AzTrials
AzTrials

Diabetic Kidney DiseasePhase 3FIGARO-DKDNCT02545049

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

A Phase 3 study testing Finerenone (BAY94-8862) in people with Diabetic Kidney Disease, run by Bayer at 975 sites in 48 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
Finerenone (BAY94-8862)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,352 participants
Where
975 sitesin 48 countries
Study dates
17 Sep 2015to 2 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women ≥18 years of age
  • 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

Who cannot join

  • Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
  • 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%

Trial locations and contacts

975 sites in 48 countries.

975 sites in 48 countries

United States173 sites
  • Study site

    Albany, New York, 12203

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Anderson, South Carolina, 29625

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Arlington, Texas, 76014

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30904

  • Study site

    Bakersfield, California, 93309

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bethlehem, Pennsylvania, 18017

  • Study site

    Birmingham, Alabama, 35294-2041

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn, New York, 11229

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Canton, Ohio, 44718

  • Study site

    Chapel Hill, North Carolina, 27312

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chula Vista, California, 91910

  • Study site

    Columbia, Missouri, 65201

  • Study site

    Columbia, Missouri, 65212

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dallas, Texas, 75251

  • Study site

    Dublin, California, 94568

  • Study site

    El Centro, California, 92243

  • Study site

    El Paso, Texas, 79902-4672

  • Study site

    Elgin, Illinois, 60123

  • Study site

    Flint, Michigan, 48504

  • Study site

    Flint, Michigan, 48532

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Lauderdale, Florida, 33312

  • Study site

    Fort Lauderdale, Florida, 33316-1958

  • Study site

    Fort Payne, Alabama, 35967

  • Study site

    Fresno, California, 93720

  • Study site

    Fresno, California, 93721

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greenville, South Carolina, 29607

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hollywood, Florida, 33024

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77008

  • Study site

    Houston, Texas, 77018

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77040

  • Study site

    Houston, Texas, 77061

  • Study site

    Houston, Texas, 77079

  • Study site

    Houston, Texas, 77095

  • Study site

    Huntsville, Alabama, 35801-4317

  • Study site

    Hutchinson, Kansas, 67502-1131

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jacksonville, Florida, 32204

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Jersey Shore, Pennsylvania, 17740

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kansas City, Missouri, 64128

  • Study site

    Kingwood, Texas, 77339

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vegas, Nevada, 89086

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Las Vegas, Nevada, 89113-2215

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lawrenceville, Georgia, 30046

  • Study site

    Loma Linda, California, 92357

  • Study site

    Los Angeles, California, 90017

  • Study site

    Los Angeles, California, 90022

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90073

  • Study site

    Macon, Georgia, 31210

  • Study site

    Manassas, Virginia, 20110

  • Study site

    McAllen, Texas, 78503

  • Study site

    McKinney, Texas, 75069

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Memphis, Tennessee, 38163

  • Study site

    Mesa, Arizona, 85210

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33032

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33130

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33145

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33165

  • Study site

    Miami, Florida, 33173

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami, Florida, 33186

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Miami Gardens, Florida, 33014

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Miami Lakes, Florida, 33016

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Missouri City, Texas, 77459

  • Study site

    Monroe, Louisiana, 71201

  • Study site

    Morton, Illinois, 61550

  • Study site

    Murrells Inlet, South Carolina, 29576

  • Study site

    Myrtle Beach, South Carolina, 29588

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    Nashville, Tennessee, 37208

  • Study site

    Nashville, Tennessee, 37232-1371

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New York, New York, 10029

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Northridge, California, 91325

  • Study site

    Ocala, Florida, 34471

  • Study site

    Omaha, Nebraska, 68124

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Orlando, Florida, 32825

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Pearland, Texas, 77584

  • Study site

    Pflugerville, Texas, 78660

  • Study site

    Phoenix, Arizona, 85016

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Port Hueneme, California, 93041

  • Study site

    Poway, California, 92064

  • Study site

    Prescott, Arizona, 86301

  • Study site

    Rancho Cucamonga, California, 91730

  • Study site

    Reno, Nevada, 89511

  • Study site

    Rialto, California, 92377

  • Study site

    Rosedale, New York, 11422

  • Study site

    Roseville, California, 95661

  • Study site

    Salem, Virginia, 24153

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    San Antonio, Texas, 78212

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229-3900

  • Study site

    San Diego, California, 92117

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Smithtown, New York, 11787

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Illinois, 62702-1311

  • Study site

    St Louis, Missouri, 63106

  • Study site

    St Louis, Missouri, 63136

  • Study site

    Staten Island, New York, 10301

  • Study site

    Sugar Land, Texas, 77478

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tomball, Texas, 77375

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Torrance, California, 90502

  • Study site

    Tucson, Arizona, 85723

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    Vista, California, 92083

  • Study site

    Waco, Texas, 76708

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Des Moines, Iowa, 50265

  • Study site

    West Palm Beach, Florida, 33401-3430

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Willoughby Hills, Ohio, 44094

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Japan71 sites
  • Study site

