Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM)

    Summary
    EudraCT number
    		 2021-003053-37
    Trial protocol
    		 BG   ES  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2023
    First version publication date
    03 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    21952
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05013008
    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, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    06 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate long-term effect of finerenone treatment, in addition to standard-of-care, on circulating blood biomarkers associated with fibrosis, congestion, inflammation and vascular function
    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
    18 Aug 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
    Austria: 18
    Country: Number of subjects enrolled
    Finland: 27
    Country: Number of subjects enrolled
    Sweden: 34
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Hong Kong: 25
    Country: Number of subjects enrolled
    Israel: 62
    Country: Number of subjects enrolled
    Japan: 169
    Country: Number of subjects enrolled
    Korea, Republic of: 48
    Country: Number of subjects enrolled
    Singapore: 14
    Country: Number of subjects enrolled
    Taiwan: 61
    Country: Number of subjects enrolled
    United States: 117
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    Bulgaria: 67
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Spain: 42
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Denmark: 71
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Russian Federation: 83
    Worldwide total number of subjects
    952
    EEA total number of subjects
    338
    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)
    429
    From 65 to 84 years
    520
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at multiple centers in 21 countries/regions between 18 August 2021 (first subject first visit) and 31 December 2021 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, 952 subjects from previous FIGARO-DKD study (2015-000950-39) were screened for this FIGAGRO-BM study. Of them, 1 subject was a screening failure and 30 subjects missed treatment and/or biomarker data at Visit 3 or 11 in FIGARO-DKD. The remaining 921 subjects were included in the modified biomarker full analysis set of FIGAGRO-BM study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Finerenone
    Arm description
    		 Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Kerendia
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
    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; oral tablet; once daily; received in previous interventional Phase 3 trial FIGARO-DKD

    Number of subjects in period 1 [1]
    		Finerenone Placebo
    Started
    478
    443
    Completed
    478
    443
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One (1) subject was screening failure and 30 subjects missed treatment and/or biomarker data at Visit 3 or 11 in FIGARO-DKD, therefore all of them were not included in the modified biomarker full analysis set of this FIGAGRO-BM study.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    		 Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

    Reporting group values
    		 Finerenone Placebo Total
    Number of subjects
    		 478 443 921
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.55 ( 9.50 ) 64.15 ( 9.65 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 120 112 232
        Male
    		 358 331 689
    Race
    Units: Subjects
        White
    		 293 283 576
        Black or African American
    		 8 7 15
        Asian
    		 173 151 324
        American Indian or Alaska Native
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Not Reported
    		 1 1 2
        Multiple
    		 2 0 2
    Plasma Matrilysin (P09237) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=427;403
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 19.618 ( 1.148 ) 18.956 ( 1.203 ) -
    Plasma von Willebrand factor (P04275) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 3.200 ( 1.793 ) 2.338 ( 1.629 ) -
    Plasma CCN family member 4 (O95388) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=470;436
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.600 ( 1.337 ) 1.578 ( 1.374 ) -
    Plasma TGF beta-1 proprotein (P01137) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. TGF: Transforming growth factor. n=471;436
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.480 ( 1.327 ) 1.425 ( 1.349 ) -
    Plasma TGF beta receptor type 3 (Q03167) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. TGF: Transforming growth factor. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.583 ( 1.631 ) 1.776 ( 1.624 ) -
    Plasma IL-15 receptor subunit alpha (Q13261) at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. IL-15: Interleukin-15. n=435;408
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.678 ( 1.432 ) 1.614 ( 1.450 ) -
    Plasma Metalloproteinase inhibitor 1 (P01033) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=432;408
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.818 ( 1.450 ) 1.824 ( 1.349 ) -
    Plasma Pappalysin-1 (Q13219) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=435;408
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 0.171 ( 3.066 ) 0.164 ( 2.762 ) -
    Plasma Protein AMBP (P02760) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=470;436
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.595 ( 1.226 ) 1.611 ( 1.225 ) -
    Plasma Proto-oncogene c-Src (P12931) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Proto-oncogene c-Src: Proto-oncogene tyrosine-protein kinase Src. n=471;438
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.770 ( 2.614 ) 1.535 ( 2.229 ) -
    Plasma Uromodulin (P07911) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=443;405
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 0.582 ( 1.752 ) 0.699 ( 1.531 ) -
    Plasma Aminopeptidase N (P15144) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=461;433
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.224 ( 1.273 ) 1.248 ( 1.300 ) -
    Plasma TNFRSF1A (P19438) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. TNFRSF1A: Tumor necrosis factor receptor superfamily member 1A. n=476;441
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 2.105 ( 1.606 ) 2.107 ( 1.575 ) -
    Plasma CCN family member 2 (P29279) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=473;439
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.245 ( 1.585 ) 1.258 ( 1.360 ) -
    Plasma PAI-1 (P05121) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. PAI-1: Plasminogen activator inhibitor 1. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.349 ( 2.148 ) 1.261 ( 1.868 ) -
    Plasma uPAR (Q03405) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. uPAR: Urokinase plasminogen activator surface receptor. n=473;439
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.744 ( 1.699 ) 1.725 ( 1.398 ) -
    Plasma C-C motif chemokine 14 (Q16627) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;441
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 3.013 ( 1.667 ) 3.056 ( 1.426 ) -
    Plasma C-C motif chemokine 16 (O15467) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.625 ( 1.776 ) 1.633 ( 1.637 ) -
    Plasma Collagen alpha-1(I) chain (P02452) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 0.646 ( 1.675 ) 0.693 ( 1.497 ) -
    Plasma Decorin (P07585) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=427;403
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.523 ( 1.233 ) 1.526 ( 1.233 ) -
    Plasma C-C motif chemokine 2 (P13500) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=444;407
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 3.065 ( 1.285 ) 3.209 ( 1.367 ) -
    Plasma Matrix metalloproteinase-9 (P14780) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=476;441
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.329 ( 2.202 ) 1.176 ( 1.985 ) -
    Plasma E-selectin (P16581) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.235 ( 1.828 ) 1.200 ( 1.577 ) -
    Plasma Thrombospondin-2 (P35442) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=476;441
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.421 ( 1.655 ) 1.452 ( 1.649 ) -
    Plasma RARRES2 (Q99969) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. RARRES2: Retinoic acid receptor responder protein 2. n=472;441
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 2.201 ( 1.580 ) 2.252 ( 1.418 ) -
    Plasma C-X-C motif chemokine 16 (Q9H2A7) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.341 ( 1.586 ) 1.353 ( 1.338 ) -
    Plasma Dickkopf-related protein 3 (Q9UBP4) level at Visit 3
    The protein concentration of biomarker levels was evaluated for 27 pre-defined plasma biomarkers. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. NPX is a unit on log2-scale that is logarithmically related to protein concentration. n=472;434
    Units: Linear NPX (2^NPX)
        geometric mean (standard deviation)
    		 1.827 ( 1.541 ) 1.925 ( 1.460 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    		 Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

