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    Clinical Trial Results:
    A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants with Proteinuric Chronic Kidney Disease

    Summary
    EudraCT number
    		 2020-002263-54
    Trial protocol
    		 DE   HU   PL  
    Global end of trial date
    06 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Sep 2023
    First version publication date
    20 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D7551C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04492722
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Södertälje, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.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
    30 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.
    Protection of trial subjects
    This study will be conducted in accordance with the protocol and with the following: consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organisations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable ICH GCP Guidelines, applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 135
    Country: Number of subjects enrolled
    Brazil: 142
    Country: Number of subjects enrolled
    United States: 110
    Country: Number of subjects enrolled
    Ukraine: 57
    Country: Number of subjects enrolled
    Malaysia: 47
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Israel: 28
    Country: Number of subjects enrolled
    Hungary: 26
    Country: Number of subjects enrolled
    Taiwan: 24
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    613
    EEA total number of subjects
    64
    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)
    289
    From 65 to 84 years
    319
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in this study from 01 October 2020 to 06 September 2022. The study was terminated early on 01 July 2022 due to lack of efficacy.

    Pre-assignment
    Screening details
    		 The screening period was for 4 weeks. Participants who met all the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg
    Arm description
    		 Participants received once daily oral dose of AZD5718 Dose 1 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received AZD5718 along with an add-on therapy of 10 mg of dapagliflozin for 8 weeks after having AZD5718 for 12 weeks alone

    Investigational medicinal product name
    AZD5718
    Investigational medicinal product code
    AZD5718
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily oral dose of AZD5718 for 20 weeks as per the arm they were randomised to

    Arm title
    		 AZD5718 Dose 2 + Dapagliflozin 10 mg
    Arm description
    		 Participants received once daily oral dose of AZD5718 Dose 2 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received AZD5718 along with an add-on therapy of 10 mg of dapagliflozin for 8 weeks after having AZD5718 for 12 weeks alone

    Investigational medicinal product name
    AZD5718
    Investigational medicinal product code
    AZD5718
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily oral dose of AZD5718 for 20 weeks as per the arm they were randomised to

    Arm title
    		 AZD5718 Dose 3 + Dapagliflozin 10 mg
    Arm description
    		 Participants received once daily oral dose of AZD5718 Dose 3 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received AZD5718 along with an add-on therapy of 10 mg of dapagliflozin for 8 weeks after having AZD5718 for 12 weeks alone

    Investigational medicinal product name
    AZD5718
    Investigational medicinal product code
    AZD5718
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily oral dose of AZD5718 for 20 weeks as per the arm they were randomised to

    Arm title
    		 Placebo + Dapagliflozin 10 mg
    Arm description
    		 Participants received once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
    Arm type
    		 Placebo and an add-on therapy

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a matching placebo to AZD5718 along with an add-on therapy of 10 mg of dapagliflozin for 8 weeks after having matching placebo to AZD5718 for 12 weeks alone

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily oral dose of matching placebo to AZD5718 for 20 weeks

    Number of subjects in period 1
    		AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Started
    154
    153
    153
    153
    Completed
    72
    82
    82
    82
    Not completed
    82
    71
    71
    71
         Due to Covid-19 pandemic
    7
    3
    7
    6
         Consent withdrawn by subject
    6
    6
    -
    3
         Physician decision
    -
    3
    1
    1
         Adverse event, non-fatal
    7
    2
    3
    -
         Death
    -
    -
    -
    1
         Failure to meet randomisation criteria
    2
    3
    4
    2
         Early termination from the study
    54
    51
    50
    50
         Development of Study Specific Withdrawal Criteria
    3
    1
    2
    2
         Lost to follow-up
    -
    1
    -
    1
         Missing
    3
    -
    -
    5
         Participants who did not receive treatment
    -
    1
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 All Randomised Subjects

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 613 613
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 289 289
        From 65-84 years
    		 319 319
        85 years and over
    		 5 5
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.5 ± 10.37 -
    Gender Categorical
    Units: Subjects
        Female
    		 208 208
        Male
    		 405 405