    Asahikawa, Hokkaido, 078-8234

  • Study site

    Atsugi, Kanagawa, 243-0035

  • Study site

    Beppu, Oita Prefecture, 874-0011

  • Study site

    Chikushino-shi, Fukuoka, 818-8502

  • Study site

    Fujisawa, Kanagawa, 251-0041

  • Study site

    Fukui, 910-8526

  • Study site

    Fukui, 918-8503

  • Study site

    Fukuoka, 811-0213

  • Study site

    Fukuoka, 814-0180

  • Study site

    Fukuoka, 815-8555

  • Study site

    Funabashi, Chiba, 273-8588

  • Study site

    Hakodate, Hokkaido, 041-8680

  • Study site

    Higashihiroshima, Hiroshima, 739-0041

  • Study site

    Ichikawa, Chiba, 272-8516

  • Study site

    Iwata, Shizuoka, 438-8550

  • Study site

    Kagoshima, 890-8760

  • Study site

    Kamakura, Kanagawa, 247-8533

  • Study site

    Kasuga, Fukuoka, 816-0864

  • Study site

    Kawaguchi, Saitama, 332-0012

  • Study site

    Kitakyushu, Fukuoka, 800-0296

  • Study site

    Kitakyushu, Fukuoka, 802-8555

  • Study site

    Kitakyushu, Fukuoka, 805-8508

  • Study site

    Kitakyushu, Fukuoka, 807-0857

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Komatsu, Ishikawa-ken, 923-8560

  • Study site

    Kumamoto, 861-4193

  • Study site

    Kumamoto, 861-8520

  • Study site

    Kumamoto, 862-0976

  • Study site

    Maebashi, Gunma, 371-0821

  • Study site

    Matsubara, Osaka, 580-0032

  • Study site

    Matsuyama, Ehime, 790-0024

  • Study site

    Matsuyama, Ehime, 791-8026

  • Study site

    Minato, Tokyo, 108-0073

  • Study site

    Musashino, Tokyo, 180-8610

  • Study site

    Nagasaki, 852-8511

  • Study site

    Nagoya, Aichi-ken, 451-8511

  • Study site

    Nagoya, Aichi-ken, 456-0058

  • Study site

    Nagoya, Aichi-ken, 457-8510

  • Study site

    Nagoya, Aichi-ken, 460-0001

  • Study site

    Nagoya, Aichi-ken, 466-8650

  • Study site

    Naka, Ibaraki, 311-0113

  • Study site

    Nakagami-gun, Okinawa, 901-2393

  • Study site

    Obihiro, Hokkaido, 080-0848

  • Study site

    Ōgaki, Gifu, 503-8502

  • Study site

    Osaka, 530-0001

  • Study site

    Osaka, 530-8480

  • Study site

    Osaka, 543-0035

  • Study site

    Osaka, 553-0003

  • Study site

    Osaka, 558-8558

  • Study site

    Ōtsu, Shiga, 520-0804

  • Study site

    Oyama, Tochigi, 323-0022

  • Study site

    Saitama, 331-8577

  • Study site

    Sanuki, Kagawa-ken, 769-2393

  • Study site

    Sapporo, Hokkaido, 007-0841

  • Study site

    Sasebo, Nagasaki, 857-1195

  • Study site

    Sayama, Saitama, 350-1305

  • Study site

    Shibuya-ku, Tokyo, 150-0002

  • Study site

    Shimajiri, Okinawa, 901-0493

  • Study site

    Shirakawa, Fukushima, 961-0005

  • Study site

    Suita, Osaka, 565-0862

  • Study site

    Tacchikawa, Tokyo, 190-8531

  • Study site

    Takamatsu, Kagawa-ken, 760-0017

  • Study site

    Takamatsu, Kagawa-ken, 760-0018

  • Study site

    Tamana, Kumamoto, 865-0016

  • Study site

    Toyota, Aichi-ken, 471-8513

  • Study site

    Ushiku, Ibaraki, 300-1207

  • Study site

    Yatsushiro, Kumamoto, 866-0824

  • Study site

    Yokohama, Kanagawa, 235-0045

  • Study site

    Yokohama, Kanagawa, 245-8575

  • Study site

    Yokohama, Kanagawa, 247-8581

  • Study site

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

China60 sites
  • Study site

    Beijing, 100028

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 100730

  • Study site

    Changchun, Jilin, 130000

  • Study site

    Changchun, Jilin, 130021

  • Study site

    Changsha, Hunan, 410008

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Changzhou, Jiangsu, 213004

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chengdu, Sichuan, 610072

  • Study site

    Chongqing, 400010

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou, Guangdong, 510120

  • Study site

    Guangzhou, Guangdong, 510150

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Guangzhou, Guangdong, 510630

