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    Clinical Trial Results:
    A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis

    Summary
    EudraCT number
    2014-003563-38
    Trial protocol
    IT   HU   CZ   ES   BE   SK   FR   Outside EU/EEA   GR  
    Global end of trial date
    15 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20140159
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02341417
    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)
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric subjects with chronic kidney disease (CKD) receiving dialysis.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. Before a subject’s participation in the clinical study, the investigator obtained written informed consent from the subject or the subject’s legally acceptable representative after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study and before any protocol-specific screening procedures or any investigational product was administered. In this study, assent was obtained from the child, except if the child was very young, and consent was obtained from the parents or legally authorized representative as defined by local law. A copy of the protocol, proposed informed consent form, other written subject information, and any proposed advertising materials was submitted to the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) for written approval. A copy of the written approval of the protocol and informed consent form must have been received by Amgen before recruitment of subjects into the study and shipment of investigational product.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jun 2015
    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: 2
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    28
    EEA total number of subjects
    8
    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)
    11
    Adolescents (12-17 years)
    17
    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 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.

    Pre-assignment
    Screening details
    This extension study enrolled participants who completed one of the parent studies 20110100 or 20130356.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    20130356 SOC
    Arm description
    Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
    Arm type
    Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar
    Pharmaceutical forms
    Film-coated tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was provided as 5 mg capsules for sprinkling or as film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.

    Arm title
    20130356 SOC + Cinacalcet
    Arm description
    Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
    Arm type
    Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was provided as 5 mg capsules for sprinkling or as film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.

    Arm title
    20110100 SOC + Cinacalcet
    Arm description
    Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
    Arm type
    Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was provided as 5 mg capsules for sprinkling or as film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.

    Number of subjects in period 1
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Started
    13
    14
    1
    Completed
    11
    12
    0
    Not completed
    2
    2
    1
         Death
    -
    -
    1
         Decision by sponsor
    2
    -
    -
         Consent withdrawn by subject
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    20130356 SOC
    Reporting group description
    Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20130356 SOC + Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20110100 SOC + Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
    Number of subjects
    13 14 1 28
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    4 6 1 11
        Adolescents (12-17 years)
    9 8 0 17
    Age Continuous
    Units: years
        median (full range (min-max))
    14 (11 to 16) 14 (9 to 16) 2 (2 to 2) -
    Gender Categorical
    Units: Subjects
        Female
    8 10 0 18
        Male
    5 4 1 10
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    0 0 0 0
        Black (or African American)
    1 4 0 5
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        White
    12 9 1 22
        Other
    0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    1 0 0 1
        Not Hispanic/Latino
    12 14 1 27
    Intact Parathyroid Hormone (iPTH)
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    1432.69 (800.19 to 1695.48) 1001.35 (525.76 to 1292.08) 907.74 (907.74 to 907.74) -
    Corrected Total Serum Calcium
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    9.56 (9.4 to 10) 9.93 (9.02 to 10.16) 10.29 (10.29 to 10.29) -
    Ionized Calcium
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.13 (1.11 to 1.23) 1.145 (1.1 to 1.28) 1.39 (1.39 to 1.39) -
    Serum Phosphorus
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    5.57 (4.86 to 6.19) 6.05 (5.31 to 6.67) 8.08 (8.08 to 8.08) -
    Calcium Phosphorus product (Ca x P)
    Units: mg²/dL²
        median (inter-quartile range (Q1-Q3))
    54.42 (48.59 to 58.82) 57.8 (50.94 to 65.65) 82.28 (82.28 to 82.28) -

    End points

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    End points reporting groups
    Reporting group title
    20130356 SOC
    Reporting group description
    Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20130356 SOC + Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20110100 SOC + Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Primary: Number of Participants with Adverse Events

