A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease
Launched by BAYER · Sep 12, 2021
Trial Information
Current as of July 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called finerenone for adults with non-diabetic chronic kidney disease (CKD). The researchers want to see if finerenone can help slow down the progression of kidney disease compared to a placebo, which is a pill that looks like the treatment but doesn’t contain any active medicine. The trial will include around 1,580 adults aged 18 and older, who will take either finerenone or the placebo once a day while continuing their current CKD medications. Participants will be involved in the trial for about 50 months, during which doctors will check their health, collect blood and urine samples, and ask about any side effects or health issues they may experience.
To be eligible for this trial, participants must have a diagnosis of chronic kidney disease with specific levels of protein in their urine and kidney function as measured in a test. They should also be on a stable dose of certain heart medications for at least four weeks before joining the study. However, individuals with diabetes, certain genetic kidney diseases, or those requiring specific kidney treatments in the past six months cannot participate. This trial is important as it may provide new insights into treating kidney disease without diabetes, potentially improving outcomes for many patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * A clinical diagnosis of chronic kidney disease and:
- • Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥ 25 but \< 90 mL/min/1.73m\^2 at screening, and
- • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.
- • Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) for at least 4 weeks prior to screening
- • K+ ≤ 4.8 mmol/L at screening
- Exclusion Criteria:
- • Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)
- • Autosomal dominant or autosomal recessive polycystic kidney disease
- • Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- • Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs)
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
Barcelona, , Spain
Hong Kong, , Hong Kong
Philadelphia, Pennsylvania, United States
Concord, New South Wales, Australia
Wollongong, New South Wales, Australia
Danville, Pennsylvania, United States
Albuquerque, New Mexico, United States
Aurora, Colorado, United States
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Atlanta, Georgia, United States
Singapore, , Singapore
Singapore, , Singapore
Chicago, Illinois, United States
Gent, , Belgium
Singapore, , Singapore
Taipei, , Taiwan
Shreveport, Louisiana, United States
Greenville, North Carolina, United States
Leuven, , Belgium
Kansas City, Kansas, United States
Shatin, , Hong Kong
Kuala Lumpur, , Malaysia
Madrid, , Spain
Kogarah, New South Wales, Australia
Valencia, , Spain
Cardiff, , United Kingdom
Beijing, , China
Taichung, , Taiwan
Kuala Lumpur, , Malaysia
Taichung, , Taiwan
Kurashiki, Okayama, Japan
Gloucester, , United Kingdom
Hamamatsu, Shizuoka, Japan
New Delhi, Delhi, India
Spokane, Washington, United States
Iowa City, Iowa, United States
Kobe, Hyogo, Japan
Itabashi Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Waterbury, Connecticut, United States
Praha 2, , Czechia
Beijing, , China
Edegem, , Belgium
Seoul, , Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Jackson, Mississippi, United States
