Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

• ClinicalTrials.gov Identifier: NCT02540993
• Recruitment Status: Completed
• First Posted: September 4, 2015
• Results First Posted: July 19, 2021
• Last Update Posted: July 19, 2021
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Drug: Finerenone (BAY94-8862); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5734 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
• Actual Study Start Date: September 17, 2015
• Actual Primary Completion Date: April 14, 2020
• Actual Study Completion Date: April 14, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Finerenone (BAY94-8862); Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy	Drug: Finerenone (BAY94-8862); Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to < 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
Placebo Comparator: Placebo; Participants received matching placebo once daily in addition to standard of care therapy	Drug: Placebo; Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Outcome Measures

Primary Outcome Measures :

1. The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death [ Time Frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months ]
   Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.

Secondary Outcome Measures :

1. The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure [ Time Frame: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months ]
   Count of participants and time from randomization to the first occurrence of the key secondary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.
2. All-cause Mortality [ Time Frame: From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months ]
   Count of participants and time from randomization until death due to any cause were evaluated. Number of participants with outcome death is reported as descriptive result and hazard ratio is reported as statistical analysis. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
3. All-cause Hospitalization [ Time Frame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months ]
   Count of participants and time from randomization to the first occurrence of a hospitalization event were evaluated. Number of participants with the event is reported as descriptive result and hazard ratio is reported as statistical analysis.
4. Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 [ Time Frame: From baseline up until Month 4 ]
   First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.
5. The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death [ Time Frame: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months ]
   Count of participants and time from randomization to the first occurrence of the secondary renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Men or women ≥18 years of age
• Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association

• Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

  • persistent high albuminuria (UACR ≥30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
  • persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to <75 mL/min/1.73 m² (CKD-EPI)

• Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

  • For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
  • Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
  • For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
• Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit

Exclusion Criteria:

• Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
• Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
• Glycated hemoglobin (HbA1c) >12%
• Mean SBP < 90 mmHg at the run-in visit or at the screening visit
• 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 antagonists [MRAs])
• Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
• Dialysis for acute renal failure within 12 weeks of run-in visit
• Renal allograft in place or scheduled within next 12 months from the run-in visit

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35294

Fort Payne, Alabama, United States, 35967

Huntsville, Alabama, United States, 35801-4317

United States, Arizona

Mesa, Arizona, United States, 85210

Phoenix, Arizona, United States, 85016

Phoenix, Arizona, United States, 85032

Prescott, Arizona, United States, 86301

Tucson, Arizona, United States, 85723

Tucson, Arizona, United States, 85724

United States, California

Arvin, California, United States, 93203

Chula Vista, California, United States, 91910

Dublin, California, United States, 94568

El Centro, California, United States, 92243

Fresno, California, United States, 93720

Fresno, California, United States, 93721

La Mesa, California, United States, 91942

Loma Linda, California, United States, 92357

Los Angeles, California, United States, 90017

Los Angeles, California, United States, 90022

Los Angeles, California, United States, 90025

Los Angeles, California, United States, 90073

Northridge, California, United States, 91325

Port Hueneme, California, United States, 93041

Poway, California, United States, 92064

Rancho Cucamonga, California, United States, 91730

Rialto, California, United States, 92377

Roseville, California, United States, 95661

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Torrance, California, United States, 90502

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New Haven, Connecticut, United States, 06520

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Fleming Island, Florida, United States, 32003

Fort Lauderdale, Florida, United States, 33316-1958

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Miami, Florida, United States, 33032

Miami, Florida, United States, 33126

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Asheboro, North Carolina, United States, 27203

Chapel Hill, North Carolina, United States, 27312

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Chattanooga, Tennessee, United States, 37404

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Arlington, Texas, United States, 76014

Corpus Christi, Texas, United States, 78414

Dallas, Texas, United States, 75216

Dallas, Texas, United States, 75246

Dallas, Texas, United States, 75251

El Paso, Texas, United States, 79935

Houston, Texas, United States, 77008

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Houston, Texas, United States, 77095

Kingwood, Texas, United States, 77339

McAllen, Texas, United States, 78503

McKinney, Texas, United States, 75069

Pearland, Texas, United States, 77584

Pflugerville, Texas, United States, 78660

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San Antonio, Texas, United States, 78215

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Saint George, Utah, United States, 84790

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Burlington, Vermont, United States, 05401

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Milwaukee, Wisconsin, United States, 53295

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San Luis, Argentina, D5702AAx

Australia, Australian Capital Territory

Garran, Australian Capital Territory, Australia, 2605

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Gosford, New South Wales, Australia, 2250

Liverpool, New South Wales, Australia, 2170

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Wollongong, New South Wales, Australia, 2500

Australia, South Australia

Adelaide, South Australia, Australia, 5000

Australia, Victoria

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Heidelberg, Victoria, Australia, 3081

