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    Clinical Trial Results:
    A randomized, parallel group, open-label, multicenter study to investigate the efficacy and safety of oral BAY 85-3934 and active comparator (darbepoetin alfa) in the maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment in Europe and Asia Pacific

    Summary
    EudraCT number
    		 2013-001192-21
    Trial protocol
    		 DE   HU   IT   ES   BG   PL  
    Global end of trial date
    23 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2016
    First version publication date
    19 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY85-3934/15261
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02021409
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee,, D-51368 Leverkusen, Germany,
    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
    23 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of 16 weeks of titrated dose treatment with BAY85-3934 versus darbepoetin as measured by hemoglobin (Hb) levels during the last 4 weeks of treatment (evaluation period).
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2014
    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
    Israel: 4
    Country: Number of subjects enrolled
    Japan: 23
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 4
    Country: Number of subjects enrolled
    Romania: 18
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Italy: 22
    Worldwide total number of subjects
    124
    EEA total number of subjects
    93
    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)
    42
    From 65 to 84 years
    78
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 47 study centers in 13 countries: Australia, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Poland, Republic of Korea, Romania, Spain, and United Kingdom between 28 January 2014 (first subject first visit) and 23 November 2015 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 196 subjects were screened, of them 72 were not included in the study due to screen failure, withdrawal by subjects and other reason. The remaining 124 subjects were randomized and assigned to treatment. Of the treated subjects, 39 entered the follow-up period and 77 subjects entered in an extension study.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAY85-3934 25 milligram (mg)
    Arm description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals.

    Arm title
    		 BAY85-3934 50 mg
    Arm description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals.

    Arm title
    		 BAY85-3934 75 mg
    Arm description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals.

    Arm title
    		 Darbepoetin
    Arm description
    		 Subjects received Darbepoetin injection intravenously (IV) or subcutaneously (SC) once every 1, 2, or 4 weeks as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Darbepoetin
    Investigational medicinal product code
    Other name
    Aranesp
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received darbepoetin injection IV or SC once every 1, 2, or 4 weeks as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals.

    Number of subjects in period 1
    		BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Started
    30
    30
    32
    32
    Completed
    21
    25
    26
    27
    Not completed
    9
    5
    6
    5
         Physician Decision
    1
    -
    1
    1
         Protocol violation
    1
    -
    -
    -
         Protocol driven decision point
    3
    -
    3
    2
         Death
    1
    -
    -
    1
         Adverse event
    2
    4
    2
    1
         Sponsor Decision
    -
    1
    -
    -
         Withdrawl by subject
    1
    -
    -
    -
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAY85-3934 25 mg
    Arm description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals during treatment period.

    Arm title
    		 BAY85-3934 50 mg
    Arm description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals during treatment period.

    Arm title
    		 BAY85-3934 75 mg
    Arm description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY85-3934
    Investigational medicinal product code
    BAY85-3934
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received BAY85-3934 tablet orally at a starting dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals during treatment period.

    Arm title
    		 Darbepoetin
    Arm description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Darbepoetin
    Investigational medicinal product code
    Other name
    Aranesp
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects received darbepoetin injection IV or SC once every 1, 2, or 4 weeks as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals during treatment period.