    End points

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    End points reporting groups
    Reporting group title
    AZD5718 Dose 1 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 1 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    AZD5718 Dose 2 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 2 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    AZD5718 Dose 3 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 3 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    Placebo + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Primary: Percentage change from baseline in reduction of urine albumin to creatinine ratio (ACR) to Week 20

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    End point title
    		 Percentage change from baseline in reduction of urine albumin to creatinine ratio (ACR) to Week 20 [1]
    End point description
    The dose response effect of AZD5718 on urine ACR at 20 weeks was evaluated. Values less than 1 indicate improvement from baseline. Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12 and who did not violate the terms of the protocol in a way that could affect the primary efficacy endpoint significantly.
    End point type
    Primary
    End point timeframe
    From Week 1 to Week 20
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Percentage change from baseline values added for ease of common public to understand.
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    69
    67
    75
    76
    Units: Percentage change from baseline
    number (confidence interval 95%)
        Week 20
    -5.49 (-21.37 to 13.60)
    -3.58 (-19.74 to 15.82)
    -8.07 (-23.24 to 10.10)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Percentage change from baseline in reduction of urine ACR to Week 12

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    End point title
    		 Percentage change from baseline in reduction of urine ACR to Week 12
    End point description
    The dose response effect of AZD5718 on urine ACR at 12 weeks was evaluated. Values less than 1 indicate improvement from baseline. Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12.
    End point type
    Secondary
    End point timeframe
    From Week 1 to Week 12
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    99
    97
    101
    104
    Units: Precentage change from baseline
    arithmetic mean (confidence interval 95%)
        Week 12
    -14.91 (-26.57 to -1.41)
    -6.71 (-19.46 to 8.07)
    -13.28 (-25.04 to 0.33)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events and serious adverse events

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    End point title
    		 Number of participants with adverse events and serious adverse events
    End point description
    The safety and tolerability profile of AZD5718 treatment was assessed. All participants who were randomised and received any study treatment. Participants were evaluated according to the actual treatment they received. If a participant had received a different treatment dose than randomised throughout the study, they would have been analysed according to the treated dose, not the randomisation dose. ST- study treatment
    End point type
    Secondary
    End point timeframe
    From Screening (Week -4 to 0) to Week 24
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    154
    152
    149
    153
    Units: Participants
        Any AE
    89
    89
    108
    96
        Any AE with outcome = death
    0
    0
    0
    1
        Any SAE (including events with outcome = death)
    13
    10
    13
    10
        Any AE leading to discontinuation of ST
    12
    3
    3
    7
        Any AE leading to dose interruption
    7
    6
    5
    10
        Any AE leading to withdrawal from study
    7
    0
    3
    1
        Any AE possibly related to ST by PI
    14
    12
    8
    14
    No statistical analyses for this end point

    Secondary: Change from baseline in 24-hours mean systolic blood pressure to Week 12

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    End point title
    		 Change from baseline in 24-hours mean systolic blood pressure to Week 12
    End point description
    The effect of AZD5718 on ambulatory blood pressure was assessed. All participants in the Full Analysis Population who had valid Ambulatory Blood Pressure data for change from baseline analyses.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 1, Day 1) to Week 12
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    69
    78
    70
    85
    Units: millimeter mercury (mm Hg)
        arithmetic mean (standard deviation)
    -2.06 ± 10.782
    1.56 ± 11.407
    -1.83 ± 9.986
    3.76 ± 11.779
    No statistical analyses for this end point

    Secondary: Plasma concentrations of AZD5718

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    End point title
    		 Plasma concentrations of AZD5718
    End point description
    The PK (plasma concentrations) of AZD5718 after repeated oral dosing for 20 weeks was supposed to be evaluated. However, due to the study termination and reduced scope of the analysis, the PK analysis was not been performed. Hence the number of participants analyzed was mentioned as "0".
    End point type
    Secondary
    End point timeframe
    From Week 2 to Week 20
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: Participants
    Notes
    [2] - Due to the study termination, participants analyzed was "0"
    [3] - Due to the study termination, participants analyzed was "0"
    [4] - Due to the study termination, participants analyzed was "0"
    [5] - Due to the study termination, participants analyzed was "0"
    No statistical analyses for this end point