Kanazawa, Ishikawa, Japan
Kumamoto, , Japan
Selangor, , Malaysia
Bunkyo Ku, Tokyo, Japan
Rostov On Don, , Russian Federation
Seoul, , Korea, Republic Of
Foshan, Guangdong, China
Athens, , Greece
Thessaloniki, , Greece
Cleveland, Ohio, United States
Taipei, , Taiwan
Nagoya, Aichi, Japan
Morioka, Iwate, Japan
Isehara, Kanagawa, Japan
Sakai, Osaka, Japan
Shanghai, , China
Wichita, Kansas, United States
Holbæk, , Denmark
San Dimas, California, United States
Baltimore, Maryland, United States
Suwa, Nagano, Japan
Chuo, Yamanashi, Japan
Guangzhou, Guangdong, China
Liuzhou, Guangxi, China
Liuzhou, Guangxi, China
Baotou, Inner Mongolia, China
Santa Fe, , Argentina
Foshan, Guangdong, China
Seoul, , Korea, Republic Of
Ostrava, , Czechia
Kaohsiung, , Taiwan
Gyeonggi Do, , Korea, Republic Of
Kemerovo, , Russian Federation
Nagoya, Aichi, Japan
Jinan, Shandong, China
Singapore, , Singapore
Iizuka, Fukuoka, Japan
Fukuoka, , Japan
Almada, , Portugal
Wuhan, , China
Busan, , Korea, Republic Of
Bethlehem, Pennsylvania, United States
Reservoir, Victoria, Australia
Rychnov Nad Kneznou, , Czechia
Kuantan, , Malaysia
Liege, , Belgium
Seoul, , Korea, Republic Of
Valencia, , Spain
Nanchang, Jiangxi, China
Lanzhou, Gansu, China
Kitakyushu, Fukuoka, Japan
Kanazawa, Ishikawa, Japan
London, , United Kingdom
Pecs, , Hungary
Nagykanizsa, , Hungary
Kfar Saba, , Israel
Beijing, , China
Heraklion, , Greece
Sheffield, South Yorkshire, United Kingdom
Sheung Wan, , Hong Kong
Athens, , Greece
Ashkelon, , Israel
Tel Aviv, , Israel
Nanjing, Jiangsu, China
Urayasu, Chiba, Japan
Xiamen, Fujian, China
Birtinya, Queensland, Australia
Matsumoto, Nagano, Japan
Szombathely, , Hungary
Xiamen, , China
Pingxiang, Jiangxi, China
Yokohama, Kanagawa, Japan
Pulau Pinang, , Malaysia
Seri Manjung, , Malaysia
Rehovot, , Israel
Athens, , Greece
Yinchuan, Ningxia, China
Lai Chi Kok, , Hong Kong
Xi'an, Shanxi, China
Brisbane, Queensland, Australia
Aguascalientes, , Mexico
Seoul, , Korea, Republic Of
Bologna, Emilia Romagna, Italy
Esbjerg, , Denmark
Roma, Lazio, Italy
Pahang, , Malaysia
Knoxville, Tennessee, United States
Kaposvar, , Hungary
Hefei, Anhui, China
Nishinomiya, Hyogo, Japan
Orlando, Florida, United States
Pingxiang, Jiangxi, China
Changchun, Jilin, China
Wichita, Kansas, United States
Kansas City, Missouri, United States
Asheville, North Carolina, United States
Bruxelles Brussel, , Belgium
Seoul, Jongno Gu, Korea, Republic Of
Guiyang, Guizhou, China
Nanning, Guangxi, China
Kawasaki, Kanagawa, Japan
Praha 2, , Czechia
Springfield, Massachusetts, United States
Seoul, , Korea, Republic Of
Dalian, Liaoning, China
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Barcelona, , Spain
Huntsville, Alabama, United States
Fukuoka, , Japan
Providence, Rhode Island, United States
Chengdu, Sichuan, China
Beer Sheva, , Israel
Znojmo, , Czechia
Haifa, , Israel
Saga, , Japan
St. Albans, Victoria, Australia
Box Hill, , Australia
Shanghai, , China
Tianjin, , China
Shatin, , Hong Kong
Ramat Gan, , Israel
Kitakyushu, Fukuoka, Japan
Changhua, , Taiwan
Huai'an, Jiangsu, China
Praha 2, , Czechia
Tsuchiura, Ibaraki, Japan
Saitama, , Japan
Guangzhou, Guangdong, China
Wollongong, New South Wales, Australia
Saint Louis, Missouri, United States
Pernik, , Bulgaria
Thessaloniki, , Greece
Zhangjiakou, Hebei, China
Kajang, Selangor, Malaysia
Nagoya, Aichi, Japan
Modena, Emilia Romagna, Italy
