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    Clinical Trial Results:
    A clinical trial collecting Data from routine ophthalmological examinations of patients who were randomized to either finerenone or placebo in the two Bayer-sponsored Phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD to investigate the effect of Finerenone on delaying the progression of Diabetic Retinopathy

    Summary
    EudraCT number
    2020-003865-20
    Trial protocol
    BG  
    Global end of trial date
    30 Jun 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jul 2022
    First version publication date
    15 Jul 2022
    Other versions
    Summary report(s)
    21618_Study Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/21618
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04795726
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ​Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, ​Bayer AG, 49 30 300139003,
    Scientific contact
    Therapeutic Area Head, ​Bayer AG, 49 30 300139003,
    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
    12 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of orally administered finerenone on the progression of diabetic retinopathy compared to placebo
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Mar 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
    Bulgaria: 47
    Country: Number of subjects enrolled
    United Kingdom: 10
    Worldwide total number of subjects
    57
    EEA total number of subjects
    47
    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)
    38
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted at 11 centers in 2 countries, between 10-Mar-2021 (first subject first visit) and 27-May-2021 (last subject last visit).

    Pre-assignment
    Screening details
    A total of 74 subjects (38 finerenone, 36 placebo) were screened (signed informed consent) from the studies FIDELIO-DKD (29 subjects) and the FIGARO-DKD (45 subjects). 70 of them (36 finerenone, 34 placebo) had available ophthalmological assessments (including screening failures). 57 subjects (29 finerenone, 28 placebo) were included in the FAS.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Finerenone
    Arm description
    Subjects received treatment in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone (Kerendia, BAY94-8862)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg or 20 mg Finerenone tablet was taken once daily, only administered in the FIDELIO-DKD or FIGARO-DKD clinical trial. Subject didn't take treatment in this study.

    Arm title
    Placebo
    Arm description
    Subjects received placebo in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD
    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
    Matching placebo was taken once daily, only administered in the FIDELIO-DKD or FIGARO-DKD clinical trial. Subject didn't take treatment in this study.

    Number of subjects in period 1
    Finerenone Placebo
    Started
    29
    28
    Completed
    26
    25
    Not completed
    3
    3
         Physician decision
    1
    -
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    Subjects received treatment in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Reporting group values
    Finerenone Placebo Total
    Number of subjects
    29 28 57
    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)
    19 19 38
        From 65-84 years
    10 9 19
        85 years and over
    0 0 0
    Gender Categorical
    Units: Subjects
        Female
    18 8 26
        Male
    11 20 31
    Race
    Units: Subjects
        White
    27 26 53
        Black or African American
    2 1 3
        Asian
    0 1 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    29 28 57

    End points

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    End points reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    Subjects received treatment in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants enrolled and allocated to this study.

    Primary: Number of subjects with progression of non-proliferative diabetic retinopathy (NPDR) at End of Year 2

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    End point title
    Number of subjects with progression of non-proliferative diabetic retinopathy (NPDR) at End of Year 2
    End point description
    Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 2 after start of treatment
    End point type
    Primary
    End point timeframe
    After start of treatment until end of Year 2
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29
    28
    Units: Subjects
    0
    1
    Statistical analysis title
    Treatment difference propotion
    Statistical analysis description
    95% confidence intervals (CIs) for the treatment difference based on a two-sided z-test for the difference of two proportions (Finerenone-placebo) using normal approximation.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.3085
    Method
    z-test
    Parameter type
    Treatment difference propotion
    Point estimate
    -0.036
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.104
         upper limit
    0.033

    Secondary: Number of subjects with progression of non-proliferative diabetic retinopathy (NPDR) at End of Year 1

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    End point title
    Number of subjects with progression of non-proliferative diabetic retinopathy (NPDR) at End of Year 1
    End point description
    Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 1 after start of treatment
    End point type
    Secondary
    End point timeframe
    After start of treatment until end of Year 1
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29
    28
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)

