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    Clinical Trial Results:
    A single-center, randomized, single-blind study in parallel groups to evaluate the efficacy and safety of a new intravenous iron HES preparation as compared to intravenous iron dextran (Cosmofer) in anemic patients

    Summary
    EudraCT number
    		 2009-014351-72
    Trial protocol
    		 AT   SK  
    Global end of trial date
    09 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2016
    First version publication date
    18 Aug 2016
    Other versions
    Summary report(s)
    		 Synopsis SWB0109

    Trial information

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    Trial identification
    Sponsor protocol code
    SWB0109
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Serumwerk Bernburg AG
    Sponsor organisation address
    Hallesche Landstrasse 105b, Bernburg, Germany, 06406
    Public contact
    Susanne Manhart, Serumwerk Bernburg AG, +49 3471860180, smanhart@serumwerk.de
    Scientific contact
    Susanne Manhart, Serumwerk Bernburg AG, +49 3471860180, smanhart@serumwerk.de
    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
    12 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare efficacy and safety of iron-HES vs Cosmofer (iron dextran)
    Protection of trial subjects
    The protocol was approved by local ethics committees 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
    		 Cosmofer (iron dextran) was chosen as comparator based on the biochemical and pharmacological similarity of HES and dextran as carrier of the iron molecule. CosmoFer® is indicated for the treatment of iron deficiency in the following indications: • When oral iron preparations cannot be used, e.g. due to intolerance, or in case of demonstrated lack of effect of oral iron therapy • Where there is a clinical need to deliver iron rapidly to iron stores. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Serum ferritin, serum iron, transferrin saturation and hypochromic red cells).
    Actual start date of recruitment
    29 Jan 2010
    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
    Slovakia: 20
    Country: Number of subjects enrolled
    Austria: 34
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    27
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were screened in the period January 2010 to May 2011. The trial took place at one site in Austria and one site in Slovakia.

    Pre-assignment
    Screening details
    		 Anemic CKD patients were recruited and screened for inclusion and exclusion criteria. No study specific procedure was done prior written informed consent was obtained.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    This is a single blind study which is justified as the main variables of this study are laboratory tests and the fact that only a single medication application was investigated.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Feramyl
    Arm description
    		 One single iron dosage was infused as specified in the reference medications's SPC (Cosmofer): After the application of the test dose an one hour Observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Feramyl 50mg/ml Ampoules
    Investigational medicinal product code
    Feramyl
    Other name
    iron HES
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The doses were selected individually after obtaining necessary parameters and calculation using using the formulae for patients suffering from anemia according to the SPC of Cosmofer. After the application of the test dose and one hour observation period one single full dose was applied as intravenous infusion over about four hours.

    Arm title
    		 Cosmofer
    Arm description
    		 One single iron dosage was infused as specified in the SPC of Cosmofer: After the application of the test dose an one hour observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cosmofer 50mg/ml ampoules
    Investigational medicinal product code
    Cosmofer
    Other name
    iron dextran
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The doses were selected individually after obtaining necessary parameters and calculation using using the formulae for patients suffering from anemia according to the SPC of Cosmofer. After the application of the test dose and one hour observation period one single full dose was applied as intravenous infusion over about four hours.

    Number of subjects in period 1
    		Feramyl Cosmofer
    Started
    27
    27
    Completed
    26
    26
    Not completed
    1
    1
         serious adverse event
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Feramyl
    Reporting group description
    		 One single iron dosage was infused as specified in the reference medications's SPC (Cosmofer): After the application of the test dose an one hour Observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.

    Reporting group title
    Cosmofer
    Reporting group description
    		 One single iron dosage was infused as specified in the SPC of Cosmofer: After the application of the test dose an one hour observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.

    Reporting group values
    		 Feramyl Cosmofer Total
    Number of subjects
    		 27 27 54
    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)
    		 60.73 ( 14.19 ) 63.09 ( 9.89 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 12 23
        Male
    		 16 15 31
    hemoglobin
    Hemoglobin at baseline of the ITT population
    Units: g/dl
        arithmetic mean (standard deviation)
    		 11.29 ( 0.95 ) 11.11 ( 1.08 ) -
    Hematocrit
    Hematocrit at baseline of the ITT population
    Units: percent
        arithmetic mean (standard deviation)
    		 34.5 ( 2.92 ) 34.11 ( 3.13 ) -
    TSAT
    Transferrin Saturation at baseline of the ITT population
    Units: percent
        arithmetic mean (standard deviation)
    		 19.55 ( 9.871 ) 19.24 ( 7.32 ) -
    SF
    Serum Ferritin (ITT Population)
    Units: µg/L
        arithmetic mean (standard deviation)
    		 79.48 ( 71.46 ) 102.5 ( 112.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    Feramyl
    Reporting group description
    		 One single iron dosage was infused as specified in the reference medications's SPC (Cosmofer): After the application of the test dose an one hour Observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.

