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Search / Trial NCT05047263

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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