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    Clinical Trial Results:
    A Multi-centre, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium-based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5 on Dialysis or Chronic Kidney Disease Stages 3b to 5 Not on Dialysis

    Summary
    EudraCT number
    		 2012-002583-27
    Trial protocol
    		 DE  
    Global end of trial date
    14 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2016
    First version publication date
    09 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MCI-196-E15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01814917
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mitsubishi Tanabe Pharma Corporation
    Sponsor organisation address
    17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, Japan, 103-8405
    Public contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), regulatory@mt-pharma-eu.com
    Scientific contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), regulatory@mt-pharma-eu.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000878-PIP02-11
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of the study were to assess the long-term efficacy and safety of treatment with colestilan (including combination therapy).
    Protection of trial subjects
    1. When specifying the amount of blood to be drawn the following guidelines were used: trial related blood loss (including loss in the procedure) should not exceed 3% of total blood volume during a period of 4 weeks and should not exceed 1% total blood volume at any single time. Subjects were enrolled to the study if they could safely provide 8 ml of blood at each visit, this is specified in exclusion criteria 2. 2. When investigating new drugs there is always a risk of unexpected side effects and occasionally allergic reactions. Subjects were closely monitored during the study. 3. Rescue treatment for hyperphosphataemia with CBPB, in addition to the allocated fixed dose of colestilan (MCI196) or CBPB, is allowable as clinically indicated. The appropriate dose was decided by the Investigator based on his/her clinical experience. 4. Rescue treatment for hypocalcaemia with calcium supplements was allowed as clinically indicated. Adjustment of dosing of Vitamin D /analogues was permitted during the study to correct hypocalcaemia. The appropriate dose was to be decided by the Investigator based on his/her clinical experience. 5. Consent/assent process: Enough time was provided to the subject/parent/caregiver to consider participation in the study. In addition to the patient information sheet and consent/assent forms, a study flipchart was provided to all sites. The flipchart was used as a tool to help explain/discuss aspects of the study in more detail, the study staff were able to answers all questions the subject/parent/caregiver may have. 6. Tablet intake - it is known that tablets can be difficult to swallow, especially for very young children. The IMP was made available also in granule formulation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2013
    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
    Turkey: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    6
    EEA total number of subjects
    5
    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)
    2
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from those who have either completed the MCI-196-E14 or MCI-196-E16 studies, or who were withdrawn from MCI-196-E14 to receive flexible dosing in this study.

    Pre-assignment
    Screening details
    		 Subjects were recruited from those who have either completed the MCI-196-E14 (EudraCT number 2012-002581-12) or MCI-196-E16 (EudraCT number 2012-002582-35) studies, or who have been withdrawn from MCI-196-E14.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MCI-196
    Arm description
    		 Colestilan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Colestilan
    Investigational medicinal product code
    MCI-196
    Other name
    Pharmaceutical forms
    Tablet, Granules
    Routes of administration
    Oral use
    Dosage and administration details
    1g tablets and granules of approx 20mg packaged in 2g or 3g sachets.

    Arm title
    		 Combination
    Arm description
    		 Colestilan and CBPB
    Arm type
    		 Experimental

    Investigational medicinal product name
    CBPB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    As per physician's guidance.

    Investigational medicinal product name
    Colestilan
    Investigational medicinal product code
    MCI-196
    Other name
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1g tablets and granules of approx 20mg packaged in 2g or 3g sachets.

    Number of subjects in period 1
    		MCI-196 Combination
    Started
    4
    2
    Completed
    1
    1
    Not completed
    3
    1
         Renal Transplant
    1
    -
         Hyperphosphataemia
    1
    -
         Early withdrawal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MCI-196
    Reporting group description
    		 Colestilan

    Reporting group title
    Combination
    Reporting group description
    		 Colestilan and CBPB

    Reporting group values
    		 MCI-196 Combination Total
    Number of subjects
    		 4 2 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 2 0 2
        Adolescents (12-17 years)
    		 2 2 4
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.8 ( 3.9 ) 17 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 3
        Male
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    MCI-196
    Reporting group description
    		 Colestilan

    Reporting group title
    Combination
    Reporting group description
    		 Colestilan and CBPB

    Primary: Proportion of responders

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    End point title
    		 Proportion of responders [1]
    End point description
    End point type
    Primary
    End point timeframe
    At week 52 or LOCF
    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: This study was prematurely terminated. The available data was very limited and highly variable. No consistent reductions (>0.5 mmol/L) from baseline in phosphorus elvels were observed for any subject after dosing with MCI-196 alone or combination therapy.
    End point values
    		 MCI-196 Combination
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Percentage
    Notes
    [2] - This study was prematurely terminated. No statistical analyses were completed.
    [3] - This study was prematurely terminated. No statistical analyses were completed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs that occur from the time written informed consent and/or assent was obtained to the End Of Study visit were recorded in the source documentation and reported in the CRF.
    Adverse event reporting additional description
    AEs were classified as “treatment-emergent” (i.e., TEAEs or serious TEAEs) if they occurred following administration of IMP. All events reported in this database are treatment emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    MCI-196
    Reporting group description
    		 Colestilan

    Reporting group title
    Combination
    Reporting group description
    		 Colestilan and CBPB

    Serious adverse events
    		 MCI-196 Combination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (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: 1%
    Non-serious adverse events
    		 MCI-196 Combination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 2 (50.00%)
    Surgical and medical procedures
    Tonsillectomy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood Parathyroid Hormone Increased
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Blood Biocarbonate Decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrostomy Tube Site Complication
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Nausea
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    0
    Abdominal distension
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Oral Herpes
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Folate Deficiency
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (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? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Jan 2015
    Study Early Termination
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    There were significant challenges to recruitment in all age groups and in this patient population. The study was terminated early due to the withdrawal of the MAA.
    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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