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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease

    Summary
    EudraCT number
    		 2021-003636-88
    Trial protocol
    		 ES   HU   BG   CZ   LT   PL   HR  
    Global end of trial date
    10 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2025
    First version publication date
    26 Dec 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KBP5074-3-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04968184
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 117743
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvӕrd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    11 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP).
    Protection of trial subjects
    As Novo Nordisk A/S was not the Sponsor of the study at the time it was conducted, Novo Nordisk A/S is unable to confirm that this study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki (Version 2013), International Council for Harmonisation (ICH) guidelines for Good Clinical Practices (GCP), the European Union Clinical Trials Directive 2001/20/EC (EUCTD), IRB/IECs, and all other applicable laws and regulations. Novo Nordisk A/S is also unable to confirm the accuracy of factual assertions contained herein concerning the conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Czechia: 11
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 52
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    China: 78
    Country: Number of subjects enrolled
    Georgia: 127
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Malaysia: 21
    Country: Number of subjects enrolled
    Serbia: 22
    Country: Number of subjects enrolled
    United States: 184
    Country: Number of subjects enrolled
    South Africa: 3
    Worldwide total number of subjects
    556
    EEA total number of subjects
    52
    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)
    180
    From 65 to 84 years
    363
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 132 sites that randomised subjects in 21 countries globally, from 27 December 2021 (first subject enrolled) to 10 July 2024 (last subject completed).

    Pre-assignment
    Screening details
    		 Subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Of the 1246 subjects screened, 690 were screen failures and 554 subjects were randomized to treatment while 2 subjects were not treated.

    Period 1
    Period 1 title
    24-week Double-Blind Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 KBP-5074
    Arm description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 once daily (QD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-5074
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KBP-5074 tablets were administered orally.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matching to KBP-5074 QD.
    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 were administered orally.

    Number of subjects in period 1
    		KBP-5074 Placebo
    Started
    281
    275
    Completed
    251
    246
    Not completed
    30
    29
         Consent withdrawn by subject
    20
    20
         Adverse event, non-fatal
    2
    -
         Death
    2
    -
         Noncompliance With the Protocol
    -
    1
         Study Terminated by Sponsor
    1
    2
         Lost to follow-up
    5
    3
         Noncompliance With Study Drug
    -
    1
         Randomized in Error
    -
    2
    Period 2
    Period 2 title
    24-week Open-Label (OL) Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 KBP-5074 - OL
    Arm description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-5074
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KBP-5074 tablets were administered orally.

    Arm title
    		 Placebo - OL
    Arm description
    		 Subjects received placebo matching to KBP-5074 QD.
    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 were administered orally.

    Number of subjects in period 2
    		KBP-5074 - OL Placebo - OL
    Started
    251
    246
    Completed
    125
    118
    Not completed
    126
    128
         Consent withdrawn by subject
    6
    9
         Trial Site Terminated by Sponsor
    10
    5
         Adverse event, non-fatal
    2
    1
         Death
    3
    1
         Noncompliance With the Protocol
    -
    1
         Study Terminated by Sponsor
    100
    110
         Lost to follow-up
    5
    1
    Period 3
    Period 3 title
    4-week Double-Blind Withdrawal(W) Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 KBP-5074 - W
    Arm description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    KBP-5074
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KBP-5074 tablets were administered orally.

    Arm title
    		 Placebo - W
    Arm description
    		 Subjects received placebo matching to KBP-5074 QD.
    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 were administered orally.

    Number of subjects in period 3
    		KBP-5074 - W Placebo - W
    Started
    125
    118
    Completed
    115
    108
    Not completed
    10
    10
         Consent withdrawn by subject
    2
    1
         Trial Site Terminated by Sponsor
    2
    -
         Study Terminated by Sponsor
    6
    8
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    KBP-5074
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 once daily (QD).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.

    Reporting group values
    		 KBP-5074 Placebo Total
    Number of subjects
    		 281 275 556
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    The intent to treat (ITT) population was defined as all randomised subjects after removal of subjects from site 508.
    Units: years
        arithmetic mean (standard deviation)
    		 67.4 ( 10.87 ) 67.9 ( 10.85 ) -
    Gender categorical
    The ITT population was defined as all randomised subjects after removal of subjects from site 508.
    Units: Subjects
        Female
    		 98 116 214
        Male
    		 183 159 342

    End points

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    End points reporting groups
    Reporting group title
    KBP-5074
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 once daily (QD).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.
    Reporting group title
    KBP-5074 - OL
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.