  • Study site

    Haikou, Hainan, 570102

  • Study site

    Haikou, Hainan, 570311

  • Study site

    Hangzhou, Zhejiang, 310013

  • Study site

    Hohhot, Inner Mongolia, 010017

  • Study site

    Huai'an, Jiangsu, 223300

  • Study site

    Lanzhou, Gansu, 730030

  • Study site

    Lianyungang, Jiangsu, 222002

  • Study site

    Nanchang, Jiangxi, 330006

  • Study site

    Nanchang, Jiangxi, 330008

  • Study site

    Nanjing, Jiangsu, 210002

  • Study site

    Nanjing, Jiangsu, 210006

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanjing, Jiangsu, 210011

  • Study site

    Nanjing, Jiangsu, 210029

  • Study site

    Nanning, Guangxi, 530021

  • Study site

    Nanning, Guangxi, 530031

  • Study site

    Qingdao, Shandong, 266071

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200062

  • Study site

    Shanghai, 200072

  • Study site

    Shanghai, 200092

  • Study site

    Shanghai, 200240

  • Study site

    Shanghai, 201199

  • Study site

    Shenyang, Liaoning, 110016

  • Study site

    Shenyang, Liaoning, 110022

  • Study site

    Suzhou, Jiangsu, 215006

  • Study site

    Taiyuan, Shanxi, 030001

  • Study site

    Taizhou, Zhejiang, 317000

  • Study site

    Tianjin, 300121

  • Study site

    Tianjin, 300142

  • Study site

    Ürümqi, Xinjiang, 830054

  • Study site

    Wenzhou, Zhejiang, 325000

  • Study site

    Wuhan, Hubei, 430022

  • Study site

    Wuhan, Hubei, 430034

  • Study site

    Wuxi, Jiangsu, 214023

  • Study site

    Xi'an, Shaanxi, 710061

  • Study site

    Xiamen, Fujian, 361003

  • Study site

    Xiamen, Fujian, 361004

  • Study site

    Yancheng, Jiangsu, 224000

  • Study site

    Yinchuan, Ningxia, 750004

  • Study site

    Zhuhai, Guangdong, 519000

Other trials in China

Russia53 sites
  • Study site

    Arkhangelsk, 163001

  • Study site

    Barnaul, 656024

  • Study site

    Chelyabinsk, 454021

  • Study site

    Irkutsk, 664079

  • Study site

    Izhevsk, 426063

  • Study site

    Kazan', 420012

  • Study site

    Kazan', 420101

  • Study site

    Kemerovo, 650002

  • Study site

    Kemerovo, 650055

  • Study site

    Kemerovo, 650066

  • Study site

    Kirov, 610014

  • Study site

    Krasnodar, 350086

  • Study site

    Krasnoyarsk, 660062

  • Study site

    Kursk, 305004

  • Study site

    Moscow, 111539

  • Study site

    Moscow, 117292

  • Study site

    Moscow, 119034

  • Study site

    Moscow, 119192

  • Study site

    Moscow, 119991

  • Study site

    Moscow, 123182

  • Study site

    Moscow, 123423

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 125315

  • Study site

    Moscow, 129110

  • Study site

    Nizhny Novgorod, 603018

  • Study site

    Nizhny Novgorod, 603126

  • Study site

    Novosibirsk, 630005

  • Study site

    Novosibirsk, 630047

  • Study site

    Novosibirsk, 630068

  • Study site

    Novosibirsk, 630089

  • Study site

    Novosibirsk, 630117

  • Study site

    Omsk, 644024

  • Study site

    Omsk, 644033

  • Study site

    Omsk, 644112

  • Study site

    Orenburg, 460040

  • Study site

    Perm, 614097

  • Study site

    Saint Petersburg, 193312

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 194223

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 195112

  • Study site

    Saint Petersburg, 195257

  • Study site

    Saint Petersburg, 197762

  • Study site

    Saint Petersburg, 199226

  • Study site

    Saratov, 410030

  • Study site

    Stavropol, 355030

  • Study site

    Syktyvkar, 167981

  • Study site

    Voronezh, 394018

  • Study site

    Voronezh, 394077

  • Study site

    Yaroslavl, 150003

  • Study site

    Yaroslavl, 150062

  • Study site

    Yekaterinburg, 620102

Other trials in Russia

Germany35 sites
  • Study site

    Bad Homburg, Hesse, 61348

  • Study site

    Bad König, Hesse, 64732

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Berlin, 10437

  • Study site

    Berlin, 12203

  • Study site

    Berlin, 13187

  • Study site

    Berlin, 13347

  • Study site

    Dortmund, North Rhine-Westphalia, 44137

  • Study site

    Dresden, Saxony, 01277

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Elsterwerda, Brandenburg, 04910

  • Study site

    Essen, North Rhine-Westphalia, 45136

  • Study site

    Frankfurt am Main, Hesse, 60313

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Hamburg, 22041

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69115

  • Study site

    Jena, Thuringia, 07747

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Leipzig, Saxony, 04249

  • Study site

    Leipzig, Saxony, 04315

  • Study site

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • Study site

    Magdeburg, Saxony-Anhalt, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55128

