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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of different oral doses of BAY 94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

    Summary
    EudraCT number
    2012-004179-38
    Trial protocol
    AT   SE   FI   NL   DE   NO   HU   PT   DK   BG   IT   ES   PL   CZ  
    Global end of trial date
    07 Aug 2014

    Results information
    Results version number
    v3(current)
    This version publication date
    16 Jul 2021
    First version publication date
    08 Aug 2015
    Other versions
    v1 , v2
    Version creation reason
    • Correction of full data set
    minor update

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/16243
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01874431
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    07 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the study was to investigate the change of urinary albumin-to-creatinine ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily over 90 days.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    Standard of care for renal and cardiovascular disease (CVD) protection (i.e. according to local guidelines: angiotensin-converting enzyme inhibitor [ACEI] or angiotensin receptor blocker [ARB] and optimal antihypertensive therapy; statins, anti-platelets, and beta-blockers; and glycemic control).
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Jun 2013
    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
    Australia: 17
    Country: Number of subjects enrolled
    Austria: 27
    Country: Number of subjects enrolled
    Bulgaria: 84
    Country: Number of subjects enrolled
    Canada: 38
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Denmark: 71
    Country: Number of subjects enrolled
    Finland: 52
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hong Kong: 7
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Israel: 64
    Country: Number of subjects enrolled
    Italy: 82
    Country: Number of subjects enrolled
    Netherlands: 22
    Country: Number of subjects enrolled
    Norway: 7
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    South Africa: 51
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Spain: 67
    Country: Number of subjects enrolled
    Sweden: 45
    Country: Number of subjects enrolled
    Taiwan: 22
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    823
    EEA total number of subjects
    569
    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)
    388
    From 65 to 84 years
    431
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 148 study centers in 23 countries, from 12 June 2013 (first subject, first visit) to 07 August 2014 (last subject, last visit). The randomization was stratified by region (Europe, North America, Asia, others [Australia, Israel, and South Africa]), and type of albuminuria at screening (very high or high albuminuria).

    Pre-assignment
    Screening details
    Of 1501 subjects screened, 823 were randomized and 821 were treated at 128 study centers.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Finerenone (BAY94-8862) (1.25 mg)
    Arm description
    1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Immediate-release (IR) light orange film-coated tablets, oval (modified oblong), containing 1.25 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (2.5 mg)
    Arm description
    2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 2.5 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (5 mg)
    Arm description
    5 mg BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 5 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (7.5 mg)
    Arm description
    7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY 94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 7.5 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (10 mg)
    Arm description
    10 mg BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 10 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (15 mg)
    Arm description
    15 mg BAY94-8862 tablet once daily in the morning for 90 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 15 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Finerenone (BAY94-8862) (20 mg)
    Arm description
    20 mg BAY94-8862 tablet once daily in the morning for 90 days
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IR light orange film-coated tablets, oval (modified oblong), containing 20 mg BAY94-8862, were administrated once daily in the morning for 90 days.

    Arm title
    Placebo
    Arm description
    Placebo tablet once daily in the morning for 90 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets (matching BAY94-8862 tablets) were administrated once daily in the morning for 90 days.

    Number of subjects in period 1 [1]
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Started
    96
    92
    100
    97
    98
    125
    119
    94
    Completed
    90
    87
    90
    91
    90
    114
    112
    90
    Not completed
    6
    5
    10
    6
    8
    11
    7
    4
         Physician decision
    -
    -
    1
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    1
    1
    1
    3
    -
         Logistical difficulties
    -
    -
    -
    -
    -
    -
    1
    -
         Protocol violation
    1
    1
    1
    -
    3
    2
    -
    1
         Adverse event
    5
    4
    6
    5
    2
    8
    2
    3
         Non-compliance
    -
    -
    -
    -
    1
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    -
    -
    -
         Sponsor decision
    -
    -
    -
    -
    1
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Number of subjects received treatment were reported in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Finerenone (BAY94-8862) (1.25 mg)
    Reporting group description
    1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (2.5 mg)
    Reporting group description
    2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (5 mg)
    Reporting group description
    5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (7.5 mg)
    Reporting group description
    7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (10 mg)
    Reporting group description
    10 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (15 mg)
    Reporting group description
    15 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (20 mg)
    Reporting group description
    20 mg BAY94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablet once daily in the morning for 90 days.