    Reporting group title
    Placebo - OL
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.
    Reporting group title
    KBP-5074 - W
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.

    Reporting group title
    Placebo - W
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.

    Primary: Change in seated trough cuff Systolic Blood Pressure (SBP) from baseline to Week 12

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    End point title
    		 Change in seated trough cuff Systolic Blood Pressure (SBP) from baseline to Week 12
    End point description
    Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, was evaluated. The intent-to-treat (ITT) Population was defined as all randomised subjects after removal of subjects from site 508.
    End point type
    Primary
    End point timeframe
    From baseline to Week 12
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    267
    255
    Units: mm Hg (millimeters of mercury)
        arithmetic mean (standard deviation)
    -12.9 ( 18.02 )
    -12.4 ( 18.73 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD - Placebo QD) between adjusted least square (LS) means of change from baseline
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.572
    Method
    		 ANCOVA
    Parameter type
    		 Difference between adjusted LS means
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 2
    Notes
    [1] - Adjusted Least Square (LS) Means are estimated using an analysis of covariance (ANCOVA) model with change in seated trough cuff SBP from baseline to Week 12 as the outcome variable.

    Primary: Change in seated trough cuff SBP from Week 48 to Week 52

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    End point title
    		 Change in seated trough cuff SBP from Week 48 to Week 52
    End point description
    Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, was evaluated. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit. Imputation of missing Week 52 SBP was done using MI assuming Missing at Random (MAR). The analysis of mean change in seated trough cuff SBP from Week 48 to Week 52 using retrieved dropout-based MI (Randomised Withdrawal Population) was not performed because the observed data for dropouts was too limited. The sensitivity analysis using MI assuming MAR was used instead.
    End point type
    Primary
    End point timeframe
    Change from Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    98
    102
    Units: mm Hg
        arithmetic mean (standard deviation)
    -0.9 ( 15.45 )
    0.9 ( 15.91 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD - Placebo QD) between adjusted LS means of change from baseline
    Comparison groups
    Placebo - W v KBP-5074 - W
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.789
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted LS mean
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 3.3
    Notes
    [2] - Adjusted LS Means are estimated using an ANCOVA model with change in seated trough cuff SBP from Week 48 to Week 52 as the outcome variable.

    Secondary: Change in seated trough cuff SBP from baseline to Week 24

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    End point title
    		 Change in seated trough cuff SBP from baseline to Week 24
    End point description
    Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, were evaluated. The ITT Population was defined as all randomised subjects after removal of subjects from site 508.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    242
    232
    Units: mm Hg
        arithmetic mean (standard deviation)
    -15.3 ( 17.76 )
    -12.8 ( 17.30 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD - Placebo QD) between adjusted LS means of change from baseline
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.096
    Method
    		 ANCOVA
    Parameter type
    		 Difference Between Adjusted LS Means
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 0.4
    Notes
    [3] - Adjusted LS Means were estimated using an ANCOVA model with change in seated trough cuff SBP from baseline to Week 24 as the outcome variable.

    Secondary: Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12

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    End point title
    		 Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12
    End point description
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated. The ITT Population was defined as all randomised subjects after removal of subjects from site 508.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    267
    255
    Units: mm Hg
        arithmetic mean (standard deviation)
    -6.3 ( 11.74 )
    -5.6 ( 11.53 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD - Placebo QD) between adjusted LS means of change from baseline
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.515
    Method
    		 ANCOVA
    Parameter type
    		 Difference between adjusted LS means
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 1.4
    Notes
    [4] - Adjusted LS Means were estimated using an ANCOVA model with change in seated trough cuff DBP from baseline to Week 12 as the outcome variable.