    Secondary: Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12

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    End point title
    		 Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12
    End point description
    The effect of AZD5718 on renal function was evaluated. Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12.
    End point type
    Secondary
    End point timeframe
    From Week 1 to Week 12
    End point values
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Number of subjects analysed
    100
    101
    105
    106
    Units: milliltire/minute/1.73m^2
    arithmetic mean (standard deviation)
        Week 2 (n= 100, 100, 105, 106)
    -0.470 ± 6.3936
    -0.140 ± 5.2801
    -0.429 ± 5.7175
    0.547 ± 5.7124
        Week 4 (n= 98,100,104, 103)
    -0.735 ± 6.5764
    0.140 ± 5.2628
    -0.817 ± 6.1986
    0.058 ± 6.3583
        Week 8 (n=100,101,104,103)
    -0.760 ± 6.0304
    -0.535 ± 5.8865
    -1.144 ± 6.5142
    -0.068 ± 5.3729
        Week 12 (n=98,94,99,101)
    -0.612 ± 6.2138
    -1.149 ± 6.1783
    -0.394 ± 6.4678
    -0.257 ± 6.4508
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Week -4 to 0) to Week 24
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    AZD5718 Dose 1 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 1 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    AZD5718 Dose 2 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 2 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    AZD5718 Dose 3 + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of AZD5718 Dose 3 for 12 weeks, and thereafter an add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Reporting group title
    Placebo + Dapagliflozin 10 mg
    Reporting group description
    		 Participants received once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.

    Serious adverse events
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 154 (7.79%)
    8 / 152 (5.26%)
    11 / 149 (7.38%)
    6 / 153 (3.92%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute leukaemia
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Venous haemorrhage
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Asthenia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body ingestion
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Pituitary apoplexy
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 152 (0.66%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    2 / 149 (1.34%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    2 / 149 (1.34%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 152 (0.00%)
    0 / 149 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 152 (0.00%)
    1 / 149 (0.67%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AZD5718 Dose 1 + Dapagliflozin 10 mg AZD5718 Dose 2 + Dapagliflozin 10 mg AZD5718 Dose 3 + Dapagliflozin 10 mg Placebo + Dapagliflozin 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 154 (10.39%)
    8 / 152 (5.26%)
    9 / 149 (6.04%)
    8 / 153 (5.23%)
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    8 / 154 (5.19%)
    3 / 152 (1.97%)
    5 / 149 (3.36%)
    8 / 153 (5.23%)
         occurrences all number
    9
    3
    9
    10
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    8 / 154 (5.19%)
    8 / 152 (5.26%)
    1 / 149 (0.67%)
    6 / 153 (3.92%)
         occurrences all number
    8
    8
    2
    6
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    6 / 154 (3.90%)
    7 / 152 (4.61%)
    9 / 149 (6.04%)
    6 / 153 (3.92%)
         occurrences all number
    6
    7
    9
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Aug 2020
    Amendment 1: Inclusion Criterion #5 Clarification that females must be of non-childbearing potential and that a pregnancy test is required for all female participants. Inclusion Criterion #6 Text added to clarify the contraceptive requirements for male participants in regions where male condoms with spermicide are not available Inclusion Criterion #6 (h) Clarification that alcohol and drug screening is completed locally using laboratory kits provided by the central laboratory, and that screening must be completed for all participants
    25 Jan 2021
    Amendment 2: Inclusion criterion 5 was updated to provide more details on the eligibility of female study participants with regard to their childbearing potential. Inclusion criterion 6 was updated to accommodate Japanese Pharmaceuticals and Medical Devices Agency (PMDA) regulations. Exclusion criterion 15 was added to exclude participants who had a known hypersensitivity to dapagliflozin or any of the excipients of the product. Exclusion criterion 23 was added to the study as follows: Participants working night shifts, and who cannot avoid strenuous manual labour during the study.

    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.
    Following study termination and reduced scope of the analysis, the PK analysis has not been performed.
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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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