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    Clinical Trial Results:
    REMODEL - Renal mode of action of semaglutide in patients with type 2 diabetes and chronic kidney disease

    Summary
    EudraCT number
    		 2020-000828-19
    Trial protocol
    		 PL   FR   IT   ES   DK  
    Global end of trial date
    21 Nov 2024

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN9535-4662
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04865770
    WHO universal trial number (UTN)
    		 U1111-1248-7912
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, 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
    13 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of once-weekly (OW) semaglutide administered subcutaneously (under the skin, s.c.) versus placebo on renal inflammation and haemodynamics, as measured by magnetic resonance imaging (MRI) in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD).
    Protection of trial subjects
    This study was conducted in accordance with the International Council for Harmonization (ICH) Good Clinical Practice (GCP), the Declaration of Helsinki, and US Food and Drug Administration (FDA) 21 US Code of Federal Regulations (CFR) 312.120. Essential documents will be maintained and archived in accordance with ICH GCP.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Apr 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
    Canada: 8
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    South Africa: 7
    Worldwide total number of subjects
    106
    EEA total number of subjects
    55
    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)
    46
    From 65 to 84 years
    60
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 31 sites in 8 countries.

    Pre-assignment
    Screening details
    		 Subjects were randomized in a 2:1 ratio to receive semaglutide or placebo, respectively. Both added to standard-of-care treatment.

    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
    		 Semaglutide 1.0 mg
    Arm description
    		 Subjects received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once-weekly subcutaneous injection of semaglutide was administered for 52 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once-weekly subcutaneous injection of placebo matched for semaglutide was administered for 52 weeks.

    Number of subjects in period 1
    		Semaglutide 1.0 mg Placebo
    Started
    71
    35
    Full analysis set
    71
    35
    Safety analysis set
    71
    35
    Completed
    58
    34
    Not completed
    13
    1
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    3
    -
         Physician decision
    9
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

    Reporting group values
    		 Semaglutide 1.0 mg Placebo Total
    Number of subjects
    		 71 35 106
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 28 18 46
        From 65-84 years
    		 43 17 60
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.4 ( 9.2 ) 65.1 ( 11.3 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 16 9 25
        Male
    		 55 26 81

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

    Subject analysis set title
    Semaglutide 1.0 mg/Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received OW treatment with 0.25 mg semaglutide or placebo from week 0 to week 4 followed by 0.5 mg semaglutide or placebo from week 4 to week 8 followed by 1 mg semaglutide or placebo from week 8 to week 52 depending on the arm they were randomised to. This arm has combined data from Semaglutide arm and Placebo arm.

    Primary: Change in kidney oxygenation (cortex), blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI) (R2*)

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    End point title
    		 Change in kidney oxygenation (cortex), blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI) (R2*)
    End point description
    Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of kidney oxygenation
    geometric mean (geometric coefficient of variation)
        Bilateral cortex (n = 58, 33)
    0.98 ( 5.35 )
    1.00 ( 7.39 )
        Right cortex (n = 58, 33)
    0.98 ( 5.65 )
    0.99 ( 7.26 )
        Left cortex (n = 58, 31)
    0.98 ( 7.51 )
    1.01 ( 9.12 )
    Statistical analysis title
    		 Bilateral cortex
    Statistical analysis description
    The responses are analysed using an Analysis of covariance (ANCOVA) with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1333
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.01
    Statistical analysis title
    		 Left cortex
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0907
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1
    Statistical analysis title
    		 Right cortex
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2487
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.01

    Primary: Change in kidney oxygenation (medulla), BOLD MRI (R2*)

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    End point title
    		 Change in kidney oxygenation (medulla), BOLD MRI (R2*)
    End point description
    Change in kidney oxygenation in medulla assessed by BOLD MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of kidney oxygenation (medulla)
    geometric mean (geometric coefficient of variation)
        Bilateral medulla (n = 57, 33)
    0.99 ( 8.97 )
    1.01 ( 11.37 )
        Right medulla (n= 57, 33)
    0.98 ( 10.09 )
    1.02 ( 10.83 )
        Left medulla (n= 58, 31)
    0.99 ( 10.25 )
    1.02 ( 13.02 )
    Statistical analysis title
    		 Bilateral medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5619
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.03
    Statistical analysis title
    		 Left medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7924
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.04
    Statistical analysis title
    		 Right medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2774
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.02

    Primary: Change in global kidney perfusion (MRI)