    Secondary: Changes in seated trough cuff SBP from baseline to Week 48

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    End point title
    		 Changes in seated trough cuff SBP from baseline to Week 48
    End point description
    Effect of KBP-5074 on SBP by assessing change in seated trough cuff SBP, was evaluated. The ITT Population was defined as all randomised subjects after removal of subjects from site 508. Subjects in Placebo QD group were switched to KBP-5074 QD after Week 24.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 48
    End point values
    		 KBP-5074 - OL Placebo - OL
    Number of subjects analysed
    140
    143
    Units: mm Hg
        arithmetic mean (standard deviation)
    -13.1 ( 16.64 )
    -17.2 ( 18.23 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD -> KBP-5074 QD – Placebo QD -> KBP-5074 QD) between LS means of change from baseline
    Comparison groups
    KBP-5074 - OL v Placebo - OL
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.095
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference between LS means
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 6.4
    Notes
    [5] - Estimated using a mixed-effect repeated model with change in seated trough cuff SBP from baseline to Week 48 as the outcome variable. The model uses an Unstructured covariance matrix.

    Secondary: Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 for subjects with UACR ≥30 mg/g at baseline

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    End point title
    		 Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 for subjects with UACR ≥30 mg/g at baseline
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with UACR ≥30 mg/g at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    204
    203
    Units: mg/g (milligram/gram)
        median (full range (min-max))
    -80.43 (-2848.0 to 1091.3)
    -12.65 (-3261.0 to 4467.8)
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s placebo
    Statistical analysis description
    Ratio of LS estimate of geometric mean ratio (GMR) of KBP-5074 QD to Placebo QD
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.331
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.09
    Notes
    [6] - Adjusted GMRs were estimated using an ANCOVA model with change in log-transformed UACR from baseline to Week 12 as the outcome variable.

    Secondary: Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline

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    End point title
    		 Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline
    End point description
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for subjects with UACR ≥30 mg/g at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. Subjects in Placebo QD group were switched to KBP-5074 QD after Week 24. Here, 'number of subjects analyzed' specifies all subjects evaluated for this endpoint and 'number analyzed in each row (n)' signifies subjects with available data that were analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12 and Week 24
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    208
    213
    Units: Percentage
    median (full range (min-max))
        Week 12 (n = 204; 203)
    -22.43 (-98.0 to 342.7)
    -9.10 (-99.6 to 3094.4)
        Week 24 (n = 185; 194)
    -34.37 (-98.3 to 407.8)
    -12.50 (-99.5 to 2865.0)
    No statistical analyses for this end point

    Secondary: Changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with macroalbuminuria

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    End point title
    		 Changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with macroalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. Here, 'number of subjects analyzed' specifies all subjects evaluated for this endpoint and 'number analyzed in each row (n)' signifies subjects with available data that were analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12, Week 24, and Week 48
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    131
    122
    Units: mg/g
    median (full range (min-max))
        Week 12 (n = 129; 115)
    -252.62 (-2848.0 to 1091.3)
    -104.83 (-3261.0 to 4467.8)
        Week 24 (n = 117; 110)
    -350.58 (-4503.7 to 1860.8)
    -70.30 (-3256.2 to 4716.8)
        Week 48 (n = 53; 53)
    -285.12 (-2599.1 to 838.5)
    -317.71 (-3567.1 to 4518.3)
    Statistical analysis title
    		 Statistical comparison at Week 12
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD The number of subjects in this analysis were 244.
    Comparison groups
    Placebo v KBP-5074
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.794
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.24
    Notes
    [7] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 12 as the outcome variable. The model used an Unstructured covariance matrix.
    Statistical analysis title
    		 Statistical comparison at Week 24
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD The number of subjects in this analysis were 227.
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.89
    Notes
    [8] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 24 as the outcome variable. The model used an Unstructured covariance matrix.
    Statistical analysis title
    		 Statistical comparison at Week 48
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD The number of subjects in this analysis were 106.
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.147
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.14
    Notes
    [9] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 48 as the outcome variable. The model used an Unstructured covariance matrix.

