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Clinical trials for Finerenone

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    19 result(s) found for: Finerenone. Displaying page 1 of 1.
    EudraCT Number: 2021-002905-89 Sponsor Protocol Number: 20186 Start Date*: 2022-10-19
    Sponsor Name:BAYER AG
    Full Title: An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults f...
    Medical condition: Treatment of children with chronic kidney disease and proteinuria
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned) DK (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) PL (Trial now transitioned) LT (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002895-29 Sponsor Protocol Number: BAY94-8862/18290 Start Date*: 2016-10-28
    Sponsor Name:Bayer AG
    Full Title: Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of finerenone 1.25 mg and 5 x 0.25 mg oro-dispersible tablet (pediatric formulatio...
    Medical condition: Treatment of diabetic kidney disease (adults) and chronic kidney disease (children).
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000306-29 Sponsor Protocol Number: 20103 Start Date*: 2021-10-04
    Sponsor Name:Bayer AG
    Full Title: A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NY...
    Medical condition: Heart failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) DK (Completed) AT (Completed) HU (Completed) BG (Completed) PT (Completed) NL (Completed) SK (Completed) GR (Completed) CZ (Completed) LT (Completed) FI (Completed) LV (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003037-11 Sponsor Protocol Number: 21839 Start Date*: 2022-04-13
    Sponsor Name:Bayer AG
    Full Title: A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants wi...
    Medical condition: Chronic kidney disease in type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10045250 Type II diabetes mellitus with renal manifestations LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002813-24 Sponsor Protocol Number: BAY94-8862/16538 Start Date*: 2016-11-15
    Sponsor Name:Bayer AG
    Full Title: Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushe...
    Medical condition: Diabetic kidney disease
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002071-19 Sponsor Protocol Number: 19920 Start Date*: 2022-02-08
    Sponsor Name:BAYER AG
    Full Title: A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an AC...
    Medical condition: Chronic kidney disease Proteinuria
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) LT (Trial now transitioned) NL (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) HU (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-003053-37 Sponsor Protocol Number: 21952 Start Date*: 2021-11-05
    Sponsor Name:Bayer AG
    Full Title: A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM)
    Medical condition: Type II Diabetes Mellitus and Diabetic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10061835 Diabetic nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000990-11 Sponsor Protocol Number: BAY94-8862/16244 Start Date*: 2015-09-09
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on t...
    Medical condition: Type II Diabetes Mellitus and Diabetic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10061835 Diabetic nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) GB (Completed) AT (Completed) CZ (Completed) ES (Completed) FI (Completed) PT (Completed) BE (Completed) NL (Completed) FR (Completed) DE (Completed) LT (Completed) PL (Completed) GR (Completed) RO (Completed) IE (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000950-39 Sponsor Protocol Number: BAY94-8862/17530 Start Date*: 2015-09-09
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular mor...
    Medical condition: Type II Diabetes Mellitus and Diabetic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10061835 Diabetic nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) HU (Completed) GB (Completed) AT (Completed) DE (Completed) CZ (Completed) ES (Completed) FI (Completed) PT (Completed) BE (Completed) BG (Completed) NL (Completed) LT (Completed) PL (Completed) FR (Completed) GR (Completed) RO (Completed) IE (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002168-17 Sponsor Protocol Number: BAY94-8862/16275 Start Date*: 2015-12-09
    Sponsor Name:Bayer HealthCare AG
    Full Title: A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in...
    Medical condition: Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004857 10076410 Chronic kidney disease stage 3 LLT
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    20.0 100000004849 10066498 Cardiac failure chronic aggravated LLT
    21.0 100000004857 10076408 Chronic kidney disease stage 1 LLT
    21.0 100000004857 10076409 Chronic kidney disease stage 2 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DK (Prematurely Ended) IE (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) HU (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended) ES (Prematurely Ended) LT (Prematurely Ended) BG (Prematurely Ended) PL (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004179-38 Sponsor Protocol Number: BAY94-8862/16243 Start Date*: 2013-05-08
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of different oral doses of BAY 94-8862 in subjects with type 2 diabetes mellitus and the clinica...
    Medical condition: Diabetic nephropathy
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038359 - Renal and urinary disorders 10061835 Diabetic nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) FI (Completed) NL (Completed) DE (Completed) NO (Completed) HU (Completed) PT (Completed) DK (Completed) BG (Completed) IT (Completed) ES (Completed) PL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-002627-15 Sponsor Protocol Number: BAY94-8862/14564 Start Date*: 2013-05-27
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart ...
    Medical condition: Subjects with worsening chronic heart failure (WCHF) and left ventricular systolic dysfunction and either type 2 diabetes mellitus (DM type 2) with or without chronic kidney disease (CKD) or modera...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10064848 Chronic kidney disease LLT
    16.1 100000004861 10045242 Type II diabetes mellitus LLT
    16.1 100000004849 10066498 Cardiac failure chronic aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) AT (Completed) SE (Completed) LT (Completed) DE (Completed) HU (Completed) CZ (Completed) NO (Completed) NL (Completed) PT (Completed) DK (Completed) IT (Completed) ES (Completed) BG (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003865-20 Sponsor Protocol Number: 21618 Start Date*: 2021-03-02
    Sponsor Name:Bayer AG
    Full Title: 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 FIDELI...
    Medical condition: Diabetic Retinopathy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10015919 - Eye disorders 10012689 Diabetic retinopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2021-000421-27 Sponsor Protocol Number: 21177 Start Date*: 2022-01-07
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression o...
    Medical condition: Non-diabetic chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) CZ (Trial now transitioned) ES (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) BG (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000740-29 Sponsor Protocol Number: 270389-030122 Start Date*: 2022-04-12
    Sponsor Name:Department of Renal Medicine, Aarhus University Hospital
    Full Title: Sodium glucose cotransporter 2 inhibitors or Mineralocorticoid receptor antagonists for the treatment of Albuminuric Chronic Kidney Disease - A randomized controlled trial
    Medical condition: Chronic Kidney Disease with albuminuria
    Disease: Version SOC Term Classification Code Term Level
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    20.0 10038359 - Renal and urinary disorders 10001580 Albuminuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-002140-51 Sponsor Protocol Number: INV-CL-106 Start Date*: 2022-12-21
    Sponsor Name:Inversago Pharma Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients with Diabetic Kidney Disease
    Medical condition: Diabetic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004857 10084917 Diabetic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000384-23 Sponsor Protocol Number: 1434-0004 Start Date*: 2022-06-15
    Sponsor Name:Boehringer Ingelheim SComm
    Full Title: A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administe...
    Medical condition: Glomerulosclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10067757 Focal segmental glomerulosclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) IE (Completed) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001661-21 Sponsor Protocol Number: WP3.protocol.v7 Start Date*: 2022-02-08
    Sponsor Name:Herlev and Gentofte Hospital
    Full Title: Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - A Pilot Study
    Medical condition: Diabetic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10012687 Diabetic renal disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-001911-96 Sponsor Protocol Number: D9488C00001 Start Date*: 2021-11-24
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants wit...
    Medical condition: Chronic kidney disease (CKD) with hyperkalaemia or at risk of hyperkalaemia
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004857 10076410 Chronic kidney disease stage 3 LLT
    23.1 100000004857 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) IT (Prematurely Ended) ES (Ongoing) PL (Prematurely Ended)
    Trial results: View results
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    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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