Thiruvananthapuram, Kerala, India
Chicago, Illinois, United States
Guangzhou, Guangdong, China
Singapore, , Singapore
Augusta, Georgia, United States
San Antonio, Texas, United States
Seoul, , Korea, Republic Of
Leiria, , Portugal
London, , United Kingdom
Changzhou, Jiangsu, China
Yatomi, Aichi, Japan
Nara, , Japan
Bhubaneswar, Odisha, India
Petah Tikva, , Israel
Taoyuan, , Taiwan
Zerifin, , Israel
Beijing, , China
Telangana, , India
Nanjing, Jiangsu, China
Albuquerque, New Mexico, United States
Matsumoto, Nagano, Japan
San Antonio, Texas, United States
Nyiregyhaza, , Hungary
Muar, , Malaysia
Sungai Petani, , Malaysia
Shanghai, , China
Chula Vista, California, United States
Ashdod, , Israel
San Dimas, California, United States
Perm, , Russian Federation
Kazan, , Russian Federation
Hyderabad, Telangana, India
Orlando, Florida, United States
Huntsville, Alabama, United States
Dallas, Texas, United States
Ipoh, , Malaysia
Kajang, , Malaysia
Thessaloniki, , Greece
Alcalá De Henares, Madrid, Spain
Reggio Emilia, Emilia Romagna, Italy
Toride, Ibaraki, Japan
Sestroretsk, , Russian Federation
Gyula, , Hungary
Arkhangelsk, , Russian Federation
Lanús, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Caba, Ciudad Auton. De Buenos Aires, Argentina
Chengdu, Sichuan, China
Ioannina, , Greece
New Delhi, Delhi, India
Wonju, Gang''Weondo, Korea, Republic Of
Seongnam Si, Gyeonggido, Korea, Republic Of
Daejeon, , Korea, Republic Of
Perak, , Malaysia
Izhevsk, , Russian Federation
Moscow, , Russian Federation
Kortrijk, , Belgium
Parma, Emilia Romagna, Italy
El Centro, California, United States
El Paso, Texas, United States
Holstebro, , Denmark
Saratov, , Russian Federation
Voronezh, , Russian Federation
Nahariya, , Israel
Tiberias, , Israel
Bergamo, Lombardia, Italy
Plzen, , Czechia
Arta, , Greece
Pavia, Lombardia, Italy
Torres Novas, Santarém, Portugal
Pilea Chortiatis, , Greece
Incheon, , Korea, Republic Of
Oak Brook, Illinois, United States
Kawasaki, Kanagawa, Japan
Bengbu, Anhui, China
Shanghai, , China
Boca Raton, Florida, United States
Urumqi, Xinjiang, China
Hinsdale, Illinois, United States
Praha 6, , Czechia
Gorna Oryahovitsa, , Bulgaria
Praha 4, , Czechia
Anyang Si, Gyeonggido, Korea, Republic Of
Los Angeles, California, United States
Poway, California, United States
S. Gate, California, United States
Middlebury, Connecticut, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Macon, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Edina, Minnesota, United States
Chapel Hill, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Orangeburg, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Mcallen, Texas, United States
San Antonio, Texas, United States
Shenandoah, Texas, United States
S. Salt Lake, Utah, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Woodbridge, Virginia, United States
Berazategui, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
San Luis, , Argentina
Santa Fe, , Argentina
Woolloongabba, , Australia
Roeselare, , Belgium
Burgas, , Bulgaria
Dobrich, , Bulgaria
Montana, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Veliko Tarnovo, , Bulgaria
Huizhou, Guangdong, China
Jiangmen, Guangdong, China
Zhangjiakou, Hebei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Taizhou, Jiangsu, China
Siping, Jilin, China
Urumchi, Xinjiang, China
Ningbo, Zhejiang, China
Wenzhou, Zhejiang, China
Chongqing, , China
Frydek Mistek, , Czechia
