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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily Administration of a Chemokine CCR2/5 Receptor Antagonist (PF-04634817) in Adults With Type 2 Diabetes and Overt Nephropathy

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-003332-23
    Trial protocol
    		 IT   DE   ES   PL   RO  
    Global end of trial date
    22 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1261007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01712061
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    01 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of PF-04634817 compared to placebo in the reduction of albuminuria following 12 weeks of treatment in subjects with Type 2 diabetes and overt nephropathy.
    Protection of trial subjects
    This study used an unblinded Internal Review Committee (IRC) for the interim analysis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Malaysia: 5
    Country: Number of subjects enrolled
    Peru: 10
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    United States: 107
    Country: Number of subjects enrolled
    Spain: 10
    Worldwide total number of subjects
    226
    EEA total number of subjects
    49
    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)
    112
    From 65 to 84 years
    114
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio [UACR] greater than or equal to (>=)300 milligrams per gram (mg/g).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 PF-04634817 150 mg Daily
    Arm description
    		 Subjects with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04634817
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg

    Arm title
    		 PF-04634817 200 mg Daily
    Arm description
    		 Subjects with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04634817
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Arm title
    		 PF-04634817 200 mg/150 mg Daily
    Arm description
    		 Subjects received either 150 mg or 200 mg once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04634817
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg or 200 mg once daily

    Arm title
    		 Placebo Daily
    Arm description
    		 Subjects were dosed orally with matching placebo tablets once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo matched PF-04634817

    Number of subjects in period 1
    		PF-04634817 150 mg Daily PF-04634817 200 mg Daily PF-04634817 200 mg/150 mg Daily Placebo Daily
    Started
    30
    140
    170
    56
    Completed
    20
    114
    134
    45
    Not completed
    10
    26
    36
    11
         Adverse event, serious fatal
    -
    -
    -
    1
         Consent withdrawn by subject
    1
    7
    8
    1
         Did Not Meet Entrance Criteria
    4
    6
    10
    3
         Adverse event, non-fatal
    4
    9
    13
    5
         Medication Error Without Associated AE
    -
    1
    1
    -
         Unspecified
    -
    3
    3
    -
         Lost to follow-up
    1
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 226 226
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 112 112
        From 65-84 years
    		 114 114
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ± 8.6 -
    Gender, Male/Female
    Units: Participants
        FEMALE
    		 43 43
        MALE
    		 183 183

    End points

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    End points reporting groups
    Reporting group title
    PF-04634817 150 mg Daily
    Reporting group description
    		 Subjects with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily for 12 weeks.

    Reporting group title
    PF-04634817 200 mg Daily
    Reporting group description
    		 Subjects with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg once daily for 12 weeks.

    Reporting group title
    PF-04634817 200 mg/150 mg Daily
    Reporting group description
    		 Subjects received either 150 mg or 200 mg once daily for 12 weeks.

    Reporting group title
    Placebo Daily
    Reporting group description
    		 Subjects were dosed orally with matching placebo tablets once daily for 12 weeks.

    Primary: Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12

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    End point title
    		 Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: percent (%)
        arithmetic mean (confidence interval 95%)
    13.27 (3.14 to 24.62)
    5.02 (-7.9 to 18.7)
    Statistical analysis title
    		 Percent Reduction from Baseline in UACR at Week 12
    Comparison groups
    PF-04634817 200 mg/150 mg Daily v Placebo Daily
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Bayesian ANCOVA
    Point estimate
    0.91785
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.09

    Secondary: Change From Baseline in UACR at Weeks 4, 8 and 16

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    End point title
    		 Change From Baseline in UACR at Weeks 4, 8 and 16 [2]
    End point description
    The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 16
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: mg/millimolar creatinine (mmolCr)
    geometric mean (geometric coefficient of variation)
        Baseline (n=157,50)
    127.41 ± 96
    121.8 ± 88
        Change From Baseline at Week 4 (n=148,46)
    0.89 ± 66
    0.91 ± 88
        Change From Baseline at Week 8 (n=134,43)
    0.9 ± 62
    0.94 ± 57
        Change From Baseline at Week 16 (n=126,37)
    0.93 ± 72
    0.92 ± 56
    No statistical analyses for this end point