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    End point title
    		 Change in global kidney perfusion (MRI)
    End point description
    Change in global kidney perfusion assessed by phase contrast MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of global kidney perfusion
    geometric mean (geometric coefficient of variation)
        Bilateral kidney (n = 49, 30)
    1.03 ( 26.43 )
    0.99 ( 24.39 )
        Right kidney (n = 50, 30)
    1.04 ( 27.84 )
    0.98 ( 28.85 )
        Left kidney (n = 50, 29)
    1.02 ( 29.25 )
    1.01 ( 26.83 )
    Statistical analysis title
    		 Bilateral kidney
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0958
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.24
    Statistical analysis title
    		 Right kidney
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0145
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.33
    Statistical analysis title
    		 Left kidney
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3311
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.21

    Primary: Change in kidney inflammation (cortex), longitudinal relaxation time (T1) mapping (MRI)

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    End point title
    		 Change in kidney inflammation (cortex), longitudinal relaxation time (T1) mapping (MRI)
    End point description
    Change in kidney inflammation in cortex assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of kidney inflammation
    geometric mean (geometric coefficient of variation)
        Bilateral cortex (n = 56, 32)
    1.01 ( 3.78 )
    1.01 ( 5.43 )
        Right cortex (n = 56, 32)
    1.01 ( 3.88 )
    1.01 ( 5.57 )
        Left cortex (n = 56, 31)
    1.01 ( 3.93 )
    1.01 ( 5.71 )
    Statistical analysis title
    		 Bilateral cortex
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8651
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02
    Statistical analysis title
    		 Left cortex
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7195
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02
    Statistical analysis title
    		 Right cortex
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.724
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02

    Primary: Change in kidney inflammation (medulla), T1 mapping (MRI)

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    End point title
    		 Change in kidney inflammation (medulla), T1 mapping (MRI)
    End point description
    Change in kidney inflammation in medulla assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of kidney inflammation (medulla)
    geometric mean (geometric coefficient of variation)
        Bilateral medulla (n = 56, 32)
    1.00 ( 3.56 )
    1.00 ( 5.13 )
        Right medulla (n = 56, 32)
    1.00 ( 3.90 )
    1.01 ( 4.85 )
        Left medulla (n = 56, 31)
    1.00 ( 3.69 )
    1.00 ( 5.91 )
    Statistical analysis title
    		 Bilateral medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9335
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02
    Statistical analysis title
    		 Left medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9017
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.02
    Statistical analysis title
    		 Right medulla
    Statistical analysis description
    The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.
    Comparison groups
    Semaglutide 1.0 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6517
    Method
    		 ANCOVA
    Parameter type
    		 Treatment ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.01

    Secondary: Change in gene expression assessed by single nucleus ribonucleic acid (RNA) sequencing (kidney biopsy)