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    End point title
    Number of Participants with Adverse Events [1]
    End point description
    Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a “yes” or “no” response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 4 weeks after the last dose; 32 weeks.
    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: The analysis of the primary, secondary, and safety endpoints was descriptive in nature.
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: participants
        Any adverse event (AE)
    9
    10
    1
        AE Grade ≥ 2
    2
    7
    1
        AE Grade ≥ 3
    2
    6
    1
        AE Grade ≥ 4
    0
    0
    1
        Serious adverse event (SAE)
    2
    6
    1
        AE leading to discontinuation of study drug
    0
    0
    0
        Fatal adverse events
    0
    0
    1
        Treatment-related adverse events (TRAE)
    5
    4
    0
        Treatment-related AE Grade ≥ 2
    0
    1
    0
        Treatment-related AE Grade ≥ 3
    0
    0
    0
        Treatment-related AE Grade ≥ 4
    0
    0
    0
        Treatment-related serious adverse events
    0
    0
    0
        TRAE leading to discontinuation of study drug
    0
    0
    0
        Fatal treatment-related adverse events
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Baseline to Mean Value During Weeks 11 and 15

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    End point title
    Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Baseline to Mean Value During Weeks 11 and 15 [2]
    End point description
    This endpoint was analyzed in participants who received SOC only in parent study 20130356. Subjects who had no iPTH values during weeks 11 to 15 were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 11 to 15
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analyzed for participants who received SOC treatment in study 20130356.
    End point values
    20130356 SOC
    Number of subjects analysed
    13
    Units: percentage of participants
        number (confidence interval 95%)
    30.8 (9.1 to 61.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Baseline to Mean Value During Weeks 12 and 28

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    End point title
    Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Baseline to Mean Value During Weeks 12 and 28 [3]
    End point description
    This endpoint was analyzed in participants who received SOC only in parent study 20130356. For subjects who had no values during week 23 and 28, the mean of the last 2 available postbaseline values collected in the dose-titration phase was used. If only 1 postbaseline value was available, this single value was used. If no postbaseline value was available, the subject was considered a non-responder.
    End point type
    Secondary
    End point timeframe
    Baseline and week 23 to 28
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analyzed for participants who received SOC treatment in study 20130356.
    End point values
    20130356 SOC
    Number of subjects analysed
    13
    Units: percentage of participants
        number (confidence interval 95%)
    23.1 (5 to 53.8)
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28

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    End point title
    Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28 [4]
    End point description
    This endpoint was analyzed in participants who received SOC only in parent study 20130356. For subjects who had no values during week 23 and 28, the mean of the last 2 available postbaseline values collected in the dose-titration phase was used. If only 1 postbaseline value was available, this single value was used. If no postbaseline value was available, the subject was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 23 to 28
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only analyzed for participants who received SOC treatment in study 20130356.
    End point values
    20130356 SOC
    Number of subjects analysed
    13
    Units: percent change
        median (inter-quartile range (Q1-Q3))
    11.43 (-20.64 to 27.27)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28

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    End point title
    Percentage of Participants who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
    End point description
    This endpoint was analyzed in the efficacy analysis set which includes all enrolled subjects in Study 20140159 who received at least one dose of cinacalcet during Study 20140159 and had at least one assessment after Study Day 1. For subjects who had no values during week 23 and 28, the mean of the last 2 available postbaseline values collected in the dose-titration phase was used. If only 1 postbaseline value was available, this single value was used. If no postbaseline value was available, the subject was considered a non-responder.
    End point type
    Secondary
    End point timeframe
    Weeks 23 to 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: percentage of participants
        number (confidence interval 95%)
    7.7 (0.2 to 36)
    21.4 (4.7 to 50.8)
    0 (0 to 97.5)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28

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    End point title
    Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
    End point description
    This analysis was conducted in the Efficacy Analysis Set. For subjects who had no values during week 23 and 28, the mean of the last 2 available postbaseline values collected in the dose-titration phase was used. If only 1 postbaseline value was available, this single value was used. If no postbaseline value was available, the subject was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 23 to 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    -0.24 (-0.46 to -0.06)
    -0.24 (-0.81 to 0.58)
    -0.74 (-0.74 to -0.74)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28

