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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)

    Summary
    EudraCT number
    		 2017-003021-15
    Trial protocol
    		 FR   GB   PL   IT  
    Global end of trial date
    19 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2023
    First version publication date
    10 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CL011_140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03536754
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 134007
    Sponsors
    Sponsor organisation name
    ChemoCentryx, Inc.
    Sponsor organisation address
    850 Maude Avenue, Mountain View, California , United States, 94043
    Public contact
    Clinical trial disclosure, ChemoCentryx, Inc., clinicaltrials@chemocentryx.com
    Scientific contact
    Clinical trial disclosure, ChemoCentryx, Inc., clinicaltrials@chemocentryx.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with FSGS with proteinuria. • The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary protein excretion in subjects with FSGS, as assessed by change from baseline in the urine protein to creatinine ratio (UPCR) at Week 12.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines. Only subjects that met all the study inclusion and none of the exclusion criteria were entered in the study. The rationale of the study, procedural details, and investigational goals were explained to each subject, along with potential risks and benefits. Each subject was assured of his/her right to withdraw from the study at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2018
    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
    Poland: 14
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    46
    EEA total number of subjects
    25
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    44
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment took place in Australia, Canada, France, Italy, New Zealand, Poland, United Kingdom, and in the United States. The target was to enroll 40 male or female subjects. The first patient was enrolled on 17 May 2018. A total of 84 subjects were screened; 38 subjects failed screening and 46 subjects were randomized.

    Pre-assignment
    Screening details
    		 Eighty-four (84) patients were screened. Screen failure occurred in 38 (45.2%) subjects due to not meeting inclusion or exclusion criteria (35 [41.7%] subjects) and other reasons (3 [3.6%] subjects).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)

    Arm title
    		 Group B - CCX140-B 5 mg QD
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CCX140-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.

    Arm title
    		 Group C -CCX140-B 10 mg BID
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CCX140-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.

    Arm title
    		 Group D -CCX140-B 15 mg BID
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CCX140-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days.

    Number of subjects in period 1
    		Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID
    Started
    12
    11
    12
    11
    Completed
    12
    11
    11
    11
    Not completed
    0
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -
    Period 2
    Period 2 title
    Open-Label Extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-label extension
    Arm description
    		 Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CCX140-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three 5 mg CCX140-B tablets, orally, BID for 84 days (12 weeks)

    Number of subjects in period 2 [1]
    		Open-label extension
    Started
    43
    Completed
    42
    Not completed
    1
         Other
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 46 subjects were randomised in Period A. Only 43 subjects entered the Open-Label Extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A - Placebo
    Reporting group description
    		 -

    Reporting group title
    Group B - CCX140-B 5 mg QD
    Reporting group description
    		 -

    Reporting group title
    Group C -CCX140-B 10 mg BID
    Reporting group description
    		 -

    Reporting group title
    Group D -CCX140-B 15 mg BID
    Reporting group description
    		 -