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    End point title
    Number of subjects with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)
    End point description
    End point type
    Secondary
    End point timeframe
    After start of treatment until end of Year 1, and until the end of Year 2
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29
    28
    Units: Subjects
        End of Year 1
    0
    0
        End of Year 2
    0
    1
    Statistical analysis title
    Treatment difference propotion until Year 2
    Statistical analysis description
    95% confidence intervals (CIs) for the treatment difference based on a two-sided z-test for the difference of two proportions (unpooled variances) using normal approximation
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.3085
    Method
    z-test
    Parameter type
    Treatment difference propotion
    Point estimate
    -0.036
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.104
         upper limit
    0.033

    Secondary: Number of subjects with diabetic macular edema (DME)

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    End point title
    Number of subjects with diabetic macular edema (DME)
    End point description
    End point type
    Secondary
    End point timeframe
    After start of treatment until end of Year 1 and end of Year 2
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29
    28
    Units: Subjects
        End of Year 1
    0
    0
        End of Year 2
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anterior segment neovascularization (ASN)

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    End point title
    Number of subjects with anterior segment neovascularization (ASN)
    End point description
    End point type
    Secondary
    End point timeframe
    After start of treatment until end of Year 1 and end of Year 2
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29
    28
    Units: Subjects
        End of Year 1
    0
    0
        End of Year 2
    0
    0
    No statistical analyses for this end point

    Secondary: Change in severity of diabetic retinopathy (DR)

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    End point title
    Change in severity of diabetic retinopathy (DR)
    End point description
    Severity grades of DR are: No DR, NPDR (mild or moderate), NPDR (severe) and PDR
    End point type
    Secondary
    End point timeframe
    From start of treatment to the end of Year 1 and end of Year 2
    End point values
    Finerenone Placebo
    Number of subjects analysed
    29 [1]
    28 [2]
    Units: Subjects
        At End of Year 1- Progression
    0
    0
        At End of Year 1- Improvement
    0
    1
        At End of Year 1- No change
    11
    7
        At End of Year 1-Unknown
    18
    20
        At End of Year 2- Progression
    0
    1
        At End of Year 2- Improvement
    0
    0
        At End of Year 2- No change
    5
    6
        At End of Year 2-Unknown
    24
    21
    Notes
    [1] - 18 subjects missed assessment at End of Year 1, 24 subjects missed assessment at End of Year 2
    [2] - 20 subjects missed assessment at End of Year 1, 21 subjects missed assessment at End of Year 2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months
    Adverse event reporting additional description
    Adverse Events Information as reported for the selected subset of subjects from study 16244 (EudraCT no. 2015-000990-11) and study 17530 (EudraCT no. 2015-000950-39) are provided. This study was conducted to support data collection for observational ReFineDR study 21311. ReFineDR study results could be found on https://clinicaltrials.bayer.com/.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Reporting group title
    Finerenone
    Reporting group description
    Subjects received treatment in phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD

    Serious adverse events
    Placebo Finerenone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 28 (21.43%)
    6 / 29 (20.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Insertion of ambulatory peritoneal catheter
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gangrene
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 29 (17.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo Finerenone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 28 (64.29%)
    18 / 29 (62.07%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostatic adenoma
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Vitrectomy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Transurethral bladder resection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Retinopexy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Cataract operation
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 29 (13.79%)
         occurrences all number
    1
    4
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Hand fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Vascular graft occlusion
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Cardiac disorders
    Mitral valve incompetence
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Bundle branch block right
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Hemiparesis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Neuralgic amyotrophy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Anaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Eye disorders
    Retinal haemorrhage
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Retinopathy hypertensive
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    Haematochezia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Furuncle
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Injection site infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Medical device site infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    In this study no additional safety data were collected. Adverse events information from study 16244 (EudraCT no. 2015-000990-11) and study 17530 (EudraCT no. 2015-000950-39) are provided.
    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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