    Reporting group values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo Total
    Number of subjects
    96 92 100 97 98 125 119 94 821
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.91 ( 9.57 ) 64.86 ( 9.09 ) 63.31 ( 8.79 ) 63.73 ( 10.04 ) 64.94 ( 9.62 ) 63.95 ( 8.34 ) 64.7 ( 9.26 ) 63.26 ( 8.68 ) -
    Gender categorical
    Units: Subjects
        Female
    18 14 29 18 21 27 30 25 182
        Male
    78 78 71 79 77 98 89 69 639
    Baseline UACR
    Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was determined from 3 first morning void samples taken on 3 consecutive days.
    Units: G/kg
        arithmetic mean (standard deviation)
    412.02 ( 507.51 ) 471.01 ( 784.84 ) 402.04 ( 535.44 ) 405.14 ( 702.63 ) 441.16 ( 571.27 ) 450.12 ( 657.04 ) 379.28 ( 457.33 ) 377.28 ( 542.27 ) -
    Baseline potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    4.323 ( 0.425 ) 4.297 ( 0.426 ) 4.314 ( 0.325 ) 4.311 ( 0.435 ) 4.297 ( 0.420 ) 4.288 ( 0.459 ) 4.294 ( 0.439 ) 4.254 ( 0.479 ) -
    Baseline eGFR
    An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    66.113 ( 21.923 ) 67.425 ( 20.164 ) 67.080 ( 22.205 ) 67.497 ( 21.917 ) 67.042 ( 20.857 ) 67.455 ( 23.646 ) 66.039 ( 22.205 ) 72.213 ( 20.434 ) -
    Baseline KDQOL-36 domain score (Effects of Kidney Disease)
    The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (serve problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" sub-score was analyzed. Data for subjects with valid data for this baseline characteristic were reported.
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    90.78 ( 10.28 ) 92.53 ( 9.57 ) 91.78 ( 12.55 ) 92.99 ( 11.04 ) 88.71 ( 16.50 ) 90.45 ( 14.39 ) 89.10 ( 17.45 ) 81.45 ( 20.42 ) -
    Baseline EQ-5D scores (EQ5D - Visual Analog Scale)
    EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state). Data for subjects with valid data for this baseline characteristic were reported.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    71.76 ( 16.39 ) 72.79 ( 14.81 ) 73.01 ( 16.21 ) 74.49 ( 15.92 ) 73.89 ( 16.47 ) 73.19 ( 16.11 ) 71.36 ( 17.49 ) 70.05 ( 17.69 ) -

    End points

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    End points reporting groups
    Reporting group title
    Finerenone (BAY94-8862) (1.25 mg)
    Reporting group description
    1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (2.5 mg)
    Reporting group description
    2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (5 mg)
    Reporting group description
    5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (7.5 mg)
    Reporting group description
    7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (10 mg)
    Reporting group description
    10 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (15 mg)
    Reporting group description
    15 mg BAY94-8862 tablet once daily in the morning for 90 days.

    Reporting group title
    Finerenone (BAY94-8862) (20 mg)
    Reporting group description
    20 mg BAY94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablet once daily in the morning for 90 days.

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    SAF (N=821) included all randomized subjects who took at least one dose of study drug and with data after beginning of treatment.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    FAS (N=812) included all subjects of the SAF who had baseline and at least one post-baseline urinary albumin-to-creatinine ratio (UACR) value.

