AzTrials
AzTrials

Chronic Kidney DiseasePhase 3FIDELIO-DKDNCT02540993

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

A Phase 3 study testing Finerenone (BAY94-8862) in people with Chronic Kidney Disease, run by Bayer at 978 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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic 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
5,734 participants
Where
978 sitesin 48 countries
Study dates
17 Sep 2015to 14 Apr 2020
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
  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

978 sites in 48 countries.

978 sites in 48 countries

United States176 sites
  • Study site

    Albany, New York, 12206

  • 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

    Arvin, California, 93203

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30904

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bethlehem, Pennsylvania, 18017

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Brooklyn, New York, 11203

  • 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

    Chattanooga, Tennessee, 37404

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chula Vista, California, 91910

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Columbia, Missouri, 65201

  • Study site

    Columbia, Missouri, 65212

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Corpus Christi, Texas, 78414-4173

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dallas, Texas, 75251

  • Study site

    Dublin, California, 94568

  • Study site

    Duluth, Georgia, 30096

  • Study site

    El Centro, California, 92243

  • Study site

    El Paso, Texas, 79935

  • Study site

    Elgin, Illinois, 60123

  • Study site

    Fleming Island, Florida, 32003

  • Study site

    Flint, Michigan, 48504

  • Study site

    Flint, Michigan, 48532

  • Study site

    Flushing, New York, 11355

  • 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

    Gainesville, Florida, 32610-0224

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Greer, South Carolina, 29651

  • 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, 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

    Kansas City, Missouri, 64111

  • Study site

    Kansas City, Missouri, 64128

  • Study site

    Kingwood, Texas, 77339

  • Study site

    La Mesa, California, 91942

  • Study site

    Lansdale, Pennsylvania, 19446-2321

  • 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

    Lilburn, Georgia, 30047

  • Study site

    Lincoln, Nebraska, 68510

  • 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, 75069-1780

  • 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, 33180

  • Study site

    Miami, Florida, 33186

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Miami Gardens, Florida, 33169

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Miami Lakes, Florida, 33016

  • Study site

    Milwaukee, Wisconsin, 53295

  • Study site

    Mineola, New York, 11501

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Monroe, Louisiana, 71201

  • Study site

    Murrells Inlet, South Carolina, 29576

  • 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, 10021

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • 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

    San Francisco, California, 94110

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Smithtown, New York, 11787

  • Study site

    Spokane Valley, Washington, 99216-3522

  • Study site

    St Louis, Missouri, 63106

  • Study site

    St Louis, Missouri, 63136

  • Study site

    St. George, Utah, 84790

  • 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

    Takoma Park, Maryland, 20912

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tampa, Florida, 33619

  • 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

    Waco, Texas, 76710

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Japan69 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

    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

    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

China57 sites
  • Study site

    Beijing, 100010

  • Study site

    Beijing, 100730

  • Study site

    Changchun, Jilin, 130000

  • Study site

    Changsha, Hunan, 410000

  • Study site

    Changsha, Hunan, 410008

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Changzhou, Jiangsu, 213004

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chengdu, Sichuan, 610072

  • Study site

    Chongqing, 400010

  • Study site

    Fuzhou, Fujian, 350025

  • 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

    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, 210000

  • Study site

    Nanjing, Jiangsu, 210006

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanjing, Jiangsu, 210029

  • Study site

    Nanning, Guangxi, 530021

  • Study site

    Nanning, Guangxi, 530031

  • Study site

    Qingdao, Shandong, 266000

  • Study site

    Qingdao, Shandong, 266071

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200072

  • Study site

    Shanghai, 200092

  • Study site

    Shanghai, 200240

  • Study site

    Shanghai, 200333

  • 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, 300052

  • Study site

    Tianjin, 300121

  • Study site

    Tianjin, 300142

  • 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

Russia52 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, 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, 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

    Ryazan, 390026

  • 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

Germany33 sites
  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • 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