    Reporting group values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Total
    Number of subjects
    		 12 11 12 11 46
    Age categorical
    Units: Subjects
        18-50 years
    		 7 8 10 7 32
        51-65 years
    		 5 3 1 3 12
        > 65 years
    		 0 0 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 4 4 5 3 16
        Male
    		 8 7 7 8 30
    UPCR at screening
    Urine protein:creatinine ratio (g protein/g creatinine) ≥3.5 Units (g/dL)
    Units: Subjects
        UPCR ≥ 3.5 at screening
    		 3 2 3 3 11
        UPCR < 3.5 at screening
    		 9 9 9 8 35
    UPCR at baseline
    Units (g/dL)
    Units: Subjects
        UPCR ≥ 3.5 at baseline
    		 1 1 3 4 9
        UPCR < 3.5 at baseline
    		 11 10 9 7 37
    Concomitant use of ACE inhibitor or ARB or aldosterone antagonists
    Units: Subjects
        Yes
    		 12 10 11 10 43
        No
    		 0 1 1 1 3
    Current use of glucocorticoids and/or immunosuppressive medications
    Units: Subjects
        Yes
    		 7 6 6 6 25
        No
    		 5 5 6 5 21
    Concomitant use of glucocorticoids
    Units: Subjects
        Yes
    		 6 4 4 5 19
        No
    		 6 7 8 6 27
    Concomitant use of all calcineurin inhibitors combined
    Includes cyclosporin or tacrolimus
    Units: Subjects
        Yes
    		 2 4 3 3 12
        No
    		 10 7 9 8 34
    Concomitant use of calcineurin inhibitors cyclosporin
    Units: Subjects
        Yes
    		 1 1 3 1 6
        No
    		 11 10 9 10 40
    Age at screening
    Mean (SD)
    Units: years
        arithmetic mean (standard deviation)
    		 46.3 ( 12.50 ) 41.7 ( 12.70 ) 37.9 ( 15.51 ) 43.4 ( 13.26 ) -
    UPCR
    urine protein:creatinine ratio
    Units: g protein/g creatinine)
        arithmetic mean (standard deviation)
    		 2.19 ( 1.029 ) 2.00 ( 1.149 ) 2.86 ( 2.008 ) 3.12 ( 2.504 ) -
    Baseline eGFR (CKD-EPI Creatinine-Cystatin C)
    Baseline estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology Collaboration Creatinine-Cystatin C)
    Units: ml/min/1.73 m 2
        arithmetic mean (standard deviation)
    		 72.75 ( 36.204 ) 56.18 ( 28.927 ) 54.67 ( 15.622 ) 61.36 ( 32.265 ) -
    Baseline urine MCP-1 creatinine ratio
    Baseline urine MCP-1 creatinine ratio MCP-1: monocyte chemoattractant protein 1
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    		 453.74 ( 438.384 ) 576.41 ( 470.089 ) 504.02 ( 388.569 ) 430.66 ( 325.651 ) -

    End points

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    End points reporting groups
    Reporting group title
    Group A - Placebo
    Reporting group description
    		 -

    Reporting group title
    Group B - CCX140-B 5 mg QD
    Reporting group description
    		 -

    Reporting group title
    Group C -CCX140-B 10 mg BID
    Reporting group description
    		 -

    Reporting group title
    Group D -CCX140-B 15 mg BID
    Reporting group description
    		 -
    Reporting group title
    Open-label extension
    Reporting group description
    		 Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.

    Primary: Change from baseline in UPCR at Week 12

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    End point title
    		 Change from baseline in UPCR at Week 12
    End point description
    Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID
    Number of subjects analysed
    12
    11
    11
    11
    Units: g protein/g creatinine
        least squares mean (confidence interval 90%)
    0.83 (0.69 to 0.99)
    1.02 (0.84 to 1.23)
    1.12 (0.93 to 1.35)
    0.87 (0.72 to 1.05)
    Statistical analysis title
    		 Mixed-Effects Model for Repeated Measures 1
    Comparison groups
    Group A - Placebo v Group B - CCX140-B 5 mg QD
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.1924
    Method
    		 Mixed effects model for repeated measure
    Parameter type
    		 LSM Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.171
    Statistical analysis title
    		 Mixed-Effects Model for Repeated Measures 2
    Comparison groups
    Group A - Placebo v Group C -CCX140-B 10 mg BID
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0612
    Method
    		 Mixed effects model for repeated measure
    Parameter type
    		 LSM Ratio
    Point estimate
    1.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.172
    Statistical analysis title
    		 Mixed-Effects Model for Repeated Measures 3
    Comparison groups
    Group A - Placebo v Group D -CCX140-B 15 mg BID
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.7653
    Method
    		 Mixed effects model for repeated measure
    Parameter type
    		 LSM Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.169
    Statistical analysis title
    		 Mixed-Effects Model for Repeated Measure 4
    Comparison groups
    Group A - Placebo v Group D -CCX140-B 15 mg BID v Group B - CCX140-B 5 mg QD v Group C -CCX140-B 10 mg BID
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.1537
    Method
    		 Mixed effects model for repeated measure
    Parameter type
    		 LSM Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.136

    Primary: Subject incidence of treatment-emergent AEs (TEAE), TEAEs leading to study withdrawal, and serious adverse events (SAEs)

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    End point title
    		 Subject incidence of treatment-emergent AEs (TEAE), TEAEs leading to study withdrawal, and serious adverse events (SAEs) [1]
    End point description
    TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12, and Week 12 to Week 24
    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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    12
    11
    43
    Units: subjects
        TEAEs
    10
    6
    8
    7
    24
        SAEs
    0
    0
    0
    0
    1
        TEAEs leading to study withdrawal
    0
    0
    1
    0
    2
    No statistical analyses for this end point