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    End point title
    Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
    End point description
    This analysis was conducted in the Efficacy Analysis Set. For subjects who had no values during week 23 and 28, the mean of the last 2 available postbaseline values collected in the dose-titration phase was used. If only 1 postbaseline value was available, this single value was used. If no postbaseline value was available, the subject was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 23 to 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    0.19 (-0.52 to 0.56)
    -0.08 (-1.41 to 0.17)
    0.82 (0.82 to 0.82)
    No statistical analyses for this end point

    Secondary: Serum Corrected Calcium at Baseline, Week 11, and Week 28

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    End point title
    Serum Corrected Calcium at Baseline, Week 11, and Week 28
    End point description
    This endpoint was analyzed using the Efficacy Analysis Set. "99999" indicates no data available.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 11 and 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Baseline
    9.56 (9.4 to 10)
    9.93 (9.02 to 10.16)
    10.29 (10.29 to 10.29)
        Week 11 (n = 12, 12, 0)
    9.35 (9.2 to 9.6)
    9.85 (9.3 to 10.65)
    99999 (99999 to 99999)
        Week 28 (n = 9, 12, 0)
    9.5 (9.3 to 10)
    9.9 (9.1 to 10.25)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Serum Phosphorus at Baseline, Week 11, and Week 28

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    End point title
    Serum Phosphorus at Baseline, Week 11, and Week 28
    End point description
    This endpoint was analyzed using the Efficacy Analysis Set. "99999" indicates no data available.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 11 and 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Baseline
    5.57 (4.86 to 6.19)
    6.05 (5.31 to 6.67)
    8.08 (8.08 to 8.08)
        Week 11 (n = 12, 12, 0)
    5.25 (4.55 to 5.8)
    6.2 (5.55 to 7.3)
    99999 (99999 to 99999)
        Week 28 (n = 9, 10, 0)
    5 (4.3 to 5.6)
    5.95 (5.7 to 6.8)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15

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    End point title
    Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
    End point description
    This analysis was conducted in the Efficacy Analysis Set. Subjects who had no iPTH values during weeks 11 and 15 were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Day 1 of cinacalcet treatment (the date that the initial dose of cinacalcet treatment was administered in study 20130356, 20110100 or 20140159) and weeks 11 to 15
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: percentage of participants
        number (confidence interval 95%)
    30.8 (9.1 to 61.4)
    35.7 (12.8 to 64.9)
    100 (2.5 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28

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    End point title
    Percentage of Participants Achieving ≥ 30% Reduction in iPTH from Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
    End point description
    This analysis was conducted in the Efficacy Analysis Set. For subjects who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the subject was considered a non-responder.
    End point type
    Secondary
    End point timeframe
    Day 1 of cinacalcet treatment (the date that the initial dose of cinacalcet treatment was administered in study 20130356, 20110100 or 20140159) and weeks 23 to 28
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: percentage of participants
        number (confidence interval 95%)
    23.1 (5 to 53.8)
    35.7 (12.8 to 64.9)
    0 (0 to 97.5)
    No statistical analyses for this end point