    Primary: Ratio of UACR at Day 90 to UACR at Baseline

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    End point title
    Ratio of UACR at Day 90 to UACR at Baseline
    End point description
    Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
    End point type
    Primary
    End point timeframe
    Baseline and Day 90±2
    End point values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Number of subjects analysed
    96 [1]
    92 [2]
    98 [3]
    96 [4]
    96 [5]
    123 [6]
    117 [7]
    94 [8]
    Units: Ratio
        least squares mean (confidence interval 90%)
    0.869 (0.772 to 0.979)
    0.89 (0.786 to 1.009)
    0.824 (0.73 to 0.929)
    0.739 (0.653 to 0.835)
    0.708 (0.627 to 0.8)
    0.63 (0.563 to 0.705)
    0.585 (0.523 to 0.654)
    0.938 (0.829 to 1.061)
    Notes
    [1] - FAS
    [2] - FAS
    [3] - FAS
    [4] - FAS
    [5] - FAS
    [6] - FAS
    [7] - FAS
    [8] - FAS
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (1.25 mg) v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1973
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.926
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.799
         upper limit
    1.074
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (2.5 mg) v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.2808
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.949
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.818
         upper limit
    1.101
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (5 mg) v Placebo
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0723
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.878
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.758
         upper limit
    1.017
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (7.5 mg) v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0039
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.787
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    0.912
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (10 mg) v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0009
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.755
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.651
         upper limit
    0.875
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (15 mg) v Placebo
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.671
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.584
         upper limit
    0.772
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.
    Comparison groups
    Finerenone (BAY94-8862) (20 mg) v Placebo
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    t-test, 1-sided
    Parameter type
    Least square mean ratio
    Point estimate
    0.624
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.542
         upper limit
    0.718

    Secondary: Change From Baseline to Day 90 in Serum Potassium

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    End point title
    Change From Baseline to Day 90 in Serum Potassium
    End point description
    Data for subjects in the SAF with valid data for this endpoint were reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 90±2
    End point values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Number of subjects analysed
    90
    87
    85
    88
    87
    109
    112
    90
    Units: millimole per liter
        least squares mean (confidence interval 90%)
    0.109 (0.03 to 0.187)
    0.123 (0.043 to 0.203)
    0.202 (0.122 to 0.282)
    0.127 (0.047 to 0.207)
    0.167 (0.087 to 0.248)
    0.238 (0.165 to 0.31)
    0.188 (0.116 to 0.259)
    0.002 (-0.077 to 0.081)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Finerenone (BAY94-8862) (1.25 mg) v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0428
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.107
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.003
         upper limit
    0.21
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Finerenone (BAY94-8862) (2.5 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0223
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.121
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.017
         upper limit
    0.225
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Finerenone (BAY94-8862) (5 mg) v Placebo
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0002
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.096
         upper limit
    0.305
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Finerenone (BAY94-8862) (7.5 mg) v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0181
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.125
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.021
         upper limit
    0.229
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Finerenone (BAY94-8862) (10 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0019
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.166
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.061
         upper limit
    0.27
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Finerenone (BAY94-8862) (15 mg) v Placebo
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.236
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.137
         upper limit
    0.334
    Statistical analysis title
    Statistical analysis 7
    Comparison groups
    Finerenone (BAY94-8862) (20 mg) v Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0002
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    0.186
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.088
         upper limit
    0.284

    Secondary: Change From Baseline to Day 90 in eGFR

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    End point title
    Change From Baseline to Day 90 in eGFR
    End point description
    An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Data for subjects in the SAF with valid data for this endpoint were reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 90±2
    End point values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Number of subjects analysed
    90
    87
    85
    88
    87
    113
    112
    90
    Units: mL/min/1.73m^2
        least squares mean (confidence interval 90%)
    -2.364 (-4.311 to -0.418)
    -3.189 (-5.164 to -1.213)
    -2.497 (-4.475 to -0.518)
    -3.378 (-5.341 to -1.415)
    -4.192 (-6.181 to -2.202)
    -3.806 (-5.563 to -2.05)
    -4.024 (-5.792 to -2.256)
    -1.578 (-3.53 to 0.373)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Finerenone (BAY94-8862) (1.25 mg) v Placebo
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.5454
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -0.786
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.337
         upper limit
    1.765
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Finerenone (BAY94-8862) (2.5 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.2186
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -1.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.177
         upper limit
    0.957
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Finerenone (BAY94-8862) (5 mg) v Placebo
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.4859
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -0.918
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.503
         upper limit
    1.667
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Finerenone (BAY94-8862) (7.5 mg) v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1677
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.358
         upper limit
    0.759
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Finerenone (BAY94-8862) (10 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0462
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -2.613
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.183
         upper limit
    -0.044
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Finerenone (BAY94-8862) (15 mg) v Placebo
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0705
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -2.228
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.643
         upper limit
    0.187
    Statistical analysis title
    Statistical analysis 7
    Comparison groups
    Finerenone (BAY94-8862) (20 mg) v Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.048
    Method
    t-test, 2-sided
    Parameter type
    Least squares mean difference
    Point estimate
    -2.446
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.869
         upper limit
    -0.022

