Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
NCT ID: NCT02545049
Last Updated: 2022-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
7352 participants
INTERVENTIONAL
2015-09-17
2021-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAY94-8862
Finerenone tablet
Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
Placebo
Matching placebo
Placebo
Matching placebo to be taken orally, once daily.
Interventions
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Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
Placebo
Matching placebo to be taken orally, once daily.
Eligibility Criteria
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Inclusion Criteria
* Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
* Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
* Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
* Serum potassium \<=4.8 mmol/L
Exclusion Criteria
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit \[class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)\]
* Dialysis for acute renal failure within 12 weeks of Run-in visit
* Renal allograft in place or scheduled kidney transplant within next 12 months
* Glycated hemoglobin (HbA1c) \>12%
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Fort Payne, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Prescott, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Chula Vista, California, United States
Dublin, California, United States
El Centro, California, United States
Fresno, California, United States
Fresno, California, United States
La Mesa, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Port Hueneme, California, United States
Poway, California, United States
Rancho Cucamonga, California, United States
Rialto, California, United States
Roseville, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Vista, California, United States
New Haven, Connecticut, United States
Waterbury, Connecticut, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Miami Gardens, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Winter Haven, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Lawrenceville, Georgia, United States
Macon, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Elgin, Illinois, United States
Morton, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
West Des Moines, Iowa, United States
Hutchinson, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Metairie, Louisiana, United States
Monroe, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Flint, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Brooklyn, New York, United States
New York, New York, United States
Rosedale, New York, United States
Smithtown, New York, United States
Staten Island, New York, United States
Asheboro, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Willoughby Hills, Ohio, United States
Beaver, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Hershey, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Murrells Inlet, South Carolina, United States
Myrtle Beach, South Carolina, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Kingwood, Texas, United States
McAllen, Texas, United States
McKinney, Texas, United States
Missouri City, Texas, United States
Pearland, Texas, United States
Pflugerville, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Alexandria, Virginia, United States
Charlottesville, Virginia, United States
Manassas, Virginia, United States
Salem, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
CABA, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
Lanús, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Sarandí, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
CABA, Ciudad Auton. de Buenos Aires, Argentina
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Córdoba, , Argentina
Córdoba, , Argentina
San Luis, , Argentina
Garran, Australian Capital Territory, Australia
Gosford, New South Wales, Australia
Kanwal, New South Wales, Australia
Liverpool, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Fitzroy, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Reservoir, Victoria, Australia
Richmond, Victoria, Australia
St Albans, Victoria, Australia
Elizabeth Vale, , Australia
Graz, Styria, Austria
Saint Stefan, Styria, Austria
Zams, Tyrol, Austria
Linz, Upper Austria, Austria
Linz, Upper Austria, Austria
Feldkirch, Vorarlberg, Austria
Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Wels, , Austria
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Ieper, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Fortaleza, Ceará, Brazil