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    End point title
    		 Change in gene expression assessed by single nucleus ribonucleic acid (RNA) sequencing (kidney biopsy)
    End point description
    Change in gene expression assessed by single nucleus RNA sequencing (kidney biopsy) from baseline (week 0) to end of treatment (week 52) is presented. Selected genes with a fold change >0.5 or <0.5 and a false discovery rate (FDR) <0.1 are presented to help identify biologically significant genes that are reliably differentially expressed in patients with conditions like Type 2 diabetes and chronic kidney disease. Data was annotated into different cell types. This was estimated with linear mixed model including subject as a random effect. These are all cell types that have differentially expressed genes that comply with threshold. This threshold is based on published in cross-sectional observational studies associated with disease impact around genes. FAS included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall 'Number subjects analyzed' = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg/Placebo
    Number of subjects analysed
    22
    Units: Log2 fold change
    number (not applicable)
        CNT-2, RSPO3
    3.468216523
        CNT-Immune, SLC8A1-AS1
    2.8531071
        EC-GC-1, KCNK6
    -1.952545192
        EC-GC-1, EMC10
    -2.485824696
        EC-GC-1, ENSG00000286145
    1.831300888
        EC-GC-1, LMF1
    -1.528463786
        EC-GC-1, ANKUB1
    1.783402404
        EC-GC-1, AHNAK
    -1.368952211
        EC-GC-1, ENSG00000286150
    1.318309657
        EC-GC-1, NSUN6
    -1.464540152
        EC-GC-1, TFCP2L1
    -2.24516792
        EC-GC-1, ENSG00000274422
    -1.860725608
        EC-GC-1, DPYD-AS1
    1.996950045
        EC-GC-1, ENSG00000248138
    2.110414741
        EC-GC-1, ACSM2B
    -1.785467699
        EC-GC-1, CCNH
    1.033873239
        EC-GC-1, QTRT1
    -2.415240141
        EC-GC-1, CROCCP3
    -1.254541813
        EC-GC-1, ENSG00000251034
    1.750285729
        EC-GC-1, LSAMP
    -2.439268964
        EC-GC-1, LHX1-DT
    -4.256689925
        EC-GC-1, ESRRG
    -1.527414037
        EC-GC-1, CNTNAP2
    -2.377391827
        EC-GC-1, ENSG00000284966
    1.665764749
        EC-GC-1, BICC1
    -1.445239386
        EC-GC-1, GNA14-AS1
    1.192645521
        EC-GC-1, GUSBP11
    -1.318511642
        EC-GC-1, ENSG00000233783
    1.668536087
        EC-GC-1, SEMA6A-AS1
    1.183886707
        EC-GC-1, RBMS3-AS2
    1.572052032
        EC-GC-1, ENSG00000286147
    -4.468841041
        EC-GC-1, LINC00342
    -1.151143461
        EC-GC-1, IRF3
    -1.566408786
        EC-GC-1, ENSG00000249207
    1.35685803
        EC-GC-1, CRADD-AS1
    1.972404772
        EC-GC-1, TOX3
    -2.206055055
        EC-GC-1, ENSG00000286458
    1.271036656
        EC-GC-1, SLC12A3
    -2.531722898
        EC-GC-1, TALAM1
    1.235573321
        EC-GC-1, PCDH17
    1.107442597
        EC-GC-1, ATP13A3
    1.078246118
        EC-GC-1, ENSG00000231772
    -2.382264501
        EC-GC-1, FBXL19
    -2.166973377
        EC-GC-1, ENSG00000254420
    1.74612131
        EC-GC-1, SPC25
    1.329461228
        EC-GC-1, SMAD4
    1.13655744
        EC-GC-1, UFM1
    1.20264148
        EC-GC-1, ENSG00000259564
    2.071724947
        EC-GC-1, SHOC1
    1.634369451
        EC-GC-1, MEF2C-AS2
    1.753288691
        EC-GC-1, ENSG00000285801
    1.440844025
        EC-GC-1, FAM228B
    -1.22996414
        EC-GC-1, GLS
    0.868999317
        EC-GC-1, GDPD4
    -6.564026305
        EC-GC-1, INSYN2A
    1.759769032
        EC-GC-1, TNFRSF14
    -1.254004029
        EC-GC-1, PRX
    -1.199880651
        EC-GC-1, PNN
    -1.024604708
        EC-GC-1, KCNQ1OT1
    -0.794847103
        EC-GC-1, ACAP3
    -1.44397269
        EC-GC-1, BASP1-AS1
    -4.83539932
        EC-GC-1, RBFOX1
    -1.706411849
        EC-GC-1, CCDC90B-AS1
    -1.678217382
        EC-GC-1, ENSG00000240499
    1.514399208
        EC-GC-1, LINC03076
    1.545248095
        EC-GC-1, LINC01409
    -1.022992954
        EC-GC-1, CCT4
    1.455396063
        EC-GC-1, CDC73
    0.802691458
        EC-GC-1, NUMA1
    -0.931923316
        EC-GC-1, FLT4
    -0.935590968
        EC-GC-1, PDLIM5
    0.764926487
        EC-GC-1, SPCS3
    1.02068757
        EC-GC-1, ENSG00000250646
    1.917331079
        EC-GC-1, ENSG00000258168
    1.083991656
        EC-GC-1, ST8SIA4
    0.901071433
        EC-GC-1, BCL2L1-AS1
    1.262413164
        EC-GC-1, NRSN2-AS1
    -1.275348201
        EC-GC-1, STARD13-AS
    1.148054491
        EC-GC-1, CFLAR-AS1
    1.168941896
        EC-GC-1, PRKAR1A
    1.257792414
        EC-GC-1, ENSG00000226239
    1.126077043
        EC-GC-1, CTNNA3
    -1.819759686
        EC-GC-1, KCNK5
    -2.491597199
        EC-GC-1, ESR2
    1.071576206
        EC-GC-1, SLC25A46
    1.062235788
        EC-GC-1, REV3L
    0.792446528
        EC-GC-1, ZC2HC1C
    2.027909336
        EC-GC-1, ENSG00000279686
    -1.453758633
        EC-GC-1, ACER1
    -5.256214457
        EC-GC-1, MALRD1
    -2.36001857
        EC-GC-1, RRBP1
    -0.837125744
        EC-GC-1, ZNF451-AS1
    1.853753635
        EC-GC-1, SHANK2
    -1.481833304
        EC-GC-1, ENSG00000248388
    2.196067138
        EC-GC-1, KPNA5
    0.936135624
        EC-GC-1, APPAT
    -1.750949862
        EC-GC-1, PCNT
    -0.932423432
        EC-GC-1, ENSG00000233848
    2.752498803
        EC-GC-1, MORF4L2
    1.28059543
        EC-GC-1, ENSG00000236283
    -1.572597604
        EC-GC-1, SNRNP70
    -0.883484114
        EC-GC-1, EXD3
    -0.805539835
        EC-GC-1, CNTNAP5
    -2.392758482
        EC-GC-1, CASR
    -2.323412555
        EC-GC-1, ENSG00000285692
    1.124516569
        EC-GC-1, WDR81
    -2.102548546
        EC-GC-1, ZNF160
    -0.907890266
        EC-GC-1, CA12
    -1.63720477
        EC-GC-1, MAPK8IP3
    -0.998528168
        EC-GC-1, ABTB3
    -2.945080572
        EC-GC-1, CHORDC1
    1.047593755
        EC-GC-1, FREM1
    -1.948982139
        EC-GC-1, FXYD6-AS1
    2.22442108
        EC-GC-1, SPACA6
    -1.045439073
        EC-GC-1, AGBL1
    -2.851170905
        EC-GC-2, NES
    -2.451444521
        EC-GC-2, ADARB2
    -3.212266234
        EC-GC-2, SERPINB9
    2.315559798
        EC-GC-2, ENSG00000274422
    -2.329265154
        EC-GC-2, BTNL9
    -2.01168798
        EC-GC-2, CPEB2
    1.51543417
        EC-GC-2, TBX2
    -2.604511077
        EC-GC-2, ENSG00000290560
    2.378813977
        EC-GC-2, CFAP54
    1.988387042
        EC-GC-2, ABI3BP
    1.57362138
        EC-GC-2, SPACA6
    -1.724379529
        EC-GC-2, ADAMTSL2
    -2.009897896
        EC-GC-2, LZTS1
    -2.659531511
        EC-GC-2, ENSG00000285744
    1.889210245
        EC-GC-2, ENSG00000225689
    -1.414674941
        EC-GC-2, LUZP2
    -4.384000321
        EC-GC-2, NCKAP5
    -1.592351284
        EC-GC-2, FAT1
    -1.855192898
        NKC-NKT, AGBL4
    -2.145446805
        NKC-NKT, TFEC
    1.989578132
        NKC-NKT, ENSG00000254186
    -2.913048038
        NKC-NKT, PDE10A
    -2.170777761
        NKC-NKT, SHANK2
    -2.431773845
        PEC, RGS6
    -3.331377896
        PEC, AHNAK
    -1.645129407
        PT-2, LRRC4C
    -2.167101922
        PT-2, DSCAM
    -3.104786855
        PT-2, RCN3
    -1.636040003
    No statistical analyses for this end point