    Secondary: Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 [3]
    End point description
    The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12 and 16
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: mg/mmolCr
    geometric mean (geometric coefficient of variation)
        Baseline (n=155,49)
    185.42 ± 97
    176.31 ± 82
        Change From Baseline at Week 4 (n=143,45)
    0.93 ± 47
    0.92 ± 76
        Change From Baseline at Week 8 (n=130,42)
    0.92 ± 50
    0.94 ± 46
        Change From Baseline at Week 12 (n=125,42)
    0.92 ± 58
    0.92 ± 79
        Change From Baseline at Week 16 (n=125,36)
    0.95 ± 58
    0.92 ± 55
    No statistical analyses for this end point

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 [4]
    End point description
    eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 4, 8, 12 and 16
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The warning is not true, statistical analysis was reported for all the arms in the baseline period.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: mL/min/1.73m^2
    arithmetic mean (standard deviation)
        Baseline (n=159,51)
    41.8 ± 12.18
    41.65 ± 13.46
        Change From Baseline at Week 1 (n=157,50)
    -0.77 ± 5.8
    -0.35 ± 5.28
        Change From Baseline at Week 4 (n=157,51)
    -1.07 ± 5.37
    -1.32 ± 5.12
        Change From Baseline at Week 8 (n=147,47)
    -1.6 ± 5.34
    -2.15 ± 6.83
        Change From Baseline at Week 12 (n=136,45)
    -1.14 ± 5.7
    -1.03 ± 5.75
        Change From Baseline at Week 16 (n=134,44)
    -2.14 ± 6.42
    -1.18 ± 5.58
    No statistical analyses for this end point

    Secondary: Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16

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    End point title
    		 Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 [5]
    End point description
    Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 16
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: mL/min/1.73m^2
    arithmetic mean (standard deviation)
        Baseline (n=159,50)
    45.28 ± 14.22
    45.36 ± 14.94
        Change From Baseline at Week 12 (n=135,44)
    -1.1 ± 6.3
    -0.7 ± 5.49
        Change From Baseline at Week 16 (n=134,43)
    -2.27 ± 6.77
    -0.91 ± 6.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 [6]
    End point description
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 4, 8, 12 and 16
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: milligrams per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Baseline (n=159,51)
    1.72 ± 0.51
    1.77 ± 0.51
        Change From Baseline at Week 1 (n=158,50)
    0.05 ± 0.22
    0.03 ± 0.17
        Change From Baseline at Week 4 (n=157,51)
    0.06 ± 0.21
    0.11 ± 0.3
        Change From Baseline at Week 8 (n=147,47)
    0.06 ± 0.21
    0.09 ± 0.24
        Change From Baseline at Week 12 (n=137,45)
    0.05 ± 0.24
    0.08 ± 0.2
        Change From Baseline at Week 16 (n=134,44)
    0.09 ± 0.3
    0.09 ± 0.29
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Cystatin C at Weeks 12 and 16

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    End point title
    		 Change From Baseline in Serum Cystatin C at Weeks 12 and 16 [7]
    End point description
    Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 16
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n=159,51)
    1.54 ± 0.43
    1.52 ± 0.41
        Change From Baseline at Week 12 (n=136,45)
    0.03 ± 0.25
    0.03 ± 0.21
        Change From Baseline at Week 16 (n=134,44)
    0.05 ± 0.26
    0.06 ± 0.25
    No statistical analyses for this end point

    Secondary: Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 [8]
    End point description
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12 and 16
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    159
    51
    Units: percent
    arithmetic mean (standard deviation)
        Baseline (n=159,51)
    7.51 ± 1.22
    7.91 ± 1.42
        Change From Baseline at Week 4 (n=157,51)
    0.03 ± 0.46
    -0.04 ± 0.46
        Change From Baseline at Week 8 (n=147,46)
    -0.02 ± 0.64
    -0.08 ± 0.71
        Change From Baseline at Week 12 (n=137,44)
    -0.01 ± 0.76
    -0.06 ± 0.81
        Change From Baseline at Week 16 (n=133,44)
    0.04 ± 0.89
    -0.04 ± 1.13
    No statistical analyses for this end point