    Secondary: Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with macroalbuminuria

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    End point title
    		 Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with macroalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. Here, 'number of subjects analyzed' specifies all subjects evaluated for this endpoint and 'number analyzed in each row (n)' signifies subjects with available data that were analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12, Week 24, and Week 48
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    131
    122
    Units: Percentage
    median (full range (min-max))
        Week 12 (n = 129; 115)
    -22.54 (-98.0 to 284.0)
    -11.40 (-99.6 to 197.5)
        Week 24 (n = 117; 110)
    -38.74 (-98.3 to 144.2)
    -12.57 (-99.5 to 386.4)
        Week 48 (n = 53; 53)
    -40.20 (-99.5 to 196.4)
    -47.43 (-99.5 to 1378.4)
    No statistical analyses for this end point

    Secondary: Change in seated trough cuff DBP from Week 48 to Week 52

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    End point title
    		 Change in seated trough cuff DBP from Week 48 to Week 52
    End point description
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit. Observed data for Dropouts too limited for retrieved dropout-based MI. MI using MAR to be used instead.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: mm Hg
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [10] - Observed data for dropouts was too limited for retrieved dropout-based MI.
    [11] - Observed data for dropouts was too limited for retrieved dropout-based MI.
    No statistical analyses for this end point

    Secondary: Change in UACR from Week 48 to Week 52 for subjects with UACR ≥30 mg/g at baseline

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    End point title
    		 Change in UACR from Week 48 to Week 52 for subjects with UACR ≥30 mg/g at baseline
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with UACR ≥30 mg/g at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    69
    75
    Units: mg/g
        median (full range (min-max))
    -17.31 (-523.8 to 5366.4)
    9.38 (-1320.7 to 3905.9)
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s placebo
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD
    Comparison groups
    KBP-5074 - W v Placebo - W
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 = 0.113
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.06
    Notes
    [12] - Estimated using an ANCOVA model with change in log of UACR from Week 48 to Week 52 as the outcome variable.

    Secondary: Percentage change in UACR from Week 48 to Week 52 in subjects with UACR ≥30 mg/g at baseline

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    End point title
    		 Percentage change in UACR from Week 48 to Week 52 in subjects with UACR ≥30 mg/g at baseline
    End point description
    Effect of KBP-5074 on UACR by assessing percentage changes in UACR for subjects with UACR ≥30 mg/g at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    69
    75
    Units: Percentage
        median (full range (min-max))
    -15.16 (-76.0 to 132.0)
    20.23 (-99.5 to 5133.0)
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    The safety and tolerability of KBP-5074 were evaluated. Treatment emergent adverse event = TEAE. Selected TEAEs include Hyperkalemia, Hypertension, Hypotension, and eGFR Decrease.
    End point type
    Secondary
    End point timeframe
    Until end of study (EOS) (Week 56) or Unscheduled visit or end of treatment or early termination (up to 32 months)
    End point values
    		 KBP-5074 Placebo KBP-5074 - OL Placebo - OL KBP-5074 - W Placebo - W
    Number of subjects analysed
    281
    273
    235
    234
    99
    107
    Units: Subjects
        Any TEAE
    154
    154
    147
    139
    40
    35
        Any TEAE Related to Study Drug
    40
    18
    33
    27
    5
    7
        Any Severe TEAEs
    12
    16
    11
    8
    1
    1
        Any Severe TEAE Related to Study Drug
    2
    1
    0
    0
    0
    0
        Any TEAE With Outcome of Death
    1
    0
    1
    1
    0
    0
        Any Fatal TEAE Related to Study Drug
    0
    0
    0
    0
    0
    0
        Any Serious TEAE (TESAE)
    20
    30
    11
    16
    4
    1
        Any Non-serious TEAE
    151
    151
    144
    137
    39
    35
        Any Serious TEAE Related to Study Drug
    0
    1
    0
    0
    0
    0
        Any TEAE Leading to Discontinuation of Treatment
    12
    7
    7
    9
    2
    1
        Any TEAE Leading to Discontinuation of Study
    9
    8
    3
    3
    0
    0
        Any TEAE Leading to Study Drug Reduced
    0
    2
    0
    2
    1
    0
        Selected TEAEs
    69
    43
    59
    72
    16
    13
    No statistical analyses for this end point

    Secondary: Changes in seated trough cuff DBP from baseline to Week 24

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    End point title
    		 Changes in seated trough cuff DBP from baseline to Week 24
    End point description
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated. The ITT Population was defined as all randomised subjects after removal of subjects from site 508.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    242
    232
    Units: mm Hg
        arithmetic mean (standard deviation)
    -6.3 ( 12.09 )
    -6.7 ( 12.43 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD - Placebo QD) between adjusted LS means of change from baseline
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0.961
    Method
    		 ANCOVA
    Parameter type
    		 Difference between Adjusted LS Means
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 2.2
    Notes
    [13] - Adjusted LS Means were estimated using an ANCOVA model with change in seated trough cuff DBP from baseline to Week 24 as the outcome variable.