    Primary: Change from baseline in Activated Partial Thromboplastin Time

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    End point title
    		 Change from baseline in Activated Partial Thromboplastin Time [2]
    End point description
    Normal Range: 23.9 - 40.0
    End point type
    Primary
    End point timeframe
    Baseline to Week 12 (double-blind treatment period) and Baseline to Week 24 (open-label extension)
    Notes
    [2] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12 [3]
    10
    10
    10 [4]
    40
    Units: second
    arithmetic mean (standard deviation)
        Week 12
    2.40 ( 4.259 )
    2.05 ( 4.396 )
    2.36 ( 2.614 )
    1.28 ( 2.508 )
    1.76 ( 4.332 )
        Week 24
    2.91 ( 4.132 )
    1.39 ( 3.187 )
    2.34 ( 6.169 )
    0.10 ( 3.223 )
    1.76 ( 4.332 )
    Notes
    [3] - 11 subjects for Week 24
    [4] - 9 subjects for Week 24
    No statistical analyses for this end point

    Primary: Change from baseline in plasma alanine aminotransferase

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    End point title
    		 Change from baseline in plasma alanine aminotransferase [5]
    End point description
    Normal Range: 6 - 41 U/L
    End point type
    Primary
    End point timeframe
    Baseline to Week 12 and Baseline to Week 24
    Notes
    [5] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    0.5 ( 2.70 )
    0.8 ( 5.22 )
    0.3 ( 3.29 )
    -1.8 ( 2.95 )
    0.0 ( 3.65 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma alkaline phosphatase

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    End point title
    		 Change from baseline in plasma alkaline phosphatase [6]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12 Baseline to Week 24
    Notes
    [6] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    10.2 ( 7.08 )
    -1.0 ( 11.59 )
    0.7 ( 15.86 )
    -1.9 ( 9.45 )
    2.3 ( 12.16 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma amylase

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    End point title
    		 Change from baseline in plasma amylase [7]
    End point description
    Normal range: 22-123 U/L
    End point type
    Primary
    End point timeframe
    From Baseline to Week 12 From baseline to Week 24
    Notes
    [7] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    3.1 ( 16.11 )
    8.9 ( 18.30 )
    5.0 ( 24.56 )
    3.9 ( 23.19 )
    5.2 ( 20.09 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma aspartate aminotransferase

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    End point title
    		 Change from baseline in plasma aspartate aminotransferase [8]
    End point description
    Normal range : 9-34 U/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [8] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    18.3 ( 6.17 )
    -0.4 ( 4.60 )
    -3.5 ( 7.71 )
    -3.2 ( 3.07 )
    -1.7 ( 5.25 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma bicarnonate

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    End point title
    		 Change from baseline in plasma bicarnonate [9]
    End point description
    Normal range: 21-33 mmol/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [9] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.5 ( 3.45 )
    -0.4 ( 3.24 )
    0.9 ( 3.59 )
    -0.6 ( 2.83 )
    0.1 ( 3.24 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma bilirubin

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    End point title
    		 Change from baseline in plasma bilirubin [10]
    End point description
    Normal range: 0.1-1.10 mg/dL
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [10] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.044 ( 0.1985 )
    -0.006 ( 0.2796 )
    0.160 ( 0.2381 )
    -0.012 ( 0.1519 )
    0.050 ( 0.2263 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma C reactive protein

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    End point title
    		 Change from baseline in plasma C reactive protein [11]
    End point description
    Normal range: 0.0-3.0 mg/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [11] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/L
        arithmetic mean (standard deviation)
    1.200 ( 3.1597 )
    2.144 ( 8.5528 )
    -1.000 ( 4.6448 )
    -1.444 ( 3.8014 )
    0.260 ( 5.4276 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma calcium

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    End point title
    		 Change from baseline in plasma calcium [12]
    End point description
    Normal range: 8.5-10.5 mg/dL
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [12] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.18 ( 0.387 )
    0.20 ( 0.427 )
    0.17 ( 0.498 )
    -0.01 ( 0.454 )
    0.14 ( 0.434 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma chloride

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    End point title
    		 Change from baseline in plasma chloride [13]
    End point description
    Normal range: 95-110 mmol/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [13] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.5 ( 2.70 )
    0.9 ( 1.79 )
    -0.8 ( 3.31 )
    3.2 ( 2.33 )
    0.6 ( 2.97 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma cholesterol