    Number of subjects in period 2 [1]
    		BAY85-3934 25 mg BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Started
    8
    12
    14
    5
    Completed
    8
    10
    14
    5
    Not completed
    0
    2
    0
    0
         Other
    -
    1
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Few of the participants entered the extension study and few of them discontinued the treatment, so there is a difference in number of subjects starting the subsequent period compared to the number completing the preceding period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAY85-3934 25 milligram (mg)
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 50 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 75 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    Darbepoetin
    Reporting group description
    		 Subjects received Darbepoetin injection intravenously (IV) or subcutaneously (SC) once every 1, 2, or 4 weeks as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin Total
    Number of subjects
    		 30 30 32 32 124
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.5 ( 8.82 ) 64.5 ( 10.18 ) 72.5 ( 10.63 ) 68.8 ( 8.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 13 16 14 61
        Male
    		 12 17 16 18 63
    Number of Japanese and Non-Japanese Subjects
    Units: Subjects
        Japanese Subjects
    		 6 6 5 6 23
        Non-Japanese Subjects
    		 24 24 27 26 101
    Estimated Glomerular Filtration Rate (eGFR)
    The eGFR was used to determine eligibility for the study and whether subjects of different stages of renal impairment / chronic kidney disease (CKD) respond differently to BAY85-3934 and to assess renal function by treatment.
    Units: milliliter/minute/1.73 square meter
        arithmetic mean (standard deviation)
    		 20.025 ( 10.4051 ) 17.674 ( 8.8648 ) 23.261 ( 13.8266 ) 21.929 ( 12.0731 ) -
    Local Laboratory Hemoglobin Levels
    Units: gram/deciliter (g/dL)
        arithmetic mean (standard deviation)
    		 10.85 ( 0.732 ) 10.74 ( 0.689 ) 10.66 ( 0.748 ) 10.85 ( 0.678 ) -

    End points

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    End points reporting groups
    Reporting group title
    BAY85-3934 25 milligram (mg)
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 50 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 75 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a starting dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.

    Reporting group title
    Darbepoetin
    Reporting group description
    		 Subjects received Darbepoetin injection intravenously (IV) or subcutaneously (SC) once every 1, 2, or 4 weeks as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject’s Hb response and the tolerability of the previous dose.
    Reporting group title
    BAY85-3934 25 mg
    Reporting group description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

    Reporting group title
    BAY85-3934 50 mg
    Reporting group description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

    Reporting group title
    BAY85-3934 75 mg
    Reporting group description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

    Reporting group title
    Darbepoetin
    Reporting group description
    		 Subjects entered a follow-up period for a duration of 8 weeks after completing treatment.

    Subject analysis set title
    Modified Intent-To-Treat (mITT)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    mITT (N= 124) included all subjects randomized to study treatment who received at least one dose of study treatment and who have at least one post-baseline efficacy value available.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF (N= 124) included all randomized subjects who received at least one dose of study treatment.

    Primary: Mean Change From Baseline in Local Laboratory Hemoglobin Level During Evaluation Period

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    End point title
    		 Mean Change From Baseline in Local Laboratory Hemoglobin Level During Evaluation Period
    End point description
    Evaluation Period was defined as the last 4 planned weeks of the study treatment period.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 13 to 16
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    26 [1]
    26 [2]
    28 [3]
    28 [4]
    Units: g/dL
        arithmetic mean (standard deviation)
    0.09 ( 1.096 )
    0.39 ( 0.561 )
    0.87 ( 0.824 )
    0.18 ( 0.777 )
    Notes
    [1] - mITT with number of subjects evaluable for this end point.
    [2] - mITT with number of subjects evaluable for this end point.
    [3] - mITT with number of subjects evaluable for this end point.
    [4] - mITT with number of subjects evaluable for this end point.
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 25 mg
    Statistical analysis description
    Results were reported including Least square mean (LS-mean) difference and 95 percent (%) confidence intervals (CI). LS-mean difference was based on constrained longitudinal data analysis (cLDA) model including the response vector consisting of baseline and values at each post-baseline time point, and the repeated measures model including treatment, randomization stratification factors, time (visit), the interaction of time by treatment, and the interaction of time by randomization factors.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.246
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 50 mg
    Statistical analysis description
    Results were reported including LS-mean difference and 95 % CI. LS-mean difference was based on cLDA model including the response vector consisting of baseline and values at each post-baseline time point, and the repeated measures model including treatment, randomization stratification factors, time (visit), the interaction of time by treatment, and the interaction of time by randomization factors.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.182
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 75 mg
    Statistical analysis description
    Results were reported including LS-mean difference and 95 % CI. LS-mean difference was based on cLDA model including the response vector consisting of baseline and values at each post-baseline time point, and the repeated measures model including treatment, randomization stratification factors, time (visit), the interaction of time by treatment, and the interaction of time by randomization factors.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.196