    Secondary: Change in glomerular basement membrane width (kidney biopsy)

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    End point title
    		 Change in glomerular basement membrane width (kidney biopsy)
    End point description
    Change in glomerular basement membrane width assessed in kidney biopsy from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall 'Number subjects analyzed' = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    12
    9
    Units: Nanometer (nm)
        arithmetic mean (standard deviation)
    -72.67 ( 96.60 )
    -8.66 ( 206.35 )
    No statistical analyses for this end point

    Secondary: Change in apparent diffusion coefficient (ADC) (cortex) (MRI)

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    End point title
    		 Change in apparent diffusion coefficient (ADC) (cortex) (MRI)
    End point description
    Change in apparent diffusion coefficient in cortex assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of ADC
    geometric mean (geometric coefficient of variation)
        Bilateral cortex (n = 51, 29)
    1.00 ( 6.56 )
    0.94 ( 11.40 )
        Left cortex (n= 52, 27)
    1.01 ( 8.50 )
    0.96 ( 10.48 )
        Right cortex (n = 52, 29)
    0.98 ( 6.70 )
    0.93 ( 12.12 )
    No statistical analyses for this end point

    Secondary: Change in ADC (medulla) (MRI)

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    End point title
    		 Change in ADC (medulla) (MRI)
    End point description
    Change in apparent diffusion coefficient in medulla assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of ADC
    geometric mean (geometric coefficient of variation)
        Bilateral medulla (n = 50, 29)
    0.98 ( 8.90 )
    0.94 ( 13.51 )
        Left medulla (n= 52, 27)
    0.99 ( 9.51 )
    0.95 ( 13.41 )
        Right medulla (n = 51, 29)
    0.98 ( 10.00 )
    0.93 ( 13.94 )
    No statistical analyses for this end point