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    End point title
    		 Change from baseline in plasma cholesterol [14]
    End point description
    Normal range: 100-200 mg/dL
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [14] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    -2.7 ( 31.11 )
    -2.0 ( 27.67 )
    18.9 ( 48.17 )
    -43.0 ( 64.17 )
    -5.6 ( 47.99 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma creatine kinase

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    End point title
    		 Change from baseline in plasma creatine kinase [15]
    End point description
    Normal range: 23-210 U/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [15] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    21.2 ( 39.65 )
    18.1 ( 59.20 )
    -19.5 ( 89.93 )
    14.2 ( 206.95 )
    11.9 ( 89.15 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma creatinine

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    End point title
    		 Change from baseline in plasma creatinine [16]
    End point description
    Normal range: 0.62-1.44 mg/dL
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [16] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.060 ( 0.1437 )
    0.033 ( 0.2461 )
    0.115 ( 0.2186 )
    0.147 ( 0.3790 )
    0.161 ( 0.3926 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma cystatin C

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    End point title
    		 Change from baseline in plasma cystatin C [17]
    End point description
    Normal range: 0.53-0.95 mg/L
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [17] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/L
        arithmetic mean (standard deviation)
    0.114 ( 0.1838 )
    0.104 ( 0.1074 )
    0.093 ( 0.2896 )
    0.018 ( 0.2198 )
    0.087 ( 0.2436 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma direct bilirubin

    		 Close Top of page
    End point title
    		 Change from baseline in plasma direct bilirubin [18]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [18] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.011 ( 0.0396 )
    0.008 ( 0.0316 )
    0.005 ( 0.0497 )
    -0.005 ( 0.0254 )
    0.004 ( 0.0373 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma glucose

    		 Close Top of page
    End point title
    		 Change from baseline in plasma glucose [19]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [19] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    11
    11
    11
    11
    40
    Units: mg/dL
        arithmetic mean (standard deviation)
    -5.3 ( 15.11 )
    1.1 ( 10.58 )
    1.5 ( 16.91 )
    -6.2 ( 14.07 )
    -0.9 ( 14.27 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma HDL cholesterol

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    End point title
    		 Change from baseline in plasma HDL cholesterol [20]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [20] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.8 ( 5.75 )
    -2.3 ( 12.95 )
    2.1 ( 20.41 )
    2.4 ( 9.65 )
    0.7 ( 9.39 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma indirect bilirubin

    		 Close Top of page
    End point title
    		 Change from baseline in plasma indirect bilirubin [21]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [21] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.043 ( 0.1033 )
    -0.009 ( 0.0919 )
    0.054 ( 0.2866 )
    -0.043 ( 0.1572 )
    0.046 ( 0.1947 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma LDL cholesterol

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    End point title
    		 Change from baseline in plasma LDL cholesterol [22]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [22] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    10
    11
    10
    10
    38
    Units: mg/dL
        arithmetic mean (standard deviation)
    12.2 ( 19.97 )
    -2.8 ( 11.36 )
    8.0 ( 24.86 )
    -8.9 ( 37.78 )
    -5.0 ( 37.61 )
    No statistical analyses for this end point

    Primary: Change from baseline in lactate dehydrogenase

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    End point title
    		 Change from baseline in lactate dehydrogenase [23]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [23] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    -10.2 ( 25.67 )
    -26.4 ( 69.73 )
    -14.5 ( 26.09 )
    5.1 ( 27.15 )
    -12.0 ( 41.83 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma pancreatic lipase

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    End point title
    		 Change from baseline in plasma pancreatic lipase [24]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [24] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: U/L
        arithmetic mean (standard deviation)
    3.6 ( 9.71 )
    8.1 ( 24.14 )
    -5.2 ( 9.81 )
    24.5 ( 51.50 )
    9.0 ( 50.27 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma magnesium

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    End point title
    		 Change from baseline in plasma magnesium [25]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [25] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.10 ( 0.148 )
    0.02 ( 0.140 )
    -0.02 ( 0.240 )
    0.09 ( 0.321 )
    0.01 ( 0.199 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma phospate

    		 Close Top of page
    End point title
    		 Change from baseline in plasma phospate [26]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [26] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.33 ( 0.609 )
    0.16 ( 0.423 )
    0.15 ( 0.596 )
    0.04 ( 0.803 )
    0.04 ( 0.580 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma potassium