    Secondary: Overall Rate of Responders in Local Hemoglobin During Evaluation Period

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    End point title
    		 Overall Rate of Responders in Local Hemoglobin During Evaluation Period
    End point description
    A responder was defined as a subject who had a mean of the Hb levels during the evaluation period in the target range (10.0 to 12.0 g/dL, inclusive), greater than or equal to (>=) 50 % of the Hb levels in the target range during the evaluation period, and no red blood cell (RBC) containing transfusion during active treatment. Evaluation Period was defined as the last 4 planned weeks of the study treatment period.
    End point type
    Secondary
    End point timeframe
    Weeks 13 to 16
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    24 [5]
    26 [6]
    28 [7]
    28 [8]
    Units: Percentage of responders
        number (not applicable)
    70.8
    80.8
    60.7
    89.3
    Notes
    [5] - mITT number of subjects evaluable for this end point.
    [6] - mITT number of subjects evaluable for this end point.
    [7] - mITT number of subjects evaluable for this end point.
    [8] - mITT number of subjects evaluable for this end point.
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 25 mg
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 42. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.2
         upper limit
    		 9.4
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 50 mg
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 46. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -8.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.9
         upper limit
    		 17.5
    Statistical analysis title
    		 Statistical Analysis for BAY85-3934 75 mg
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 42. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -28.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.3
         upper limit
    		 -0.7

    Secondary: Time Within Hemoglobin Target Range During Active Treatment

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    End point title
    		 Time Within Hemoglobin Target Range During Active Treatment
    End point description
    Time within the treatment target was defined as the sum of all days where subject Hb values were within protocol defined treatment target. Hb target range was defined as 10.0 to 12.0 g/dL, inclusive.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [9]
    30 [10]
    32 [11]
    32 [12]
    Units: days
        median (full range (min-max))
    87.35 (0 to 112)
    84.35 (0 to 114)
    65.15 (0 to 111)
    106.4 (11.8 to 118)
    Notes
    [9] - mITT
    [10] - mITT
    [11] - mITT
    [12] - mITT
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hemoglobin During Active Treatment

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    End point title
    		 Change From Baseline in Hemoglobin During Active Treatment
    End point description
    Hb was analysed using the blood samples drawn during the active treatment period of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 3, 5, 7, 9, 11, 13, 14, 15, 16 and 17
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [13]
    30 [14]
    32 [15]
    32 [16]
    Units: g/dL
    arithmetic mean (standard deviation)
        Change at Week 2
    -0.08 ( 0.594 )
    -0.07 ( 0.35 )
    -0.12 ( 0.553 )
    0 ( 0.531 )
        Change at Week 3
    0.01 ( 0.671 )
    -0.06 ( 0.627 )
    0.17 ( 0.584 )
    0.12 ( 0.728 )
        Change at Week 5
    0.13 ( 0.883 )
    0.22 ( 0.804 )
    0.31 ( 0.916 )
    0.2 ( 0.689 )
        Change at Week 7
    -0.01 ( 1.096 )
    0.18 ( 0.598 )
    0.53 ( 1.048 )
    0.34 ( 0.71 )
        Change at Week 9
    0.02 ( 1.142 )
    0.23 ( 0.817 )
    0.62 ( 1.123 )
    0.37 ( 0.804 )
        Change at Week 11
    -0.06 ( 1.284 )
    0.04 ( 0.808 )
    0.6 ( 1.262 )
    0.21 ( 0.735 )
        Change at Week 13
    -0.01 ( 1.361 )
    0.17 ( 0.85 )
    0.95 ( 1.242 )
    0.26 ( 0.746 )
        Change at Week 14
    0.05 ( 1.309 )
    0.08 ( 0.735 )
    0.86 ( 1.148 )
    0.29 ( 0.729 )
        Change at Week 15
    0.01 ( 1.2 )
    0.33 ( 0.856 )
    0.8 ( 1.036 )
    0.24 ( 0.815 )
        Change at Week 16
    0.07 ( 1.236 )
    0.27 ( 0.854 )
    0.63 ( 1.073 )
    0.2 ( 0.918 )
        Change at Week 17
    0.01 ( 1.045 )
    0.19 ( 0.902 )
    0.56 ( 1.1 )
    0.11 ( 0.924 )
    Notes
    [13] - mITT
    [14] - mITT
    [15] - mITT
    [16] - mITT
    No statistical analyses for this end point