    Reporting group title
    Cosmofer
    Reporting group description
    		 One single iron dosage was infused as specified in the SPC of Cosmofer: After the application of the test dose an one hour observation period for rare anaphylactic reactions was scheduled according to the Cosmofer SPC. Thereafter - provided no adverse reaction was observed - one single full dose was applied as intravenous Infusion over about four hours.

    Primary: hemoglobin

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    End point title
    		 hemoglobin
    End point description
    Primary endpoint was the hemoglobin Level at day 7.
    End point type
    Primary
    End point timeframe
    hemoglobin at day 7
    End point values
    		 Feramyl Cosmofer
    Number of subjects analysed
    26
    26
    Units: g/dl
    arithmetic mean (standard deviation)
        hemoglobin
    11.61 ( 0.92 )
    11.5 ( 1.23 )
    Statistical analysis title
    		 Analysis of the primary variable
    Statistical analysis description
    Analysis of the primary variable was performed based on the absolute values of hemoglobin at day 7 using the observed cases technique. The Primary endpoint was tested for equivalence of the ratio average hemoglobin of the test medication vs the reference medication. This is the only confirmatory evaluation of the study data.
    Comparison groups
    Feramyl v Cosmofer
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.7128 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.0097
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9581
         upper limit
    		 1.0641
    Notes
    [1] - The results of the analysis according to Fieller's theorem show an average ratio Feramyl/Cosmofer at day of 101% with a 95%-CI ranging from 96% to 106%.
    [2] - non-significant

    Secondary: Hematocrit (HCT)

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    End point title
    		 Hematocrit (HCT)
    End point description
    Hematocrit at day 7 of the PP population. The secondary endpoints for efficacy were the items of the iron Status (HCT, TSAT, SF) at day 7.
    End point type
    Secondary
    End point timeframe
    time points of assessment: at baseline, at 30 min after infusion, at day 7
    End point values
    		 Feramyl Cosmofer
    Number of subjects analysed
    26
    26
    Units: percent
    arithmetic mean (standard deviation)
        HCT
    35.13 ( 2.66 )
    35.11 ( 3.5 )
    No statistical analyses for this end point

    Secondary: Transferrin saturation (TSAT)

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    End point title
    		 Transferrin saturation (TSAT)
    End point description
    TSAT at day 7 of the PP population. The secondary endpoints for efficacy were the items of the iron status (HCT, TSAT, SF) at day 7.
    End point type
    Secondary
    End point timeframe
    time points of assessment: at baseline, at 30 min after infusion, at day 7
    End point values
    		 Feramyl Cosmofer
    Number of subjects analysed
    26
    26
    Units: percent
    arithmetic mean (standard deviation)
        TSAT
    35.347 ( 14.484 )
    43.424 ( 17.907 )
    No statistical analyses for this end point

    Secondary: Serum ferritin (SF)

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    End point title
    		 Serum ferritin (SF)
    End point description
    SF at day 7 of the PP population. The secondary endpoints for efficacy were the items of the iron Status (HCT, TSAT, SF) at day 7
    End point type
    Secondary
    End point timeframe
    time points of assessment: at baseline, at 30 min after infusion, at day 7
    End point values
    		 Feramyl Cosmofer
    Number of subjects analysed
    26
    26
    Units: µg/L
    arithmetic mean (standard deviation)
        SF
    512.1 ( 159.11 )
    601.93 ( 235.78 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    January 2010 - May 2011
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12
    Reporting groups
    Reporting group title
    Feramyl
    Reporting group description
    		 -

    Reporting group title
    Cosmofer
    Reporting group description
    		 -

    Serious adverse events
    		 Feramyl Cosmofer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Anaphylactoid reaction
    Additional description: The Patient developed the SAE after administration of the test dose within a few minutes. The Situation was not reported life-threatening and teh Patient recovered completely in a few days.
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    urinary retention and infection
    Additional description: The Patient had a two years history of recurrent Problems in the urinary tract and developed 5 days after the full dose of cosmofer urinary symptoms. A hospitalization was necessary for treatment of the urinary retention and infection.
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Feramyl Cosmofer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 27 (14.81%)
    3 / 27 (11.11%)
    Cardiac disorders
    Bradycardia
    Additional description: very short bradycardia and vertigo
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Cephalea
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    arm pain
    Additional description: mild pain in the arm
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    nocturnal sweat
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: mild dyspnoea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
    Additional description: mild eczema in teh Region of the interphalangeal limb of finger V
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    skin coloration
    Additional description: The Patient got accidentally some amount of the infusion paravenously into the subcutis of his right forearm within the first 30 min.
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    Additional description: mild pain in the chest and the shoulder
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Hip pain
    Additional description: pain in the left hip Joint 3 days after infusion
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2010
    to change the the inclusion criteria "age" from 30 years to 18 years to include more patients
    11 May 2010
    to allow inpatients
    07 Sep 2010
    The Submission of the protocol (Version 2) for Centre 2 - which was identical and included the two amendments of Centre 1 - was accepted by the UNB (University of Bratislava) ethics committee at 7th of September 2010. Also the State Institute for Drug Control (SIDC) of the Republic of Slovakia accepted the protocol at 12th of October 2010.

    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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