Fortaleza, Ceará, Brazil
Fortaleza, Ceará, Brazil
Brasília, Federal District, Brazil
Aparecida de Goiânia, Goiás, Brazil
Goiânia, Goiás, Brazil
Juiz de Fora, Minas Gerais, Brazil
Uberlândia, Minas Gerais, Brazil
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Bernardo do Campo, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São José dos Campos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Blagoevgrad, , Bulgaria
Botevgrad, , Bulgaria
Dimitrovgrad, , Bulgaria
Gorna Oryahovitsa, , Bulgaria
Kazanlak, , Bulgaria
Kozloduy, , Bulgaria
Lukovit, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Razgrad, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Yambol, , Bulgaria
Edmonton, Alberta, Canada
Burnaby, British Columbia, Canada
Coquitlam, British Columbia, Canada
New Westminster, British Columbia, Canada
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Cambridge, Ontario, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Sarnia, Ontario, Canada
Smith Falls, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Greenfield Park, Quebec, Canada
Laval, Quebec, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, , Canada
Osorno, Los Lagos Region, Chile
Las Condes, Santiago Metropolitan, Chile
Providencia, Santiago Metropolitan, Chile
Providencia, Santiago Metropolitan, Chile
San Bernardo, Santiago Metropolitan, Chile
San Miguel, Santiago Metropolitan, Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Xiamen, Fujian, China
Xiamen, Fujian, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Zhuhai, Guangdong, China
Nanning, Guangxi, China
Nanning, Guangxi, China
Haikou, Hainan, China
Haikou, Hainan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Changsha, Hunan, China
Hohhot, Inner Mongolia, China
Changzhou, Jiangsu, China
Huai'an, Jiangsu, China
Lianyungang, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Wuxi, Jiangsu, China
Yancheng, Jiangsu, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Yinchuan, Ningxia, China
Xi'an, Shaanxi, China
Qingdao, Shandong, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Ürümqi, Xinjiang, China
Hangzhou, Zhejiang, China
Taizhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Medellín, Antioquia, Colombia
Medellín, Antioquia, Colombia
Medellín, Antioquia, Colombia
Barranquilla, Atlántico, Colombia
Barranquilla, Atlántico, Colombia
Bogotá, Bogota D.C., Colombia
Bogotá, Bogota D.C., Colombia
Cundinamarca, Bogota D.C., Colombia
Manizales, Caldas Department, Colombia
Zipaquirá, Cundinamarca, Colombia
Pasto, Departamento de Nariño, Colombia
Armenia, Quindío Department, Colombia
Pereira, Risaralda Department, Colombia
Cali, Valle del Cauca Department, Colombia
Cali, Valle del Cauca Department, Colombia
Barranquilla, , Colombia
Bogotá, , Colombia
Floridablanca, , Colombia
Medellín, , Colombia
Beroun, , Czechia
Brandýs nad Labem, , Czechia
Břeclav, , Czechia
Česká Lípa, , Czechia
Český Krumlov, , Czechia
Český Krumlov, , Czechia
Frýdek-Místek, , Czechia
Hodonín, , Czechia
Holešov, , Czechia
Hranice, , Czechia
Kopřivnice, , Czechia
Krnov, , Czechia
Mladá Boleslav, , Czechia
Olomouc, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Vlašim, , Czechia
Aalborg, , Denmark
Aarhus N, , Denmark
Esbjerg, , Denmark
Gentofte Municipality, , Denmark
Hellerup, , Denmark
Herlev, , Denmark
Hillerød, , Denmark
Holbæk, , Denmark
Holstebro, , Denmark
Hvidovre, , Denmark
Kolding, , Denmark
København NV, , Denmark
Odense C, , Denmark
Svendborg, , Denmark
Viborg, , Denmark
Jyväskylä, , Finland
Kajaani, , Finland
Kerava, , Finland
Klaukkala, , Finland
Kuopio, , Finland
Nurmijärvi, , Finland
Oulu, , Finland
Rauma, , Finland
Seinäjoki, , Finland
Tampere, , Finland
Turku, , Finland
Vantaa, , Finland
Bois-Guillaume, , France
Boulogne-sur-Mer, , France
Brest, , France
Colmar, , France
Dijon, , France
Grenoble, , France
Le Coudray, , France
Le Creusot, , France
Lyon, , France
Mulhouse, , France
Nîmes, , France
Paris, , France
Saint-Herblain, , France
Tourcoing, , France
Vandœuvre-lès-Nancy, , France
Vénissieux, , France
Heidelberg, Baden-Wurttemberg, Germany
Ludwigsburg, Baden-Wurttemberg, Germany
Sinzheim, Baden-Wurttemberg, Germany
Nuremberg, Bavaria, Germany
Schweinfurt, Bavaria, Germany
Würzburg, Bavaria, Germany
Elsterwerda, Brandenburg, Germany
Bad Homburg, Hesse, Germany
Bad König, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Göttingen, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Nettetal, North Rhine-Westphalia, Germany
Witten, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Athens, , Greece
Chaïdári, , Greece
Larissa, , Greece
