebo.

    Reporting group values
    		 Group A, iron isomaltoside Group B, placebo Total
    Number of subjects
    		 43 42 85
    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
    Age was calculated by subtracting the screening visit date with the birth date.
    Units: years
        arithmetic mean (standard deviation)
    		 23.2 ( 3.7 ) 24.9 ( 6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 42 85
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all subjects who were randomized and received at least one dose of the trial drug.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS population consisted of all subjects who were randomized, received at least one dose of the trial drug, and had at least one post baseline Hb assessment.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population included all subjects in the FAS who did not have any major protocol deviation.

    Subject analysis sets values
    		 Safety population Full analysis set Per protocol analysis set
    Number of subjects
    82
    80
    74
    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
    Age was calculated by subtracting the screening visit date with the birth date.
    Units: years
        arithmetic mean (standard deviation)
    24.1 ( 5.1 )
    24.1 ( 5.1 )
    24.3 ( 5.3 )
    Gender categorical
    Units: Subjects
        Female
    82
    80
    74
        Male
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Group A, iron isomaltoside
    Reporting group description
    		 1000 mg iron isomaltoside was administered as a single IV infusion.

    Reporting group title
    Group B, placebo
    Reporting group description
    		 A 100 ml 0.9 % sodium chloride solution was used as an IV placebo.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all subjects who were randomized and received at least one dose of the trial drug.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS population consisted of all subjects who were randomized, received at least one dose of the trial drug, and had at least one post baseline Hb assessment.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population included all subjects in the FAS who did not have any major protocol deviation.

    Primary: Change in Hb concentration from baseline to right before the third blood donation, FAS

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    End point title
    		 Change in Hb concentration from baseline to right before the third blood donation, FAS
    End point description
    Change in Hb concentration from baseline to right before the third blood donation. Analysis performed on the FAS.
    End point type
    Primary
    End point timeframe
    Change in Hb concentration from baseline to right before the third blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    39
    34
    Units: g/dL
        arithmetic mean (standard deviation)
    1.8 ( 0.777 )
    0.45 ( 0.883 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The primary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment as factor and baseline value as covariate.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2527
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8979
         upper limit
    		 1.6076
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1782

    Primary: Change in Hb concentration from baseline to right before the third blood donation, PP

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    End point title
    		 Change in Hb concentration from baseline to right before the third blood donation, PP
    End point description
    Change in Hb concentration from baseline to right before the third blood donation. Analysis performed on the PP analysis set.
    End point type
    Primary
    End point timeframe
    Change in Hb concentration from baseline to right before the third blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    35
    33
    Units: g/dL
        arithmetic mean (standard deviation)
    1.86 ( 0.74 )
    0.44 ( 0.896 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The primary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3054
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9357
         upper limit
    		 1.6751
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1854

    Secondary: Change in Hb concentrations from baseline to right before second donation

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    End point title
    		 Change in Hb concentrations from baseline to right before second donation
    End point description
    Change in Hb concentrations from baseline to right before second donation. Analysis performed on the FAS.
    End point type
    Secondary
    End point timeframe
    Change in Hb concentrations from baseline to right before second donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    40
    38
    Units: g/dL
        arithmetic mean (standard deviation)
    1.72 ( 0.748 )
    1.35 ( 0.801 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The secondary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0327
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3538
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.678
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.163

    Secondary: Change in p-ferritin concentrations from baseline to 12 weeks after first blood donation

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    End point title
    		 Change in p-ferritin concentrations from baseline to 12 weeks after first blood donation
    End point description
    Change in p-ferritin concentrations from baseline to 12 weeks after first blood donation. Analysis performed on the FAS.
    End point type
    Secondary
    End point timeframe
    Change in p-ferritin concentrations from baseline to 12 weeks after first blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    39
    36
    Units: ng/mL
        arithmetic mean (standard deviation)
    149.5 ( 69.75 )
    9.1 ( 10.51 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The secondary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    135.0135
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 112.135
         upper limit
    		 157.892
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.477

    Secondary: Change in p-ferritin concentrations from baseline to 12 weeks after second blood donation