Reservoir, Victoria, Australia, 3073

Richmond, Victoria, Australia, 3121

St. Albans, Victoria, Australia, 3021

Australia

Box Hill, Australia, 3128

Elizabeth Vale, Australia, 5112

Austria

Linz, Oberösterreich, Austria, 4020

Linz, Oberösterreich, Austria, 4021

Graz, Steiermark, Austria, 8036

Saint Stefan, Steiermark, Austria, 8511

Feldkirch, Vorarlberg, Austria, 6807

Innsbruck, Austria, 6020

Salzburg, Austria, 5020

St. Pölten, Austria, 3100

Wels, Austria, 4600

Wien, Austria, 1030

Wien, Austria, 1060

Wien, Austria, 1090

Wien, Austria, 1130

Belgium

Antwerpen, Belgium, 2060

Bruxelles - Brussel, Belgium, 1070

Edegem, Belgium, 2650

Gent, Belgium, 9000

Ieper, Belgium, 8900

Kortrijk, Belgium, 8500

Leuven, Belgium, 3000

Liege, Belgium, 4000

Roeselare, Belgium, 8800

Brazil

Feira de Santana, Bahia, Brazil, 44001-584

Salvador, Bahia, Brazil, 40415-065

Fortaleza, Ceará, Brazil, 60115-282

Fortaleza, Ceará, Brazil, 60430-140

Fortaleza, Ceará, Brazil

Brasilia, Distrito Federal, Brazil, 70.200-730

Aparecida de Goiania, Goiás, Brazil, 74935-530

Goiania, Goiás, Brazil, 74605-020

Juiz de Fora, Minas Gerais, Brazil, 36036-330

Uberlândia, Minas Gerais, Brazil, 38411-186

Campina Grande do Sul, Parana, Brazil, 83430 000

Curitiba, Parana, Brazil, 80030-110

Curitiba, Parana, Brazil, 80230-130

Curitiba, Parana, Brazil, 80440-020

Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001

Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000

Santo Andre, Sao Paulo, Brazil

São José do Rio Preto, Sao Paulo, Brazil, 15090-000

São José dos Campos, Sao Paulo, Brazil, 12243-280

São Paulo, Sao Paulo, Brazil

Rio de Janeiro, Brazil, 20241-180

Rio de Janeiro, Brazil, 21941-913

Sao Paulo, Brazil, 01223-001

Sao Paulo, Brazil, 01228-200

Sao Paulo, Brazil, 04039-000

Bulgaria

Blagoevgrad, Bulgaria, 2700

Botevgrad, Bulgaria, 2140

Dimitrovgrad, Bulgaria, 6400

Gorna Oryahovitsa, Bulgaria, 5100

Kazanlak, Bulgaria, 6102

Kozloduy, Bulgaria, 3320

Lukovit, Bulgaria, 5770

Plovdiv, Bulgaria, 4002

Plovdiv, Bulgaria, 4004

Razgrad, Bulgaria, 7200

Sliven, Bulgaria, 8800

Smolyan, Bulgaria, 4700

Sofia, Bulgaria, 1233

Sofia, Bulgaria, 1407

Sofia, Bulgaria, 1606

Sofia, Bulgaria, 1680

Stara Zagora, Bulgaria, 6000

Varna, Bulgaria, 9000

Yambol, Bulgaria, 8600

Canada, British Columbia

Burnaby, British Columbia, Canada, V3J 1N4

Coquitlam, British Columbia, Canada, V3K 3P4

New Westminster, British Columbia, Canada, V3L 0A6

Canada, Newfoundland and Labrador

Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7

St. John's, Newfoundland and Labrador, Canada, A1A 3R5

Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 1V8

Canada, Ontario

Cambridge, Ontario, Canada, N1R 7L6

Hamilton, Ontario, Canada, L8M 1K7

Hamilton, Ontario, Canada, L8N 4A6

Kitchener, Ontario, Canada, N2G 4V5

Newmarket, Ontario, Canada, L3Y 5G8

Oshawa, Ontario, Canada, L1G 2B9

Ottawa, Ontario, Canada, K1K 4L2

Sarnia, Ontario, Canada, N7T 4X3

Smith Falls, Ontario, Canada, K7A 4W8

Sudbury, Ontario, Canada, P3A 1W8

Thornhill, Ontario, Canada, L4J 1W3

Toronto, Ontario, Canada, M4G 3E8

Toronto, Ontario, Canada, M5C 2T2

Waterloo, Ontario, Canada, N2J 1C4

Canada, Quebec

Greenfield Park, Quebec, Canada, J4V 2H1

Laval, Quebec, Canada, H7T 2P5

Mirabel, Quebec, Canada, J7J 2K8

Montreal, Quebec, Canada, H1M 1B1

Montreal, Quebec, Canada, H2K 1H2

Montreal, Quebec, Canada, H3G 1A4

Montreal, Quebec, Canada, H4A 3J1

Montreal, Quebec, Canada, H4A 3T2

Montreal, Quebec, Canada, H4J 1C5

Canada

Quebec, Canada, G1V 4W2

Chile

Osorno, Los Lagos, Chile, 5311092

Las Condes, Santiago, Chile, 7591047

Providencia, Santiago, Chile, 7500520

Providencia, Santiago, Chile, 7500710

Providencia, Santiago, Chile, 7500922

San Bernardo, Santiago, Chile, 8053095

San Miguel, Santiago, Chile, 8910108

Santiago, Chile, 8330008

Santiago, Chile, 8331143

Santiago, Chile, 8380456

China, Fujian

Fuzhou, Fujian, China, 350025

Xiamen, Fujian, China, 361003

Xiamen, Fujian, China, 361004

China, Gansu

Lanzhou, Gansu, China, 730030

China, Guangdong

Guangzhou, Guangdong, China, 510080

Guangzhou, Guangdong, China, 510120

Guangzhou, Guangdong, China, 510150

Guangzhou, Guangdong, China, 510405

Guangzhou, Guangdong, China, 510630

Zhuhai, Guangdong, China, 519000

China, Guangxi

Nanning, Guangxi, China, 530021

Nanning, Guangxi, China, 530031

China, Hainan

Haikou, Hainan, China, 570102

Haikou, Hainan, China, 570311

China, Hubei

Wuhan, Hubei, China, 430022

Wuhan, Hubei, China, 430034

China, Hunan

Changsha, Hunan, China, 410008

Changsha, Hunan, China, 410011

Changsha, Hunan, China, 410013

China, Jiangsu

Changzhou, Jiangsu, China, 213004

Huai'An, Jiangsu, China, 223300

Lianyungang, Jiangsu, China, 222002

Nanjing, Jiangsu, China, 210006

Nanjing, Jiangsu, China, 210008

Nanjing, Jiangsu, China, 210011

Nanjing, Jiangsu, China, 210029

Suzhou, Jiangsu, China, 215006

Wuxi, Jiangsu, China, 214023

Yancheng, Jiangsu, China, 224005

China, Jiangxi

Nanchang, Jiangxi, China, 330006

Nanchang, Jiangxi, China, 330008

China, Jilin

Changchun, Jilin, China, 130000

Changchun, Jilin, China, 130021

China, Liaoning

Shenyang, Liaoning, China, 110004

Shenyang, Liaoning, China, 110016

China, Ningxia

Yinchuan, Ningxia, China, 750004

China, Shaanxi

Xi'an, Shaanxi, China, 710061

China, Shandong

Qingdao, Shandong, China, 266000

Qingdao, Shandong, China, 266071

China, Shanxi

Taiyuan, Shanxi, China, 030001

China, Sichuan

Chengdu, Sichuan, China, 610041

Chengdu, Sichuan, China, 610072

China, Zhejiang

Hangzhou, Zhejiang, China, 310013

Taizhou, Zhejiang, China, 317000

Wenzhou, Zhejiang, China, 325000

China

Beijing, China, 100010

Beijing, China, 100730

Chongqing, China, 400010

Shanghai, China, 200025

Shanghai, China, 200040

Shanghai, China, 200062

Shanghai, China, 200072

Shanghai, China, 200092

Shanghai, China, 200240

Shanghai, China, 201199

Tianjin, China, 300052

Tianjin, China, 300121

Tianjin, China, 300142

Colombia

Medellín, Antioquia, Colombia, 050034

Medellín, Antioquia, Colombia, 0

Medellín, Antioquia, Colombia

Barranquilla, Atlántico, Colombia, 0

Barranquilla, Atlántico, Colombia

Manizales, Caldas, Colombia

Zipaquirá, Cundinamarca, Colombia, 0

Bogotá, Distrito Capital De Bogotá, Colombia, 0

Cundinamarca, Distrito Capital De Bogotá, Colombia

Armenia, Quindío, Colombia, 0

Cali, Valle Del Cauca, Colombia, 760032

Cali, Valle Del Cauca, Colombia

Floridablanca, Colombia

Medellín, Colombia

Czechia

Beroun, Czechia, 266 01

Brandys nad Labem, Czechia, 250 01

Breclav, Czechia, 690 02

Ceska Lipa, Czechia, 470 01

Cesky Krumlov, Czechia, 381 01

Cesky Krumlov, Czechia, 381 27

Frydek-Mistek, Czechia, 738 01

Hodonin, Czechia, 695 01

Holesov, Czechia, 769 01

Hranice, Czechia, 753 001

Koprivnice, Czechia, 742 21

Krnov, Czechia, 794 01

Mlada Boleslav, Czechia, 293 50

Olomouc, Czechia, 775 20

Olomouc, Czechia, 779 00

Ostrava, Czechia, 702 00

Plzen, Czechia, 301 66

Prague 6, Czechia, 169 00

Praha 2, Czechia, 12808

Praha 4, Czechia, 140 00

Praha 4, Czechia, 140 46

Praha 5, Czechia, 150 00

Vlasim, Czechia, 258 01

Denmark

Aalborg, Denmark, 9000

Aarhus N, Denmark, 8200

Esbjerg, Denmark, 6700

Gentofte, Denmark, 2820

Hellerup, Denmark, 2900

Herlev, Denmark, 2730

Hillerød, Denmark, DK-3400

Holbæk, Denmark, 4300

Holstebro, Denmark, DK-7500

Hvidovre, Denmark, 2650

Kolding, Denmark, 6000

København NV, Denmark, 2400

Odense C, Denmark, DK-5000