    Secondary: Changes in seated trough cuff DBP from baseline to Week 48

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    End point title
    		 Changes in seated trough cuff DBP from baseline to Week 48
    End point description
    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated. The ITT Population was defined as all randomised subjects after removal of subjects from site 508.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 48
    End point values
    		 KBP-5074 - OL Placebo - OL
    Number of subjects analysed
    140
    143
    Units: mm Hg
        arithmetic mean (standard deviation)
    -8.1 ( 11.09 )
    -10.0 ( 12.00 )
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Difference (KBP-5074 QD -> KBP-5074 QD – Placebo QD -> KBP-5074 QD) between LS Means of change from baseline
    Comparison groups
    KBP-5074 - OL v Placebo - OL
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0.244
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS means
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 3.8
    Notes
    [14] - Estimated using a mixed-effect repeated model with change in seated trough cuff DBP from baseline to Week 48 as the outcome variable. The model used an Unstructured covariance matrix.

    Secondary: Changes in UACR from baseline to Week 24 for subjects with UACR ≥30 mg/g at baseline

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    End point title
    		 Changes in UACR from baseline to Week 24 for subjects with UACR ≥30 mg/g at baseline
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with UACR ≥30 mg/g at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    185
    194
    Units: mg/g
        median (full range (min-max))
    -140.90 (-4503.7 to 1860.8)
    -11.44 (-3256.2 to 4716.8)
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s Placebo
    Statistical analysis description
    Ratio of Adjusted LS estimate of GMR of KBP-5074 QD to Placebo QD
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.97
    Notes
    [15] - Adjusted GMRs are estimated using an ANCOVA model with change in log-transformed UACR from baseline to Week 24 as the outcome variable.

    Secondary: Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with microalbuminuria

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    End point title
    		 Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with microalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. Here, 'number of subjects analyzed' specifies all subjects evaluated for this endpoint and 'number analyzed in each row (n)' signifies subjects with available data that were analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12, Week 24, and Week 48
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    77
    91
    Units: Percentage
    median (full range (min-max))
        Week 12 (n = 75; 88)
    -22.23 (-91.0 to 342.7)
    -6.44 (-89.9 to 3094.4)
        Week 24 (n = 68; 84)
    -27.93 (-91.5 to 407.8)
    -12.27 (-92.2 to 2865.0)
        Week 48 (n = 40; 47)
    -27.39 (-95.1 to 1977.5)
    -11.39 (-80.2 to 2976.1)
    No statistical analyses for this end point

    Secondary: Changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with microalbuminuria

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    End point title
    		 Changes in UACR from baseline to Week 12, Week 24, and Week 48 in subjects with microalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. Here, 'number of subjects analyzed' specifies all subjects evaluated for this endpoint and 'number analyzed in each row (n)' signifies subjects with available data that were analyzed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12, Week 24, and Week 48
    End point values
    		 KBP-5074 Placebo
    Number of subjects analysed
    77
    91
    Units: mg/g
    median (full range (min-max))
        Week 12 (n = 75; 88)
    -10.98 (-180.4 to 503.5)
    -5.46 (-248.8 to 1095.4)
        Week 24 (n = 68; 84)
    -16.96 (-208.5 to 516.0)
    -7.32 (-214.6 to 1127.2)
        Week 48 (n = 40; 47)
    -23.75 (-248.4 to 1715.6)
    -7.05 (-231.0 to 1622.1)
    Statistical analysis title
    		 Statistical comparison at Week 12
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD Number of subjects in this analysis were 163.
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 = 0.167
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.07
    Notes
    [16] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 12 as the outcome variable. The model used an Unstructured covariance matrix.
    Statistical analysis title
    		 Statistical comparison at Week 24
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD Number of subjects in this analysis were 152.
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.09
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.04
    Notes
    [17] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 24 as the outcome variable. The model used an Unstructured covariance matrix.
    Statistical analysis title
    		 Statistical comparison at Week 48
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD Number of subjects in this analysis were 87.
    Comparison groups
    KBP-5074 v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 = 0.642
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.36
    Notes
    [18] - Estimated using a mixed-effect repeated model with change in log of UACR from baseline to Week 48 as the outcome variable. The model used an Unstructured covariance matrix.