    Secondary: Number of Subjects Meeting Specific Local Hemoglobin Criteria in Evaluation Period

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    End point title
    		 Number of Subjects Meeting Specific Local Hemoglobin Criteria in Evaluation Period
    End point description
    Evaluation Period was defined as the last 4 planned weeks of the study treatment period. The following were the specific hemoglobin criteria that were to be met: greater than (>) 50 % of the Hb levels below the lower limit of 10.0 g/dL, mean of the Hb levels below the lower limit of 10.0 g/dL, > 50% of the Hb levels above the upper limit of 12.0 g/dL, mean of the Hb levels above the upper limit of 12.0 g/dL.
    End point type
    Secondary
    End point timeframe
    Weeks 13 to 16
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    24 [17]
    26 [18]
    28 [19]
    28 [20]
    Units: Subjects
        > 50% of the Hb levels below the lower limit of 10
    2
    1
    1
    2
        Mean of the Hb levels below the lower limit of 10
    4
    2
    2
    2
        > 50% of the Hb levels above the upper limit of 12
    2
    1
    7
    1
        Mean of the Hb levels above the upper limit of 12
    3
    3
    8
    1
    Notes
    [17] - mITT number of subjects evaluable for this end point.
    [18] - mITT number of subjects evaluable for this end point.
    [19] - mITT number of subjects evaluable for this end point.
    [20] - mITT number of subjects evaluable for this end point.
    Statistical analysis title
    		 BAY85-3934 25mg (> 50% of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 4. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.8
         upper limit
    		 28.3
    Statistical analysis title
    		 BAY85-3934 50mg (> 50% of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 3. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.8
         upper limit
    		 23.9
    Statistical analysis title
    		 BAY85-3934 75mg (> 50% of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 3. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.7
         upper limit
    		 23.9
    Statistical analysis title
    		 BAY85-3934 25 mg (Mean of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 6. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 35.9
    Statistical analysis title
    		 BAY85-3934 50 mg (Mean of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 4. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 27.6
    Statistical analysis title
    		 BAY85-3934 75 mg (Mean of Hb levels below 10 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 4. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 27.3
    Statistical analysis title
    		 BAY85-3934 25mg (> 50% of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 3. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 31.7
    Statistical analysis title
    		 BAY85-3934 50mg (> 50% of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 2. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.5
         upper limit
    		 27.3
    Statistical analysis title
    		 BAY85-3934 75mg (> 50% of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 8. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    21.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 47
    Statistical analysis title
    		 BAY85-3934 25 mg (Mean of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 4. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.4
         upper limit
    		 35.5
    Statistical analysis title
    		 BAY85-3934 50 mg (Mean of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 4. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.8
         upper limit
    		 34.5
    Statistical analysis title
    		 BAY85-3934 75 mg (Mean of Hb levels above 12 g/dL)
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 9. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 50.2

    Secondary: Treatment Exposure by Dose Level

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    End point title
    		 Treatment Exposure by Dose Level
    End point description
    Treatment exposure was defined as number of days subject was on study treatment, calculated as last study treatment dose date - first study treatment dose date + 1. Here mcg/kg = microgram/kilogram.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [21]
    30 [22]
    32 [23]
    32 [24]
    Units: mg for BAY85-3934;mcg/kg for Darbepoetin
        arithmetic mean (standard deviation)
    26.3 ( 12.38 )
    45.6 ( 17.11 )
    63.1 ( 26.15 )
    0.03 ( 0.022 )
    Notes
    [21] - mITT
    [22] - mITT
    [23] - mITT
    [24] - mITT
    No statistical analyses for this end point