    Secondary: Change in mean renal artery resistive index (RARI) (MRI)

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    End point title
    		 Change in mean renal artery resistive index (RARI) (MRI)
    End point description
    Change in renal arterial resistive index assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of RARI
    geometric mean (geometric coefficient of variation)
        Bilateral renalartery (n = 54, 32)
    0.97 ( 7.00 )
    1.01 ( 6.13 )
        Right renalartery (n = 56, 33)
    0.98 ( 8.38 )
    1.01 ( 8.62 )
        Left renalartery (n = 55, 30)
    0.97 ( 7.44 )
    1.01 ( 6.43 )
    No statistical analyses for this end point

    Secondary: Change in mean arterial flow (MRI)

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    End point title
    		 Change in mean arterial flow (MRI)
    End point description
    Change in mean arterial flow assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Number of subjects analyzed= FAS. Number Analyzed(n) = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    71
    35
    Units: Ratio of Mean arterial flow
    geometric mean (geometric coefficient of variation)
        Bilateral renalartery (n = 56, 32)
    0.96 ( 24.96 )
    0.96 ( 25.06 )
        Right renalartery (n = 56, 33)
    0.97 ( 30.21 )
    0.95 ( 29.09 )
        Left renalartery (n = 57, 30)
    0.96 ( 25.06 )
    0.98 ( 27.38 )
    No statistical analyses for this end point

    Secondary: Change in natriuresis (urinary sodium excretion) (urinalysis)

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    End point title
    		 Change in natriuresis (urinary sodium excretion) (urinalysis)
    End point description
    Change in natriuresis (urinary sodium excretion) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall 'Number subjects analyzed' = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    57
    32
    Units: Millimoles per day (mmol/day)
        arithmetic mean (standard deviation)
    -7.3 ( 71.3 )
    -26.9 ( 85.2 )
    No statistical analyses for this end point

    Secondary: Change in albumin excretion rate (urinalysis)

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    End point title
    		 Change in albumin excretion rate (urinalysis)
    End point description
    Change in albumin excretion rate (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall 'Number subjects analyzed' = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    56
    33
    Units: Milligrams per day (mg/d)
        arithmetic mean (standard deviation)
    -81.9 ( 708.8 )
    -233.2 ( 964.8 )
    No statistical analyses for this end point

    Secondary: Change in kidney function (creatinine clearance) (urinalysis)

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    End point title
    		 Change in kidney function (creatinine clearance) (urinalysis)
    End point description
    Change in kidney function (creatinine clearance) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented. Full analysis set included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall 'Number subjects analyzed' = number of subjects with available data for particular timepoint, for the respective arms.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 52)
    End point values
    		 Semaglutide 1.0 mg Placebo
    Number of subjects analysed
    53
    33
    Units: Milliliter per minute (ml/min)
        arithmetic mean (standard deviation)
    3.8 ( 26.6 )
    -12.6 ( 34.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 57
    Adverse event reporting additional description
    Safety analysis set. All presented TEAEs: AE with onset in all observed data points from 1st date of study product until permanent discontinuation of treatment. A subject died after discontinuing study by physician decision so counted in physician decision category in Subject Disposition in semaglutide arm.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to semaglutide s.c. once a week until week 52.

    Reporting group title
    Semaglutide 1.0 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, milligrams [mg]) once weekly for 8 weeks followed by a maintenance dose of semaglutide 1.0 mg s.c. once weekly until week 52.

    Serious adverse events
    		 Placebo Semaglutide 1.0 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 35 (14.29%)
    14 / 71 (19.72%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Anger
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 71 (5.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Semaglutide 1.0 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 35 (31.43%)
    15 / 71 (21.13%)
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 71 (5.63%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 71 (5.63%)
         occurrences all number
    2
    5
    Diarrhoea
         subjects affected / exposed
    4 / 35 (11.43%)
    4 / 71 (5.63%)
         occurrences all number
    5
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2021
    To align minimum requirements for the kidney biopsy sites, kidney biopsy procedure and sponsor oversight. In addition, one randomisation criteria was added to ensure stable dose of RAAS blocking agent between screening and randomisation.
    24 May 2022
    To update few inclusion criteria as it is expected to beneficially impact on recruitment without compromising the study integrity or subject safety. Minor editorial changes were made to increase consistency and clarity.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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