A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

1,664

Participants

Timeline

Start Date

June 23, 2022

Primary Completion Date

March 14, 2025

Study Completion Date

March 14, 2025

Conditions
Type 2 Diabetes MellitusChronic Kidney Disease
Interventions
DRUG

Finerenone (BAY94-8862 ) 10 mg

oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2

DRUG

Empagliflozin

oral administration, once daily

DRUG

Empagliflozin Placebo

Matching placebo to empagliflozin oral administration, once daily

DRUG

Finerenone (BAY94-8862 ) 20 mg

oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2

DRUG

Finerenone Placebo

Matching Placebo to Finerenone oral administration once daily

Trial Locations (185)

833

Chang Gung Memorial Hospital Kaohsiung, Kaohsiung City

1796

Cardiologicum Pirna / Dresden-Seidnitz, Pirna

3000

UZ Leuven Gasthuisberg, Leuven

3080

Seoul National University Hospital, Seoul

5278

Kyung Hee University Hospital at Gangdong, Seoul

6042

CHU de Charleroi Hôpital civil, Lodelinsart

7442

Hallym University Kangnam Sacred Heart Hospital, Seoul

8500

AZ Groeninge Campus Kennedylaan, Kortrijk

8800

AZ Delta, Roeselare

8900

Regionaal ZH Jan Yperman Campus Mariaziekenhuis, Ieper

9000

AZ St-Lucas Campus St-Lucas, Ghent

UZ Gent, Ghent

9300

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst, Aalst

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia, Orbassano

10941

Circuit Clinical/Crystal Run, Middletown

11217

Taipei Veterans General Hospital, Taipei

12203

Charité Campus Benjamin Franklin (CBF), Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