    Secondary: Duration of Exposure

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    End point title
    		 Duration of Exposure
    End point description
    Treatment duration (days) = date of last study drug - date of first study drug + 1.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [25]
    30 [26]
    32 [27]
    32 [28]
    Units: days
        arithmetic mean (standard deviation)
    102.6 ( 25.65 )
    104.6 ( 26.79 )
    107.7 ( 22.96 )
    103.2 ( 24.61 )
    Notes
    [25] - mITT
    [26] - mITT
    [27] - mITT
    [28] - mITT
    No statistical analyses for this end point

    Secondary: Number of Subjects With Excessive Increase in Hemoglobin Levels and With Greater Than 13 gram/deciliter During Treatment Period

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    End point title
    		 Number of Subjects With Excessive Increase in Hemoglobin Levels and With Greater Than 13 gram/deciliter During Treatment Period
    End point description
    Treatment period of the study is at least 16 weeks from randomisation of subjects. Excessive increase in Hb values was defined as an increase of > 1 g/dL over a 2-week period or > 2 g/dL over a 4-week period.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [29]
    30 [30]
    32 [31]
    32 [32]
    Units: subjects
        Hb > 13 g/dL at any time
    2
    2
    5
    3
        Excessive increase of Hb with >1 g/dL over 2 weeks
    3
    7
    9
    5
        Excessive increase of Hb with >2 g/dL over 4 weeks
    0
    3
    3
    0
    Notes
    [29] - mITT
    [30] - mITT
    [31] - mITT
    [32] - mITT
    Statistical analysis title
    		 Statistical analysis-BAY85-3934 25mg v Darbepoetin
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 5. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 25 milligram (mg) v Darbepoetin
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 22.7
    Statistical analysis title
    		 Statistical analysis-BAY85-3934 50mg v Darbepoetin
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 5. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 50 mg v Darbepoetin
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.3
         upper limit
    		 22.7
    Statistical analysis title
    		 Statistical analysis-BAY85-3934 75mg v Darbepoetin
    Statistical analysis description
    Analysis was based on Miettinen and Nurminen method (an unconditional, asymptotic method) stratified by randomization stratification factor(s) (if the total observed subjects were less than 5) and without stratification factors if the total observed subjects were more than 5. Number of subjects in this analysis was 8. The number of subjects mentioned in the table is auto-generated and therefore cannot be edited.
    Comparison groups
    BAY85-3934 75 mg v Darbepoetin
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference from darbepoetin
    Point estimate
    6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.5
         upper limit
    		 31.4

    Secondary: Number of Subjects Requiring Titration of Dose (Down-Titration, Up- Titration)

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    End point title
    		 Number of Subjects Requiring Titration of Dose (Down-Titration, Up- Titration)
    End point description
    Individual dose-titration was based on regular local laboratory Hb levels measured. Dose of study treatment (for BAY 85-3934 and darbepoetin) was titrated according to pre-defined criteria taking into account the subject's Hb response and the tolerability of the previous dose.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [33]
    30 [34]
    32 [35]
    32 [36]
    Units: subjects
        Number of dose down-titration: 0
    16
    15
    8
    26
        Number of dose down-titration: 1
    14
    7
    12
    3
        Number of dose down-titration: 2
    0
    8
    9
    3
        Number of dose down-titration: 3
    0
    0
    3
    0
        Number of dose up-titration: 0
    20
    22
    21
    27
        Number of dose up-titration: 1
    5
    3
    6
    3
        Number of dose up-titration: 2
    4
    4
    5
    2
        Number of dose up-titration: 3
    1
    1
    0
    0
    Notes
    [33] - mITT
    [34] - mITT
    [35] - mITT
    [36] - mITT
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A Serious Adverse Event (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; any other medically important serious event as judged by the investigator.
    End point type
    Secondary
    End point timeframe
    From baseline up to 16 weeks
    End point values
    		 BAY85-3934 25 milligram (mg) BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Number of subjects analysed
    30 [37]
    30 [38]
    32 [39]
    32 [40]
    Units: subjects
    5
    7
    7
    6
    Notes
    [37] - SAF
    [38] - SAF
    [39] - SAF
    [40] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study drug administration up to the end of the treatment plus 3 days (Up to 119 days)
    Adverse event reporting additional description
    Treatment Emergent AEs for Safety Population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    BAY85-3934 25 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a dose of 25 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject's Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 50 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a dose of 50 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject's Hb response and the tolerability of the previous dose.

