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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis

    Summary
    EudraCT number
    		 2010-023150-37
    Trial protocol
    		 ES   HU   BE   SK   DE   Outside EU/EEA  
    Global end of trial date
    30 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    20070208
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01277510
    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
    30 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
    Protection of trial subjects
    This study was conducted in accordance with applicable country regulations and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. All parents or legally acceptable representatives provided written informed consent before the subject underwent 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
    		 All participants, regardless of treatment assignment, eceived standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 23
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Mexico: 1
    Worldwide total number of subjects
    43
    EEA total number of subjects
    11
    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)
    32
    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
    		 The first patient was enrolled on 28 June 2011 and the last patient enrolled was on 15 January 2013. Eligible participants were between the ages of 6 to less than 18 years old who had chronic kidney (CKD) and secondary hyperparathyroidism treated with either hemodialysis or peritoneal dialysis for ≥ 2 months.

    Pre-assignment
    Screening details
    		 This study consisted of a 30-week randomized, double-blind phase followed by a 30-week open-label phase. Participants were randomized 1:1 to receive either cinacalcet or placebo in the double-blind phase. All participants received cinacalcet in the open-label phase.

    Period 1
    Period 1 title
    Double-blind Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets and capsules for sprinkling identical to active treatment.

    Arm title
    		 Cinacalcet
    Arm description
    		 Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar, Mimpara
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

    Number of subjects in period 1
    		Placebo Cinacalcet
    Started
    21
    22
    Received Investigational Product
    21
    22
    Completed
    8
    4
    Not completed
    13
    18
         Consent withdrawn by subject
    2
    -
         Administrative decision
    7
    9
         Other
    1
    1
         Death
    -
    1
         Adverse event
    1
    -
         Non-compliance
    -
    1
         Protocol-specified criteria
    2
    6
    Period 2
    Period 2 title
    Open-label Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Cinacalcet
    Arm description
    		 Participants who received standard of care and placebo during the double-blind phase received cinacalcet with standard of care for 30 weeks during the open-label phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
    Arm type
    		 Open-label

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar, Mimpara
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

    Arm title
    		 Cinacalcet/Cinacalcet
    Arm description
    		 Participants who received standard of care and cinacalcet during the double-blind phase continued to receive cinacalcet with standard of care for an additional 30 weeks during the open-label phase. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cinacalcet
    Investigational medicinal product code
    Other name
    Sensipar, Mimpara
    Pharmaceutical forms
    Capsule, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

    Number of subjects in period 2
    		Placebo/Cinacalcet Cinacalcet/Cinacalcet
    Started
    8
    4
    Received investigational product
    6
    4
    Completed
    1
    1
    Not completed
    7
    3
         Never received investigational product
    2
    -
         Administrative decision
    4
    3
         Protocol-specified criteria
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase.

    Reporting group title
    Cinacalcet
    Reporting group description
    		 Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg.

    Reporting group values
    		 Placebo Cinacalcet Total
    Number of subjects
    		 21 22 43
    Age, Customized
    Units: participants
        6 to < 12 years
    		 5 6 11
        12 to < 18 years
    		 16 16 32
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.2 ± 2.9 13.3 ± 3.6 -
    Gender, Male/Female
    Units: participants
        Female
    		 10 12 22
        Male
    		 11 10 21
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 15 16 31
        Black or African American
    		 6 5 11
        Other
    		 0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 5 3 8
        Not Hispanic or Latino
    		 16 19 35
    Intact Parathyroid Hormone (iPTH)
    Units: pg/mL
        arithmetic mean (standard deviation)
    		 795.8 ± 537.9 757.1 ± 440.1 -
    Corrected Total Serum Calcium
    Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)).
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 9.88 ± 0.62 9.91 ± 0.54 -
    Serum Phosphorous
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 6.37 ± 1.48 6.68 ± 1.78 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase.