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    End point title
    		 Change from baseline in plasma potassium [27]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [27] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    11
    11
    11
    10
    38
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.09 ( 0.327 )
    0.12 ( 0.232 )
    -0.09 ( 0.305 )
    0.23 ( 0.789 )
    0.00 ( 0.514 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma protein

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    End point title
    		 Change from baseline in plasma protein [28]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [28] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: g/dL
        arithmetic mean (standard deviation)
    0.17 ( 0.320 )
    0.05 ( 0.305 )
    -0.11 ( 0.575 )
    -0.09 ( 0.396 )
    0.00 ( 0.515 )
    No statistical analyses for this end point

    Primary: Change from baseline in prothrombin intl. normalised ratio

    		 Close Top of page
    End point title
    		 Change from baseline in prothrombin intl. normalised ratio [29]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [29] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    10
    10
    10
    40
    Units: N/A
        arithmetic mean (standard deviation)
    0.03 ( 0.210 )
    0.01 ( 0.160 )
    0.10 ( 0.141 )
    0.01 ( 0.088 )
    0.08 ( 0.387 )
    No statistical analyses for this end point

    Primary: Change from baseline in prothrombin time

    		 Close Top of page
    End point title
    		 Change from baseline in prothrombin time [30]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [30] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    10
    10
    10
    40
    Units: second
        arithmetic mean (standard deviation)
    0.48 ( 1.566 )
    0.07 ( 1.561 )
    0.69 ( 1.268 )
    0.33 ( 0.736 )
    0.78 ( 3.445 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma sodium

    		 Close Top of page
    End point title
    		 Change from baseline in plasma sodium [31]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [31] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.0 ( 2.22 )
    1.8 ( 3.89 )
    0.9 ( 3.59 )
    2.5 ( 5.05 )
    1.0 ( 3.46 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma triglycerides

    		 Close Top of page
    End point title
    		 Change from baseline in plasma triglycerides [32]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [32] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    16.6 ( 123.84 )
    5.7 ( 51.48 )
    -16.5 ( 25.80 )
    -23.2 ( 123.79 )
    -2.6 ( 80.08 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma urate

    		 Close Top of page
    End point title
    		 Change from baseline in plasma urate [33]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [33] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.51 ( 0.485 )
    0.04 ( 1.107 )
    -0.28 ( 0.877 )
    -0.08 ( 0.926 )
    -0.05 ( 1.040 )
    No statistical analyses for this end point

    Primary: Change from baseline in plasma urea nitrogen

    		 Close Top of page
    End point title
    		 Change from baseline in plasma urea nitrogen [34]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [34] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    41
    Units: mg/dL
        arithmetic mean (standard deviation)
    2.8 ( 3.65 )
    -2.6 ( 4.18 )
    3.6 ( 5.95 )
    1.1 ( 11.42 )
    2.3 ( 6.15 )
    No statistical analyses for this end point

    Primary: Changes for baseline in basophils

    		 Close Top of page
    End point title
    		 Changes for baseline in basophils [35]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [35] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: 10^9/L
        arithmetic mean (standard deviation)
    0.02 ( 0.058 )
    0.03 ( 0.047 )
    0.02 ( 0.60 )
    -0.03 ( 0.048 )
    0.02 ( 0.063 )
    No statistical analyses for this end point

    Primary: Change from baseline basophils/leukocytes

    		 Close Top of page
    End point title
    		 Change from baseline basophils/leukocytes [36]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [36] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    0.08 ( 0.389 )
    -0.01 ( 0.459 )
    0.18 ( 0.547 )
    -0.13 ( 0.419 )
    0.16 ( 0.433 )
    No statistical analyses for this end point

    Primary: Change from baseline in eosinophils

    		 Close Top of page
    End point title
    		 Change from baseline in eosinophils [37]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [37] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    12
    11
    39
    Units: 10^9/L
        arithmetic mean (standard deviation)
    0.01 ( 0.108 )
    0.01 ( 0.122 )
    0.00 ( 0.184 )
    0.01 ( 0.099 )
    0.03 ( 0.162 )
    No statistical analyses for this end point

    Primary: Change from baseline in Eosinophils/Leukocytes

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    End point title
    		 Change from baseline in Eosinophils/Leukocytes [38]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [38] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    0.32 ( 1.375 )
    0.09 ( 0.984 )
    -0.02 ( 2.245 )
    0.33 ( 1.430 )
    0.27 ( 1.922 )
    No statistical analyses for this end point