Hodonin, , Czechia
Copenhagen, , Denmark
Herlev, , Denmark
Odense C, , Denmark
Patra, , Greece
Budapest, , Hungary
Ahmedabad, Gujar?T, India
Hadapsar, Maharashtra, India
Mumbai, Maharashtra, India
Nashik, Maharashtra, India
Kolkata, West Bengal, India
Reggio Calabria, Calabria, Italy
Napoli, Campania, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Monza Brianza, Lombardia, Italy
Catania, Sicilia, Italy
Minokamo, Gifu, Japan
Hiratsuka, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Suwa, Nagano, Japan
Irima Gun, Saitama, Japan
Fuchu, Tokyo, Japan
Goyang Si, Gyeonggido, Korea, Republic Of
Goyang Si, Gyeonggido, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Kedah, , Malaysia
Negeri Sembilan, , Malaysia
Perak, , Malaysia
Selangor, , Malaysia
Culiacán, Sinaloa, Mexico
Puerto De Veracruz, Veracruz, Mexico
Aguascalientes, , Mexico
Carnaxide, Lisboa, Portugal
Lisboa, , Portugal
Chelyabinsk, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Omsk, , Russian Federation
Saint Petersburg, , Russian Federation
Yaroslavl, , Russian Federation
Ferrol, A Coruña, Spain
L'hospitalet De Llobregat, Barcelona, Spain
Burela, Lugo, Spain
Madrid, , Spain
Valencia, , Spain
New Taipei City, Taipei, Taiwan
Canterbury, Kent, United Kingdom
Taichung, , Taiwan
Pernik, , Bulgaria
Buenos Aires, , Argentina
Córdoba, , Argentina
Edegem, Antwerpen, Belgium
Kortrijk, West Vlaanderen, Belgium
Kistarcsa, , Hungary
Koshigaya, Saitama, Japan
Teugbyeolsi, Seoul, Korea, Republic Of
Aguascalientes, , Mexico
Carnaxide, Lisboa, Portugal
Barcelona, , Spain
Knoxville, Tennessee, United States
San Luis, , Argentina
Seoul, , Korea, Republic Of
Orlando, Florida, United States
Kistarcsa, , Hungary
Chennai, Tamil Nadu, India
Aguascalientes, , Mexico
Barcelona, , Spain
Barcelona, , Spain
Liuzhou, Guangxi, China
Brno, , Czechia
Hsin Chu, , Taiwan
Hyderabad, , India
Missing, San Luis, Argentina
Brno, , Czechia
Burela, Lugo, Spain
Almada, , Portugal
Leiria, , Portugal
San Luis, , Argentina
Ahmedabad, , India
Jackson, Mississippi, United States
Shah Alam, , Malaysia
Fukuoka, , Japan
Jackson, Mississippi, United States
Houston, Texas, United States
Kortrijk, West Vlaanderen, Belgium
Kaposvar, , Hungary
Szombathely, , Hungary
Torres Novas, Santarém, Portugal
Dobrich, , Bulgaria
Gorna Oryahovitsa, , Bulgaria
New Taipei City, Taipei, Taiwan
Lanus, Buenos Aires, Argentina
Holstebro, , Denmark
Woolloongabba, Queensland, Australia
Spokane, Washington, United States
Sheung Wan, , Hong Kong
Bhubaneswar, Delhi, India
Hinsdale, Illinois, United States
Holstebro, , Denmark
Madrid, , Spain
Spokane Valley, Washington, United States
Odense C, , Denmark
Shatin, , Hong Kong
Kistarcsa, , Hungary
Herning, , Denmark
Kanazawa, Ishikawa, Japan
Lisboa, , Portugal
Lai Chi Kok, , Hong Kong
Nagykanizsa, , Hungary
Jinan, Shandong, China
Kistarcsa, , Hungary
New Haven, Connecticut, United States
Stara Zagora, , Bulgaria
Canterbury, Kent, United Kingdom
Beer Sheva, , Israel
Petach Tikva, , Israel
Urumchi, Xinjiang, China
Valencia, , Spain
Jinan, Shandong, China
Almada, Setúbal, Portugal
Hong Kong, , Hong Kong
Modena, Emilia Romagna, Italy
Aurora, Colorado, United States
Los Angeles, California, United States
San Dimas, California, United States
Middlebury, Connecticut, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Edina, Minnesota, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
