A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Launched by BAYER · Feb 23, 2022
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:
- • In Part A: eGFR 40-90 ml/min/1.73m\^2 (with no more than 20% having an eGFR \>75 ml/min/1.73m\^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR \<60 mL/min/1.73 m\^2 within 3 months or have a registered diagnosis of CKD.
- • In Part B: eGFR 30-90 ml/min/1.73m\^2 (with no more than 20% having an eGFR \>75 ml/min/1.73m\^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR \<60 mL/min/1.73 m\^2 within 3 months or have a registered diagnostic of CKD.
- • 100 ≤UACR \<5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
- • Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening \<11%.
- • Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
- Exclusion Criteria:
- • Participants with type 1 diabetes (T1D).
- • Participant with hepatic insufficiency classified as Child-Pugh C.
- • Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg.
- • Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- • Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- • Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
- • Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Saint Louis, Missouri, United States
Madrid, , Spain
Memphis, Tennessee, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Gent, , Belgium
Seoul, , Korea, Republic Of
Taipei, , Taiwan
Madrid, , Spain
San Antonio, Texas, United States
Taipei, , Taiwan
Leuven, , Belgium
Bangalore, Karnataka, India
Kansas City, Missouri, United States
Taipei, , Taiwan
A Coruña, , Spain
Valencia, , Spain
Valencia, , Spain
Granada, , Spain
Osaka, , Japan
Taichung, , Taiwan
Taichung, , Taiwan
Granada, , Spain
Paris, , France
Waterbury, Connecticut, United States
Edegem, , Belgium
Seoul, , Korea, Republic Of
Kumamoto, , Japan
Hamilton, Ontario, Canada
Apeldoorn, , Netherlands
Seoul, , Korea, Republic Of
Troy, Michigan, United States
Asheboro, North Carolina, United States
Los Angeles, California, United States
Taipei, , Taiwan
Amsterdam, , Netherlands
Kitakyushu, Fukuoka, Japan
Kaohsiung, , Taiwan
Heidelberg, Baden Württemberg, Germany
Amsterdam, , Netherlands
Gyeonggi Do, , Korea, Republic Of
New Taipei City, , Taiwan
Salem, Virginia, United States
Roeselare, , Belgium
Chikushino, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Chicago, Illinois, United States
San Antonio, Texas, United States
New Delhi, Delhi, India
Ashkelon, , Israel
København Nv, , Denmark
New Taipei City, , Taiwan
Vallejo, California, United States
Santiago De Compostela, A Coruña, Spain
Montreal, Quebec, Canada
Multiple Locations, , Korea, Republic Of
Barcelona, , Spain
Milano, Lombardia, Italy
Pisa, Toscana, Italy
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Esbjerg, , Denmark
Kitchener, Ontario, Canada
Kansas City, Missouri, United States
Gyeonggi Do, , Korea, Republic Of
Milano, Lombardia, Italy
Multiple Locations, , Japan
Metairie, Louisiana, United States
Seoul, , Korea, Republic Of
Holon, , Israel
Milano, Lombardia, Italy
Fukuoka, , Japan
Beer Sheva, , Israel
Seongnam Si, Gyeonggido, Korea, Republic Of
Dordrecht, , Netherlands
Changhua, , Taiwan
Orlando, Florida, United States
Sarnia, Ontario, Canada
Savannah, Georgia, United States
Multiple Locations, , Taiwan
Plymouth, Massachusetts, United States
Saint Louis, Missouri, United States
Bergamo, Lombardia, Italy
Fukui, , Japan
Multiple Locations, , France
Multiple Locations, , Italy
Multiple Locations, , Canada
Multiple Locations, , Spain
San Antonio, Texas, United States
Verona, Veneto, Italy
Torino, Piemonte, Italy
Lincoln, Nebraska, United States
Seoul, Other, Korea, Republic Of
Madrid, Other, Spain
Salt Lake City, Utah, United States
Matsuyama, Ehime, Japan
Afula, , Israel
Tel Aviv, , Israel
Foggia, Puglia, Italy
Ferrol, A Coruña, Spain
Telangana, , India
San Antonio, Texas, United States
Zefat, , Israel
Jena, Thüringen, Germany
Jaipur, Rajasthan, India
Lodelinsart, Hainaut, Belgium
Dordrecht, , Netherlands
Secunderabad, , India
Mcallen, Texas, United States
Saint Louis, Missouri, United States
Hyderabad, Telangana, India
Taipei, Other, Taiwan
Alcalá De Henares, Madrid, Spain
Berlin, , Germany
La Tronche, , France
Petach Tikva, , Israel
Wonju, Gang''Weondo, Korea, Republic Of
Daejeon, , Korea, Republic Of
Kortrijk, , Belgium
Jena, Thüringen, Germany
Parma, Emilia Romagna, Italy
Jerez De La Frontera, Cádiz, Spain
Corpus Christi, Texas, United States
Holstebro, , Denmark
Kitakyushu, Fukuoka, Japan
Naka, Ibaraki, Japan
Nahariya, , Israel
Gent, , Belgium
Ieper, , Belgium
Incheon, Incheon Gwang''Yeogsi, Korea, Republic Of
Visakhapatnam, Andhra Pradesh, India
Dijon, , France
Nimes Cedex 9, , France
Toronto, Ontario, Canada
Belagavi, Karnataka, India
Herlev, , Denmark