Nea Ionia, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Shatin, , Hong Kong
Sheung Wan, , Hong Kong
Wong Tai Sin, , Hong Kong
Baja, , Hungary
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Kistarcsa, , Hungary
Nyíregyháza, , Hungary
Nyíregyháza, , Hungary
Pápa, , Hungary
Siófok, , Hungary
Szeged, , Hungary
Szentes, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Cork, , Ireland
Dublin, , Ireland
Galway, , Ireland
Afula, , Israel
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Nahariya, , Israel
Nazareth, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Safed, , Israel
Sakhnin, , Israel
Tel Aviv, , Israel
Tel Aviv, , Israel
Tel Aviv, , Israel
Tel Aviv, , Israel
Tiberias, , Israel
Ẕerifin, , Israel
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Genoa, Liguria, Italy
Genoa, Liguria, Italy
Bergamo, Lombardy, Italy
Bergamo, Lombardy, Italy
Bergamo, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Monza Brianza, Lombardy, Italy
Turin, Piedmont, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Sassari, Sardinia, Italy
Catania, Sicily, Italy
Messina, Sicily, Italy
Pisa, Tuscany, Italy
Verona, Veneto, Italy
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyota, Aichi-ken, Japan
Funabashi, Chiba, Japan
Ichikawa, Chiba, Japan
Matsuyama, Ehime, Japan
Matsuyama, Ehime, Japan
Chikushino-shi, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Shirakawa, Fukushima, Japan
Ōgaki, Gifu, Japan
Maebashi, Gunma, Japan
Higashihiroshima, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Obihiro, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Naka, Ibaraki, Japan
Ushiku, Ibaraki, Japan
Komatsu, Ishikawa-ken, Japan
Sanuki, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Atsugi, Kanagawa, Japan
Fujisawa, Kanagawa, Japan
Kamakura, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Tamana, Kumamoto, Japan
Yatsushiro, Kumamoto, Japan
Sasebo, Nagasaki, Japan
Beppu, Oita Prefecture, Japan
Yufu, Oita Prefecture, Japan
Nakagami-gun, Okinawa, Japan
Shimajiri, Okinawa, Japan
Matsubara, Osaka, Japan
Suita, Osaka, Japan
Kawaguchi, Saitama, Japan
Sayama, Saitama, Japan
Ōtsu, Shiga, Japan
Iwata, Shizuoka, Japan
Oyama, Tochigi, Japan
Minato, Tokyo, Japan
Musashino, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Tacchikawa, Tokyo, Japan
Fukui, , Japan
Fukui, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Kagoshima, , Japan
Kumamoto, , Japan
Kumamoto, , Japan
Kumamoto, , Japan
Nagasaki, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Saitama, , Japan
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Utena, , Lithuania
Vilnius, , Lithuania
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Pahang, , Malaysia
Kuala Selangor, , Malaysia
Perak, , Malaysia
Perak, , Malaysia
Pulau Pinang, , Malaysia
Putrajaya, , Malaysia
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Mexico City, Mexico City, Mexico
Mexico City, Mexico City, Mexico
Mexico City, Mexico City, Mexico
México D.F., Mexico City, Mexico
México, D. F., Mexico City, Mexico
México, D. F., Mexico City, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo León, Mexico
Querétaro City, Querétaro, Mexico
San Juan del Río, Querétaro, Mexico
Culiacán, Sinaloa, Mexico
Culiacán, Sinaloa, Mexico
Mazatlán, Sinaloa, Mexico
Puerto de Veracruz, Veracruz, Mexico
Xalapa, Veracruz, Mexico
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Durango, , Mexico
Alkmaar, , Netherlands
Almere Stad, , Netherlands
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Geleen, , Netherlands
Groningen, , Netherlands
Hoogeveen, , Netherlands
The Hague, , Netherlands
Zwijndrecht, , Netherlands
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Hawkes Bay, , New Zealand
Palmerston North, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Ålesund, , Norway
Hamar, , Norway
Hamar, , Norway
Kløfta, , Norway
Kongsvinger, , Norway
Kristiansand, , Norway
Levanger, , Norway
Lierskogen, , Norway
Oslo, , Norway
Oslo, , Norway
Skedsmokorset, , Norway
Iloilo City, , Philippines
Marikina City, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Bialystok, , Poland
Bydgoszcz, , Poland
Chojnice, , Poland
Gdansk, , Poland
Gdynia, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Rzeszów, , Poland
Skorzewo, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Covilha, Castelo Branco District, Portugal
Loures, Lisbon District, Portugal
Funchal, Madeira, Portugal
Matosinhos Municipality, Porto District, Portugal
Torres Novas, Santarém District, Portugal
Setúbal, Setúbal District, Portugal
Almada, , Portugal
Amadora, , Portugal