    Primary: Change from baseline in Erythrocyte Mean Corpuscular HGB Concentration

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    End point title
    		 Change from baseline in Erythrocyte Mean Corpuscular HGB Concentration [39]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [39] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.20 ( 0.603 )
    -0.18 ( 0.778 )
    -0.24 ( 0.439 )
    -0.16 ( 0.556 )
    -0.28 ( 0.891 )
    No statistical analyses for this end point

    Primary: Change from baseline in Erythrocyte Mean Corpuscular Hemoglobin

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    End point title
    		 Change from baseline in Erythrocyte Mean Corpuscular Hemoglobin [40]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [40] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: picogram(s)
        arithmetic mean (standard deviation)
    -0.2 ( 0.58 )
    -0.3 ( 0.47 )
    -0.5 ( 0.82 )
    0.0 ( 0.82 )
    -0.1 ( 0.80 )
    No statistical analyses for this end point

    Primary: Change from baseline in Erythrocyte Mean Corpuscular Volume

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    End point title
    		 Change from baseline in Erythrocyte Mean Corpuscular Volume [41]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [41] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: fL
        arithmetic mean (standard deviation)
    -0.21 ( 1.472 )
    -0.02 ( 2.093 )
    -0.33 ( 1.251 )
    0.03 ( 1.931 )
    0.44 ( 1.801 )
    No statistical analyses for this end point

    Primary: Change from baseline in erythrocytes

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    End point title
    		 Change from baseline in erythrocytes [42]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [42] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: 10^12/L
        arithmetic mean (standard deviation)
    -0.004 ( 0.2946 )
    0.055 ( 0.2211 )
    0.010 ( 0.2326 )
    -0.55 ( 0.1761 )
    -0.003 ( 0.2968 )
    No statistical analyses for this end point

    Primary: Change from baseline in hematocrit

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    End point title
    		 Change from baseline in hematocrit [43]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [43] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: NA
        arithmetic mean (standard deviation)
    -0.3 ( 2.34 )
    0.5 ( 2.11 )
    -0.1 ( 2.26 )
    -0.8 ( 1.55 )
    0.2 ( 2.61 )
    No statistical analyses for this end point

    Primary: Change from baseline in hemoglobin

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    End point title
    		 Change from baseline in hemoglobin [44]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [44] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.12 ( 0.802 )
    0.13 ( 0.588 )
    -0.10 ( 0.784 )
    -0.25 ( 0.488 )
    -0.07 ( 0.923 )
    No statistical analyses for this end point

    Primary: Change from baseline in leukocytes

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    End point title
    		 Change from baseline in leukocytes [45]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [45] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: 10^3/microlitre
        arithmetic mean (standard deviation)
    -0.98 ( 1.915 )
    0.45 ( 1.012 )
    0.37 ( 1.819 )
    -0.09 ( 1.928 )
    -0.09 ( 1.711 )
    No statistical analyses for this end point

    Primary: Change from baseline in lymphocytes

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    End point title
    		 Change from baseline in lymphocytes [46]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [46] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: 10^3/L
        arithmetic mean (standard deviation)
    -0.080 ( 0.2152 )
    0.122 ( 0.3541 )
    0.099 ( 0.4865 )
    0.194 ( 0.9257 )
    0.161 ( 0.4165 )
    No statistical analyses for this end point

    Primary: Change from baseline in lymphocytes/leukocytes

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    End point title
    		 Change from baseline in lymphocytes/leukocytes [47]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [47] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    2.51 ( 5.052 )
    0.06 ( 6.287 )
    -0.99 ( 8.132 )
    1.52 ( 7.013 )
    2.61 ( 7.099 )
    No statistical analyses for this end point

    Primary: Change from baseline in monocytes/leukocytes

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    End point title
    		 Change from baseline in monocytes/leukocytes [48]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [48] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    1.38 ( 1.641 )
    0.25 ( 2.056 )
    0.99 ( 3.022 )
    0.56 ( 1.532 )
    -0.21 ( 2.262 )
    No statistical analyses for this end point

    Primary: Change from baseline in neutrophils

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    End point title
    		 Change from baseline in neutrophils [49]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [49] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: 10^3/L
        arithmetic mean (standard deviation)
    -0.954 ( 1.6290 )
    0.255 ( 1.1041 )
    0.137 ( 1.6023 )
    -0.289 ( 1.4171 )
    -0.281 ( 1.5104 )
    No statistical analyses for this end point