    Reporting group title
    Cinacalcet
    Reporting group description
    		 Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg.
    Reporting group title
    Placebo/Cinacalcet
    Reporting group description
    		 Participants who received standard of care and placebo during the double-blind phase received cinacalcet with standard of care for 30 weeks during the open-label phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

    Reporting group title
    Cinacalcet/Cinacalcet
    Reporting group description
    		 Participants who received standard of care and cinacalcet during the double-blind phase continued to receive cinacalcet with standard of care for an additional 30 weeks during the open-label phase. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

    Primary: Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase

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    End point title
    		 Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
    End point description
    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used. The full analysis set, which includes all randomized participants with at least 1 post-baseline assessment, was used for the analysis.
    End point type
    Primary
    End point timeframe
    From Baseline to the Efficacy Assessment Phase, Weeks 25-30
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    21
    22
    Units: percentage of participants
        number (not applicable)
    19
    54.5
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Endpoints 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm’s method at 0.05 should the primary endpoint achieve a significant result.
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (Cinacalcet - Placebo)
    Point estimate
    35.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.76
         upper limit
    		 62.24
    Notes
    [1] - Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).

    Secondary: Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 pmol/L) During the Efficacy Assessment Phase

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    End point title
    		 Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 pmol/L) During the Efficacy Assessment Phase
    End point description
    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
    End point type
    Secondary
    End point timeframe
    From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    21
    22
    Units: percentage of participants
        number (not applicable)
    23.8
    27.3
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.826 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (Cinacalcet - Placebo)
    Point estimate
    3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.58
         upper limit
    		 29.51
    Notes
    [2] - Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).

    Secondary: Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period

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    End point title
    		 Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period
    End point description
    Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
    End point type
    Secondary
    End point timeframe
    From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    21
    22
    Units: percent change
        least squares mean (confidence interval 95%)
    -1 (-4.9 to 2.9)
    -4.6 (-8.4 to -0.9)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.147 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 1.3
    Notes
    [3] - Baseline age group was used as covariate.

    Secondary: Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase

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    End point title
    		 Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase
    End point description
    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
    End point type
    Secondary
    End point timeframe
    From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    20
    22
    Units: percent change
        least squares mean (confidence interval 95%)
    10.2 (-0.8 to 21.2)
    4.9 (-5.5 to 15.3)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.454 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.4
         upper limit
    		 8.9
    Notes
    [4] - Baseline age group was used as covariate.

    Secondary: Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase

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    End point title
    		 Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase
    End point description
    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    21
    22
    Units: percent change
        least squares mean (confidence interval 95%)
    8 (-1.8 to 17.7)
    -2 (-11.4 to 7.4)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.117 [5]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 2.6
    Notes
    [5] - Baseline age group was used as covariate.

    Secondary: Growth Velocity from Baseline to End of Double-blind Phase

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    End point title
    		 Growth Velocity from Baseline to End of Double-blind Phase
    End point description
    Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.
    End point type
    Secondary
    End point timeframe
    From Baseline to end of Efficacy Assessment at Week 30
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    19 [6]
    17 [7]
    Units: cm/year
        least squares mean (confidence interval 95%)
    3.1 (0.7 to 5.6)
    3.3 (0.8 to 5.8)
    Notes
    [6] - Full analysis set. Only participants with available data were included in the analysis.
    [7] - Full analysis set. Only participants with available data were included in the analysis.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.896 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 3.6
    Notes
    [8] - No adjustments for multiplicity were made. Baseline age group was used as covariate.

    Secondary: Growth Velocity From End of Double-blind Phase to End of Open-label Phase

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    End point title
    		 Growth Velocity From End of Double-blind Phase to End of Open-label Phase
    End point description
    Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.
    End point type
    Secondary
    End point timeframe
    End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
    End point values
    		 Placebo/Cinacalcet Cinacalcet/Cinacalcet
    Number of subjects analysed
    7 [9]
    3 [10]
    Units: cm/year
        arithmetic mean (standard deviation)
    2.75 ± 3.23
    1.21 ± 1.31
    Notes
    [9] - Full analysis set. Only participants with available data were included in the analysis.
    [10] - Full analysis set. Only participants with available data were included in the analysis.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase

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    End point title
    		 Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase
    End point description
    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
    End point type
    Secondary
    End point timeframe
    From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
    End point values
    		 Placebo Cinacalcet
    Number of subjects analysed
    12 [11]
    18 [12]
    Units: percent change
        least squares mean (confidence interval 95%)
    -1.5 (-8.6 to 5.6)
    -2.3 (-8.2 to 3.5)
    Notes
    [11] - Full analysis set. Only participants with available data were included in the analysis.
    [12] - Full analysis set. Only participants with available data were included in the analysis.
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Cinacalcet
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.854 [13]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 7.9
    Notes
    [13] - Baseline age group was used as covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    60 Weeks + 30 Days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Double-blind Phase: Placebo
    Reporting group description
    		 Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase.