    Bochum, North Rhine-Westphalia, 44787

  • 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

    Hoyerswerda, Saxony, 02977

  • Study site

    Jena, Thuringia, 07747

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Leipzig, Saxony, 04249

  • Study site

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • Study site

    Mainz, Rhineland-Palatinate, 55128

  • Study site

    Münster, North Rhine-Westphalia, 48145

  • Study site

    Nettetal, North Rhine-Westphalia, 41334

  • Study site

    Schweinfurt, Bavaria, 97421

  • Study site

    Witten, North Rhine-Westphalia, 58455

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

Canada30 sites
  • Study site

    Burnaby, British Columbia, V3J 1N4

  • Study site

    Cambridge, Ontario, N1R 7L6

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • 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, H3G 1A4

  • Study site

    Montreal, Quebec, H4A 3J1

  • Study site

    Montreal, Quebec, H4A 3T2

  • Study site

    Montreal, Quebec, QC H4J 1C5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 2C3

  • 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, 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, 08907

  • Study site

    Barcelona, 8036

  • Study site

    Boadilla del Monte, Madrid, 28660

  • 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

    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

Brazil25 sites
  • Study site

    Aparecida de Goiânia, Goiás, 74935-530

  • Study site

    Brasília, Federal District, 70.200-730

  • Study site

    Curitiba, Paraná, 80030-110

  • Study site

    Curitiba, Paraná, 80230-130

  • Study site

    Curitiba, Paraná, 80440-020

  • Study site

    Feira de Santana, Estado de Bahia, 44001-584

  • 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

    Minas Gerais, 38400-368

  • Study site

    Paraná, Paraná, 83430-000

  • 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

    Salvador, Estado de Bahia, 40415-065

  • Study site

    Santo André, São Paulo

  • 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

  • Study site

    São Paulo, 01223-001

  • Study site

    São Paulo, 01228-200

  • Study site

    São Paulo, 04039-000

Other trials in Brazil

Poland25 sites
  • Study site

    Bialystok, 15-351

  • Study site

    Bydgoszcz, 85-079

  • Study site

    Chojnice, 89-600

  • Study site

    Gdansk, 80-214

  • 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

    Olsztyn, 10-561

  • 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 01

  • Study site

    Kopřivnice, 742 21

  • Study site

    Krnov, 794 01

  • Study site

    Mladá Boleslav, 29301

  • Study site

    Olomouc, 779 00

  • Study site

    Olomouc, 77900

  • 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

    Padova, Veneto, 35128

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Sassari, Sardinia, 07026

  • Study site

    Turin, Piedmont, 10023

  • Study site

    Turin, Piedmont, 10043

  • Study site

    Verona, Veneto, 37126

Other trials in Italy

Ukraine22 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, 03049

  • Study site

    Kiev, 04050

  • Study site

    Kiev, 04114

  • Study site

    Kiev, 1601

  • Study site

    Kyiv, 03037

  • Study site

    Lviv, 79010

  • Study site

    Mykolayiv, 54003

  • Study site

    Ternopil, 46002

  • Study site

    Uzhhorod, 88018

  • Study site

    Vinnytsia, 21001

  • Study site

    Zaporizhzhya, 69001

  • Study site

    Zaporizhzhya, 69600

Other trials in Ukraine

Israel21 sites
  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Beersheba, 8410101