  • Study site

    Münster, North Rhine-Westphalia, 48145

  • Study site

    Nettetal, North Rhine-Westphalia, 41334

  • Study site

    Nuremberg, Bavaria, 90443

  • Study site

    Schweinfurt, Bavaria, 97421

  • Study site

    Sinzheim, Baden-Wurttemberg, 76547

  • Study site

    Witten, North Rhine-Westphalia, 58455

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

Canada31 sites
  • Study site

    Burnaby, British Columbia, V3J 1N4

  • Study site

    Cambridge, Ontario, N1R 7L6

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    Edmonton, Alberta, T5A 4L8

  • Study site

    Greater Sudbury, Ontario, P3A 1W8

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    Halifax, Nova Scotia, B3H 1V8

  • Study site

    Hamilton, Ontario, L8M 1K7

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kitchener, Ontario, N2G 4V5

  • Study site

    Laval, Quebec, H7T 2P5

  • Study site

    Mirabel, Quebec, J7J 2K8

  • Study site

    Montreal, Quebec, H1M 1B1

  • Study site

    Montreal, Quebec, H2K 1H2

  • Study site

    Montreal, Quebec, H4A 3J1

  • Study site

    Montreal, Quebec, H4A 3T2

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Study site

    New Westminster, British Columbia, V3L 0A6

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1K 4L2

  • Study site

    Québec, G1V 4W2

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Smith Falls, Ontario, K7A 4W8

  • Study site

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

  • Study site

    Thornhill, Ontario, L4J 1W3

  • Study site

    Toronto, Ontario, M3J 1N2

  • Study site

    Toronto, Ontario, M4G 3E8

  • Study site

    Toronto, Ontario, M5C 2T2

  • Study site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Spain26 sites
  • Study site