Braga, , Portugal
Faro, , Portugal
Leiria, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Porto, , Portugal
Viana do Castelo, , Portugal
Cidra, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Alba Iulia, Alba, Romania
Oradea, Bihor County, Romania
Baia Mare, Maramureş, Romania
Ploieşti, Prahova, Romania
Timișoara, Timiș County, Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Galati, , Romania
Iași, , Romania
Oradea, , Romania
Satu Mare, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Chelyabinsk, , Russia
Irkutsk, , Russia
Izhevsk, , Russia
Kazan', , Russia
Kazan', , Russia
Kemerovo, , Russia
Kemerovo, , Russia
Kemerovo, , Russia
Kirov, , Russia
Krasnodar, , Russia
Krasnoyarsk, , Russia
Kursk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Omsk, , Russia
Omsk, , Russia
Orenburg, , Russia
Perm, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Stavropol, , Russia
Syktyvkar, , Russia
Voronezh, , Russia
Voronezh, , Russia
Yaroslavl, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Banská Bystrica, , Slovakia
Bardejov, , Slovakia
Nitra, , Slovakia
Rimavská Sobota, , Slovakia
Rožňava, , Slovakia
Žilina, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Benoni, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Lenasia South, Gauteng, South Africa
Newtown, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Soweto, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Isipingo Rail, KwaZulu-Natal, South Africa
Tongaat, KwaZulu-Natal, South Africa
Middelburg, Mpumalanga, South Africa
Witbank, Mpumalanga, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Wŏnju, Gang''weondo, South Korea
Anyang-si, Gyeonggido, South Korea
Seongnam-si, Gyeonggido, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Ferrol, A Coruña, Spain
Badalona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Manresa, Barcelona, Spain
Sant Joan Despí, Barcelona, Spain
Jerez de la Frontera, Cádiz, Spain
Burela de Cabo, Lugo, Spain
Alcalá de Henares, Madrid, Spain
Getafe, Madrid, Spain
Sagunto, Valencia, Spain
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Granada, , Spain
Jaén, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Gothenburg, , Sweden
Lund, , Sweden
Lund, , Sweden
Örebro, , Sweden
Örebro, , Sweden
Rättvik, , Sweden
Skövde, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Uppsala, , Sweden
Olten, Canton of Solothurn, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Lausanne, Canton of Vaud, Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Changhua, , Taiwan
Kaohsiung City, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Aydin, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Kocaeli, , Turkey (Türkiye)
Malatya, , Turkey (Türkiye)
Sivas, , Turkey (Türkiye)
Cherkasy, , Ukraine
Chernivtsi, , Ukraine
Dnipro, , Ukraine
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Mykolayiv, , Ukraine
Ternopil, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Llanelli, Carmarthenshire, United Kingdom
Liverpool, Merseyside, United Kingdom
Northampton, Northamptonshire, United Kingdom
Carshalton, Surrey, United Kingdom
Birmingham, West Midlands, United Kingdom
Chichester, West Sussex, United Kingdom
Bristol, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Hà Nội, , Vietnam
Hà Nội, , Vietnam
Ho Chi Minh City, , Vietnam
Ho Chi Minh City, , Vietnam
Ho Chi Minh City, , Vietnam
Countries
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References
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Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.
Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2025 Sep 2. doi: 10.1681/ASN.0000000877. Online ahead of print. No abstract available.
Rossing P, Birkenfeld AL, Fioretto P, McGill JB, Anker SD, Pitt B, Rohwedder K, Scalise A, Scott C, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index: FIDELITY Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 2;20(7):968-977. doi: 10.2215/CJN.0000000700.
Singh AK, James G, Anker SD, Pitt B, Rossing P, Ruilope LM, Farjat AE, Farag YMK, Roberts L, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone Efficacy in Patients with Chronic Kidney Disease, Type 2 Diabetes, and Anemia in FIDELITY. JACC Adv. 2025 Feb;4(2):101524. doi: 10.1016/j.jacadv.2024.101524.
Pitt B, Agarwal R, Anker SD, Rossing P, Ruilope L, Herzog CA, Greenberg B, Pecoits-Filho R, Lambelet M, Lawatscheck R, Scalise A, Filippatos G. Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone-a FIDELITY analysis. Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):10-19. doi: 10.1093/ehjcvp/pvae074.
