Clinical trials: Finerenone
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
This is an observational study, in which data from people in the United States (US) with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied.
- Trial name
- FIRST-2 (NCT05703880)
- Testing
- Finerenone (Kerendia, BAY948862)
- Where
- 2 sites in United States
- Volunteers
- 15,948 people
- Sponsor
- Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied.
- Trial name
- FINEROD (NCT06278207)
- Testing
- Finerenone (BAY 94-8862)
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 50,000 people
- Sponsor
- Bayer
Heart Failure
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
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…
- Trial name
- FINEARTS-HF (NCT04435626)
- Testing
- Finerenone (BAY94-8862)
- Where
- 661 sites in United States, Argentina and 35 more
- Volunteers
- 6,016 people
- Sponsor
- Bayer
Heart Failure
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic…
- Trial name
- ARTS-HF (NCT01807221)
- Testing
- Finerenone (BAY94-8862), Inspra (eplerenone)
- Where
- 172 sites in United States, Australia and 23 more
- Volunteers
- 1,066 people
- Sponsor
- Bayer
Type 2 Diabetes, Chronic Kidney Disease (CKD) Stages G2 to G3b
A Study to Learn More About How Well Finerenone Works in Real-world in People With Type 2 Diabetes and Chronic Kidney Disease in Primary Care (IMSS= Instituto Mexicano Del Seguro Social)
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who…
- Trial name
- FINE-IMSS-MX (NCT07841015)
- Testing
- Finerenone
- Where
- Mexico
- Volunteers
- 800 people
- Sponsor
- Bayer
Chronic Kidney Disease, Type 2 Diabetes
An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results
This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied.
- Trial name
- FLAMINGO (NCT05640180)
- Testing
- Finerenone (Kerendia, BAY94-8862), Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
- Where
- United States
- Volunteers
- 17,847 people
- Sponsor
- Bayer
Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth.
- Trial name
- NCT07116512
- Testing
- Finerenone (BAY94-8862): intervention A, Finerenone (BAY94-8862): intervention B
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetic Kidney Disease (DKD)
Rubix LS Diabetic Kidney Disease (DKD) Registry Study
Diabetic kidney disease (DKD) is a common complication of type 2 diabetes that can lead to kidney failure and increases the risk of cardiovascular disease.
- Trial name
- NCT07348718
- Testing
- Kidney-Protective Therapies Used in Routine Care
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Rubix LS
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score
This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.
- Trial name
- FINEXPLORER (NCT07554469)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied.
- Trial name
- 22663 (NCT06608212)
- Testing
- Finerenone (Kerendia, BAY948862), Others except finerenone
- Where
- United States
- Volunteers
- 238,038 people
- Sponsor
- Bayer
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Heart Failure
BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
- Trial name
- ARTS (NCT01345656)
- Testing
- BAY94-8862, Spironolactone
- Where
- 50 sites in Austria, Belgium and 8 more
- Volunteers
- 457 people
- Sponsor
- Bayer
Pharmacokinetics
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers
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…
- Trial name
- NCT02956109
- Testing
- Finerenone (BAY94-8862): 1 0mg tablet, Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets, Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions in a Chinese Population.
This is a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China.
- Trial name
- FIRST-2_CN (NCT07124039)
- Testing
- Finerenone (Kerendia, BAY948862)
- Where
- China
- Volunteers
- 6,537 people
- Sponsor
- Bayer
Chronic Kidney Disease, Proteinuria
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.
- Conditions
- Chronic Kidney Disease, Proteinuria, Children
- Trial name
- FIONA OLE (NCT05457283)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 151 sites in United States, Argentina and 30 more
- Volunteers
- 100 people
- Sponsor
- Bayer
Diabetic Nephropathies
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.
- Trial name
- ARTS-DN (NCT01874431)
- Testing
- Finerenone (BAY94-8862)
- Where
- 147 sites in United States, Australia and 21 more
- Volunteers
- 823 people
- Sponsor
- Bayer
Pharmacokinetics
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
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…
- Trial name
- NCT02957396
- Testing
- Finerenone (BAY94-8862): 20 mg intact tablet, Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet, Finerenone (BAY94-8862): 20 mg suspension
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Heart Failure
Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with…
- Trial name
- ARTS-HF Japan (NCT01955694)
- Testing
- BAY94-8862, Eplerenone
- Where
- 29 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
- Trial name
- IN-REALITY (NCT06763146)
- Testing
- Finerenone (Kerendia, BAY948862)
- Where
- India
- Volunteers
- 1,200 people
- Sponsor
- Bayer
Worsening Chronic Heart Failure, Chronic Kidney Disease
A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should.
- Trial name
- NCT04908436
- Testing
- Finerenone (BAY94-8862)
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bayer