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    Clinical Trial Results:
    A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

    Summary
    EudraCT number
    		 2013-004958-18
    Trial protocol
    		 LT   SK   IT   HU   ES   BE   CZ   PT   DE   Outside EU/EEA   GR   FR  
    Global end of trial date
    23 Jun 2016

    Results information
    Results version number
    		 v1
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    20130356
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02138838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen, Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000078-PIP01-07
    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
    23 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. All subjects or legally acceptable representatives provided written informed consent after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study and before undergoing any study-related procedures, including screening procedures. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). No subjects were recruited into the study and no investigational product (IP) was shipped until the IRB/IEC gave written approval of the protocol and ICF and Amgen received copies of these approvals.
    Background therapy
    		 Vitamin D sterols, calcium supplementation and/or phosphate binders were administered as appropriate per individual clinic practice as standard of care.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 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
    Belgium: 3
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    55
    EEA total number of subjects
    20
    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)
    18
    Adolescents (12-17 years)
    37
    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
    		 This study was conducted at 32 centers in Belgium, Czech Republic, France, Germany, Greece, Hungary, Lithuania, Poland, Portugal, Russia Federation, Slovakia, Spain, Ukraine, and the US.

    Pre-assignment
    Screening details
    		 Following the completion of a screening period of up to 14 days, eligible subjects were randomized to 1 of 2 treatment groups in a 1:1 ratio administration of cinacalcet daily in addition to standard of care (SOC) therapy or SOC therapy alone. Subjects remained on treatment for 20 weeks or until the time of renal transplant or parathyroidectomy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of Care
    Arm description
    		 Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

    Arm title
    		 Cinacalcet
    Arm description
    		 In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    AMG 073
    Other name
    Sensipar®, Mimpara®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in subjects who could swallow tablets.

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

    Number of subjects in period 1
    		Standard of Care Cinacalcet
    Started
    28
    27
    Received Study Drug
    28
    25
    Completed
    20
    16
    Not completed
    8
    11
         Consent withdrawn by subject
    1
    5
         Study closure
    7
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of Care
    Reporting group description
    		 Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

    Reporting group title
    Cinacalcet
    Reporting group description
    		 In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

    Reporting group values
    		 Standard of Care Cinacalcet Total
    Number of subjects
    		 28 27 55
    Age Categorical
    Units: Subjects
        6 to < 12 years
    		 9 9 18
        12 to < 18 years
    		 19 18 37
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.4 ( 3.5 ) 12.8 ( 3.9 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 15 12 27
        Male
    		 13 15 28
    Race
    Units: Subjects
        Black (or African American)
    		 4 5 9
        White
    		 23 19 42
        Mixed Race
    		 0 1 1
        Other
    		 1 2 3
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 4 0 4
        Not Hispanic/Latino
    		 24 27 51

    End points

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    End points reporting groups
    Reporting group title
    Standard of Care
    Reporting group description
    		 Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

    Reporting group title
    Cinacalcet
    Reporting group description
    		 In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

    Primary: Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma Intact Parathyroid Hormone (iPTH) During the Efficacy Assessment Period

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    End point title
    		 Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma Intact Parathyroid Hormone (iPTH) During the Efficacy Assessment Period
    End point description
    This endpoint was the primary endpoint in all countries except the US. The analysis was performed using the full analysis set, which included all randomized subjects. Missing data were handled using the last value carried forward method.
    End point type
    Primary
    End point timeframe
    Baseline and the efficacy assessment period, weeks 17 to 20
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    28
    27
    Units: percentage of participants
        number (not applicable)
    32.1
    22.2
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.42 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment Difference
    Point estimate
    -9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.3
         upper limit
    		 13.4
    Notes
    [1] - A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm’s method at 0.05 (2-sided) should the primary endpoint achieve a significant result.
    [2] - Cochran-Mantel-Haenszel stratified by baseline age group

    Primary: Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15

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    End point title
    		 Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
    End point description
    This endpoint was the primary endpoint in the US only. The analysis was performed in the full analysis set using non-responder imputation.
    End point type
    Primary
    End point timeframe
    Baseline and weeks 11-15
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    28
    27
    Units: percentage of participants
        number (not applicable)
    17.9
    25.9
    Statistical analysis title
    		 Primary nalysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment Difference
    Point estimate
    8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.7
         upper limit
    		 29.9
    Notes
    [3] - Cochran-Mantel-Haenszel test stratified by baseline age group