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    End point title
    		 Change in p-ferritin concentrations from baseline to 12 weeks after second blood donation
    End point description
    Change in p-ferritin concentrations from baseline to 12 weeks after second blood donation. Analysis performed on the FAS.
    End point type
    Secondary
    End point timeframe
    Change in p-ferritin concentrations from baseline to 12 weeks after second blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    40
    33
    Units: ng/mL
        arithmetic mean (standard deviation)
    62.9 ( 31.82 )
    1.2 ( 9.47 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The secondary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    59.7535
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48.177
         upper limit
    		 71.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.805

    Secondary: Change in transferrin saturation concentrations from baseline to 12 weeks after first blood donation

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    End point title
    		 Change in transferrin saturation concentrations from baseline to 12 weeks after first blood donation
    End point description
    Change in transferrin saturation concentrations from baseline to 12 weeks after first blood donation. Analysis performed on the FAS.
    End point type
    Secondary
    End point timeframe
    Change in transferrin saturation concentrations from baseline to 12 weeks after first blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    39
    36
    Units: Percentage
        arithmetic mean (standard deviation)
    15.821 ( 11.9822 )
    6.75 ( 11.2868 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The secondary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.821
         upper limit
    		 14.519
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.432

    Secondary: Change in transferrin saturation concentrations from baseline to 12 weeks after second blood donation

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    End point title
    		 Change in transferrin saturation concentrations from baseline to 12 weeks after second blood donation
    End point description
    Change in transferrin saturation concentrations from baseline to 12 weeks after second blood donation. Analysis performed on the FAS.
    End point type
    Secondary
    End point timeframe
    Change in transferrin saturation concentrations from baseline to 12 weeks after second blood donation.
    End point values
    		 Group A, iron isomaltoside Group B, placebo
    Number of subjects analysed
    40
    33
    Units: Percentage
        arithmetic mean (standard deviation)
    12.625 ( 9.6548 )
    2.848 ( 13.0411 )
    Statistical analysis title
    		 Test for superiority, ANCOVA
    Statistical analysis description
    The secondary efficacy analysis was performed using an analysis of covariance (ANCOVA) with treatment.
    Comparison groups
    Group A, iron isomaltoside v Group B, placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.7474
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.869
         upper limit
    		 15.626
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.446

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time a subject had signed the informed consent form and until he/she had completed the study, all AEs/SAEs were reported in the CRF.
    Adverse event reporting additional description
    An AE was described in the following manner: The nature of the event will be described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Group A, iron isomaltoside
    Reporting group description
    		 1000 mg iron isomaltoside was administered as a single IV infusion.

    Reporting group title
    Group B, placebo
    Reporting group description
    		 A 100 ml 0.9 % sodium chloride solution will be used as an IV placebo.

    Serious adverse events
    		 Group A, iron isomaltoside Group B, placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A, iron isomaltoside Group B, placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 41 (68.29%)
    31 / 41 (75.61%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
         occurrences all number
    2
    4
    Headache
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
         occurrences all number
    3
    4
    Migraine
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    5 / 41 (12.20%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Infections and infestations
    Cystitis
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Influenza
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
         occurrences all number
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    7 / 41 (17.07%)
    7 / 41 (17.07%)
         occurrences all number
    8
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2014
    • Change of inclusion criterion 3 from ‘P-ferritin < 30 ng/mL’ to ‘P-ferritin < 60 ng/mL’ • Change of inclusion criterion 8 from a specific list of contraceptives required to the more general term ‘adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method)’ • Specification that pre-planned procedures and pre-existing conditions that had not worsened were to be recorded on the medical history pages of the CRF • Change from the current SmPC to the current Investigator’s Brochure for assessing expectedness of AEs • Specification that it was the responsibility of Pharmacosmos to evaluate the SARs for expectedness • Specification of the time period for reporting of AEs (from the time a subject had signed the ICF and until she had completed the trial) • Change of reporting of SAEs (to be reported to Drug Safety, Pharmacosmos, instead of to Max Neeman International) • The sentence stating that the trial would have a review committee for regular review of safety data was deleted
    05 Aug 2015
    • The requirement of a maximum of 40 subjects to participate in the exercise test at visit 2 and visit 2a was removed

    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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