    A Coruña, 15006

  • Study site

    Alcalá de Henares, Madrid, 28805

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08023

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Burela de Cabo, Lugo, 27880

  • Study site

    Córdoba, 14004

  • Study site

    Ferrol, A Coruña, 15405

  • Study site

    Getafe, Madrid, 28905

  • Study site

    Granada, 18012

  • Study site

    Jaén, 23007

  • Study site

    Jerez de la Frontera, Cádiz, 11407

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28041

  • Study site

    Málaga, 29010

  • Study site

    Manresa, Barcelona, 08243

  • Study site

    Sagunto, Valencia, 46520

  • Study site

    Sant Joan Despí, Barcelona, 08970

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46014

  • Study site

    Valencia, 46017

  • Study site

    Valencia, 46026

Other trials in Spain

Brazil24 sites
  • Study site

    Aparecida de Goiânia, Goiás, 74935-530

  • Study site

    Brasília, Federal District, 70.200-730

  • Study site

    Campina Grande do Sul, Paraná, 83430 000

  • Study site

    Curitiba, Paraná, 80030-110

  • Study site

    Curitiba, Paraná, 80230-130

  • Study site

    Curitiba, Paraná, 80440-020

  • Study site

    Fortaleza, Ceará, 60115-282

  • Study site

    Fortaleza, Ceará, 60430-140

  • Study site

    Fortaleza, Ceará

  • Study site

    Goiânia, Goiás, 74605-020

  • Study site

    Juiz de Fora, Minas Gerais, 36036-330

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Rio de Janeiro, 20241-180

  • Study site

    Rio de Janeiro, 21941-913

  • Study site

    São Bernardo do Campo, São Paulo, 09715-090

  • Study site

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

  • Study site

    São José dos Campos, São Paulo, 12243-280

  • Study site

    São Paulo, São Paulo, 04029-000

  • Study site

    São Paulo, São Paulo

  • Study site

    São Paulo, 01223-001

  • Study site

    São Paulo, 01228-200

  • Study site

    São Paulo, 04039-000

  • Study site

    Uberlândia, Minas Gerais, 38411-186

Other trials in Brazil

Poland24 sites
  • Study site

    Bialystok, 15-351

  • Study site

    Bydgoszcz, 85-079

  • Study site

    Chojnice, 89-600

  • Study site

    Gdansk, 80-952

  • Study site

    Gdynia, 81-537

  • Study site

    Katowice, 40-040

  • Study site

    Krakow, 30-510

  • Study site

    Krakow, 31-156

  • Study site

    Krakow, 31-261

  • Study site

    Krakow, 31-559

  • Study site

    Lodz, 90-153

  • Study site

    Lodz, 92-213

  • Study site

    Lodz, 94-060

  • Study site

    Lublin, 20-538

  • Study site

    Poznan, 60-834

  • Study site

    Rzeszów, 35-055

  • Study site

    Skorzewo, 60-185

  • Study site

    Szczecin, 70-111

  • Study site

    Torun, 87-100

  • Study site

    Warsaw, 01-868

  • Study site

    Warsaw

  • Study site

    Wroclaw, 51-162

  • Study site

    Wroclaw, 51-685

  • Study site

    Zabrze, 41-800

Other trials in Poland

Czechia23 sites
  • Study site

    Beroun, 266 01

  • Study site

    Brandýs nad Labem, 250 01

  • Study site

    Břeclav, 690 02

  • Study site

    Česká Lípa, 470 01

  • Study site

    Český Krumlov, 381 01

  • Study site

    Český Krumlov, 381 27

  • Study site

    Frýdek-Místek, 738 01

  • Study site

    Hodonín, 695 01

  • Study site

    Holešov, 769 01

  • Study site

    Hranice, 753 001

  • Study site

    Kopřivnice, 742 21

  • Study site

    Krnov, 794 01

  • Study site

    Mladá Boleslav, 293 50

  • Study site

    Olomouc, 775 20

  • Study site

    Olomouc, 779 00

  • Study site

    Ostrava, 702 00

  • Study site

    Pilsen, 301 66

  • Study site

    Prague, 12808

  • Study site

    Prague, 140 00

  • Study site

    Prague, 140 46

  • Study site

    Prague, 150 00

  • Study site

    Prague, 169 00

  • Study site

    Vlašim, 258 01

Other trials in Czechia

Italy22 sites
  • Study site

    Bergamo, Lombardy, 24020

  • Study site

    Bergamo, Lombardy, 24047

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Cagliari, Sardinia, 09134

  • Study site

    Catania, Sicily, 95124

  • Study site

    Genoa, Liguria, 16011

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Messina, Sicily, 98125

  • Study site

    Milan, Lombardy, 20024

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20142

  • Study site

    Milan, Lombardy, 20157

  • Study site

    Monza Brianza, Lombardy, 20832

  • Study site

    Naples, Campania, 80131

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Sassari, Sardinia, 07026

  • Study site

    Turin, Piedmont, 10024

  • Study site

    Turin, Piedmont, 10043

  • Study site

    Verona, Veneto, 37126

Other trials in Italy

Ukraine21 sites
  • Study site

    Cherkasy, 18009

  • Study site

    Chernivtsi, 58002

  • Study site

    Dnipro, 49000

  • Study site

    Dnipro, 49023

  • Study site

    Ivano-Frankivsk, 76008

  • Study site

    Kharkiv, 61037

  • Study site

    Kharkiv, 61039

  • Study site

    Kharkiv, 61058

  • Study site

    Kharkiv, 61070

  • Study site

    Kiev, 01021

  • Study site

    Kiev, 04050

  • Study site

    Kiev, 04114

  • Study site

    Kiev, 1601

  • Study site

    Kyiv, 03037

  • Study site

    Kyiv, 03049

  • Study site

    Lviv, 79010

  • Study site

    Mykolayiv, 54003

  • Study site

    Ternopil, 46002

  • Study site

    Vinnytsia, 21001

  • Study site

    Zaporizhzhya, 69000

  • Study site

    Zaporizhzhya, 69001

Other trials in Ukraine

Hungary20 sites
  • Study site

    Baja, 6500

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1042

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1088

  • Study site

    Budapest, 1089

  • Study site

    Budapest, 1134

  • Study site

    Budapest, 1135

  • Study site

    Debrecen, 4031

  • Study site

    Eger, 3300

  • Study site

    Kistarcsa, H-2143

  • Study site

    Nyíregyháza, 4400

  • Study site

    Nyíregyháza, 4405

  • Study site

    Pápa, 8500

  • Study site

    Siófok, 8600

  • Study site

    Szeged, 6725

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szentes, 6600

  • Study site

    Szombathely, 9700

Other trials in Hungary

Israel20 sites
  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Holon, 5822012

  • Study site

    Jerusalem, 9112001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Nahariya, 2210001

  • Study site

    Nahariya, 22100

  • Study site

    Nazareth, 16100

  • Study site

    Ramat Gan, 5262000

  • Study site

    Rehovot, 7610001

  • Study site

    Safed, 1311001

  • Study site

    Sakhnin, 3081000

  • Study site

    Tel Aviv, 6203854

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tel Aviv, 6905234

  • Study site

    Tel Aviv, 6937947

  • Study site

    Tiberias, 1528001

  • Study site

    Tsrifin, 7030000

Other trials in Israel

Mexico20 sites
  • Study site

    Aguascalientes, 20219

  • Study site

    Chihuahua City, 31238

  • Study site

    Cuernavaca, Morelos, 62250

  • Study site

    Culiacán, Sinaloa, 80200

  • Study site

    Culiacán, Sinaloa, 80230

  • Study site

    Durango, 34000

  • Study site

    Guadalajara, Jalisco, 44600

  • Study site

    Guadalajara, Jalisco, 44657

  • Study site

    Mazatlán, Sinaloa, 82110

  • Study site

    Mexico City, Mexico City, 06729

  • Study site

    Mexico City, Mexico City, 11650

  • Study site

    Mexico City, Mexico City, 6700

  • Study site

    México D.F., Mexico City, 14080

  • Study site

    México, D. F., Mexico City, 11850

  • Study site

    México, D. F., Mexico City, 3100

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Puerto de Veracruz, Veracruz, 91900

  • Study site

    Querétaro City, Querétaro, 76000

  • Study site

    San Juan del Río, Querétaro, 76800

  • Study site

    Xalapa, Veracruz, 91193

Other trials in Mexico

Colombia19 sites
  • Study site

    Armenia, Quindío Department, 0

  • Study site

    Barranquilla, Atlántico, 0

  • Study site

    Barranquilla, Atlántico

  • Study site

    Barranquilla

  • Study site

    Bogotá, Bogota D.C., 0

  • Study site

    Bogotá, Bogota D.C.