Svendborg, Denmark, 5700

Viborg, Denmark, 8800

Finland

Jyväskylä, Finland, 40620

Kajaani, Finland, 87140

Kerava, Finland, 04200

Klaukkala, Finland, 01800

Kuopio, Finland, 70100

Nurmijärvi, Finland, 01900

Oulu, Finland, 90100

Rauma, Finland, 26100

Seinäjoki, Finland, 60100

Tampere, Finland, 33520

Turku, Finland, 20521

Vantaa, Finland, 01600

France

Bois-guillaume, France, 76230

Bordeaux, France, 33000

Boulogne Sur Mer, France, 62321

Brest, France, 29200

COLMAR Cedex, France, 68024

Dijon, France, 21000

La Rochelle, France, 17019

La Tronche, France, 38700

Le Coudray, France, 28630

Le Creusot, France, 71200

Lyon Cedex, France, 69437

Mulhouse, France, 68051

NIMES cedex 9, France, 30029

Paris, France, 75018

PESSAC cedex, France, 33608

Saint Herblain, France, 44093

Saint Priest En Jarez, France, 42270

Tourcoing, France, 59280

Vandoeuvre-les-nancy, France, 54500

Venissieux, France, 69200

Germany

Heidelberg, Baden-Württemberg, Germany, 69115

Ludwigsburg, Baden-Württemberg, Germany, 71640

Schweinfurt, Bayern, Germany, 97421

Würzburg, Bayern, Germany, 97080

Elsterwerda, Brandenburg, Germany, 04910

Bad König, Hessen, Germany, 64732

Frankfurt, Hessen, Germany, 60313

Frankfurt, Hessen, Germany, 60596

Göttingen, Niedersachsen, Germany, 37075

Hannover, Niedersachsen, Germany, 30625

Aachen, Nordrhein-Westfalen, Germany, 52074

Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545

Bochum, Nordrhein-Westfalen, Germany, 44787

Dortmund, Nordrhein-Westfalen, Germany, 44137

Düsseldorf, Nordrhein-Westfalen, Germany, 40210

Düsseldorf, Nordrhein-Westfalen, Germany, 40225

Essen, Nordrhein-Westfalen, Germany, 45136

Münster, Nordrhein-Westfalen, Germany, 48145

Nettetal, Nordrhein-Westfalen, Germany, 41334

Witten, Nordrhein-Westfalen, Germany, 58455

Ludwigshafen, Rheinland-Pfalz, Germany, 67059

Mainz, Rheinland-Pfalz, Germany, 55128

Dresden, Sachsen, Germany, 01277

Dresden, Sachsen, Germany, 01307

Hoyerswerda, Sachsen, Germany, 02977

Leipzig, Sachsen, Germany, 04103

Leipzig, Sachsen, Germany, 04249

Jena, Thüringen, Germany, 07747

Berlin, Germany, 10437

Berlin, Germany, 12203

Berlin, Germany, 13187

Berlin, Germany, 13347

Hamburg, Germany, 22041

Greece

Alexandroupolis, Greece, 68100

Athens, Greece, 11527

Athens, Greece, 14455

Chaidari, Greece, 12462

Larissa, Greece, 41100

Nea Ionia, Greece, 14233

Thessaloniki, Greece, 54642

Thessaloniki, Greece, 56403

Hong Kong

Hong Kong, Hong Kong

Shatin, Hong Kong

Sheung Wan, Hong Kong

Wong Tai Sin, Hong Kong

Hungary

Baja, Hungary, 6500

Balatonfured, Hungary, 8230

Budapest, Hungary, 1036

Budapest, Hungary, 1042

Budapest, Hungary, 1088

Budapest, Hungary, 1089

Budapest, Hungary, 1134

Budapest, Hungary, 1135

Debrecen, Hungary, 4031

Eger, Hungary, 3300

Kaposvar, Hungary, 7400

Kistarcsa, Hungary, 2143

Nyiregyhaza, Hungary, 4400

Nyiregyhaza, Hungary, 4405

Papa, Hungary, 8500

Siofok, Hungary, 8600

Szeged, Hungary

Szekesfehervar, Hungary, 8000

Szentes, Hungary, 6600

Szombathely, Hungary, 9700

Veszprem, Hungary, 8200

Ireland

Cork, Ireland

Dublin, Ireland, D07 R2WY

Dublin, Ireland, DUBLIN 4

Galway, Ireland

Israel

Afula, Israel, 1834111

Ashkelon, Israel, 7830604

Beer Sheva, Israel, 8410101

Hadera, Israel, 3810101

Haifa, Israel, 3109601

Holon, Israel, 5822012

Jerusalem, Israel, 9112001

Kfar Saba, Israel, 4428164

Nahariya, Israel, 2210001

Nahariya, Israel, 22100

Nazareth, Israel, 16100

Ramat Gan, Israel, 5262000

Rehovot, Israel, 7610001

Sakhnin, Israel, 3081000

Tel Aviv, Israel, 6203854

Tel Aviv, Israel, 6423906

Tel Aviv, Israel, 6905234

Tel Aviv, Israel, 6937947

Tiberias, Israel, 1528001

Zefat, Israel, 1311001

Zerifin, Israel, 7030000

Italy

Napoli, Campania, Italy, 80131

Bologna, Emilia-Romagna, Italy, 40138

Parma, Emilia-Romagna, Italy, 43126

Reggio Emilia, Emilia-Romagna, Italy, 42123

Genova, Liguria, Italy, 16011

Genova, Liguria, Italy, 16132

Bergamo, Lombardia, Italy, 24020

Bergamo, Lombardia, Italy, 24047

Bergamo, Lombardia, Italy, 24127

Milano, Lombardia, Italy, 20024

Milano, Lombardia, Italy, 20132

Milano, Lombardia, Italy, 20142

Milano, Lombardia, Italy, 20157

Monza Brianza, Lombardia, Italy, 20832

Torino, Piemonte, Italy, 10023

Torino, Piemonte, Italy, 10043

Cagliari, Sardegna, Italy, 09134

Sassari, Sardegna, Italy, 07026

Catania, Sicilia, Italy, 95124

Messina, Sicilia, Italy, 98125

Padova, Veneto, Italy, 35128

Verona, Veneto, Italy, 37126

Japan

Nagoya, Aichi, Japan, 451-8511

Nagoya, Aichi, Japan, 456-0058

Nagoya, Aichi, Japan, 457-8510

Nagoya, Aichi, Japan, 460-0001

Nagoya, Aichi, Japan, 466-8650

Toyota, Aichi, Japan, 471-8513

Funabashi, Chiba, Japan, 273-8588

Ichikawa, Chiba, Japan, 272-8516

Matsuyama, Ehime, Japan, 790-0024

Matsuyama, Ehime, Japan, 791-8026

Chikushino, Fukuoka, Japan, 818-8502

Kasuga, Fukuoka, Japan, 816-0864

Kitakyushu, Fukuoka, Japan, 800-0296

Kitakyushu, Fukuoka, Japan, 802-8555

Kitakyushu, Fukuoka, Japan, 805-8508

Kitakyushu, Fukuoka, Japan, 807-0857

Shirakawa, Fukushima, Japan, 961-0005

Ogaki, Gifu, Japan, 503-8502

Maebashi, Gunma, Japan, 371-0821

Higashihiroshima, Hiroshima, Japan, 739-0041

Asahikawa, Hokkaido, Japan, 078-8234

Hakodate, Hokkaido, Japan, 041-8680

Obihiro, Hokkaido, Japan, 080-0848

Sapporo, Hokkaido, Japan, 007-0841

Kobe, Hyogo, Japan, 650-0047

Naka, Ibaraki, Japan, 311-0113

Ushiku, Ibaraki, Japan, 300-1207

Komatsu, Ishikawa, Japan, 923-8560

Sanuki, Kagawa, Japan, 769-2393

Takamatsu, Kagawa, Japan, 760-0017

Takamatsu, Kagawa, Japan, 760-0018

Atsugi, Kanagawa, Japan, 243-0035

Fujisawa, Kanagawa, Japan, 251-0041

Kamakura, Kanagawa, Japan, 247-8533

Yokohama, Kanagawa, Japan, 235-0045

Yokohama, Kanagawa, Japan, 245-8575

Yokohama, Kanagawa, Japan, 247-8581

Tamana, Kumamoto, Japan, 865-0016

Yatsushiro, Kumamoto, Japan, 866-0824

Sasebo, Nagasaki, Japan, 857-1195

Beppu, Oita, Japan, 874-0011

Yufu, Oita, Japan, 879-5593

Nakagami-gun, Okinawa, Japan, 901-2393

Shimajiri, Okinawa, Japan, 901-0493

Suita, Osaka, Japan, 565-0862

Kawaguchi, Saitama, Japan, 332-0012

Sayama, Saitama, Japan, 350-1305

Otsu, Shiga, Japan, 520-0804

Iwata, Shizuoka, Japan, 438-8550

Oyama, Tochigi, Japan, 323-0022

Minato, Tokyo, Japan, 108-0073

Musashino, Tokyo, Japan, 180-8610

Shibuya-ku, Tokyo, Japan, 150-0002

Fukui, Japan, 910-8526

Fukui, Japan, 918-8503

Fukuoka, Japan, 811-0213

Fukuoka, Japan, 814-0180

Fukuoka, Japan, 815-8555

Kagoshima, Japan, 890-8760

Kumamoto, Japan, 861-4193

Kumamoto, Japan, 861-8520

Kumamoto, Japan, 862-0976

Nagasaki, Japan, 852-8511

Osaka, Japan, 530-0001

Osaka, Japan, 530-8480

Osaka, Japan, 543-0035

Osaka, Japan, 553-0003

Osaka, Japan, 558-8558

Saitama, Japan, 331-8577

Korea, Republic of

Chuncheon, Gang''weondo, Korea, Republic of, 24253

Wonju, Gang''weondo, Korea, Republic of, 26426

Anyang-si, Gyeonggido, Korea, Republic of, 14068

Goyang-si, Gyeonggido, Korea, Republic of, 10475

Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, Korea, Republic of, 21431

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 17985

Busan, Korea, Republic of, 47392

Busan, Korea, Republic of, 49241

Daejeon, Korea, Republic of, 35015

Seoul,, Korea, Republic of, 01830

Seoul, Korea, Republic of, 02841

Seoul, Korea, Republic of, 03080

Seoul, Korea, Republic of, 03722

Seoul, Korea, Republic of, 05278

Seoul, Korea, Republic of, 05355

Seoul, Korea, Republic of, 05505

Seoul, Korea, Republic of, 06351