    Secondary: Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 pmol/L) During Weeks 17 to 20

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    End point title
    		 Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 pmol/L) During Weeks 17 to 20
    End point description
    This analysis was performed in the full analysis set using last value carried forward imputation.
    End point type
    Secondary
    End point timeframe
    Weeks 17 - 20
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    28
    27
    Units: percentage of participants
        number (not applicable)
    17.9
    7.4
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment Difference
    Point estimate
    -10.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.7
         upper limit
    		 6.8
    Notes
    [4] - Cochran-Mantel-Haenszel test stratified by baseline age group

    Secondary: Percent Change in iPTH from Baseline to the Mean Value During Weeks 17 to 20

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    End point title
    		 Percent Change in iPTH from Baseline to the Mean Value During Weeks 17 to 20
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 17-20
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    27
    24
    Units: percent change
        least squares mean (standard error)
    -11.3 ( 11.1 )
    7.7 ( 11.73 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 50.5
    Notes
    [5] - Analysis of covariance (ANCOVA) with baseline age group as the covariate.

    Secondary: Percent Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20

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    End point title
    		 Percent Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
    End point description
    This analysis was performed in the full analysis set using last value carried forward imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 17-20
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    28
    24
    Units: percent change
        least squares mean (standard error)
    0.06 ( 0.126 )
    -0.28 ( 0.135 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.01
    Notes
    [6] - Analysis of covariance (ANCOVA) with baseline age group as the covariate.

    Secondary: Percent Change in Serum Phosphorous from Baseline to the Mean Value During Weeks 17 to 20

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    End point title
    		 Percent Change in Serum Phosphorous from Baseline to the Mean Value During Weeks 17 to 20
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 17-20
    End point values
    		 Standard of Care Cinacalcet
    Number of subjects analysed
    26
    24
    Units: percent change
        least squares mean (standard error)
    -0.09 ( 0.258 )
    0.67 ( 0.266 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Standard of Care v Cinacalcet
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 1.48
    Notes
    [7] - Analysis of covariance (ANCOVA) with baseline age group as the covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Weeks
    Adverse event reporting additional description
    20130356 Final
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Cinacalcet
    Reporting group description
    		 In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

    Reporting group title
    Standard of Care
    Reporting group description
    		 Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

    Serious adverse events
    		 Cinacalcet Standard of Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 30 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Renovascular hypertension
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (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: 0%
    Non-serious adverse events
    		 Cinacalcet Standard of Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 25 (80.00%)
    17 / 30 (56.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Venous stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Catheter placement
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Catheter removal
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Vessel puncture site pain
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nasal discharge discolouration
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood parathyroid hormone decreased
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood phosphorus increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Ligament sprain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Overdose
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Post procedural oedema
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Procedural headache
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 30 (13.33%)
         occurrences all number
    5
    4
    Hypoaesthesia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Neurological symptom
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Lip blister
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Acne
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hypertonic bladder
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Endocrine disorders
    Precocious puberty
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 30 (6.67%)
         occurrences all number
    4
    7
    Myalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Cellulitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hepatitis B
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Lip infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Peritonitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    6 / 25 (24.00%)
    2 / 30 (6.67%)
         occurrences all number
    7
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Nov 2014
    •to incorporate information regarding the transition of eligible subjects to an open label extension study (Amgen Study 20140159) at the conclusion of the treatment period in this study. Language regarding the potential to conduct an interim analysis was also incorporated.
    06 Aug 2015
    •US-specific primary and secondary endpoints were added to the protocol to satisfy a request from the US FDA •Language was added to allow IP holding for other adverse events that warrant IP dose withhold. The original protocol only specified hold criteria for corrected calcium, ionized calcium, iPTH, and symptomatic hypocalcemia •Restart criteria was made consistent for all IP holds •The dose adjustments section was revised for clarity •The wording to indicate SOC therapy that is commercially available will not usually be provided or reimbursed by Amgen (except if required by local regulation) and will need to be provided to study centers in Russia was added. •An ECG at week 20/end of IP was added.

    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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