  • Study site

    Bogotá

  • Study site

    Cali, Valle del Cauca Department, 760032

  • Study site

    Cali, Valle del Cauca Department

  • Study site

    Cundinamarca, Bogota D.C.

  • Study site

    Floridablanca

  • Study site

    Manizales, Caldas Department

  • Study site

    Medellín, Antioquia, 050034

  • Study site

    Medellín, Antioquia, 0

  • Study site

    Medellín, Antioquia

  • Study site

    Medellín

  • Study site

    Pasto, Departamento de Nariño

  • Study site

    Pereira, Risaralda Department

  • Study site

    Zipaquirá, Cundinamarca, 0

Other trials in Colombia

Romania19 sites
  • Study site

    Alba Iulia, Alba, 510053

  • Study site

    Baia Mare, Maramureş, 430222

  • Study site

    Brasov, 500269

  • Study site

    Bucharest, 010507

  • Study site

    Bucharest, 010627

  • Study site

    Bucharest, 010825

  • Study site

    Bucharest, 014142

  • Study site

    Bucharest, 020614

  • Study site

    Bucharest, 031818

  • Study site

    Bucharest, 050538

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Galati, 800001

  • Study site

    Iași, 700547

  • Study site

    Oradea, Bihor County, 410519

  • Study site

    Oradea, 410159

  • Study site

    Ploieşti, Prahova, 100179

  • Study site

    Satu Mare, 440055

  • Study site

    Timișoara, Timiș County, 300456

  • Study site

    Timișoara, 300736

Other trials in Romania

Bulgaria18 sites
  • Study site

    Blagoevgrad, 2700

  • Study site

    Botevgrad, 2140

  • Study site

    Dimitrovgrad, 6400

  • Study site

    Gorna Oryahovitsa, 5100

  • Study site

    Kazanlak, 6102

  • Study site

    Kozloduy, 3320

  • Study site

    Lukovit, 5770

  • Study site

    Plovdiv, 4002

  • Study site

    Plovdiv, 4004

  • Study site

    Razgrad, 7200

  • Study site

    Sliven, 8800

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1680

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9000

  • Study site

    Yambol, 8600

Other trials in Bulgaria

Portugal18 sites
  • Study site

    Almada, 2801-951

  • Study site

    Amadora, 2720-276

  • Study site

    Braga, 4710-243

  • Study site

    Covilha, Castelo Branco District, 6200-251

  • Study site

    Faro, 8000-386

  • Study site

    Funchal, Madeira, 9004-514

  • Study site

    Leiria, 2410-197

  • Study site

    Lisbon, 1069-166

  • Study site

    Lisbon, 1250-189

  • Study site

    Lisbon, 1449-005

  • Study site

    Lisbon, 1500-650

  • Study site

    Loures, Lisbon District, 2674-514

  • Study site

    Matosinhos Municipality, Porto District, 4464-513

  • Study site

    Porto, 4099-001

  • Study site

    Porto, 4200-319

  • Study site

    Setúbal, Setúbal District, 2900-446

  • Study site

    Torres Novas, Santarém District, 2350-754

  • Study site

    Viana do Castelo, 4901-858

Other trials in Portugal

South Africa17 sites
  • Study site

    Benoni, Gauteng, 1501

  • Study site

    Cape Town, Western Cape, 7570

  • Study site

    Cape Town, Western Cape, 7925

  • Study site

    Durban, KwaZulu-Natal, 4030

  • Study site

    Isipingo Rail, KwaZulu-Natal, 4110

  • Study site

    Johannesburg, Gauteng, 2198

  • Study site

    Lenasia South, Gauteng, 1835

  • Study site

    Middelburg, Mpumalanga, 1055

  • Study site

    Newtown, Gauteng, 2113

  • Study site

    Port Elizabeth, Eastern Cape, 6045

  • Study site

    Pretoria, Gauteng, 0002

  • Study site

    Pretoria, Gauteng, 0181

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Soweto, Gauteng, 1818

  • Study site

    Tongaat, KwaZulu-Natal, 4400

  • Study site

    Witbank, Mpumalanga, 1035

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Australia16 sites
  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Brisbane, Queensland, 4064

  • Study site

    Elizabeth Vale, 5112

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Gosford, New South Wales, 2250