Wilmington, North Carolina, United States
Cleveland, Ohio, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Orangeburg, South Carolina, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Shenandoah, Texas, United States
S. Salt Lake, Utah, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Woodbridge, Virginia, United States
Berazategui, Buenos Aires, Argentina
Lanus, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Caba, Ciudad Auton. De Buenos Aires, Argentina
San Luis, , Argentina
Santa Fe, , Argentina
Montana, , Bulgaria
Pernik, , Bulgaria
Sofia, , Bulgaria
Bengbu, Anhui, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Baotou, Inner Mongolia, China
Siping, Jilin, China
Chengdu, Sichuan, China
Beijing, , China
Copenhagen, , Denmark
Esbjerg, , Denmark
Herlev, , Denmark
Holbæk, , Denmark
Arta, , Greece
Ioannina, , Greece
Budapest, , Hungary
Ahmedabad, Gujarat, India
Ahmedabad, Gujarat, India
Ashkelon, , Israel
Tiberias, , Israel
Reggio Emilia, Emilia Romagna, Italy
Milano, Lombardia, Italy
Rho, Lombardia, Italy
Catania, Sicilia, Italy
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Shah Alam, Selangor, Malaysia
Kedah, , Malaysia
Negeri Sembilan, , Malaysia
Missing, Aguascalientes, Mexico
Culiacán, Sinaloa, Mexico
Puerto De Veracruz, Veracruz, Mexico
Carnaxide, Lisboa, Portugal
L'hospitalet De Llobregat, Barcelona, Spain
Missing, Valencia, Spain
Madrid, , Spain
Taipei, , Taiwan
Knoxville, Tennessee, United States
Bologna, Emilia Romagna, Italy
Roma, Lazio, Italy
Valencia, , Spain
Hong Kong, , Hong Kong
Moriyama, Saitama, Japan
Parma, Emilia Romagna, Italy
Ashdod, , Israel
Macon, Georgia, United States
Danville, Pennsylvania, United States
Spokane Valley, Washington, United States
Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina
Brno, Jihomoravsky Kraj, Czechia
Hong Kong, , Hong Kong
Napoli, Campania, Italy
Bergamo, Lombardia, Italy
Dallas, Texas, United States
Pylaía, , Greece
Desio, Lombardia, Italy
Pavia, Lombardia, Italy
Catania, Sicilia, Italy
Gangdong, Seoul, Korea, Republic Of
Seremban, Negeri Sembilan, Malaysia
Aguascalientes, , Mexico
Zhubei, , Taiwan
Chula Vista, California, United States
Jinan, Shandong, China
Legnano, Lombardia, Italy
Chula Vista, California, United States
El Centro, California, United States
Hodonin, , Czechia
Singapore, , Singapore
Gloucester, , United Kingdom
London, , United Kingdom
Atlanta, Georgia, United States
Rho, Lombardia, Italy
Heraklion, , Greece
Ioannina, , Greece
Meridian, Idaho, United States
Baltimore, Maryland, United States
Thessaloniki, , Greece
Modena, Emilia Romagna, Italy
Hinsdale, Illinois, United States
Chula Vista, California, United States
Boca Raton, Florida, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Catania, Sicilia, Italy
Valencia, , Spain
Pernik, , Bulgaria
London, , United Kingdom
London, , United Kingdom
Cardiff, , United Kingdom
Madrid, , Spain
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Orangeburg, South Carolina, United States
Pernik, , Bulgaria
Burela, Lugo, Spain
Alcalá De Henares, Madrid, Spain
Sheffield, South Yorkshire, United Kingdom
Gloucester, , United Kingdom
Almada, , Portugal
Torres Novas, , Portugal
Incheon, Incheon Gwang''Yeogsi, Korea, Republic Of
San Luis, Provincia De San Luis, Argentina
Ferrol, , Spain
Hsin Chu, Hsinchu, Taiwan
San Antonio, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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