    Reporting group title
    Double-blind Phase: Cinacalcet
    Reporting group description
    		 Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg.

    Reporting group title
    Open-label Phase: Placebo/Cinacalcet
    Reporting group description
    		 Participants who received standard of care and placebo during the double-blind phase received cinacalcet with standard of care for 30 weeks during the open-label phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

    Reporting group title
    Open-label Phase: Cinacalcet/Cinacalcet
    Reporting group description
    		 Participants who received standard of care and cinacalcet during the double-blind phase continued to receive cinacalcet with standard of care for an additional 30 weeks during the open-label phase. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

    Serious adverse events
    		 Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Placebo/Cinacalcet Open-label Phase: Cinacalcet/Cinacalcet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 21 (42.86%)
    9 / 22 (40.91%)
    3 / 6 (50.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 22 (9.09%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Medical device complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thirst
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Rubber sensitivity
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Catheter site cellulitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food intolerance
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         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
    		 Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Placebo/Cinacalcet Open-label Phase: Cinacalcet/Cinacalcet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 21 (80.95%)
    16 / 22 (72.73%)
    6 / 6 (100.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypertension
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    0
    3
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Catheter site pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Catheter site related reaction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Chills
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 22 (4.55%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Device breakage
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Device leakage
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Face oedema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Local swelling
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 22 (4.55%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    5
    1
    2
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 22 (4.55%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    4
    3
    2
    0
    Dyspnoea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Anxiety
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Daydreaming
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Staring
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood calcium abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dialysis related complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Femur fracture
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Overdose
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Procedural hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Procedural nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular graft complication
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Mitral valve stenosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Epilepsy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 22 (13.64%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    4
    4
    1
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    1
    1
    Syncope
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 22 (13.64%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Eye disorders
    Keratitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 22 (13.64%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    2
    4
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 22 (18.18%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    2
    6
    2
    1
    Vomiting
         subjects affected / exposed
    5 / 21 (23.81%)
    7 / 22 (31.82%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    9
    10
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dandruff
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hirsutism
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Leukocyturia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Knee deformity
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 22 (13.64%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 22 (13.64%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Catheter site infection
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Device related infection
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 22 (13.64%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 22 (9.09%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    3
    2
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peritonitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fluid overload
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    4 / 21 (19.05%)
    5 / 22 (22.73%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    8
    12
    8
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2011
    The following changes were made to address FDA comments: - changed PK samples from being an optional study for hemodialysis subjects only to being mandatory for both hemodialysis and peritoneal dialysis subjects - amended the post-dose collection windows for hemodialysis subjects - specified that approximately 35% of enrolled subjects were to be in the younger age group of 6 to less than12 years - changed growth velocity endpoints from exploratory endpoints to secondary endpoints - included infections as an adverse event of interest
    31 Jan 2012
    - replaced Appendix E with a newly written Investigational Product Instruction Manual - assisted with enrollment challenges by changing the entry criterion for iPTH to a value that better accommodated regional differences in iPTH thresholds for initiating treatment - at the request of EMA, the exploratory endpoint of assessing the percent change in ionized calcium from baseline to the mean value during the EAP was changed to a secondary endpoint
    20 Jun 2012
    - added worksheet on adverse events as Appendix E - clarified/updated definition of standard of care, entry criteria, and concomitant therapy - updated safety reporting language to comply with the European Union Clinical Trial Directive

    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.
    The study was terminated early with a smaller sample size. However, the study was still sufficiently powered for the double-blind phase. The data collected in the open-label phase is very sparse.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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