  • Study site

    Heidelberg, Victoria, 3081

  • Study site

    Kanwal, New South Wales, 2259

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Melbourne, Victoria, 3052

  • Study site

    New Lambton Heights, New South Wales, 2305

  • Study site

    Prahran, Victoria, 3181

  • Study site

    Reservoir, Victoria, 3073

  • Study site

    Richmond, Victoria, 3121

  • Study site

    St Albans, Victoria, 3021

  • Study site

    Wollongong, New South Wales, 2500

Other trials in Australia

France16 sites
  • Study site

    Bois-Guillaume, 76230

  • Study site

    Boulogne-sur-Mer, 62321

  • Study site

    Brest, 29200

  • Study site

    Colmar, 68024

  • Study site

    Dijon, 21000

  • Study site

    Grenoble, 38043

  • Study site

    Le Coudray, 28630

  • Study site

    Le Creusot, 71200

  • Study site

    Lyon, 69437

  • Study site

    Mulhouse, 68051

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75018

  • Study site

    Saint-Herblain, 44093

  • Study site

    Tourcoing, 59280

  • Study site

    Vandœuvre-lès-Nancy, 54500

  • Study site

    Vénissieux, 69200

Other trials in France

Denmark15 sites
  • Study site

    Aalborg, 9000

  • Study site

    Aarhus N, 8200

  • Study site

    Esbjerg, 6700

  • Study site

    Gentofte Municipality, 2730

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hillerød, DK-3400

  • Study site

    Holbæk, 4300

  • Study site

    Holstebro, DK-7500

  • Study site

    Hvidovre, 2650

  • Study site

    København NV, 2400

  • Study site

    Kolding, 6000

  • Study site

    Odense C, DK-5000

  • Study site

    Svendborg, 5700

  • Study site

    Viborg, 8800

Other trials in Denmark

Argentina14 sites
  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1056ABJ

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1426ABP

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1429BWN

  • Study site

    CABA, Buenos Aires, C1120AAC

  • Study site

    CABA, Ciudad Auton. de Buenos Aires, C1018DES

  • Study site

    Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC

  • Study site

    Córdoba, X5000AAW Córdoba

  • Study site

    Córdoba, X5000JHQ

  • Study site

    Junín, Buenos Aires, B6000GMA

  • Study site

    Lanus, Buenos Aires, B1824KAJ

  • Study site

    Mar del Plata, Buenos Aires, B7602CBM

  • Study site

    San Luis, D5702AAx

  • Study site

    Sarandí, Buenos Aires, 1872

Other trials in Argentina

Turkey (Türkiye)14 sites
  • Study site

    Ankara

  • Study site

    Antalya, 07003

  • Study site

    Antalya, 07059

  • Study site

    Aydin, 09100

  • Study site

    Istanbul, 34303

  • Study site

    Istanbul, 34722

  • Study site

    Istanbul, 34899

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35180

  • Study site

    Izmir, 35540

  • Study site

    Kayseri, 38039

  • Study site

    Kocaeli, 41380

  • Study site

    Malatya, 44280

  • Study site

    Sivas, 58140

Other trials in Turkey (Türkiye)

Austria13 sites
  • Study site

    Feldkirch, Vorarlberg, 6807

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Linz, Upper Austria, 4021

  • Study site

    Saint Stefan, Styria, 8511

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1060

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Wels, 4600

  • Study site

    Zams, Tyrol, 6511

Other trials in Austria

Netherlands13 sites
  • Study site

    Alkmaar, 1815 JD

  • Study site

    Almere Stad, 1315 RA

  • Study site

    Amersfoort, 3818 TZ

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Apeldoorn, 7334 DZ

  • Study site

    Breda, 4818 CK

  • Study site

    Eindhoven, 5600 PD

  • Study site

    Geleen, 6162 BG

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoogeveen, 7909 AA

  • Study site

    The Hague, 2545 CH

  • Study site

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

South Korea13 sites
  • Study site

    Anyang-si, Gyeonggido, 14068

  • Study site

    Busan, 49241

  • Study site

    Daegu, 42601

  • Study site

    Seongnam-si, Gyeonggido, 13620

  • Study site

    Seoul, Seoul Teugbyeolsi, 03080

  • Study site

    Seoul, 02841

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05278

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 07441

  • Study site

    Seoul, 110-746

  • Study site

    Wŏnju, Gang''weondo, 26426

Other trials in South Korea

Sweden13 sites
  • Study site

    Gothenburg, 413 45

  • Study site

    Gothenburg, 413 46

  • Study site

    Lund, 221 85

  • Study site

    Lund, 222 21

  • Study site

    Örebro, 701 85

  • Study site

    Örebro, 703 62

  • Study site

    Rättvik, 795 30

  • Study site

    Skövde, 541 50

  • Study site

    Stockholm, 113 24

  • Study site

    Stockholm, 114 46

  • Study site

    Stockholm, 182 88

  • Study site

    Uppsala, 751 85

  • Study site

    Uppsala, 752 37

Other trials in Sweden

Finland12 sites
  • Study site

    Jyväskylä, 40620

  • Study site

    Kajaani, 87140

  • Study site

    Kerava, 04200

  • Study site

    Klaukkala, 01800

  • Study site

    Kuopio, 70100

  • Study site

    Nurmijärvi, 01900

  • Study site

    Oulu, 90100

  • Study site

    Rauma, 26100

  • Study site

    Seinäjoki, 60100

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20521

  • Study site

    Vantaa, 01600

Other trials in Finland

United Kingdom12 sites
  • Study site

    Birmingham, West Midlands, B15 2SQ

  • Study site

    Bristol, BS10 5NB

  • Study site

    Carshalton, Surrey, SM5 1AA

  • Study site

    Chichester, West Sussex, PO19 6SE

  • Study site

    Glasgow, G20 OSP

  • Study site

    Liverpool, Merseyside, L7 8XP

  • Study site

    Llanelli, Carmarthenshire, SA14 8QF

  • Study site

    London, E1 1BB

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    London, SE5 9RS

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Thailand4 sites
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Ireland3 sites
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Singapore3 sites
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About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Being tested
Finerenone (BAY94-8862), Placebo
Keywords
Type 2 Diabetes, Kidney diseases
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (BAY94-8862)Drug