    Secondary: Change in UACR from Week 48 to Week 52 in subjects with macroalbuminuria

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    End point title
    		 Change in UACR from Week 48 to Week 52 in subjects with macroalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    37
    37
    Units: mg/g
        median (full range (min-max))
    -42.15 (-523.8 to 5366.4)
    13.66 (-1320.7 to 3905.9)
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s placebo
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD
    Comparison groups
    KBP-5074 - W v Placebo - W
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.636
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.51
    Notes
    [19] - Estimated using an ANCOVA model with change in log of UACR from Week 48 to Week 52 as the outcome variable.

    Secondary: Percentage change in UACR from Week 48 to Week 52 in subjects with macroalbuminuria

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    End point title
    		 Percentage change in UACR from Week 48 to Week 52 in subjects with macroalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    37
    37
    Units: Percentage
        median (full range (min-max))
    -11.98 (-76.0 to 109.7)
    7.64 (-99.5 to 5133.0)
    No statistical analyses for this end point

    Secondary: Change in UACR from Week 48 to Week 52 in subjects with microalbuminuria

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    End point title
    		 Change in UACR from Week 48 to Week 52 in subjects with microalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    32
    38
    Units: mg/g
        median (full range (min-max))
    -11.76 (-274.8 to 24.2)
    9.07 (-561.4 to 1547.4)
    Statistical analysis title
    		 Statistical comparison of KBP-5074 v/s placebo
    Statistical analysis description
    Ratio of LS estimate of GMR of KBP-5074 QD to Placebo QD
    Comparison groups
    KBP-5074 - W v Placebo - W
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.83
    Notes
    [20] - Estimated using an ANCOVA model with change in log of UACR from Week 48 to Week 52 as the outcome variable.

    Secondary: Percentage change in UACR from Week 48 to Week 52 in subjects with microalbuminuria

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    End point title
    		 Percentage change in UACR from Week 48 to Week 52 in subjects with microalbuminuria
    End point description
    Effect of KBP-5074 on UACR by assessing changes in UACR for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was evaluated. The UACR Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug, had a baseline UACR measurement, had UACR ≥30 mg/g at baseline, and had at least 1 post-dose UACR measurement. The Randomised Withdrawal Population was defined as all randomised subjects, after removal of subjects from site 508, who were randomised at the Week 48 Visit into the Randomised Double-Blind Withdrawal Period and had at least 1 SBP measurement after the Week 48 Visit.
    End point type
    Secondary
    End point timeframe
    From Week 48 to Week 52
    End point values
    		 KBP-5074 - W Placebo - W
    Number of subjects analysed
    32
    38
    Units: Percentage
        median (full range (min-max))
    -15.85 (-57.8 to 132.0)
    26.84 (-64.2 to 246.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until end of study (EOS) (Week 56) or Unscheduled visit or end of treatment or early termination (up to 32 months)
    Adverse event reporting additional description
    The Safety Population was defined as all randomised subjects, after removal of subjects from site 508, who received at least 1 dose of randomised study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    KBP-5074
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.

    Reporting group title
    KBP-5074 - OL
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.

    Reporting group title
    Placebo - OL
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.

    Reporting group title
    KBP-5074 - W
    Reporting group description
    		 Subjects received 0.25 mg to a maximum dose of 0.5 mg of KBP-5074 QD.

    Reporting group title
    Placebo - W
    Reporting group description
    		 Subjects received placebo matching to KBP-5074 QD.