    Secondary: Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time

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    End point title
    Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
    End point description
    This analysis was conducted in the Efficacy Analysis Set with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (the date that the initial dose of cinacalcet treatment was administered in study 20130356, 20110100 or 20140159), and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, 56, and 60
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: percent change
    median (inter-quartile range (Q1-Q3))
        Week 3 (n = 13, 14, 1)
    10.16 (-4.42 to 20.24)
    -6.88 (-30.86 to 41.81)
    55.54 (55.54 to 55.54)
        Week 7 (n = 13, 13, 1)
    1.99 (-37.82 to 17.42)
    -4.96 (-40.93 to 32.44)
    9.78 (9.78 to 9.78)
        Week 11 (n = 12, 13, 1)
    19.75 (-27.88 to 84.96)
    -7.64 (-30.77 to 13.37)
    -7 (-7 to -7)
        Week 15 (n = 12, 14, 1)
    -7.67 (-59.96 to 51.23)
    -13.04 (-68.59 to 10.74)
    -73.85 (-73.85 to -73.85)
        Week 17 (n = 2, 12, 1)
    -23.93 (-59.61 to 11.75)
    -3.09 (-40.52 to 21.4)
    -20.02 (-20.02 to -20.02)
        Week 18 (n = 0, 12, 1)
    99999 (99999 to 99999)
    -29.85 (-54.42 to 31.15)
    -7.49 (-7.49 to -7.49)
        Week 19 (n = 10, 12, 0)
    -37.17 (-69.24 to 21.47)
    -3.5 (-50.02 to 19.16)
    99999 (99999 to 99999)
        Week 20 (n = 1, 11, 1)
    -13.12 (-13.12 to -13.12)
    0.44 (-35.1 to 66.13)
    160.8 (160.8 to 160.8)
        Week 23 (n = 10, 14, 0)
    -9.05 (-52.43 to 28.64)
    -6.65 (-35.13 to 83.11)
    99999 (99999 to 99999)
        Week 27 (n = 10, 13, 0)
    -8.5 (-69.2 to 18.78)
    16.36 (-59.79 to 50.23)
    99999 (99999 to 99999)
        Week 31 (n = 0, 13, 0)
    99999 (99999 to 99999)
    32.3 (-58.73 to 75.48)
    99999 (99999 to 99999)
        Week 35 (n = 0, 12, 0)
    99999 (99999 to 99999)
    16.82 (-70.15 to 82.83)
    99999 (99999 to 99999)
        Week 39 (n = 0, 12, 0)
    99999 (99999 to 99999)
    0.09 (-58.27 to 86.94)
    99999 (99999 to 99999)
        Week 43 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -17.13 (-47.15 to 47.3)
    99999 (99999 to 99999)
        Week 48 (n = 0, 10, 0)
    99999 (99999 to 99999)
    -45.67 (-66.01 to 33.64)
    99999 (99999 to 99999)
        Week 52 (n = 0, 1, 0)
    99999 (99999 to 99999)
    86.5 (86.5 to 86.5)
    99999 (99999 to 99999)
        End of treatment (n = 10, 12, 0)
    -8.5 (-69.2 to 18.78)
    -45.67 (-74.62 to 34.62)
    99999 (99999 to 99999)
        End of study (n = 1, 1, 0)
    105.27 (105.27 to 105.27)
    20.21 (20.21 to 20.21)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time

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    End point title
    Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
    End point description
    This analysis was conducted in the Efficacy Analysis Set with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (the date that the initial dose of cinacalcet treatment was administered in study 20130356, 20110100 or 20140159), and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, 56, and 60
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Week 3 (n = 13, 14, 1)
    -0.18 (-0.26 to -0.11)
    0.19 (0.05 to 0.32)
    -0.1 (-99999 to 99999)
        Week 7 (n = 13, 13, 1)
    -0.34 (-0.44 to -0.24)
    -0.01 (-0.23 to 0.21)
    -0.5 (-99999 to 99999)
        Week 11 (n = 12, 13, 1)
    -0.35 (-0.46 to -0.24)
    -0.06 (-0.19 to 0.07)
    -0.5 (-99999 to 99999)
        Week 15 (n = 12, 14, 1)
    -0.37 (-0.62 to -0.12)
    0.06 (-0.18 to 0.3)
    0.5 (-99999 to 99999)
        Week 17 (n = 2, 12, 1)
    -0.02 (-0.24 to 0.2)
    -0.11 (-0.45 to 0.22)
    -0.8 (-99999 to 99999)
        Week 18 (n = 0, 12, 1)
    99999 (99999 to 99999)
    -0.17 (-0.35 to 0.02)
    -0.3 (-99999 to 99999)
        Week 19 (n = 10, 12, 1)
    -0.43 (-0.6 to -0.26)
    -0.2 (-0.37 to -0.03)
    -0.1 (-99999 to 99999)
        Week 20 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -0.01 (-0.18 to 0.16)
    99999 (-99999 to 99999)
        Week 21 (n = 0, 9, 1)
    99999 (99999 to 99999)
    -0.36 (-0.63 to -0.09)
    -2.6 (-99999 to 99999)
        Week 23 (n = 9, 12, 0)
    -0.18 (-0.24 to -0.12)
    -0.2 (-0.47 to 0.08)
    99999 (99999 to 99999)
        Week 27 (n = 9, 13, 0)
    -0.14 (-0.25 to -0.02)
    -0.24 (-0.41 to -0.07)
    99999 (99999 to 99999)
        Week 31 (n = 0, 13, 0)
    99999 (99999 to 99999)
    0 (-0.2 to 0.19)
    99999 (99999 to 99999)
        Week 35 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -0.42 (-0.57 to -0.26)
    99999 (99999 to 99999)
        Week 39 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -0.63 (-0.84 to -0.43)
    99999 (99999 to 99999)
        Week 43 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -0.37 (-0.63 to -0.11)
    99999 (99999 to 99999)
        Week 48 (n = 0, 10, 0)
    99999 (99999 to 99999)
    -0.55 (-0.87 to -0.23)
    99999 (99999 to 99999)
        Week 52 (n = 0, 1, 0)
    99999 (99999 to 99999)
    -0.16 (-99999 to 99999)
    99999 (99999 to 99999)
        End of treatment (n = 9, 12, 0)
    0.18 (0.02 to 0.34)
    -0.04 (-0.26 to 0.18)
    99999 (99999 to 99999)
        End of study (n = 1, 0, 0)
    1 (-99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percent Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time