  • Study site

    Hadera, 3810101

  • 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

Bulgaria20 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, 4000

  • Study site

    Plovdiv, 4002

  • Study site

    Plovdiv, 4004

  • Study site

    Razgrad, 7200

  • Study site

    Sliven, 8800

  • Study site

    Smolyan, 4700

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1680

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9000

  • Study site

    Yambol, 8600

Other trials in Bulgaria

France20 sites
  • Study site

    Bois-Guillaume, 76230

  • Study site

    Bordeaux, 33000

  • Study site

    Boulogne-sur-Mer, 62321

  • Study site

    Brest, 29200

  • Study site

    Colmar, 68024

  • Study site

    Dijon, 21000

  • Study site

    La Rochelle, 17019

  • Study site

    La Tronche, 38700

  • 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

    Pessac, 33608

  • Study site

    Saint-Herblain, 44093

  • Study site

    Saint-Priest-en-Jarez, 42270

  • Study site

    Tourcoing, 59280

  • Study site

    Vandœuvre-lès-Nancy, 54500

  • Study site

    Vénissieux, 69200

Other trials in France

Hungary20 sites
  • Study site

    Baja, 6500

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1042

  • 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, 2143

  • Study site

    Nyíregyháza, 4400

  • Study site

    Nyíregyháza, 4405

  • Study site

    Pápa, 8500

  • Study site

    Siófok, 8600

  • Study site

    Szeged

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szentes, 6600

  • Study site

    Szombathely, 9700

  • Study site

    Veszprém, 8200

Other trials in Hungary

South Africa19 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

    Petoria, Gauteng

  • Study site

    Port Elizabeth, Eastern Cape, 6045

  • Study site

    Pretoria, Gauteng, 0002

  • Study site

    Pretoria, Gauteng, 0181

  • Study site

    Pretoria, 0002

  • 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

South Korea19 sites
  • Study site

    Anyang-si, Gyeonggido, 14068

  • Study site

    Busan, 47392

  • Study site

    Busan, 49241

  • Study site

    Chuncheon, Gang''weondo, 0

  • Study site

    Daejeon, 35015

  • Study site

    Goyang-si, Gyeonggido, 10475

  • Study site

    Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, 21431

  • Study site

    Seoul, Seoul Teugbyeolsi, 03080

  • Study site

    Seoul, Seoul Teugbyeolsi, 17985

  • Study site

    Seoul, 01830

  • Study site

    Seoul, 02841

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05278

  • Study site

    Seoul, 05355

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 07061

  • Study site

    Seoul, 07441

  • Study site

    Wŏnju, Gang''weondo, 26426

Other trials in South Korea

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

Mexico17 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

    Guadalajara, Jalisco, 44600

  • Study site

    Guadalajara, Jalisco, 44657

  • Study site

    Mazatlán, Sinaloa, 82110

  • Study site

    Mexico City, Mexico City, 6700

  • Study site

    Mexico City, 06726

  • 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

    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

Romania17 sites
  • Study site

    Alba Iulia, Alba, 510053

  • Study site

    Baia Mare, Maramureş, 430222

  • 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, 410159

  • Study site

    Ploieşti, Prahova, 100179

  • Study site

    Satu Mare, 440192

  • Study site

    Timișoara, Timiș County, 300456

  • Study site

    Timișoara, 300736

Other trials in Romania

Colombia16 sites
  • Study site

    Armenia, Quindío Department, 0

  • Study site

    Baranquilla, Atlántico, 080020

  • Study site

    Barranquilla, Atlántico, 080020

  • Study site

    Barranquilla, Atlántico, 0

  • Study site

    Bogotá, Bogota D.C., 0

  • 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, 050023

  • Study site

    Medellín, Antioquia, 050034

  • Study site

    Medellín, Antioquia, 0

  • Study site

    Medellín, Antioquia

  • Study site

    Medellín

  • Study site

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Netherlands15 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

    Dordrecht, 3318 AT

  • Study site

    Eindhoven, 5600 PD

  • Study site

    Geleen, 6162 BG

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoogeveen, 7909 AA

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    The Hague, 2545 CH

  • Study site

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

United Kingdom15 sites
  • Study site

    Bristol, BS10 5NB

  • Study site

    Carshalton, Surrey, SM5 1AA

  • Study site

    Chichester, West Sussex, PO19 6SE

  • Study site

    Leicester, Leicestershire, LE5 4PW

  • Study site

    Liverpool, Merseyside, L7 8XP

  • Study site

    Llanelli, Carmarthenshire, SA14 8QF

  • Study site

    London, E1 1BB

  • Study site

    London, NW3 2QG

  • Study site

    London, SE5 9RS

  • Study site

    Manchester, M8 5RB

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Newcastle upon Tyne, Vale of Glamorgan, the, NE1 4LP