    Secondary: Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12

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    End point title
    		 Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 [9]
    End point description
    End point type
    Secondary
    End point timeframe
    1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this secondary endpoint. Secondary analyses included tabulations of summary statistics of all continuous secondary endpoints.
    End point values
    		 PF-04634817 150 mg Daily PF-04634817 200 mg Daily
    Number of subjects analysed
    30
    140
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1: 1 Hour Post-Dose (n=29,124)
    434.5 ± 65
    524.4 ± 83
        Day 1: 2 Hours Post-Dose (n=30,139)
    579.3 ± 37
    602.9 ± 52
        Day 1: 4 Hours Post-Dose (n=29,137)
    497.4 ± 38
    547.7 ± 46
        Week 1: Pre-Dose (n=28,131)
    294.4 ± 60
    231.2 ± 73
        Week 1: 2 Hours Post-Dose (n=28,132)
    884.8 ± 42
    865 ± 55
        Week 4: Pre-Dose (n=25,126)
    231.3 ± 51
    239.5 ± 87
        Week 4: 2 Hours Post-Dose (n=24,122)
    785.8 ± 45
    918 ± 55
        Week 8: Pre-Dose (n=23,113)
    310.2 ± 79
    245.2 ± 77
        Week 8: 2 Hours Post-Dose (n=23,114)
    730 ± 70
    895 ± 57
        Week 12 (n=20,113)
    320.1 ± 75
    252.3 ± 84
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 [10]
    End point description
    Wk=Week
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Weeks 1, 4, 8, 12 and 16
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    170
    56
    Units: millimeters of mercury (mm Hg)
    arithmetic mean (standard deviation)
        Supine SBP: Baseline (n=168,53)
    140.4 ± 13.96
    139.9 ± 13.6
        Supine SBP:Change From Baseline Wk 1 (n=164,53)
    -0.8 ± 12.75
    -1.6 ± 12.87
        Supine SBP:Change From Baseline Wk 4 (n=154,49)
    -0.5 ± 15.43
    -1.6 ± 14.19
        Supine SBP:Change From Baseline Wk 8 (n=142,47)
    -3.4 ± 12.94
    -1.1 ± 13.71
        Supine SBP:Change From Baseline Wk 12 (n=134,45)
    -2 ± 13.28
    -1.3 ± 13.23
        Supine SBP:Change From Baseline Wk 16 (n=138,45)
    -2.4 ± 15.14
    -0.3 ± 14.41
        Supine DBP: Baseline (n=168,53)
    75.9 ± 8.97
    77.1 ± 6.88
        Supine DBP:Change From Baseline Wk 1 (n=164,53)
    -0.2 ± 6.94
    -2.7 ± 7.58
        Supine DBP:Change From Baseline Wk 4 (n=154,49)
    0.1 ± 8.23
    -1.8 ± 7.47
        Supine DBP:Change From Baseline Wk 8 (n=142,47)
    -1.9 ± 7.46
    -1.5 ± 7.05
        Supine DBP:Change From Baseline Wk 12 (n=134,45)
    -0.9 ± 6.88
    -0.2 ± 6.69
        Supine DBP:Change From Baseline Wk 16 (n=138,45)
    -1.7 ± 7.98
    0.9 ± 8.4
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 [11]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Weeks 1, 4, 8, 12 and 16
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    170
    56
    Units: beats per minute (bpm)
    arithmetic mean (standard deviation)
        Baseline (n=168,53)
    68.7 ± 9.74
    69.3 ± 9.3
        Change From Baseline at Week 1 (n=164,53)
    0.1 ± 5.86
    -0.7 ± 5.63
        Change From Baseline at Week 4 (n=154,49)
    0.3 ± 6.01
    -1 ± 6.63
        Change From Baseline at Week 8 (n=142,47)
    0.2 ± 6.54
    1.4 ± 6.77
        Change From Baseline at Week 12 (n=134,45)
    0.2 ± 7.03
    0.5 ± 7.33
        Change From Baseline at Week 16 (n=138,45)
    1.4 ± 8.22
    -0.1 ± 6.92
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16

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    End point title
    		 Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 [12]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Weeks 1, 4, 8, 12 and 16
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    170
    56
    Units: kilograms (kg)
    arithmetic mean (standard deviation)
        Baseline (n=167,53)
    93.8 ± 23.97
    95.1 ± 25.95
        Change From Baseline at Week 1 (n=163,53)
    0 ± 1.03
    0.3 ± 1.42
        Change From Baseline at Week 4 (n=153,49)
    0 ± 1.74
    0.4 ± 3.29
        Change From Baseline at Week 8 (n=141,47)
    0.1 ± 2.45
    0.7 ± 2.74
        Change From Baseline at Week 12 (n=134,45)
    0.3 ± 2.66
    0.7 ± 3.02
        Change From Baseline at Week 16 (n=137,45)
    -0.1 ± 2.79
    0.2 ± 3.37
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

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    End point title
    		 Number of Subjects With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern [13]
    End point description
    The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16 (follow-up visit)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    167
    53
    Units: subjects
    154
    49
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings

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    End point title
    		 Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings [14]
    End point description
    Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Weeks 1, 4 and 12
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    170
    56
    Units: subjects
        Maximum PR Interval >=300 msec (n=164,55)
    3
    0
        Maximum QRS Complex >=140 msec (n=169,56)
    2
    1
        Maximum QT Interval >=500 msec (n=169,56)
    0
    0
        Maximum QTc Interval 450-<480 msec (n=169,56)
    23
    11
        Maximum QTc Interval 480-<500 msec (n=169,56)
    4
    1
        Maximum QTc Interval >=500 msec (n=169,56)
    0
    0
        Maximum QTcF Interval 450-<480 msec (n=169,56)
    11
    5
        Maximum QTcF Interval 480-<500 msec (n=169,56)
    1
    1
        Maximum QTcF Interval >=500 msec (n=169,56)
    1
    0
        PR Interval >=25/50% IFB (n=163,53)
    3
    0
        QRS Complex >=50% IFB (n=169,55)
    3
    0
        QTc Interval 30-<60 msec IFB (n=169,55)
    15
    4
        QTc Interval >=60 msec IFB (n=169,55)
    0
    0
        QTcF Interval 30-<60 msec IFB (n=169,55)
    8
    3
        QTcF Interval >=60 msec IFB (n=169,55)
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [15]
    End point description
    An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to 28 days after last study drug administration
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    170
    56
    Units: subjects
        Adverse Events
    106
    36
        Serious Adverse Events
    17
    5
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Increased Fasting Blood Glucose

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    End point title
    		 Number of Subjects With Increased Fasting Blood Glucose [16]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 16 (follow-up visit)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this safety endpoint. Safety data were summarized using Sponsor Data Standards.
    End point values
    		 PF-04634817 200 mg/150 mg Daily Placebo Daily
    Number of subjects analysed
    167
    53
    Units: subjects
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after last study drug administration
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PF-04634817 150 mg
    Reporting group description
    		 Subjects with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were dosed orally with matching placebo tablets once daily for 12 weeks.

    Reporting group title
    PF-04634817 200 mg
    Reporting group description
    		 Subjects with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg once daily for 12 weeks.

    Serious adverse events
    		 PF-04634817 150 mg Placebo PF-04634817 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    5 / 56 (8.93%)
    11 / 140 (7.86%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    2 / 140 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Homicide
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 56 (1.79%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 56 (1.79%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythrodermic psoriasis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 56 (0.00%)
    2 / 140 (1.43%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 56 (1.79%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 56 (1.79%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 56 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-04634817 150 mg Placebo PF-04634817 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 30 (36.67%)
    15 / 56 (26.79%)
    40 / 140 (28.57%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 56 (0.00%)
    1 / 140 (0.71%)
         occurrences all number
    2
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 56 (5.36%)
    6 / 140 (4.29%)
         occurrences all number
    2
    3
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    4 / 140 (2.86%)
         occurrences all number
    2
    1
    7
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 56 (7.14%)
    8 / 140 (5.71%)
         occurrences all number
    3
    4
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 56 (5.36%)
    12 / 140 (8.57%)
         occurrences all number
    2
    3
    12
    Nausea
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 56 (3.57%)
    5 / 140 (3.57%)
         occurrences all number
    2
    2
    7
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    0 / 140 (0.00%)
         occurrences all number
    2
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    2 / 140 (1.43%)
         occurrences all number
    2
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 56 (5.36%)
    6 / 140 (4.29%)
         occurrences all number
    2
    3
    8
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 56 (3.57%)
    5 / 140 (3.57%)
         occurrences all number
    2
    2
    6
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    1 / 140 (0.71%)
         occurrences all number
    2
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 56 (1.79%)
    2 / 140 (1.43%)
         occurrences all number
    3
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2012
    Electrocardiogram (ECG) assessments were modified and guidance on participant withdrawal ("stopping rules") was included as requested by the Food and Drug Administration (FDA). Exclusion criterion was loosened to exclude subjects with a history of proteinuria >8.5 g/day.
    27 Sep 2013
    Dose adjustment to 150 mg once daily (QD) in subjects with eGFR <30 mL/min.1.73 m^2 was added. Screening window was extended to 35 days to accomodate additional TB testing and chest X-ray if necessary. Inclusion criterion for eGFR was changed from 30-59 mL/min/1.73 m^2 to 20-75 mL/min/1.73 m^2 based on the results from a previous study. Inclusion criterion of UPCR >=390 mg/g was removed. Lifestyle guidelines relating to condom use by male subjects was removed.

    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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    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
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