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    End point title
    Percent Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
    End point description
    This analysis was conducted in the Efficacy Analysis Set with available data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (the date that the initial dose of cinacalcet treatment was administered in study 20130356, 20110100 or 20140159), and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, 56, and 60
    End point values
    20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
    Number of subjects analysed
    13
    14
    1
    Units: mg/dL
    median (inter-quartile range (Q1-Q3))
        Week 3 (n = 13, 14, 1)
    -0.24 (-0.56 to -0.08)
    0.81 (-0.54 to 1.07)
    5.6 (-99999 to 99999)
        Week 7 (n = 13, 13, 1)
    -0.16 (-0.5 to 0.17)
    0.37 (0.1 to 0.64)
    0.3 (-99999 to 99999)
        Week 11 (n = 12, 12, 1)
    0.01 (-0.33 to 0.36)
    1.17 (0.87 to 1.47)
    0 (-99999 to 99999)
        Week 15 (n = 12, 14, 1)
    -0.52 (-0.79 to -0.25)
    0.96 (0.71 to 1.2)
    -1.9 (-99999 to 99999)
        Week 17 (n = 2, 12, 0)
    -0.08 (-0.19 to 0.03)
    1.57 (0.96 to 2.19)
    99999 (99999 to 99999)
        Week 18 (n = 0, 12, 1)
    99999 (99999 to 99999)
    0.61 (0.3 to 0.93)
    -0.9 (-99999 to 99999)
        Week 19 (n = 10, 12, 1)
    -0.45 (-0.74 to -0.16)
    0.91 (0.37 to 1.44)
    -0.3 (-99999 to 99999)
        Week 20 (n = 0, 11, 0)
    99999 (99999 to 99999)
    0.84 (0.16 to 1.51)
    99999 (99999 to 99999)
        Week 21 (n = 0, 9, 1)
    99999 (99999 to 99999)
    0.17 (-0.67 to 1.01)
    0.1 (-99999 to 99999)
        Week 23 (n = 9, 12, 0)
    -0.37 (-0.78 to 0.05)
    0.55 (0.12 to 0.98)
    99999 (99999 to 99999)
        Week 27 (n = 9, 13, 0)
    -0.18 (-0.53 to 0.18)
    0.76 (0.27 to 1.24)
    99999 (99999 to 99999)
        Week 31 (n = 0, 13, 0)
    99999 (99999 to 99999)
    0.83 (0.24 to 1.42)
    99999 (99999 to 99999)
        Week 35 (n = 0, 12, 0)
    99999 (99999 to 99999)
    -0.03 (-0.51 to 0.45)
    99999 (99999 to 99999)
        Week 39 (n = 0, 12, 0)
    99999 (99999 to 99999)
    0.4 (-0.11 to 0.91)
    99999 (99999 to 99999)
        Week 43 (n = 0, 12, 0)
    99999 (99999 to 99999)
    0.33 (-0.21 to 0.86)
    99999 (99999 to 99999)
        Week 48 (n = 0, 8, 0)
    99999 (99999 to 99999)
    0.6 (-0.21 to 1.42)
    99999 (99999 to 99999)
        Week 52 (n = 0, 1, 0)
    99999 (99999 to 99999)
    0.61 (-99999 to 99999)
    99999 (99999 to 99999)
        End of treatment (n = 9, 10, 0)
    -0.18 (-0.53 to 0.18)
    0.43 (-0.25 to 1.11)
    99999 (99999 to 99999)
        End of study (n = 1, 0, 0)
    1.2 (-99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    32 Weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    20130356 SOC
    Reporting group description
    Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20130356 SOC+Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    20110100 SOC+Cinacalcet
    Reporting group description
    Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