Seoul, Korea, Republic of, 07061

Seoul, Korea, Republic of, 07441

Lithuania

Kaunas, Lithuania, LT-45217

Kaunas, Lithuania, LT-48259

Kaunas, Lithuania, LT-49449

Klaipeda, Lithuania, LT-92304

Utena, Lithuania, LT-28142

Vilnius, Lithuania, LT-08661

Malaysia

Johor Bahru, Malaysia, 80100

Kelantan, Malaysia, 15200

Kelantan, Malaysia

Kuala Lumpur, Malaysia, 59100

Pahang, Malaysia, 25100

Perak, Malaysia, 30450

Perak, Malaysia, 32040

Pulau Pinang, Malaysia, 10450

Putrajaya, Malaysia, 62250

Selangor, Malaysia, 47000

Mexico

Ciudad de México, Distrito Federal, Mexico, 6700

México D.F., Distrito Federal, Mexico, 14080

México, D. F., Distrito Federal, Mexico, 11850

México, D. F., Distrito Federal, Mexico, 3100

Guadalajara, Jalisco, Mexico, 44600

Guadalajara, Jalisco, Mexico, 44657

Cuernavaca, Morelos, Mexico, 62250

Queretaro, Querétaro, Mexico, 76000

San Juan del Río, Querétaro, Mexico, 76800

Culiacán, Sinaloa, Mexico, 80200

Culiacán, Sinaloa, Mexico, 80230

Mazatlán, Sinaloa, Mexico, 82110

Puerto de Veracruz, Veracruz, Mexico, 91900

Xalapa, Veracruz, Mexico, 91193

Aguascalientes, Mexico, 20219

Chihuahua, Mexico, 31238

Ciudad de México, Mexico, 06726

Netherlands

Alkmaar, Netherlands, 1815 JD

Almere, Netherlands, 1315 RA

Amersfoort, Netherlands, 3818 TZ

Amsterdam, Netherlands, 1091 AC

Amsterdam, Netherlands, 1105 AZ

Apeldoorn, Netherlands, 7334 DZ

Breda, Netherlands, 4818 CK

Den Haag, Netherlands, 2545 CH

Dordrecht, Netherlands, 3318 AT

Eindhoven, Netherlands, 5600 PD

Geleen, Netherlands, 6162 BG

Groningen, Netherlands, 9713 GZ

Hoogeveen, Netherlands, 7909 AA

Nieuwegein, Netherlands, 3435 CM

Zwijndrecht, Netherlands, 3331 LZ

New Zealand

Auckland, New Zealand, 2025

Auckland, New Zealand

Christchurch, New Zealand

Hamilton, New Zealand, 3204

Hawkes Bay, New Zealand, 4130

Palmerston North, New Zealand, 4414

Tauranga, New Zealand, 3110

Wellington, New Zealand

Norway

Hamar, Norway, 2317

Hamar, Norway

Kløfta, Norway, 2040

Kristiansand, Norway, 4604

Levanger, Norway, 7601

Oslo, Norway, 0176

Oslo, Norway, 0450

Skedsmokorset, Norway, 2020

Trondheim, Norway, 7030

Ålesund, Norway

Philippines

Iloilo City, Philippines, 5000

Marikina City, Philippines

Pasig City, Philippines, 1600

Quezon City, Philippines, 1102

Quezon City, Philippines, 1110

Quezon City, Philippines, 1112

Poland

Bialystok, Poland, 15-351

Bydgoszcz, Poland, 85-079

Chojnice, Poland, 89-600

Gdansk, Poland, 80-952

Gdynia, Poland, 81-537

Katowice, Poland, 40-040

Krakow, Poland, 30-510

Krakow, Poland, 31-156

Krakow, Poland, 31-261

Krakow, Poland, 31-559

Lodz, Poland, 90-153

Lodz, Poland, 92-213

Lodz, Poland, 94-060

Lublin, Poland, 20-538

Olsztyn, Poland, 10-561

Poznan, Poland, 60-834

Rzeszow, Poland, 35-055

Skorzewo, Poland, 60-185

Szczecin, Poland, 70-111

Torun, Poland, 87-100

Warszawa, Poland, 01-868

Warszawa, Poland

Wroclaw, Poland, 51-162

Wroclaw, Poland, 51-685

Zabrze, Poland, 41-800

Portugal

Covilha, Castelo Branco, Portugal, 6200-251

Loures, Lisboa, Portugal, 2674-514

Matosinhos, Porto, Portugal, 4464-513

Funchal, Região Autónoma Da Madeira, Portugal, 9004-514

Torres Novas, Santarém, Portugal, 2350-754

Setubal, Setúbal, Portugal, 2900-446

Almada, Portugal, 2801-951

Amadora, Portugal, 2720-276

Braga, Portugal, 4710-243

Faro, Portugal, 8000-386

Leiria, Portugal, 2410-197

Lisboa, Portugal, 1069-166

Lisboa, Portugal, 1250-189

Lisboa, Portugal, 1449-005

Lisboa, Portugal, 1500-650

Porto, Portugal, 4099-001

Porto, Portugal, 4200-319

Viana do Castelo, Portugal, 4901-858

Puerto Rico

Cidra, Puerto Rico, 00739

San Juan, Puerto Rico, 00909-3004

Romania

Alba-Iulia, Alba, Romania, 510053

Baia Mare, Maramures, Romania, 430222

Ploiesti, Prahova, Romania, 100179

Timisoara, Timis, Romania, 300456

Bucuresti, Romania, 010507

Bucuresti, Romania, 010627

Bucuresti, Romania, 010825

Bucuresti, Romania, 014142

Bucuresti, Romania, 020614

Bucuresti, Romania, 031818

Bucuresti, Romania, 050538

Cluj-Napoca, Romania, 400006

Galati, Romania, 800001

Iasi, Romania, 700547

Oradea, Romania, 410159

Satu Mare, Romania, 440055

Timisoara, Romania, 300736

Russian Federation

Arkhangelsk, Russian Federation, 163001

Barnaul, Russian Federation, 656024

Chelyabinsk, Russian Federation, 454021

Irkutsk, Russian Federation, 664079

Izhevsk, Russian Federation, 426063

Kazan, Russian Federation, 420012

Kazan, Russian Federation, 420101

Kemerovo, Russian Federation, 650002

Kemerovo, Russian Federation, 650055

Kemerovo, Russian Federation, 650066

Kirov, Russian Federation, 610014

Krasnodar, Russian Federation, 350086

Krasnoyarsk, Russian Federation, 660062

Kursk, Russian Federation, 305004

Moscow, Russian Federation, 111539

Moscow, Russian Federation, 117292

Moscow, Russian Federation, 119034

Moscow, Russian Federation, 119991

Moscow, Russian Federation, 123182

Moscow, Russian Federation, 123423

Moscow, Russian Federation, 125101

Moscow, Russian Federation, 125315

Moscow, Russian Federation, 129110

Nizhny Novgorod, Russian Federation, 603018

Nizhny Novgorod, Russian Federation, 603126

Novosibirsk, Russian Federation, 630047

Novosibirsk, Russian Federation, 630089

Novosibirsk, Russian Federation, 630091

Novosibirsk, Russian Federation, 630117

Omsk, Russian Federation, 644024

Omsk, Russian Federation, 644033

Omsk, Russian Federation, 644112

Orenburg, Russian Federation, 460040

Perm, Russian Federation, 614097

Ryazan, Russian Federation, 390026

Saratov, Russian Federation, 410030

St. Petersburg, Russian Federation, 193312

St. Petersburg, Russian Federation, 194044

St. Petersburg, Russian Federation, 194223

St. Petersburg, Russian Federation, 194354

St. Petersburg, Russian Federation, 195067

St. Petersburg, Russian Federation, 195112

St. Petersburg, Russian Federation, 195257

St. Petersburg, Russian Federation, 197762

St. Petersburg, Russian Federation, 199226

Stavropol, Russian Federation, 355030

Syktyvkar, Russian Federation, 167981

Voronezh, Russian Federation, 394018

Voronezh, Russian Federation, 394077

Yaroslavl, Russian Federation, 150003

Yaroslavl, Russian Federation, 150062

Yekaterinburg, Russian Federation, 620102

Singapore

Singapore, Singapore, 119074

Singapore, Singapore, 169608

Singapore, Singapore, 169609

Singapore, Singapore, 529889

Singapore, Singapore, 768828

Slovakia

Bardejov, Slovakia, 085 01

Nitra, Slovakia, 949 11

Rimavska Sobota, Slovakia, 979 01

Roznava, Slovakia, 048 01

Zilina, Slovakia, 01001

South Africa

Port Elizabeth, Eastern Cape, South Africa, 6045

Johannesburg, Gauteng, South Africa, 2198

Johannesburg, Gauteng, South Africa

Lenasia South, Gauteng, South Africa, 1829

Newtown, Gauteng, South Africa, 2113

Petoria, Gauteng, South Africa

Pretoria, Gauteng, South Africa, 0084

Pretoria, Gauteng, South Africa, 0181

Soweto, Gauteng, South Africa, 1818

Durban, Kwazulu-Natal, South Africa, 4030

Isipingo Rail, Kwazulu-Natal, South Africa, 4110

Tongaat, Kwazulu-Natal, South Africa, 4400

Middelburg, Mpumalanga, South Africa, 1050

Witbank, Mpumalanga, South Africa, 1035

Cape Town, Western Cape, South Africa, 7569

Cape Town, Western Cape, South Africa, 7925

Somerset West, Western Cape, South Africa, 7130

Worcester, Western Cape, South Africa, 6850

Pretoria, South Africa, 0002

Spain

Ferrol, A Coruña, Spain, 15405

Badalona, Barcelona, Spain, 08916

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Manresa, Barcelona, Spain, 08243