    Serious adverse events
    		 KBP-5074 Placebo KBP-5074 - OL Placebo - OL KBP-5074 - W Placebo - W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 281 (7.12%)
    30 / 273 (10.99%)
    11 / 235 (4.68%)
    16 / 234 (6.84%)
    4 / 99 (4.04%)
    1 / 107 (0.93%)
         number of deaths (all causes)
    1
    0
    1
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    1
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    1 / 99 (1.01%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    1 / 99 (1.01%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Hypotension
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Aortic dissection
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Shock
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Venous thrombosis limb
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    2 / 281 (0.71%)
    2 / 273 (0.73%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    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
    Asthma
         subjects affected / exposed
    0 / 281 (0.00%)
    2 / 273 (0.73%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 281 (0.00%)
    2 / 273 (0.73%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Epistaxis
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    0 / 0
    Lung opacity
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Product issues
    Device loosening
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Device occlusion
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Investigations
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 281 (0.00%)
    2 / 273 (0.73%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    Ejection fraction decreased
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Joint injury
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    2 / 281 (0.71%)
    1 / 273 (0.37%)
    1 / 235 (0.43%)
    3 / 234 (1.28%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 281 (0.36%)
    2 / 273 (0.73%)
    1 / 235 (0.43%)
    2 / 234 (0.85%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Atrial fibrillation
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    2 / 234 (0.85%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Bradycardia
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Sinus node dysfunction
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    1 / 235 (0.43%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac failure acute
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    1 / 99 (1.01%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Nodal rhythm
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Loss of consciousness
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Cerebral infarction
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 273 (1.10%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Transient ischaemic attack
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    1 / 99 (1.01%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Diabetic retinopathy
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    5 / 281 (1.78%)
    4 / 273 (1.47%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 4
    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
    Acute kidney injury
         subjects affected / exposed
    3 / 281 (1.07%)
    1 / 273 (0.37%)
    1 / 235 (0.43%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Tenosynovitis
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Rhabdomyolysis
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Fistula
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Osteoarthritis
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    1 / 99 (1.01%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 281 (1.07%)
    7 / 273 (2.56%)
    1 / 235 (0.43%)
    3 / 234 (1.28%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 281 (0.71%)
    2 / 273 (0.73%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    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
    COVID-19
         subjects affected / exposed
    0 / 281 (0.00%)
    4 / 273 (1.47%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    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
    Sepsis
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    2 / 235 (0.85%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Infected skin ulcer
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Bronchitis
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    1 / 234 (0.43%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    3 / 281 (1.07%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    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
    Dehydration
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Hypoglycaemia
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 273 (0.37%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Hyponatraemia
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    1 / 235 (0.43%)
    0 / 234 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 KBP-5074 Placebo KBP-5074 - OL Placebo - OL KBP-5074 - W Placebo - W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 281 (13.88%)
    16 / 273 (5.86%)
    40 / 235 (17.02%)
    43 / 234 (18.38%)
    13 / 99 (13.13%)
    6 / 107 (5.61%)
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    16 / 281 (5.69%)
    9 / 273 (3.30%)
    17 / 235 (7.23%)
    15 / 234 (6.41%)
    7 / 99 (7.07%)
    6 / 107 (5.61%)
         occurrences all number
    19
    9
    26
    21
    10
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 281 (0.00%)
    0 / 273 (0.00%)
    0 / 235 (0.00%)
    0 / 234 (0.00%)
    6 / 99 (6.06%)
    0 / 107 (0.00%)
         occurrences all number
    0
    0
    0
    0
    6
    0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    25 / 281 (8.90%)
    9 / 273 (3.30%)
    28 / 235 (11.91%)
    31 / 234 (13.25%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    30
    14
    34
    47
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2022
    Amendment 1 The purpose of this amendment was to update the inclusion and exclusion criteria and add a risk assessment for the Coronavirus Disease Pandemic.
    22 Dec 2023
    Amendment 2 The main purpose of this protocol amendment was to provide statistical analysis plan alignment, clarifications including biomarker analysis to include urine sampling, treatment emergent adverse events, disclosure and publication policy, concomitant medication with emergency use medicines, and administrative change to update company address. Other minor edits were made throughout the protocol amendment for minor clarification and to correct grammatical errors, inconsistencies, and formatting. The Schedule of Study Procedures and clinical laboratory analytes were updated to reflect changes.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Apr 2024
    Based on a pre-planned interim analysis of this study, an Independent Data Monitoring Committee (IDMC) concluded on 24 Apr 2024 that the study met the prespecified futility criteria – meaning that the study did not meet its primary endpoint of change in SBP from baseline to Week 12. Based on the IDMC futility determination, it was decided to early terminate the study. Additionally, data from one study site (site 508) were excluded due to data reliability and integrity concerns related to that site.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to futility of efficacy. All data were analyzed and reported except site 508 due to data reliability and integrity concerns. Sponsorship was transferred from KBP Biosciences to Novo Nordisk after termination.
    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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