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    Clinical Trial Results:
    Sodium glucose cotransporter 2 inhibitors or Mineralocorticoid receptor antagonists for the treatment of Albuminuric Chronic Kidney Disease - A randomized controlled trial

    Summary
    EudraCT number
    		 2022-000740-29
    Trial protocol
    		 DK  
    Global end of trial date
    29 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    270389-030122
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Henrik Birn
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 35, Aarhus N, Denmark, 8200
    Public contact
    Frederik Husum Mårup, Department of Renal Medicine, Aarhus University Hospital, fremaa@rm.dk
    Scientific contact
    Frederik Husum Mårup, Department of Renal Medicine, Aarhus University Hospital, fremaa@rm.dk
    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
    08 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to investigate and compare the effect of Finerenone and Dapagliflozine on albuminuria, both separately and in combination, added to treatment with ACE-I/ARB in patients with non-diabetic chronic kidney disease and albuminuria.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jun 2022
    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
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    12
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited from the nephrology dept. in Aarhus

    Pre-assignment
    Screening details
    		 Patients in the outpatient clinic were pre-screened based on their biochemistry. Eligible patients were invited to the study, and consenting patients were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FINEDAPA
    Arm description
    		 Finerenone first, then Dapagliflozin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg

    Arm title
    		 DAPAFINE
    Arm description
    		 Dapagliflozin first, then finerenone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg

    Number of subjects in period 1
    		FINEDAPA DAPAFINE
    Started
    10
    10
    Completed
    10
    10
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FINEDAPA
    Arm description
    		 Finerenone first, then Dapagliflozin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg

    Arm title
    		 DAPAFINE
    Arm description
    		 Dapagliflozin first, then finerenone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg

    Number of subjects in period 2
    		FINEDAPA DAPAFINE
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FINEDAPA
    Reporting group description
    		 Finerenone first, then Dapagliflozin

    Reporting group title
    DAPAFINE
    Reporting group description
    		 Dapagliflozin first, then finerenone

    Reporting group values
    		 FINEDAPA DAPAFINE Total
    Number of subjects
    		 10 10 20
    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)
    		 4 5 9
        From 65-84 years
    		 6 5 11
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61 ( 17 ) 59 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 5
        Male
    		 8 7 15
    mGFR
    Units: ml/min
        arithmetic mean (standard deviation)
    		 37 ( 6 ) 30 ( 9 ) -
    eGFR
    Units: ml/min
        arithmetic mean (standard deviation)
    		 36 ( 5 ) 32 ( 3 ) -
    UACR
    Urine albumine creatinine ratio
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    		 449 (399 to 501) 491 (443 to 922) -
    Plasma potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4.2 ( 0.3 ) 4.1 ( 0.3 ) -
    Systolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 127 ( 11 ) 130 ( 12 ) -
    Diastolic BP
    Units: mmHg
        arithmetic mean (standard deviation)
    		 81 ( 8 ) 79 ( 4 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.6 ( 4.7 ) 24.9 ( 5.1 ) -
    24h albuminuria
    Units: mg/day
        median (inter-quartile range (Q1-Q3))
    		 853 (512 to 1225) 683 (325 to 1087) -

    End points

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    End points reporting groups
    Reporting group title
    FINEDAPA
    Reporting group description
    		 Finerenone first, then Dapagliflozin

    Reporting group title
    DAPAFINE
    Reporting group description
    		 Dapagliflozin first, then finerenone
    Reporting group title
    FINEDAPA
    Reporting group description
    		 Finerenone first, then Dapagliflozin

    Reporting group title
    DAPAFINE
    Reporting group description
    		 Dapagliflozin first, then finerenone

    Primary: UACR

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    End point title
    		 UACR
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 FINEDAPA DAPAFINE FINEDAPA DAPAFINE
    Number of subjects analysed
    10
    10
    10
    10
    Units: mg/g
        median (confidence interval 95%)
    339 (208 to 553)
    453 (278 to 738)
    304 (188 to 491)
    299 (184 to 483)
    Statistical analysis title
    		 T-test
    Statistical analysis description
    Baseline to 8 weeks: Change in both groups combined
    Comparison groups
    FINEDAPA v DAPAFINE v FINEDAPA v DAPAFINE
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46
         upper limit
    		 -24

    Secondary: 24h albuminuria

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    End point title
    		 24h albuminuria
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 FINEDAPA DAPAFINE FINEDAPA DAPAFINE
    Number of subjects analysed
    10
    10
    10
    10
    Units: mg/day
        median (confidence interval 95%)
    564 (306 to 1038)
    655 (357 to 1201)
    497 (285 to 866)
    412 (236 to 718)
    No statistical analyses for this end point

    Secondary: mGFR

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    End point title
    		 mGFR
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 FINEDAPA DAPAFINE FINEDAPA DAPAFINE
    Number of subjects analysed
    10
    10
    10
    10
    Units: ml/min
        arithmetic mean (confidence interval 95%)
    34 (29 to 40)
    28 (22 to 34)
    30 (25 to 35)
    24 (19 to 29)
    No statistical analyses for this end point

    Secondary: eGFR

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    End point title
    		 eGFR
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 FINEDAPA DAPAFINE FINEDAPA DAPAFINE
    Number of subjects analysed
    10
    10
    10
    10
    Units: ml/min
        arithmetic mean (confidence interval 95%)
    33 (30 to 36)
    31 (29 to 34)
    32 (29 to 34)
    27 (24 to 29)
    No statistical analyses for this end point

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 FINEDAPA DAPAFINE FINEDAPA DAPAFINE
    Number of subjects analysed
    10
    10
    10
    10
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    126 (119 to 132)
    125 (118 to 132)
    117 (109 to 126)
    121 (112 to 129)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    FINEDAPA
    Reporting group description
    		 Finerenone first, then Dapagliflozin

    Reporting group title
    DAPAFINE
    Reporting group description
    		 Dapagliflozin first, then finerenone

    Serious adverse events
    		 FINEDAPA DAPAFINE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Relapse atrial flutter
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         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: 1%
    Non-serious adverse events
    		 FINEDAPA DAPAFINE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    5 / 10 (50.00%)
    Cardiac disorders
    Atrial premature complexes
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Skin infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    EGFR decline >25%
         subjects affected / exposed
    4 / 10 (40.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Hyperkalaemia (>5.0)
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2022
    Spironolactone changed to finerenone Inclusion criteria change: eGFR from 25-60 to 25-45 Age from 18-75 to 18-80 Albuminuria from 200-2000 to 150-2000mg/g

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38186886
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