Sant Joan Despi, Barcelona, Spain, 08970

Jerez de la Frontera, Cádiz, Spain, 11407

Burela, Lugo, Spain, 27880

Alcalá de Henares, Madrid, Spain, 28805

Boadilla del Monte, Madrid, Spain, 28660

Getafe, Madrid, Spain, 28905

Sagunto, Valencia, Spain, 46520

A Coruña, Spain, 15006

Barcelona, Spain, 08003

Barcelona, Spain, 08025

Barcelona, Spain, 08035

Barcelona, Spain, 08036

Córdoba, Spain, 14004

Granada, Spain, 18012

Jaén, Spain, 23007

Madrid, Spain, 28007

Madrid, Spain, 28041

Málaga, Spain, 29010

Valencia, Spain, 46010

Valencia, Spain, 46014

Valencia, Spain, 46017

Valencia, Spain, 46026

Sweden

Göteborg, Sweden, 413 45

Göteborg, Sweden, 413 46

Lund, Sweden, 221 85

Lund, Sweden, 222 21

Rättvik, Sweden, 795 30

Skövde, Sweden, 541 50

Stockholm, Sweden, 113 24

Stockholm, Sweden, 114 46

Stockholm, Sweden, 141 86

Stockholm, Sweden, 182 88

Uppsala, Sweden, 751 85

Uppsala, Sweden, 752 37

Örebro, Sweden, 701 85

Örebro, Sweden, 703 62

Switzerland

Liestal, Basel-Landschaft, Switzerland, 4410

St. Gallen, Sankt Gallen, Switzerland, 9007

St. Gallen, Sankt Gallen, Switzerland, 9016

Olten, Solothurn, Switzerland, 4600

Frauenfeld, Thurgau, Switzerland, 8501

Lausanne, Vaud, Switzerland, 1011

Bern, Switzerland, 3010

Genève, Switzerland, 1205

Taiwan

Changhua, Taiwan, 50006

Kaohsiung, Taiwan, 833

New Taipei City, Taiwan, 220

Taichung, Taiwan, 40447

Taichung, Taiwan, 40705

Taipei, Taiwan, 10016

Taipei, Taiwan, 110

Taipei, Taiwan, 11217

Taoyuan, Taiwan, 333423

Thailand

Bangkok, Thailand, 10400

Bangkok, Thailand

Chiangmai, Thailand, 50200

Khon Kaen, Thailand, 40002

Turkey

Ankara, Turkey

Antalya, Turkey, 07058

Edirne, Turkey, 22030

Izmir, Turkey, 35540

Kayseri, Turkey, 38039

Kocaeli, Turkey, 41380

Malatya, Turkey, 44280

Samsun, Turkey, 55139

Sivas, Turkey, 58140

Ukraine

Cherkasy, Ukraine, 18009

Chernivtsi, Ukraine, 58002

Dnipro, Ukraine, 49000

Dnipro, Ukraine, 49023

Ivano-Frankivsk, Ukraine, 76008

Kharkiv, Ukraine, 61037

Kharkiv, Ukraine, 61039

Kharkiv, Ukraine, 61058

Kharkiv, Ukraine, 61070

Kiev, Ukraine, 01021

Kiev, Ukraine, 03049

Kiev, Ukraine, 04050

Kiev, Ukraine, 04114

Kiev, Ukraine, 1601

Kyiv, Ukraine, 03037

Lviv, Ukraine, 79010

Mykolayiv, Ukraine, 54003

Ternopil, Ukraine, 46002

Uzhgorod, Ukraine, 88018

Vinnytsia, Ukraine, 21001

Zaporizhzhya, Ukraine, 69001

Zaporizhzhya, Ukraine, 69600

United Kingdom

Llanelli, Carmarthenshire, United Kingdom, SA14 8QF

Leicester, Leicestershire, United Kingdom, LE5 4PW

Salford, Manchester, United Kingdom, M6 8HD

Liverpool, Merseyside, United Kingdom, L7 8XP

Northampton, Northamptonshire, United Kingdom, NN1 5BD

Carshalton, Surrey, United Kingdom, SM5 1AA

Newcastle Upon Tyne, Vale Of Glamorgan, The, United Kingdom, NE1 4LP

Chichester, West Sussex, United Kingdom, PO19 6SE

Bristol, United Kingdom, BS10 5NB

London, United Kingdom, E1 1BB

London, United Kingdom, NW3 2QG

London, United Kingdom, SE5 9RS

Manchester, United Kingdom, M8 5RB

Middlesborough, United Kingdom, TS4 3BW

Portsmouth, United Kingdom, PO6 3LY

Vietnam

Ha Noi, Vietnam, 10000

Ha Noi, Vietnam

Ho Chi Minh City, Vietnam, 70000

Ho Chi Minh City, Vietnam, 84

Ho Chi Minh City, Vietnam

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

  Study Documents (Full-Text)

Documents provided by Bayer:

Study Protocol  [PDF] February 26, 2019

Statistical Analysis Plan  [PDF] February 14, 2020

More Information

Additional Information:

Click here to find results for studies related to Bayer products 

Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

Publications of Results:

Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.

Other Publications:

Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Nowack C, Kolkhof P, Ferreira AC, Schloemer P, Filippatos G; on behalf of the FIDELIO-DKD study investigators; FIDELIO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):333-344. doi: 10.1159/000503713. Epub 2019 Oct 25.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rossing P, Burgess E, Agarwal R, Anker SD, Filippatos G, Pitt B, Ruilope LM, Gillard P, MacIsaac RJ, Wainstein J, Joseph A, Brinker M, Roessig L, Scott C, Bakris GL; FIDELIO-DKD Investigators:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); National lead investigators:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); Diego Aizenberg; Inés Bartolacci; Diego Besada; Julio Bittar; Mariano Chahin; Alicia Elbert; Elizabeth Gelersztein; Alberto Liberman; Laura Maffei; Federico Pérez Manghi; Hugo Sanabria; Augusto Vallejos; Gloria Viñes; Alfredo Wassermann; Walter Abhayaratna; Shamasunder Acharya; Elif Ekinci; Darren Lee; Richard MacIsaac; Peak Mann Mah; Craig Nelson; David Packham; Alexia Pape; Simon Roger; Hugo Stephenson; Michael Suranyi; Gary Wittert; Elizabeth Vale; Martin Clodi; Christoph Ebenbichler; Evelyn Fliesser-Görzer; Ursula Hanusch; Michael Krebs; Karl Lhotta; Bernhard Ludvik; Gert Mayer; Peter Neudorfer; Bernhard Paulweber; Rudolf Prager; Wolfgang Preiß; Friedrich Prischl; Gerit-Holger Schernthaner; Harald Sourij; Martin Wiesholzer; Peter Doubel; Wendy Engelen; Pieter Gillard; Jean-Michel Hougardy; Jean-Marie Krzesinski; Bart Maes; Marijn Speeckaert; Koen Stas; Luc van Gaal; Hilde Vanbelleghem; Daniela Antunes; Roberto Botelho; Claudia Brito; Luis Canani; Maria Eugenia Canziani; Maria Cerqueira; Rogerio de Paula; Freddy Eliaschewitz; Carlos Eduardo Figueiredo; Adriana Forti; Miguel Hissa; Maurilo Leite Jr; Emerson Lima; Irene Noronha; Bruno Paolino; Nathalia Paschoalin; Raphael Paschoalin; Roberto Pecoits Filho; Marcio Pereira; Evandro Portes; Dalton Precoma; Rosangela Rea; Miguel Riella; Joao Eduardo Salles; Eduardo Vasconcellos; Sergio Vencio; Emiliya Apostolova; Radostina Boshnyashka; Ghassan Farah; Dimitar Georgiev; Valentina Gushterova; Neli Klyuchkova; Mariya Lucheva; Petya Manova; Dotska Minkova; Boyan Nonchev; Mariyana Pichmanova; Zhulieta Prakova; Rangel Rangelov; Rosen Rashkov; Pavel Stanchev; Bilyana Stoyanovska-Elencheva; Zhivko Tagarev; Theodora Temelkova-Kurktschieva; Svetla Vasileva; Mariana Yoncheva-Mihaylova; Paul Barre; Brian Carlson; James Conway; Serge Cournoyer; Richard Dumas; Sameh Fikry; Richard Goluch; Pavel Hamet; Randolph Hart; Sam Henein; Joanne Liutkus; Francois Madore; Valdemar Martinho; Giuseppe Mazza; Philip McFarlane; Dennis O'Keefe; Sean Peterson; Daniel Schwartz; Daniel Shu; Andrew Steele; Guy Tellier; Karthik Tennankore; Sheldon Tobe; George Tsoukas; Richard Tytus; Louise Vitou; Michael Walsh; Stanley Weisnagel; Igor Wilderman; Jean-Francois Yale; Jorge Cobos; Juan Godoy; Fernando González; Sergio Lobos; Juan Carlos Palma; Juan Carlos Prieto; Eliana Reyes; Carmen Romero; Victor Saavedra; Mario Vega; Ruifang Bu; Hanqing Cai; Nan Chen; Qinkai Chen; Dejun Chen; Jinluo Cheng; Youping Dong; Junwu Dong; Tianjun Guan; Chuanming Hao; Wen Huang; Fangfang Jiang; Minxiang Lei; Ling Li; Zhonghe Li; Xuemei Li; Jingmei Li; Yan Li; Xinling Liang; Bo Liang; Fang Liu; Yinghong Liu; Yuantao Liu; Zhihong Liu; Gang Long; Guoyuan Lu; Weiping Lu; Yibing Lu; Ping Luo; Jianhua Ma; Zhaohui Mo; Jianying Niu; Ai Peng; Jiansong Shen; Feixia Shen; Bingyin Shi; Qing Su; Zhuxing Sun; Shuifu Tang; Nanwei Tong; Hao Wang; Xinjun Wang; Lihua Wang; Guixia Wang; Jianqin Wang; Yangang Wang; Li Wang; Jiali Wei; Tianfeng Wu; Chaoqing Wu; Changying Xing; Fei Xiong; Xudong Xu; Ning Xu; Tiekun Yan; Jinkui Yang; Aiping Yin; Longyi Zeng; Hao Zhang; Yanlin Zhang; Ying Zhang; Wenjing Zhao; Zhiquan Zhao; Hongguang Zheng; Ling Zhong; Dalong Zhu; Yongze Zhuang; Clara Arango; Sandra Barrera; Nelly Beltrán López; Diego Benitez; Guillermo Blanco; Andrés Cadena; Julian Coronel; Carlos Cure; Carlos Durán; Alexander González; Gustavo Guzmán; Eric Hernández; Jaime Ibarra; Carlos Jaramillo; Nicolás Jaramillo; William Kattah; Dora Molina; Gregorio Sánchez; Mónica Terront; Freddy Trujillo; Miguel Urina; Ruben Vargas; Iván Villegas; Hernán Yupanqui; Dino Alferi; Michal Brada; Jiri Brezina; Petr Bucek; Tomas Edelsberger; Drahomira Gulakova; Jitka Hasalova Zapletalova; Olga Hola; Lucie Hornova; Jana Houdova; Helena Hrmova; David Karasek; Sarka Kopecka; Richard Kovar; Eva Krcova; Jiri Kuchar; Vlasta Kutejova; Hana Lubanda; Ivo Matyasek; Magdalena Mokrejsova; Libor Okenka; Martin Prazny; Jiri Pumprla; Pavel Tomanek; Jesper Bech; Jens Faber; Gunnar Gislason; Jørgen Hangaard; Grzegorz Jaroslaw Pacyk; Claus Juhl; Thure Krarup; Morten Lindhardt; Sten Madsbad; Joan Nielsen; Ulrik Pedersen-Bjergaard; Per Poulsen; Ole Rasmussen; Peter Rossing; Karoline Schousboe; Mikko Honkasalo; Kari Humaloja; Kristiina Kananen; Ilkka Kantola; Arvo Koistinen; Pirkko Korsoff; Jorma Lahtela; Sakari Nieminen; Tuomo Nieminen; Karita Sadeharju; Jorma Strand; Sakari Sulosaari; Bertrand Cariou; François Chantrel; Sylvaine Clavel; Christian Combe; Jean-Pierre Fauvel; Karim Gallouj; Didier Gouet; Bruno Guerci; Dominique Guerrot; Maryvonne Hourmant; Alexandre Klein; Christophe Mariat; Michel Marre; Rafik Mesbah; Yannick Le Meur; Arnaud Monier; Olivier Moranne; Pierre Serusclat; Benoit Vendrely; Bruno Verges; Philippe Zaoui; Christoph Axthelm; Andreas Bergmann; Andreas L. Birkenfeld; Hermann Braun; Klaus Busch; Christel Contzen; Stefan Degenhardt; Karl Derwahl; Thomas Giebel; Andreas Hagenow; Hermann Haller; Christoph Hasslacher; Thomas Horacek; Wolfgang Jungmair; Christof Kloos; Thorsten Koch; Thilo Krüger; Anja Mühlfeld; Joachim Müller; Andreas Pfützner; Frank Pistrosch; Ludger Rose; Lars Rump; Volker Schettler; Ingolf Schiefke; Heike Schlichthaar; Bernd Schröppel; Thomas Schürholz; Helena Sigal; Lutz Stemler; Georg Strack; Heidrun Täschner; Nicole Toursarkissian; Diethelm Tschöpe; Achim Ulmer; Markus van der Giet; Christoph Wanner; Bernhard R. Winkelmann; Ioannis Boletis; Erifili Hatziagelaki; Ioannis Ioannidis; Theodora Kounadi; Ioanna Makriniotou; Dorothea Papadopoulou; Aikaterini Papagianni; Ploumis Passadakis; Ioannis Stefanidis; Tai Pang Ip; Paul Lee; On Yan Andrea Luk; Angela Wang; Vincent Yeung; Dora Bajcsi; Peter Danos; Eleonora Harcsa; Szilvia Kazup; Katalin Keltai; Robert Kirschner; Julianna Kiss; Laszlo Kovacs; Beata Lamboy; Botond Literati-Nagy; Margit Mileder; Laszlo Nagy; Ebrahim Noori; Gabor Nyirati; Gizella Petro; Karoly