  • Study site

    Northampton, Northamptonshire, NN1 5BD

  • Study site

    Portsmouth, PO6 3LY

  • Study site

    Salford, Manchester, M6 8HD

Other trials in United Kingdom

Denmark14 sites
  • Study site

    Aalborg, 9000

  • Study site

    Aarhus N, 8200

  • Study site

    Esbjerg, 6700

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hillerød, 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

Sweden14 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, 141 86

  • Study site

    Stockholm, 182 88

  • Study site

    Uppsala, 751 85

  • Study site

    Uppsala, 752 37

Other trials in Sweden

Argentina13 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, 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

Australia13 sites
  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Box Hill, 3128

  • 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

    Liverpool, New South Wales, 2170

  • Study site

    New Lambton, New South Wales, 2305

  • 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

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

    Sankt Pölten, 3100

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1060

  • Study site

    Vienna, 1090

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    Wels, 4600

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Finland12 sites
  • Study site

    Jyväskylä, 40620

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    Klaukkala, 01800

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    Oulu, 90100

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    Rauma, 26100

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Chile10 sites
  • Study site

    Las Condes, Santiago Metropolitan, 7591047

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    Santiago, 8380456

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Norway10 sites
  • Study site

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    Hamar

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    Kristiansand, 4604

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    Skedsmokorset, 2020

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Belgium9 sites
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    Kortrijk, 8500

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    Leuven, 3000

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    Liège, 4000

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    Roeselare, 8800

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Taiwan9 sites
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    Kaohsiung City, 833

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    New Taipei City, 220

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    Taichung, 40447

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    Taipei, 100

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Turkey (Türkiye)9 sites
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New Zealand8 sites
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Philippines6 sites
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Singapore5 sites
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Slovakia5 sites
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Vietnam5 sites
  • Study site

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  • Study site

    Hà Nội

  • Study site

    Ho Chi Minh City, 70000

  • Study site

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  • Study site

    Ho Chi Minh City

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Hong Kong4 sites
  • Study site

    Hong Kong

  • Study site

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Ireland4 sites
  • Study site

    Cork

  • Study site

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  • Study site

    Dublin, DUBLIN 4

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    Galway

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Thailand4 sites
  • Study site

    Bangkok, 10400

  • Study site

    Bangkok

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    Chiang Mai, 50200

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Puerto Rico2 sites
  • Study site

    Cidra, 00739

  • Study site

    San Juan, 00909-3004

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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 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

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.

Being tested
Finerenone (BAY94-8862), Placebo
Keywords
CKD, Diabetic Kidney Disease, Type 2 Diabetes, Kidney diseases
Medical subject headings
Renal Insufficiency, Chronic, 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

    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

  • PlaceboDrug

    Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Study groups in NCT02540993
Study groupRoleWhat they receive
Finerenone (BAY94-8862)ExperimentalParticipants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
Receives: Drug: Finerenone (BAY94-8862)
PlaceboPlacebo comparatorParticipants received matching placebo once daily in addition to standard of care therapy
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 Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death

    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.

    Measured: 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

Secondary outcomes (5)
  1. The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure

    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.

    Measured: 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

  2. All-cause Mortality

    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.

    Measured: From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months

  3. All-cause Hospitalization

    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.

    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 of 32 months

  4. Change in Urinary Albumin-to-creatinine Ratio (UACR) 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

    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.

    Measured: 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

Timeline

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

  1. First posted4 Sep 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completion14 Apr 2020
  4. Study completion14 Apr 2020

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
5,734 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02540993
Sponsor's protocol ID
16244
Other IDs
2015-000990-11, 2015
Acronym
FIDELIO-DKD
Status last verified
Jul 2023
First submitted
2 Sep 2015
Last updated
24 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 31655812
  • 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.

    PubMed 33264825
  • 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.

    PubMed 33198491
  • 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
  • Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.

    PubMed 41198855
  • Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.

    PubMed 41196655
  • 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
  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.

    PubMed 40526444
  • 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
  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone (BAY94-8862) in people with Chronic Kidney Disease, run by Bayer at 978 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 10 inclusion and 8 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 978 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 19 Jul 2021). 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 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). 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 NCT02540993, which also lists 33 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 24 Jul 2023.

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