    Primary: Change from baseline in neutrophils/leukocytes

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    End point title
    		 Change from baseline in neutrophils/leukocytes [50]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [50] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    -4.28 ( 5.941 )
    -0.39 ( 6.548 )
    -0.16 ( 8.247 )
    -2.28 ( 7.230 )
    -2.84 ( 7.830 )
    No statistical analyses for this end point

    Primary: Change from baseline in platelets

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    End point title
    		 Change from baseline in platelets [51]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [51] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    10
    11
    10
    43
    Units: 10^9/L
        arithmetic mean (standard deviation)
    5.2 ( 31.68 )
    26.2 ( 30.10 )
    4.8 ( 28.72 )
    0.9 ( 27.65 )
    19.1 ( 54.30 )
    No statistical analyses for this end point

    Primary: Change from baseline in reticulocytes/erythorcytes

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    End point title
    		 Change from baseline in reticulocytes/erythorcytes [52]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [52] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    10
    39
    Units: N/A
        arithmetic mean (standard deviation)
    -0.08 ( 0.626 )
    -0.11 ( 0.554 )
    -0.30 ( 0.615 )
    -0.12 ( 0.290 )
    -0.14 ( 0.536 )
    No statistical analyses for this end point

    Primary: Change from baseline in urine albumin

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    End point title
    		 Change from baseline in urine albumin [53]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [53] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    42
    Units: mg/dL
        arithmetic mean (standard deviation)
    1.117 ( 118.7664 )
    -19.044 ( 119.7149 )
    -8.455 ( 53.9332 )
    -35.964 ( 178.9164 )
    -28.433 ( 107.8847 )
    No statistical analyses for this end point

    Primary: Change from baseline in urine creatinine

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    End point title
    		 Change from baseline in urine creatinine [54]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [54] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    42
    Units: mg/dL
        arithmetic mean (standard deviation)
    10.65 ( 35.931 )
    -11.67 ( 33.423 )
    -15.37 ( 30.920 )
    25.30 ( 84.654 )
    -6.96 ( 31.530 )
    No statistical analyses for this end point

    Primary: Change from baseline in urine protein

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    End point title
    		 Change from baseline in urine protein [55]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 12 From baseline to Week 24
    Notes
    [55] - 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: Due to the small sample size and abbreviated summary of data no per-protocol analyses was carried out
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    42
    Units: mg/dL
        arithmetic mean (standard deviation)
    -19.3 ( 139.96 )
    -8.9 ( 134.17 )
    -9.0 ( 80.51 )
    -80.6 ( 230.57 )
    -35.1 ( 144.93 )
    No statistical analyses for this end point

    Secondary: Change from baseline in estimated glomerular filtration rate (eGFR) at Week 12 and Week 24

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    End point title
    		 Change from baseline in estimated glomerular filtration rate (eGFR) at Week 12 and Week 24
    End point description
    Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 13 and Baseline to Week 24
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 Baseline to Week 24
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    43
    Units: mL/min/1.73m2
    arithmetic mean (standard deviation)
        CKD-EPI Cystatin C equation Week 12
    -4.9 ( 11.74 )
    -3.1 ( 3.91 )
    -1.6 ( 8.61 )
    0.2 ( 9.51 )
    -1.7 ( 9.49 )
        CKD-EPI Cystatin C equation Week 24
    -0.8 ( 6.63 )
    -3.2 ( 10.40 )
    -1.3 ( 9.69 )
    -3.2 ( 9.60 )
    -2.0 ( 8.86 )
        CKD-EPI Creatinine equation Week 12
    -3.0 ( 6.47 )
    -4.2 ( 11.50 )
    -3.9 ( 5.74 )
    -4.8 ( 9.68 )
    -4.7 ( 9.68 )
        CKD-EPI Creatinine equation Week 24
    -3.1 ( 5.74 )
    -8.2 ( 9.89 )
    -5.3 ( 10.59 )
    -2.0 ( 8.29 )
    -4.7 ( 8.80 )
        CKD-EPI Creatinine-Cystatin C equation Week 12
    -5.3 ( 8.92 )
    -3.5 ( 5.61 )
    -2.6 ( 6.53 )
    -2.8 ( 8.57 )
    -3.2 ( 8.43 )
        CKD-EPI Creatinine-Cystatin C equation Week 24
    -2.4 ( 5.24 )
    -5.5 ( 9.20 )
    -3.2 ( 9.18 )
    -2.8 ( 7.93 )
    -3.4 ( 7.82 )
        MDRD Creatinine equation Week 12
    -4.7 ( 10.82 )
    -5.1 ( 13.75 )
    -4.6 ( 6.23 )
    -6.7 ( 14.03 )
    -5.6 ( 13.76 )
        MDRD Creatinine equation Week 24
    -4.5 ( 11.12 )
    -8.8 ( 12.85 )
    -5.9 ( 10.05 )
    -4.0 ( 10.77 )
    -5.8 ( 10.95 )
    No statistical analyses for this end point