Schneider; Albert Szocs; Szilard Vasas; Krisztina Wudi; Zsolt Zilahi; Marianna Zsom; Joe Eustace; John Holian; Donal Reddan; Yvonne O'Meara; Rosane Abramof Ness; Faiad Adawi; Zaher Armaly; Shaul Atar; Sydney Ben Chetrit; Noa Berar Yanay; Gil Chernin; Mahmud Darawsha; Shai Efrati; Mazen Elias; Evgeny Farber; Mariela Glandt; Ehud Grossman; Majdi Halabi; Khaled Khazim; Idit Liberty; Ofri Mosenzon; Assy Nimer; Doron Schwartz; Julio Wainstein; Yoram Yagil; Robert Zukermann; Aneliya Ilieva Parvanova; Angelo Avogaro; Giovanni Giorgio Battaglia; Maurizio Tiziano Bevilacqua; Enzo Bonora; Carlo Antonio Bossi; Paolo Calabrò; Franco Luigi Cavalot; Roberto Cimino; Mario Gennaro Cozzolino; Salvatore David; Michele Emdin; Enrico Fiaccadori; Paolo Fiorina; Carlo Bruno Giorda; Maria Cristina Gregorini; Gaetano La Manna; Davide Carlo Maggi; Roberta Manti; Giancarla Meregalli; Antonello Pani; Norberto Perico; PierMarco Piatti; Antonio Pisani; Antonio Ettore Pontiroli; Paola Ponzani; Gennaro Santorelli; Domenico Santoro; Renzo Scanziani; Ugo Teatini; Giancarlo Tonolo; Roberto Trevisan; Anna Maria Veronelli; Giorgio Luciano Viviani; Hideo Araki; Osamu Ebisui; Naruhiro Fujita; Ryuichi Furuya; Yoshiyuki Hamamoto; Masahiro Hatazaki; Terumasa Hayashi; Takayuki Higashi; Yoshihide Hirohata; Shuji Horinouchi; Masayuki Inagaki; Masao Ishii; Tamayo Ishiko; Hideaki Jinnouchi; Hidetoshi Kanai; Daisuke Kanda; Hideo Kanehara; Masayuki Kashima; Kiyoe Kato; Takeshi Katsuki; Katsunori Kawamitsu; Satsuki Kawasaki; Fumi Kikuchi; Hidetoshi Kikuchi; Kunihisa Kobayashi; Junko Koide; Miyuki Kubota; Yoshiro Kusano; Hajime Maeda; Sunao Matsubayashi; Kazunari Matsumoto; Yasuto Matsuo; Naoki Matsuoka; Hiroaki Miyaoka; Satoshi Murao; Mikihiro Nakayama; Jun Nakazawa; Takashi Nomiyama; Masayuki Noritake; Takayuki Ogiwara; Hiroshi Ohashi; Hideki Okamoto; Takeshi Osonoi; Nobuhiro Sasaki; Taiji Sekigami; Taro Shibasaki; Hirotaka Shibata; Junji Shinoda; Hiroshi Sobajima; Kazuya Sugitatsu; Toshiyuki Sugiura; Toru Sugiyama; Daisuke Suzuki; Hiroyuki Suzuki; Masaaki Suzuki; Asami Takeda; Asami Tanaka; Seiichi Tanaka; Izumi Tsunematsu; Makoto Ujihara; Daishiro Yamada; Masayo Yamada; Kazuo Yamagata; Ken Yamakawa; Fumiko Yamakawa; Yoshimitsu Yamasaki; Yuko Yambe; Taihei Yanagida; Hidekatsu Yanai; Tetsuyuki Yasuda; Dovile Kriauciuniene; Jurate Lasiene; Antanas Navickas; Lina Radzeviciene; Egle Urbanaviciene; Gediminas Urbonas; Audrone Velaviciene; Rohana Abd Ghani; Nor Azizah Aziz; Li Yuan Lee; Chek Loong Loh; Norhaliza Mohd Ali; Nurain Mohd Noor; Nik Nur Fatnoon Nik Ahmad; Jeyakantha Ratnasingam; Wan Hasnul Halimi Bin Wan Hasan; Wan Mohd Izani Wan Mohamed; Sandro Avila Pardo; Miriam Bastidas Adrian; Alfredo Chew Wong; Jorge Escobedo de la Peña; Guillermo Fanghänel Salmón; Guillermo González Gálvez; Ramiro Gutiérrez Ochoa; Saúl Irizar Santana; Magdalena Madero Rovalo; Gustavo Méndez Machado; Luis Nevarez Ruiz; Denisse Ramos Ibarra; Gabriel Ramos López; Leobardo Sauque Reyna; Gustavo Solache Ortiz; Rafael Valdez Ortiz; Juan Villagordoa Mesa; R.C. Bakker; J.N.M. Barendregt; A.H. Boonstra; Willem Bos; C.B. Brouwer; M. van Buren; Ron Gansevoort; Adriaan Kooy; Marielle Krekels; Ruud J.M. van Leendert; Louis A.G. Lieverse; P.T. Luik; E. Lars Penne; Peter Smak Gregoor; Liffert Vogt; John Baker; Veronica Crawford; Rick Cutfield; Peter Dunn; Jeremy Krebs; Kingsley Nirmalaraj; Russell Scott; Nine Smuts; Erik Eriksen; Trine Finnes; Hans Høivik; Thomas Karlsson; Peter Scott Munk; Maria Radtke; Knut Risberg; Jan Rocke; Leidulv Solnør; Aud-Eldrid Stenehjem; Anne-Beathe Tafjord; Glenda Pamugas; Araceli Panelo; Ronald Perez; Maribel Tanque; Louie Tirador; Michael Villa; Patrycja Butrymowicz; Kazimierz Ciechanowski; Grazyna Cieslik; Edward Franek; Janusz Gumprecht; Michal Hoffmann; Jolanta Krzykowska; Ilona Kurnatowska; Katarzyna Landa; Adam Madrzejewski; Katarzyna Madziarska; Stanislaw Mazur; Piotr Napora; Michal Nowicki; Anna Ocicka-Kozakiewicz; Barbara Rewerska; Teresa Rusicka; Jan Ruxer; Ewa Skokowska; Andrzej Stankiewicz; Tomasz Stompor; Agnieszka Tiuryn-Petrulewicz; Katarzyna Wasilewska; Bogna Wierusz-Wysocka; Renata Wnetrzak-Michalska; Edgar Almeida; Rosa Ballesteros; Carlos Barreto; Idalina Beirao; Rita Birne; Cesar Esteves; Jose Guia; Susana Heitor; Olinda Marques; Pedro Melo; Fernando Nolasco; Amalia Pereira; Cristina Roque; Francisco Rosario; Gil Silva; Ana Silva; Fernando Teixeira e Costa; Ana Vila Lobos; Gregorio Cortes-Maisonet; Amaury Roman-Miranda; Adrian Albota; Cornelia Bala; Hortensia Barbonta; Elena Caceaune; Doina Catrinoui; Ciprian Constantin; Adriana Dumitrescu; Nicoleta Mindrescu; Cristina Mistode; Gabriela Negrisanu; Adriana Onaca; Silvia Paveliu; Ella Pintilei; Lavinia Pop; Amorin Popa; Alexandrina Popescu; Gabriela Radulian; Iosif Szilagyi; Liana Turcu; Georgeta Vacaru; Adrian Vlad; Mikhail Antsiferov; Mikhail Arkhipov; Andrey Babkin; Olga Barbarash; Vitaliy Baranov; Elena Chernyavskaya; Arkadiy Demko; Alexander Dreval; Anton Edin; Polina Ermakova; Valentin Fadeev; Albert Galyavich; Leyla Gaysina; Ivan Gordeev; Irina Ipatko; Marina Kalashnikova; Yuriy Khalimov; Vadim Klimontov; Zhanna Kobalava; Elena Kosmacheva; Natalya Koziolova; Lyudmila Kvitkova Sergey Levashov; Roman Libis; Vyacheslav Marasaev; Natalia Malykh; Vladimir Martynenko; Sofya Malyutina; Imad Merai; Ashot Mkrtumyan; Galina Nechaeva; Nina Petunina; Shamil Palyutin; Leonid Pimenov; Elena Rechkova; Tatyana Rodionova; Oksana Rymar; Ruslan Sardinov; Olga Semenova; Alexander Sherenkov; Oleg Solovev; Elena Smolyarchuk; Leonid Strongin; Olga Ukhanova; Nadezhda Verlan; Natalya Vorokhobina; Davyd Yakhontov; Sergey Yakushin; Elena Zakharova; Alsu Zalevskaya; Olga Zanozina; Elena Zhdanova; Larisa Zhukova; Tatyana Zykova; Chee Fang Sum; Sufi Muhummad Suhail; Ru San Tan; Anantharaman Vathsala; Edmund Wong; Jana Babikova; Ingrid Buganova; Andrej Dzupina; Zuzana Ochodnicka; Dalibor Sosovec; Denisa Spodniakova; Fayzal Ahmed; Aslam Amod; Sindeep Bhana; Larry Distiller; Dirkie Jansen van Rensburg; Mukesh Joshi; Shaifali Joshi; Deepak Lakha; Essack Mitha; Gracjan Podgorski; Naresh Ranjith; Brian Rayner; Paul Rheeder; Mohamed Sarvan; Mary Seeber; Heidi Siebert; Mohammed Tayob; Julien Trokis; Dorothea Urbach; Louis van Zyl; Bum-Soon Choi; Moon Gi Choi; ChoonHee Chung; YouCheol Hwang; ChongHwa Kim; InJoo Kim; JaeHyeon Kim; SinGon Kim; SungGyun Kim; Tae Hee Kim; WooJe Lee; ByungWan Lee; Kang Wook Lee; Kook-Hwan Oh; Ji Eun Oh; Yun Kyu Oh; Dong-Jin Oh; Junbeom Park; Seok Joon Shin; Su-Ah Sung; Jae Myung Yu; Irene Agraz; Francisco Javier