    Subject analysis set title
    Modified biomarker full analysis set (mBFAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects with valid informed consent for this biomarker study (including both Study 21952 and the protocol addendum for FIGARO-DKD), which met the following criteria: a. Study enrollment criteria as defined in the study protocol. b. Analyzed biomarker samples at Visit 3 (4 months) and Visit 11 (36 months); Biomarker samples that were shipped at ambient temperatures were not analyzed. c. On Treatment at Visit 3 (4 months) and Visit 11 (36 months). “On treatment” was defined to include all participants who had not permanently discontinued the study treatment in FIGARO-DKD at Visit 3 or Visit 11. Study drug interruptions at these timepoints were not considered.

    Primary: Mean change in plasma biomarker levels after 36 months of treatment versus 4 months of treatment in a set of 27 pre-defined biomarkers

    		 Close Top of page
    End point title
    		 Mean change in plasma biomarker levels after 36 months of treatment versus 4 months of treatment in a set of 27 pre-defined biomarkers
    End point description
    The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. TGF: Transforming growth factor; IL-15: Interleukin-15; Proto-oncogene c-Src: Proto-oncogene tyrosine-protein kinase Src; TNFRSF1A: Tumor necrosis factor receptor superfamily member 1A; PAI-1: Plasminogen activator inhibitor 1; uPAR: Urokinase plasminogen activator surface receptor; RARRES2: Retinoic acid receptor responder protein 2
    End point type
    Primary
    End point timeframe
    At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
    End point values
    		 Finerenone Placebo
    Number of subjects analysed
    478 [1]
    443 [2]
    Units: NPX
    number (not applicable)
        Matrilysin (P09237) n=387;386
    0.020
    0.086
        von Willebrand factor (P04275) n=466;429
    -0.030
    0.177
        CCN family member 4 (O95388) n=461;433
    0.150
    0.219
        TGF beta-1 proprotein (P01137) n=463;433
    0.166
    0.244
        TGF beta receptor type 3 (Q03167) n=466;429
    0.180
    0.292
        IL-15 receptor subunit alpha (Q13261) n=410;382
    0.165
    0.237
        Metalloproteinase inhibitor 1 (P01033) n=425;402
    0.079
    0.145
        Pappalysin-1 (Q13219) n=410;382
    0.121
    0.349
        Proto-oncogene c-Src (P12931) n=466;434
    -0.111
    -0.000
        Protein AMBP (P02760) n=461;433
    0.049
    0.063
        Uromodulin (P07911) n=437;400
    -0.029
    -0.065
        Aminopeptidase N (P15144) n=453;427
    0.007
    0.029
        TNFRSF1A (P19438) n=470;436
    0.203
    0.244
        PAI-1 (P05121) n=466;429
    -0.082
    -0.042
        CCN family member 2 (P29279) n=470;433
    0.115
    0.142
        uPAR (Q03405) n=470;433
    0.150
    0.173
        C-C motif chemokine 14 (Q16627) n=464;435
    0.101
    0.127
        C-C motif chemokine 16 (O15467) n=466;429
    0.062
    0.077
        Collagen alpha-1(I) chain (P02452) n=466;429
    0.139
    0.153
        Decorin (P07585) n=387;386
    0.120
    0.121
        C-C motif chemokine 2 (P13500) n=426;386
    0.001
    0.005
        Matrix metalloproteinase-9 (P14780) n=470;436
    0.103
    0.111
        E-selectin (P16581) n=466;429
    0.013
    0.014
        Thrombospondin-2 (P35442) n=470;436
    0.077
    0.079
        RARRES2 (Q99969) n=464;435
    0.049
    0.032
        C-X-C motif chemokine 16 (Q9H2A7) n=466;429
    0.082
    0.088
        Dickkopf-related protein 3 (Q9UBP4) n=466;429
    0.070
    0.077
    Notes
    [1] - mBFAS
    [2] - mBFAS
    Statistical analysis title
    		 Matrilysin (P09237)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.001 [4]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [4] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 von Willebrand factor (P04275)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.002 [6]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [5] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [6] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 CCN family member 4 (O95388)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.044 [8]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [7] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [8] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 TGF beta-1 proprotein (P01137)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.044 [10]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [9] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [10] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 TGF beta receptor type 3 (Q03167)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.127 [12]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [11] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [12] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 IL-15 receptor subunit alpha (Q13261)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0.21 [14]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [13] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [14] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Metalloproteinase inhibitor 1 (P01033)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.215 [16]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [15] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [16] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Pappalysin-1 (Q13219)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.215 [18]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [17] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [18] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Proto-oncogene c-Src (P12931)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.745 [20]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [19] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [20] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Protein AMBP (P02760)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.762 [22]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [21] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [22] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Uromodulin (P07911)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0.762 [24]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [23] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [24] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Aminopeptidase N (P15144)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 = 0.762 [26]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [25] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [26] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 TNFRSF1A (P19438)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 = 0.762 [28]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [27] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [28] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Plasminogen activator inhibitor 1 (P05121)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0.917 [30]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [29] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [30] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 CCN family member 2 (P29279)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.917 [32]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [31] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [32] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 uPAR (Q03405)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    P-value
    		 = 0.917 [34]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [33] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [34] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 C-C motif chemokine 14 (Q16627)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    P-value
    		 = 0.917 [36]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [35] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [36] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 C-C motif chemokine 16 (O15467)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.979 [38]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [37] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [38] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Collagen alpha-1(I) chain (P02452)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    P-value
    		 = 0.979 [40]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [39] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [40] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Decorin (P07585)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    P-value
    		 = 0.979 [42]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [41] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [42] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 C-C motif chemokine 2 (P13500)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    P-value
    		 = 0.979 [44]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [43] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [44] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Matrix metalloproteinase-9 (P14780)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    P-value
    		 = 0.979 [46]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [45] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [46] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 E-selectin (P16581)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    P-value
    		 = 0.979 [48]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [47] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [48] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Thrombospondin-2 (P35442)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    P-value
    		 = 0.979 [50]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [49] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [50] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 RARRES2 (Q99969)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    P-value
    		 = 0.979 [52]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [51] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [52] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 C-X-C motif chemokine 16 (Q9H2A7)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    P-value
    		 = 0.979 [54]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [53] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [54] - Adjusted using Benjamini-Hochberg Procedure
    Statistical analysis title
    		 Dickkopf-related protein 3 (Q9UBP4)
    Statistical analysis description
    The NPX differences (corresponding to log-transformed ratio to baseline) of biomarker levels were analyzed.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    921
    Analysis specification
    Pre-specified
    Analysis type
    		 other [55]
    P-value
    		 = 0.979 [56]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [55] - The hypotheses ‘H0i: βi=0’ (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.
    [56] - Adjusted using Benjamini-Hochberg Procedure

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    This was a retrospective, add-on biomarker study to the multi-center interventional Phase 3 study FIGARO-DKD (2015-000950-39). There were no study-specific safety assessments in this study. Safety of the subjects was monitored within the FIGARO-DKD study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This study was a retrospective, add-on biomarker study to the multi-center, interventional Phase 3 study FIGARO-DKD (2015-000950-39). There was no study-specific safety assessment in this study.Safety of the subjects was monitored within the FIGARO-DKD study.

    More information

    		 Close Top of page

    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.
    This study was a retrospective, add-on biomarker study to the multi-center, interventional Phase 3 study FIGARO-DKD (2015-000950-39). Blood plasma samples that were originally collected for PK analysis during the conduct of FIGARO-DKD study.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA