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Last Updated: February 3, 2023

CLINICAL TRIALS PROFILE FOR FINERENONE


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All Clinical Trials for Finerenone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02540993 ↗ Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease Completed Bayer Phase 3 2015-09-17 The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.
NCT02545049 ↗ Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease Completed Bayer Phase 3 2015-09-17 The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
NCT02956109 ↗ Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers Completed Bayer Phase 1 2016-11-16 Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.
NCT02957396 ↗ Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects Completed Bayer Phase 1 2016-11-17 Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.
NCT04435626 ↗ Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Ex Recruiting Bayer Phase 3 2020-09-14 The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 5500 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
NCT04795726 ↗ A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy, DR) Completed Bayer N/A 2021-03-11 Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Finerenone

Condition Name

Condition Name for Finerenone
Intervention Trials
Chronic Kidney Disease 6
Diabetic Kidney Disease 2
Pharmacokinetics 2
Proteinuria 2
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Condition MeSH

Condition MeSH for Finerenone
Intervention Trials
Kidney Diseases 8
Renal Insufficiency, Chronic 7
Diabetes Mellitus, Type 2 4
Diabetes Mellitus 3
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Clinical Trial Locations for Finerenone

Trials by Country

Trials by Country for Finerenone
Location Trials
United States 139
Japan 103
China 78
Germany 37
Italy 35
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Trials by US State

Trials by US State for Finerenone
Location Trials
California 5
North Carolina 5
Missouri 5
Louisiana 5
Iowa 5
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Clinical Trial Progress for Finerenone

Clinical Trial Phase

Clinical Trial Phase for Finerenone
Clinical Trial Phase Trials
Phase 3 6
Phase 2 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Finerenone
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Finerenone

Sponsor Name

Sponsor Name for Finerenone
Sponsor Trials
Bayer 13
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Sponsor Type

Sponsor Type for Finerenone
Sponsor Trials
Industry 13
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