    Secondary: Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)

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    End point title
    Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)
    End point description
    The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" sub-score was analyzed. Data for subjects in FAS with valid data for this endpoint were reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 90±2
    End point values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Number of subjects analysed
    89
    84
    87
    89
    88
    113
    109
    89
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    -2.116 (-4.521 to 0.289)
    0.104 (-2.369 to 2.577)
    -1.229 (-3.643 to 1.185)
    -1.185 (-3.597 to 1.226)
    -2.596 (-5.049 to -0.142)
    0.112 (-2.054 to 2.278)
    0.058 (-2.146 to 2.263)
    0.747 (-1.684 to 3.178)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Finerenone (BAY94-8862) (1.25 mg) v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0757
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -2.863
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.022
         upper limit
    0.297
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Finerenone (BAY94-8862) (2.5 mg) v Placebo
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.6941
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -0.643
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.851
         upper limit
    2.565
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Finerenone (BAY94-8862) (5 mg) v Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.2228
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.976
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.155
         upper limit
    1.203
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Finerenone (BAY94-8862) (7.5 mg) v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.2313
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.932
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.098
         upper limit
    1.234
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Finerenone (BAY94-8862) (10 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0386
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -3.342
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.509
         upper limit
    -0.176
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Finerenone (BAY94-8862) (15 mg) v Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.677
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -0.634
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.624
         upper limit
    2.355
    Statistical analysis title
    Statistical analysis 7
    Comparison groups
    Finerenone (BAY94-8862) (20 mg) v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.6536
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -0.688
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.699
         upper limit
    2.322

    Secondary: Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)

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    End point title
    Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)
    End point description
    EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state). Data for subjects in FAS with valid data for this endpoint were reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 90±2
    End point values
    Finerenone (BAY94-8862) (1.25 mg) Finerenone (BAY94-8862) (2.5 mg) Finerenone (BAY94-8862) (5 mg) Finerenone (BAY94-8862) (7.5 mg) Finerenone (BAY94-8862) (10 mg) Finerenone (BAY94-8862) (15 mg) Finerenone (BAY94-8862) (20 mg) Placebo
    Number of subjects analysed
    89
    83
    86
    89
    86
    112
    109
    88
    Units: scores on a scale
        least squares mean (confidence interval 95%)
    1.381 (-1.22 to 3.982)
    3.888 (1.208 to 6.568)
    3.124 (0.494 to 5.754)
    2.851 (0.241 to 5.461)
    2.698 (0.026 to 5.37)
    2.743 (0.394 to 5.092)
    1.914 (-0.465 to 4.292)
    4.425 (1.794 to 7.057)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Finerenone (BAY94-8862) (1.25 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0816
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -3.044
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.471
         upper limit
    0.383
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Finerenone (BAY94-8862) (2.5 mg) v Placebo
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.7625
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -0.537
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.027
         upper limit
    2.953
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Finerenone (BAY94-8862) (5 mg) v Placebo
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.4603
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.301
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.759
         upper limit
    2.157
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Finerenone (BAY94-8862) (7.5 mg) v Placebo
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3678
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.574
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.004
         upper limit
    1.855
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Finerenone (BAY94-8862) (10 mg) v Placebo
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3279
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.727
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.191
         upper limit
    1.736
    Statistical analysis title
    Statistical analysis 6
    Comparison groups
    Finerenone (BAY94-8862) (15 mg) v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3102
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -1.682
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.935
         upper limit
    1.57
    Statistical analysis title
    Statistical analysis 7
    Comparison groups
    Finerenone (BAY94-8862) (20 mg) v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1317
    Method
    t-test, 2-sided
    Parameter type
    Least square mean difference
    Point estimate
    -2.511
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.778
         upper limit
    0.755

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 93 days after the start of study drug
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Finerenone (BAY 94-8862) (1.25 mg)
    Reporting group description
    1.25 milligram (mg) BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(2.5 mg)
    Reporting group description
    2.5 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(5 mg)
    Reporting group description
    5 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(7.5 mg)
    Reporting group description
    7.5 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(10 mg)
    Reporting group description
    10 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(20 mg)
    Reporting group description
    20 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Finerenone (BAY 94-8862)(15 mg)
    Reporting group description
    15 mg BAY 94-8862 tablet once daily in the morning for 90 days

    Reporting group title
    Placebo
    Reporting group description
    Placebo tablet once daily in the morning for 90 days

    Serious adverse events
    Finerenone (BAY 94-8862) (1.25 mg) Finerenone (BAY 94-8862)(2.5 mg) Finerenone (BAY 94-8862)(5 mg) Finerenone (BAY 94-8862)(7.5 mg) Finerenone (BAY 94-8862)(10 mg) Finerenone (BAY 94-8862)(20 mg) Finerenone (BAY 94-8862)(15 mg) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 96 (5.21%)
    3 / 92 (3.26%)
    7 / 100 (7.00%)
    8 / 97 (8.25%)
    2 / 98 (2.04%)
    4 / 119 (3.36%)
    6 / 125 (4.80%)
    3 / 94 (3.19%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    1 / 125 (0.80%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    1 / 125 (0.80%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary artery bypass
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toe amputation
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Local swelling
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    1 / 119 (0.84%)
    2 / 125 (1.60%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    1 / 119 (0.84%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    1 / 98 (1.02%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    1 / 94 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Subcutaneous abscess
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    1 / 98 (1.02%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    1 / 97 (1.03%)
    0 / 98 (0.00%)
    2 / 119 (1.68%)
    2 / 125 (1.60%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    1 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 97 (0.00%)
    0 / 98 (0.00%)
    0 / 119 (0.00%)
    0 / 125 (0.00%)
    0 / 94 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Finerenone (BAY 94-8862) (1.25 mg) Finerenone (BAY 94-8862)(2.5 mg) Finerenone (BAY 94-8862)(5 mg) Finerenone (BAY 94-8862)(7.5 mg) Finerenone (BAY 94-8862)(10 mg) Finerenone (BAY 94-8862)(20 mg) Finerenone (BAY 94-8862)(15 mg) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 96 (14.58%)
    7 / 92 (7.61%)
    13 / 100 (13.00%)
    11 / 97 (11.34%)
    10 / 98 (10.20%)
    12 / 119 (10.08%)
    11 / 125 (8.80%)
    8 / 94 (8.51%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 96 (6.25%)
    1 / 92 (1.09%)
    3 / 100 (3.00%)
    1 / 97 (1.03%)
    3 / 98 (3.06%)
    1 / 119 (0.84%)
    5 / 125 (4.00%)
    2 / 94 (2.13%)
         occurrences all number
    6
    1
    3
    1
    3
    1
    5
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 96 (5.21%)
    2 / 92 (2.17%)
    4 / 100 (4.00%)
    2 / 97 (2.06%)
    2 / 98 (2.04%)
    5 / 119 (4.20%)
    3 / 125 (2.40%)
    2 / 94 (2.13%)
         occurrences all number
    5
    2
    4
    2
    2
    5
    4
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 96 (7.29%)
    4 / 92 (4.35%)
    8 / 100 (8.00%)
    9 / 97 (9.28%)
    5 / 98 (5.10%)
    8 / 119 (6.72%)
    4 / 125 (3.20%)
    5 / 94 (5.32%)
         occurrences all number
    7
    4
    8
    9
    5
    9
    4
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2013
    Amendment 1 was implemented globally. In this amendment changes to ensure consistency within the document and the central and local laboratory as well as clarifications of the study procedure have been implemented.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/26325557
    http://www.ncbi.nlm.nih.gov/pubmed/31583611
    http://www.ncbi.nlm.nih.gov/pubmed/33107592
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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