    10 mg or 20 mg Finerenone tablet to be given orally, once daily.

  • PlaceboDrug

    Matching placebo to be taken orally, once daily.

Study groups in NCT02545049
Study groupRoleWhat they receive
BAY94-8862ExperimentalFinerenone tablet
Receives: Drug: Finerenone (BAY94-8862)
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.

    Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.

    Measured: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.

Secondary outcomes (5)
  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.

    Number of participants with 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 were reported as descriptive result.

    Measured: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.

  2. All-cause Hospitalization

    Number of participants with first occurrence of a hospitalization event were reported as descriptive result.

    Measured: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months

  3. All-cause Mortality

    Number of participants with death due to any cause were reported as descriptive result. 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.

    Measured: From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months

  4. Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to 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.

    Measured: From baseline up until Month 4

  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

    Number of participants with first occurrence of the 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 reported as descriptive result.

    Measured: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completion2 Feb 2021
  4. Study completion2 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545049
Sponsor's protocol ID
17530
Other IDs
2015-000950-39, 2015
Acronym
FIGARO-DKD
Status last verified
Apr 2022
First submitted
2 Sep 2015
Last updated
15 Apr 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • 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.

    PubMed 31665733
  • 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.

    PubMed 34449181
  • Lo KB, Ostrominski JW, Hamatani Y, Claggett BL, Agarwal R, Anker SD, Filippatos G, Rossing P, Ruilope LM, Pitt B, Briasoulis A, Stamatelopoulos K, Brinker M, Schloemer P, Glasauer A, Solomon SD, Vaduganathan M. Finerenone Across Cardiovascular-Kidney-Metabolic Syndrome Stages: Post Hoc Analysis of the FIDELITY Randomized Clinical Trials. JAMA Cardiol. 2026 Jul 1;11(7):679-684. doi: 10.1001/jamacardio.2026.1365.

    PubMed 42234437
  • Mielke J, Strunz T, Lee J, Schloemer P; GCKD Investigators; Gallone G. An integrative framework for drug target discovery bridging clinical trial and genetic data insights. J Transl Med. 2026 Mar 13;24(1):374. doi: 10.1186/s12967-026-07806-x.

    PubMed 41827014
  • Weingold R, Filippatos G, Anker SD, Wanner C, Shafi T, Tangri N, Pitt B, Brinker M, Scott C, Roberts L, Rossing P, Inzucchi SE; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY. J Diabetes Complications. 2026 Apr;40(4):109274. doi: 10.1016/j.jdiacomp.2026.109274. Epub 2026 Jan 31.

    PubMed 41679125
  • Munoz Mendoza J, Weir MR, Anker SD, Filippatos G, Rossing P, Ahlers C, Brinker M, Fatoba ST, Horvat-Broecker A, Rohwedder K, Fornoni A; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in People with CKD, Type 2 Diabetes, and History of Nephrectomy. Clin J Am Soc Nephrol. 2026 Mar 1;21(3):414-424. doi: 10.2215/CJN.0000000932. Epub 2026 Jan 14.

    PubMed 41533467
  • Katayama S, Anker SD, Zhu D, Kim S, Wu MJ, Kawanami D, Rossing P, Ruilope LM, Ahlers C, Brinker M, Mann A, Tian Y, Yamashita S, Pitt B; FIDELIO-DKD and FIGARO-DKD Investigators. Efficacy and safety of finerenone in Asian patients with type 2 diabetes and chronic kidney disease: A FIDELITY analysis by baseline kidney function. J Diabetes Complications. 2026 Jan;40(1):109213. doi: 10.1016/j.jdiacomp.2025.109213. Epub 2025 Nov 4.

    PubMed 41289823
  • 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. 2026 Feb 1;37(2):390-393. doi: 10.1681/ASN.0000000877. Epub 2025 Sep 2. No abstract available.

    PubMed 40892478
  • 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.

    PubMed 40315020
  • 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.

    PubMed 40021271
  • 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.

    PubMed 39380152
  • 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.

    PubMed 38508632
  • 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.

    PubMed 38048573
  • 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.

    PubMed 38046911
  • 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.

    PubMed 37745646

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone (BAY94-8862) in people with Diabetic Kidney Disease, run by Bayer at 975 sites in 48 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 975 sites in United States, Japan, China, Russia, Germany and 43 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02545049, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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