Bansal S, Canziani MEF, Birne R, Anker SD, Bakris GL, Filippatos G, Rossing P, Ruilope LM, Farjat AE, Kolkhof P, Lage A, Brinker M, Pitt B. Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials. BMJ Open. 2024 Mar 19;14(3):e076444. doi: 10.1136/bmjopen-2023-076444.
Agarwal R, Tu W, Farjat AE, Farag YMK, Toto R, Kaul S, Lawatscheck R, Rohwedder K, Ruilope LM, Rossing P, Pitt B, Filippatos G, Anker SD, Bakris GL; FIDELIO-DKD and FIGARO-DKD Investigators. Impact of Finerenone-Induced Albuminuria Reduction on Chronic Kidney Disease Outcomes in Type 2 Diabetes : A Mediation Analysis. Ann Intern Med. 2023 Dec;176(12):1606-1616. doi: 10.7326/M23-1023. Epub 2023 Dec 5.
Flack JM, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Adler SG, Fried L, Jamerson K, Toto R, Brinker M, Farjat AE, Kolkhof P, Lawatscheck R, Joseph A, Bakris GL; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials. Kidney Med. 2023 Sep 28;5(12):100730. doi: 10.1016/j.xkme.2023.100730. eCollection 2023 Dec.
Rosas SE, Ruilope LM, Anker SD, Pitt B, Rossing P, Bonfanti AAC, Correa-Rotter R, Gonzalez F, Munoz CFJ, Pergola P, Umpierrez GE, Scalise A, Scott C, Lawatscheck R, Joseph A, Bakris GL; FIDELIO-DKD and FIGARO-DKD investigators. Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. Kidney Med. 2023 Aug 1;5(10):100704. doi: 10.1016/j.xkme.2023.100704. eCollection 2023 Oct.
Sarafidis P, Agarwal R, Pitt B, Wanner C, Filippatos G, Boletis J, Tuttle KR, Ruilope LM, Rossing P, Toto R, Anker SD, Liu ZH, Joseph A, Ahlers C, Brinker M, Lawatscheck R, Bakris G; FIDELIO-DKD and FIGARO-DKD Investigators. Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes: A FIDELITY Subgroup Analysis. Clin J Am Soc Nephrol. 2023 May 1;18(5):602-612. doi: 10.2215/CJN.0000000000000149. Epub 2023 Apr 7.
Agarwal R, Pitt B, Palmer BF, Kovesdy CP, Burgess E, Filippatos G, Malyszko J, Ruilope LM, Rossignol P, Rossing P, Pecoits-Filho R, Anker SD, Joseph A, Lawatscheck R, Wilson D, Gebel M, Bakris GL. A comparative post hoc analysis of finerenone and spironolactone in resistant hypertension in moderate-to-advanced chronic kidney disease. Clin Kidney J. 2022 Oct 30;16(2):293-302. doi: 10.1093/ckj/sfac234. eCollection 2023 Feb.
Filippatos G, Anker SD, August P, Coats AJS, Januzzi JL, Mankovsky B, Rossing P, Ruilope LM, Pitt B, Sarafidis P, Teerlink JR, Kapelios CJ, Gebel M, Brinker M, Joseph A, Lage A, Bakris G, Agarwal R. Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis. Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):183-191. doi: 10.1093/ehjcvp/pvad001.
Filippatos G, Anker SD, Pitt B, Rossing P, Joseph A, Kolkhof P, Lambelet M, Lawatscheck R, Bakris GL, Ruilope LM, Agarwal R. Finerenone and Heart Failure Outcomes by Kidney Function/Albuminuria in Chronic Kidney Disease and Diabetes. JACC Heart Fail. 2022 Nov;10(11):860-870. doi: 10.1016/j.jchf.2022.07.013. Epub 2022 Oct 12.
Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.
Filippatos G, Anker SD, Pitt B, McGuire DK, Rossing P, Ruilope LM, Butler J, Jankowska EA, Michos ED, Farmakis D, Farjat AE, Kolkhof P, Scalise A, Joseph A, Bakris GL, Agarwal R. Finerenone efficacy in patients with chronic kidney disease, type 2 diabetes and atherosclerotic cardiovascular disease. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):85-93. doi: 10.1093/ehjcvp/pvac054.
Filippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13.
Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.
Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
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Other Identifiers
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2015-000950-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17530
Identifier Type: -
Identifier Source: org_study_id
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