    Reporting group title
    Total
    Reporting group description
    All participants who received cinacalcet in study 20140159.

    Serious adverse events
    20130356 SOC 20130356 SOC+Cinacalcet 20110100 SOC+Cinacalcet Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    6 / 14 (42.86%)
    1 / 1 (100.00%)
    9 / 28 (32.14%)
         number of deaths (all causes)
    0
    0
    1
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Venous occlusion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Catheter placement
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tachypnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Local swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroduodenitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device damage
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 1 (100.00%)
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis infective
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Staphylococcal infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    20130356 SOC 20130356 SOC+Cinacalcet 20110100 SOC+Cinacalcet Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 13 (69.23%)
    10 / 14 (71.43%)
    1 / 1 (100.00%)
    20 / 28 (71.43%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    1
    Venous haemorrhage
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Surgical and medical procedures
    Catheter placement
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Complication associated with device
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Local swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Mass
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Nodule
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    0
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Staring
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Heat exhaustion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Contusion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Ulna fracture
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Investigations
    Adjusted calcium decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Blood parathyroid hormone decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Pulmonary calcification
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Loss of consciousness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    2
    0
    0
    2
    Tremor
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Constipation
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Duodenogastric reflux
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Gastritis erosive
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Gastroduodenitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    4
    0
    4
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Rash
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    0
    2
    Joint swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    2
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    1
    0
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    3 / 28 (10.71%)
         occurrences all number
    4
    4
    0
    8
    Infections and infestations
    Herpes virus infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    Pyelonephritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    3
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2014
    • Language regarding the transition of eligible subjects from the parent Study 20130356 was incorporated. • Updates were also made to study procedures for consistency with the cinacalcet pediatric program.
    22 Jul 2015
    • Eligible subjects from Study 20110100 were included in this study. • Dosing procedures were revised to: 1) include withholding criteria for adverse events, 2) make restarting criteria consistent across dose holds, 3) clarify dose adjustments, and 4) clarify day 1 ionized calcium criteria. • Eligibility of subjects who turned 18 years of age while participating in Study 20130356 was clarified. • Language was added to allow standard of care therapy that is commercially available to be provided by Amgen if required by local regulation, since these therapeutics would need to be provided to Russian sites.
    16 Mar 2016
    • Eligibility criteria and study procedures were revised to allow eligible subjects who were ongoing at the time an administrative decision was made to end Studies 20130356 and 20110100 to enroll in this study. • Inclusion criteria for iPTH and corrected serum calcium were added for subjects in the Study 20130356 SOC group. • Subjects who had a new onset of seizure or worsening of pre-existing seizure disorder were excluded. • Additional secondary efficacy and exploratory endpoints were included. • The statistical methods were also revised to clarify that interim analyses could be conducted and the timing of the primary analysis, as well as to add the definition of the efficacy analysis set.

    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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