Ampudia; Hanane Bouarich; Francesca Calero; Cristina Castro; Secundino Cigarrán Guldris; Josep Cruzado Garrit; Fernando de Álvaro; Josep Galcerán; Olga González Albarrán; Julio Hernández Jaras; Meritxell Ibernón; Francisco Martínez Deben; Ma Dolores Martínez Esteban; José María Pascual Izuel; Judith Martins; Juan Mediavilla; Alfredo Michán; Julio Pascual Santos; Esteban Poch; Manuel Polaina Rusillo; Carlos Sánchez Juan; Rafael Santamaría Olmo; José Julián Segura de la Morena; Alfonso Soto; Maribel Troya; Annette Bruchfeld; Dan Curiac; Ken Eliasson; Malin Frank; Gregor Guron; Olof Hellberg; Margareta Hellgren; Hans Larnefeldt; Carl-Johan Lindholm; Magnus Löndahl; Erik Rein-Hedin; Inga Soveri; Jonas Spaak; Bengt-Olov Tengmark; Daniel Ackermann; Stefan Bilz; Michel Burnier; Christian Forster; Stefan Kalbermatter; Andreas Kistler; Antoinette Pechére-Bertschi; Bernd Schultes; Chiz-Tzung Chang; Cheng-Chieh Hung; Ju-Ying Jiang; Chien-Te Lee; Shuei-Liong Lin; Der-Cherng Tarng; Shih-Te Tu; Mai-Szu Wu; Ming-Ju Wu; Chaicharn Deerochanawong; Chagriya Kitiyakara; Vuddhidej Ophascharoensuk; Chatlert Pongchaiyakul; Bancha Satirapoj; Necmi Eren; Ibrahim Gul; Okan Gulel; Ismail Kocyigit; Abdulbaki Kumbasar; Idris Sahin; Ramazan Sari; Burak Sayin; Talat Tavli; Sedat Ustundag; Yavuz Yenicerioglu; Iryna Bondarets; Volodymyr Botsyurko; Viktoriia Chernikova; Oleksandra Donets; Ivan Fushtey; Mariia Grachova; Anna Isayeva; Dmytro Kogut; Julia Komisarenko; Nonna Kravchun; Kateryna Malyar; Borys Mankovsky; Liliya Martynyuk; Vitaliy Maslyanko; Halyna Myshanych; Larysa Pererva; Nataliia Pertseva; Oleksandr Serhiyenko; Ivan Smirnov; Liubov Sokolova; Vasyl Stryzhak; Maryna Vlasenko; Ahmad AbouSaleh; Jonathan Barratt; Cuong Dang; Hassan Kahal; Adam Kirk; Anne Kilvert; Sui Phi Kon; Kieran McCafferty; Dipesh Patel; Sam Rice; Arutchelvam Vijayaraman; Yuk-ki Wong; Martin Gibson; Mona Wahba; Reza Zaidi; Idalia Acosta; Atoya Adams; Sharon Adler; Dilawar Ajani; Slamat Ali; Radica Alicic; Amer Al-Karadsheh; Sreedhara Alla; D. Allison; Nabil Andrawis; Ahmed Arif; Ahmed Awad; Masoud Azizad; Michael Bahrami; Shweta Bansal; Steven Barag; Ahmad Barakzoy; Mark Barney; Joshua Barzilay; Khalid Bashir; Jose Bautista; Srinivasan Beddhu; Diogo Belo; Sabrina Benjamin; Ramin Berenji; Anuj Bhargava; Jose Birriel; Stephen Brietzke; Frank Brosius; Osvaldo Brusco; Anna Burgner; Robert Busch; Rafael Canadas; Maria Caramori; Jose Cardona; Christopher Case; Humberto Cruz; Ramprasad Dandillaya; Dalia Dawoud; Zia Din; Bradley Dixon; Ankur Doshi; James Drakakis; Mahfouz El Shahawy; Ashraf El-Meanawy; Mohammed El-Shahawy; John Evans; George Fadda; Umar Farooq; Roland Fernando; Raymond Fink; Brian First; David Fitz-Patrick; John Flack; Patrick Fluck; Leon Fogelfeld; Vivian Fonseca; Juan Frias; Claude Galphin; Luis Garcia-Mayol; Gary Goldstein; Edgar Gonzalez; Francisco Gonzalez-Abreu; Ashwini Gore; David Grant; Violet Habwe; Maxine Hamilton; Jamal Hammoud; Stuart Handelsman; Israel Hartman; Glenn Heigerick; Andrew Henry; German Hernandez; Carlos Hernandez-Cassis; Carlos Herrera; Joachim Hertel; Wenyu Huang; Rogelio Iglesias; Ali Iranmanesh; Timothy Jackson; Mahendra Jain; Kenneth Jamerson; Karen Johnson; Eric Judd; Joshua Kaplan; Zeid Kayali; Bobby Khan; Muhammad Khan; Sourabh Kharait; M. Sue Kirkman; Nelson Kopyt; Wayne Kotzker; Csaba Kovesdy; Camil Kreit; Arvind Krishna; Saeed Kronfli; Keung Lee; Derek LeJeune; Brenda Lemus; Carlos Leon-Forero; Douglas Linfert; Henry Lora; Alexander Lurie; Geetha Maddukuri; Alexander Magno; Louis Maletz; Sreedhar Mandayam; Mariana Markell; Ronald Mayfield; Caroline Mbogua; Dierdre McMullen; Carl Meisner; Stephen Minton; Bharat Mocherla; Rajesh Mohandas; Manuel Montero; Moustafa Moustafa; Salil Nadkarni; Samer Nakhle; Jesus Navarro; Nilda Neyra; Romanita Nica; Philip Nicol; Paul Norwood; Visal Numrungroad; Richard O'Donovan; A. Odugbesan; Jorge Paoli-Bruno; Samir Parikh; Rakesh Patel; Aldo Peixoto; Pablo Pergola; Alan Perlman; Karlton Pettis; Roberto Pisoni; Mirela Ponduchi; Jorge Posada; Sharma Prabhakar; Jai Radhakrishnan; Mahboob Rahman; Rupesh Raina; Anjay Rastogi; Efrain Reisin; Marc Rendell; David Robertson; Michael Rocco; Hugo Romeu; Sylvia Rosas; Jack Rosenfeld; Dennis Ross; Jeffrey Rothman; Lance Rudolph; Yusuf Ruhullah; Gary Ruoff; Jeffrey Ryu; Mandeep Sahani; Ramin Sam; Garfield Samuels; William Sanchez; Vladimir Santos; Scott Satko; Sanjeev Saxena; David Scott; Gilberto Seco; Melvin Seek; Harvey Serota; Tariq Shafi; Nauman Shahid; Michael Shanik; Santosh Sharma; Arjun Sinha; James Smelser; Mark Smith; Kyaw Soe; Richard Solomon; Eugene Soroka; Joseph Soufer; Bruce Spinowitz; Leslie Spry; Rosa Suarez; Bala Subramanian; Harold Szerlip; Aparna Tamirisa; Stephen Thomson; Tuan-Huy Tran; Richard Treger; Gretel Trullenque; Thomas Turk; Guillermo Umpierrez; Daniel Urbach; Martin Valdes; Shujauddin Valika; Damaris Vega; Peter Weissman; Adam Whaley-Connell; Jonathan Winston; Jonathan Wise; Alan Wynne; Steven Zeig; Phuong Chu; Lam Van Hoang; Tran Khanh; Nguyen Thi Phi Nga; Pham Nguyen Son; Lan Phuong Tran. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. Diabetes Care. 2022 Apr 1;45(4):888-897. doi: 10.2337/dc21-1944.

Rossing P, Filippatos G, Agarwal R, Anker SD, Pitt B, Ruilope LM, Chan JCN, Kooy A, McCafferty K, Schernthaner G, Wanner C, Joseph A, Scheerer MF, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. Kidney Int Rep. 2021 Oct 14;7(1):36-45. doi: 10.1016/j.ekir.2021.10.008. eCollection 2022 Jan.

Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Ruilope LM, Boletis J, Toto R, Umpierrez GE, Wanner C, Wada T, Scott C, Joseph A, Ogbaa I, Roberts L, Scheerer MF, Bakris GL. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post-hoc analyses from FIDELIO-DKD compared to reported CREDENCE results. Nephrol Dial Transplant. 2021 Nov 25. pii: gfab336. doi: 10.1093/ndt/gfab336. [Epub ahead of print]

Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.

Erraez S, López-Mesa M, Gómez-Fernández 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. Review. 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.

Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02540993
• Other Study ID Numbers: 16244; 2015-000990-11 ( EudraCT Number )
• First Posted: September 4, 2015
• Results First Posted: July 19, 2021
• Last Update Posted: July 19, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

CKD; Diabetic Kidney Disease; Type 2 Diabetes; Kidney diseases

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Renal Insufficiency; Diabetes Complications