Naka, Ibaraki, Japan
Anyang Si, Gyeonggido, Korea, Republic Of
Kolkata, West Bengal, India
Milano, Lombardia, Italy
Seoul, Songpa Gu,, Korea, Republic Of
Lyon Cedex, , France
Frankfurt, Hessen, Germany
Dortmund, Nordrhein Westfalen, Germany
Ludwigshafen, Rheinland Pfalz, Germany
Pirna, Sachsen, Germany
Genova, Liguria, Italy
Sassari, Sardegna, Italy
Catania, Sicilia, Italy
Osaka, , Japan
Amersfoort, , Netherlands
Amsterdam, , Netherlands
New Taipei City,, , Taiwan
Taichung, , Taiwan
Mesa, Arizona, United States
Savannah, Georgia, United States
Versailles, Kentucky, United States
Norfolk, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Middletown, New York, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
Kinston, North Carolina, United States
Cincinnati, Ohio, United States
El Paso, Texas, United States
Spokane, Washington, United States
Calgary, Alberta, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Concord, Ontario, Canada
Etobicoke, Ontario, Canada
Nepean, Ontario, Canada
Waterloo, Ontario, Canada
Mirabel, Quebec, Canada
Montréal, Quebec, Canada
Ville Saint Laurent, Quebec, Canada
Holstebro, , Denmark
Hamburg, , Germany
Pisa, Toscana, Italy
Memphis, Tennessee, United States
Kinston, North Carolina, United States
El Paso, Texas, United States
Mirabel, Quebec, Canada
Seoul, , Korea, Republic Of
Barcelona, , Spain
Barcelona, , Spain
Corpus Christi, Texas, United States
Ferrol, A Coruña, Spain
Barcelona, , Spain
Fukuoka, , Japan
Nîmes, , France
West Palm Beach, Florida, United States
Waterloo, Ontario, Canada
Jaipur, , India
Majadahonda, , Spain
Malaga, , Spain
Hendersonville, North Carolina, United States
Cheonan, Chungcheongnamdo, Korea, Republic Of
Asheboro, North Carolina, United States
New Taipei City, , Taiwan
Castilleja De La Cuesta, , Spain
A Coruna, A Coruña, Spain
Kanpur, Uttar Pradesh, India
Ahmedabad, , India
Bengaluru, , India
Bengaluru, , India
Chennai, , India
Cuttack, , India
Hyderabad, , India
Jaipur, , India
Kozhikode, , India
Mangalore, , India
Mumbai, , India
Mysore, , India
Nagapur, , India
Nagpur, , India
Pune, , India
Pune, , India
Vadodara, , India
Madrid, , Spain
Marbella, , Spain
Surprise, Arizona, United States
Northridge, California, United States
Sylmar, California, United States
Delray Beach, Florida, United States
Jacksonville, Florida, United States
Ocoee, Florida, United States
Port Charlotte, Florida, United States
East Point, Georgia, United States
Metairie, Louisiana, United States
Annapolis, Maryland, United States
Plymouth, Massachusetts, United States
Saint Joseph, Missouri, United States
Columbus, Ohio, United States
Dakota Dunes, South Dakota, United States
Dakota Dunes, South Dakota, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lewisville, Texas, United States
San Antonio, Texas, United States
Aalst, , Belgium
Mississauga, Ontario, Canada
Holstebro, , Denmark
Chieti, , Italy
Obihiro, Hokkaido, Japan
Hakusan, , Japan
Ansan Si, Kyung Ki Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Herlev, , Denmark
New Delhi, , India
Jerusalem, , Israel
Bhubaneswar, Delhi, India
Savannah, Georgia, United States
Hinsdale, Illinois, United States
Fort Wayne, Indiana, United States
Holstebro, , Denmark
Belgaum, Karnataka, India
Jaipur, Rajasthan, India
Herning, , Denmark
Hakusan, Ishikawa, Japan
Hakusan, , Japan
Tbc, Ontario, Canada
New Delhi, Delhi, India
Secunderabad, , India
Dordrecht, , Netherlands
Beer Sheva, , Israel
Holon, , Israel
Petach Tikva, , Israel
Jena, Thüringen, Germany
Esbjerg, , Denmark
Ashkelon, , Israel
Rho, Lombardia, Italy
Afula, , Israel
Visakhapatnam, Ap, India
Naka Shi, Ibaraki, Japan
Los Angeles, California, United States
Saint Joseph, Michigan, United States
Dakota Dunes, South Dakota, United States
Aalst, Oost Vlaanderen, Belgium
København, , Denmark
Grenoble Cedex 9, , France
Pirna, Sachsen, Germany
Ahmedabad, Gj, India
Nagapur, Mh, India
Milano, Lombardia, Italy
Orbassano, Piemonte, Italy
Sassari, Sardegna, Italy
Verona, Veneto, Italy
Osaka, , Japan
Marbella, Malaga, Spain
Castilleja De La Cuesta, Sevilla, Spain
Granada, , Spain
Salem, Virginia, United States
Parma, Emilia Romagna, Italy
Bergamo, Lombardia, Italy
Milano, Lombardia, Italy
San Giovanni Rotondo, Puglia, Italy
Pisa, Toscana, Italy
Chieti, , Italy
El Paso, Texas, United States
Milano, Lombardia, Italy
Delray Beach, Florida, United States
Waterloo, Ontario, Canada
Olbia, Sardegna, Italy
Holon, , Israel
Mcallen, Texas, United States
Lyon Cedex, , France
Mysore, Karnataka, India
Chiavari, Liguria, Italy
Guri Si, Gyeonggi, Korea, Republic Of
Atlanta, Georgia, United States
Greenville, North Carolina, United States
Rho, Lombardia, Italy
Kansas City, Missouri, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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