    Secondary: Proportion of subjects achieving complete or partial renal remission at Week 12 and Week 24

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    End point title
    		 Proportion of subjects achieving complete or partial renal remission at Week 12 and Week 24
    End point description
    1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24
    End point type
    Secondary
    End point timeframe
    Endpoint at Week 12 Endpoint at Week 24
    End point values
    		 Group A - Placebo Group B - CCX140-B 5 mg QD Group C -CCX140-B 10 mg BID Group D -CCX140-B 15 mg BID Open-label extension
    Number of subjects analysed
    12
    11
    11
    11
    43
    Units: subjects
        Complete renal remission
    0
    0
    0
    0
    0
        Partial remission (definition 1)
    1
    0
    0
    1
    4
        Partial remission (definition 2)
    0
    0
    0
    0
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline to Week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    All CCX140-B treated - overall study
    Reporting group description
    		 All the patients who received CCX140-B at least once during the double-blind and/or the open-label extension are included. One patient who received the placebo treatment in the double-blind period and did not enter in the open-label extenstion is not included in this reporting group. This patient did not experience any adverse event.

    Serious adverse events
    		 All CCX140-B treated - overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: The SAE acute kidney injury was considered Possibly Related by the Investigator but not by the Sponsor.
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All CCX140-B treated - overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 45 (73.33%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    11
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    8 / 45 (17.78%)
         occurrences all number
    9
    Fatigue
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    5
    Oedema
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    5
    Muscle spasms
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    7 / 45 (15.56%)
         occurrences all number
    10

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2017
    An update was made to the guidelines for dose modification.
    18 Jan 2018
    1. Stratification criteria was updated. 2. The inclusion and exclusion criteria were updated. 3. The secondary objective to evaluate the effect of CCX140-B on renal function was updated 4. The table describing the dose modification guidelines for single subjects was moved to the study design section of the protocol. 5. Screening investigations were clarified. 6. A clinical safety laboratory assessment was added. 10. The pregnancies, special situation, and serious AE (SAE) reporting instructions were updated.
    15 Feb 2018
    1. ACTG-BPNST Screening assessment were updated. 2. Changes were made to the dose modification guidelines 3. The inclusion criterion for female subjects of childbearing potential was updated. 4. The exclusion criteria were updated. 5. The timeframe for recording of prior medications was updated. 6. It was clarified that the time of blood collection should be recorded for all PK sample blood draws. 7. Safety assessments during the Early Termination Visit were updated.
    29 Oct 2018
    1. The analysis of the primary efficacy objective was clarified to be at Week 12. 2. A secondary objective to evaluate the effect of CCX140-B treatment was added. 3. The inclusion criterion for female subjects of childbearing potential was updated. 4. The exclusion criteria was updated. 5. Secondary efficacy endpoints were updated 6. The Blinded Treatment Period, the Open-Label Extension and the Follow-up Period were clarified. 7. A 24-hour urine collection schedule and investigations were added and clarified. 8. The timing of PK blood sample collection was clarified. 9. It was clarified that following the 12-week Blinded Treatment Period, the study would evaluate up to 24 weeks of treatment with CCX140-B. 10. The dose modification guidelines for clarified. 11. Potentially prohibited medications taken prior to enrolment that were to be recorded were specified. 12. Language describing the usage of local laboratories was removed. 13. Study procedures were added. 14. Reminders for discontinuing subjects after the completion of all study procedures were added. 15. The collection of whole blood for the assessment of elimination upon discontinuation of treatment was clarified. 16. Efficacy assessment was clarified. 17. The clinical safety laboratory assessments were updated. 18. Sample collection for PD measurement was clarified. 19. An exploratory efficacy endpoint was updated.

    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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