    Reporting group title
    BAY85-3934 75 mg
    Reporting group description
    		 Subjects received BAY85-3934 tablet orally at a dose of 75 mg once daily up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject's Hb response and the tolerability of the previous dose.

    Reporting group title
    Darbepoetin
    Reporting group description
    		 Subjects received Darbepoetin injection IV or SC as per individual subject regimen according to the local label up to 16 weeks which was titrated at 4-week intervals according to pre-defined criteria taking into account the subject's Hb response and the tolerability of the previous dose.

    Serious adverse events
    		 BAY85-3934 25 mg BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 30 (23.33%)
    7 / 32 (21.88%)
    6 / 32 (18.75%)
         number of deaths (all causes)
    1
    0
    0
    1
         number of deaths resulting from adverse events
    1
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Refractory anaemia with an excess of blasts
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Ileus
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Oedematous pancreatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Azotaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Chronic kidney disease
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Renal failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Renal impairment
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Infections and infestations
    Encephalitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Hyponatraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BAY85-3934 25 mg BAY85-3934 50 mg BAY85-3934 75 mg Darbepoetin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 30 (66.67%)
    23 / 30 (76.67%)
    19 / 32 (59.38%)
    16 / 32 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 30 (10.00%)
    6 / 30 (20.00%)
    5 / 32 (15.63%)
    4 / 32 (12.50%)
         occurrences all number
    4
    8
    5
    7
    Hypotension
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    1
    1
    Pallor
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Dialysis device insertion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemodialysis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Peritoneal dialysis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth extraction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Chest pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    1
    1
    Influenza like illness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 30 (13.33%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
         occurrences all number
    2
    4
    1
    2
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prostatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Interstitial lung disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
         occurrences all number
    2
    0
    2
    1
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood chloride decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Electrocardiogram pr prolongation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Electrocardiogram qt prolonged
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mycobacterium tuberculosis complex test positive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Serum ferritin decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Venous pressure jugular increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    Ichthyosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Cardiac failure
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 30 (13.33%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    1
    4
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Enterocolitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    2
    1
    Umbilical hernia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema asteatotic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prurigo
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Urticaria
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    4 / 32 (12.50%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Renal failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal impairment
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urethral stenosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Arthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
         occurrences all number
    1
    0
    2
    1
    Gouty arthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infected fistula
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
         occurrences all number
    2
    2
    2
    1
    Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gout
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    1
    0
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
         occurrences all number
    0
    3
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2014
    This protocol amendment included the following modifications: changed the lower value of the baseline Hb range from 10.0 to 9.0 gram/deciliter, added heart failure as an adjudicated SAE, removed exclusion criterion regarding phosphodiesterase type 5 (PDE5) inhibitors or nitrates, removed atrial fibrillation from exclusion criteria, changed timing of Hb assessment from within “2” to “3” days prior to visit, updated the status of the BAY85-3934 phase I studies, clarified hyporesponsiveness to darbepoetin by total dose at microg/kilogram/week, allowed re-screening of subjects who fail the criterion regarding folate and vitamin B12.

    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.
    Decimal places were automatically truncated if last decimal equals zero.
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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
    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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