14068

Hallym University Sacred Heart Hospital, Anyang-si

16043

ASL 4 Chiavarese, Chiavari

20017

Azienda Socio Sanitaria Territoriale Rhodense, Rho

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia, Milan

20132

Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico, Milan

20142

Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica, Milan

21000

Hôpital François Mitterrand - Dijon, Dijon

21431

The Catholic University of Korea, Incheon St.Mary's Hospital, Incheon

22041

Diabetes Zentrum Wandsbek, Hamburg

23561

Taipei Medical University - Shuang Ho Hospital, New Taipei City

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia, Bergamo

24153

Salem VA Medical Center - Endocrinology, Salem

26426

Yonsei University Wonju Christian Hospital, Wŏnju

27203

Randolph Medical Associates, Asheboro

27834

Eastern Nephrology Associates - Greenville West, Greenville

28040

Hospital Clinico San Carlos, Madrid

Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD), Madrid

28504

Eastern Nephrology Associates - Kinston, Kinston

28792

Blue Sky, MD/ Lamond Family Medicine, Hendersonville

28805

Hospital Principe de Asturias, Alcalá de Henares

29603

H. Costa del Sol (Marbella), Marbella

30029

Hopital Carémeau - Nîmes, Nîmes

30303

Grady Memorial Hospital - Endocrinology, Atlanta

30344

Southeast Kidney Associates, East Point

31151

Soon Chun Hyang University Cheonan Hospital, Cheonan

31406

Velocity Clinical Research - Savannah, Savannah

33445

Florida Kidney Physicians - Delray Beach Nephrology, Delray Beach

33952

Innovative Research Institute, Port Charlotte

35015

Chung Nam National University Hospital, Daejeon

37134

Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo, Verona

38043

Center Hospitalier Michallon - Grenoble, Grenoble

38119

DarSalud Care / LifeDOC Research, Memphis

38163

University of Tennessee Health Science Center, Memphis

40383

Versailles Family Medicine, Versailles

40705

Taichung Veterans General Hospital, Taichung

43126

Azienda Ospedaliero Universitaria Parma - SC Nefrologia, Parma

44137

Diabetologische Schwerpunkt Praxis Dortmund, Dortmund

45242

Velocity Clinical Research, Cincinnati, Cincinnati

46010

Hospital Clínico Universitario de Valencia, Valencia

46017

Hospital Universitario Dr. Peset, Valencia

48085

Oakland Medical Center, Dakota Dunes

49085

Lake Michigan Nephrology, Saint Joseph

50006

Changhua Christian Hospital, Changhua

56124

Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia, Pisa

57049

Dunes Clinical Research LLC, Dakota Dunes

60596

ClinPhenomics GmbH&Co. KG, Frankfurt am Main

63136

St. Louis Heart & Vascular, PC, St Louis

64111

Clinical Research Consultants, Kansas City

64128

Kansas City VA Medical Center - Endocrinology, Kansas City

66100

"Università degli Studi G. D'Annunzio di Chieti - Endocrinologia", Chieti

67059

Zentrum für Diabetologie und Ernährungsmedizin, Ludwigshafen am Rhein

68510

Somnos Clinical Research, Lincoln

68701

Meridian Clinical Research- Norfolk, Norfolk

69003

Hôpital Edouard Herriot - Lyon Cedex, Lyon

69115

St. Josefskrankenhaus, Heidelberg

70006

Nola Care Clinical Research, Metairie

Omega Clinical Research Center, Metairie

71013

Casa Sollievo della Sofferenza - Endocrinologia, San Giovanni Rotondo

75014

Hôpital Saint Joseph, Paris

75057

North Texas Kidney Disease Associates, PLLC, Lewisville

77008

Global Kidney Center, Houston

78212

Clinical Advancement Center, PLLC, San Antonio

78249

University of Texas Health Science Center, San Antonio

78503

Biopharma Informatic - McAllen, TX, McAllen

79925

DaVita Clinical Research- El Paso, El Paso

84117

Olympus Family Medicine, Salt Lake City

85374

Southwest Kidney Institute, PLC, Surprise

89102

Healor Primary Care / CCT Research, Las Vegas

89119

Santa Rosa Medical Centers of Nevada / CCT Research, Las Vegas

90022

Academic Medical Research Institute, Los Angeles

91325

Northridge Hospital, Northridge

94592

Touro University California, Vallejo

99202

MultiCare Rockwood Clinic Diabetes & Endocrinology Center, Spokane

110017

Max Super Speciality Hospital (MSSH) - Saket, New Delhi

110076

Indraprastha Apollo Hospital, New Delhi

208002

G.S.V.M. Medical College, Kanpur

302017

Sawami Man Singh (SMS) Medical College & Attached Hospitals, Jaipur

302020

Eternal Heart Care Centre (EHCC) and Research Institute, Jaipur

404327

China Medical University Hospital, Taichung

411001

Grant Medical Foundation - Ruby Hall Clinic (RHC), Pune

411057

Lifepoint Multispecialty Hospital, Pune

440009

Government Medical College and Hospital (GMCH) Nagpur, Nagpur

440010

Asian Kidney Hospital and Medical Centre, Nagapur

500003

Krishna Institute Of Medical Science, Secunderabad

500012

Osmania General Hospital, Telangana

500082

Nizam's Institute of Medical Sciences (NIMS), Hyderabad

560076

Dr. Bantwal's Clinic, Bengaluru

575003

Vinaya Hospital and Research Centre (A Unit of KIMS), Mangalore

590010

K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi

673008

Government Medical College, Kozhikode

700020

Institute of Post-Graduate Medical Education and Research, Kolkata

751019

All India Institute of Medical Sciences, Bhubaneswar

911200

Hadassah University Medical Center (HUMC), Jerusalem

1311001

Health Corporation of the Ziv Medical Center (R.A.), Safed

2210001

Health Corporation of Galilee Medical Center, Nahariya

91342-1437

Olive View - UCLA Medical Center, Sylmar

06708

Chase Medical Research, LLC, Waterbury

34761-4547

West Orange Endocrinology & Clinical Research, Ocoee

33401-3430

Metabolic Research Institute, Inc., West Palm Beach

02360

South Shore Nephrology, Plymouth

63110-1010

Washington University School of Medicine in St. Louis, St Louis

27599-7155

University of North Carolina Kidney Center, Chapel Hill

78414-4173

Office of Osvaldo A. Brusco, MD, Corpus Christi

75208-2362

Thyroid, Endocrinology, and Diabetes (TED) PA, Dallas

77024-2593

Victorium Clinical Research, Houston

T2H 2G4

LMC Manna Research - Calgary, Calgary

L8M 1K7

Hamilton Medical Research Group, Hamilton

L5H4K9

William Osler Health centre, Sakuara Medical, Mississauga

N7T 4X3

Bluewater Clinical Research Group, Sarnia

N2J 1C4

Sameh Fikry Professional Corporation, Waterloo

N2T 0C1

Clinical Research Solutions, Inc., Waterloo

H2R 1V6

Recherche GCP Research, Montreal

H2X 3E4

Centre Hospitalier de l'Université de Montréal (CHUM), Montreal

H4T 1Z9

LMC Clinical Research Inc. Montreal, Saint-Laurent

DK-2400

Bispebjerg Hospital - Hjerteafdeling, Copenhagen

Unknown

"Hospital of South West Jutland , Department of Endocrinology Research"

"Steno Diabetes Center Copenhagen , Herlev - Clinical and Translational Research Department"

"Region Midtjylland , Regionshospitalet Godstrup - Nephrology Department"

Many Locations, Multiple Locations

King George Hospital, Visakhapatnam

Mavani Dialysis & Kidney Center, Ahmedabad

Bangalore Medical College & Research Institute, Bengaluru

Government Kilpauk Medical College Hospital, Chennai

Sriram Chandra Bhanj Medical College & Hospital, Cuttack

Vedanta Kidney Care, Vadodara

"HaEmek Medical Center , Internal Medicine C Department - Research Unit"

"Barzilai Medical Center , Department of Nephrology and Hypertension"

"Clalit Health , Soroka Medical Center - Internal Medicine Department"

"Edith Wolfson Medical Center , Internal Medicine Department"

"Rabin Medical Center , Beilinson Hospital - Internal Medicine C Department"

Many Locations, Multiple Locations

Many Locations, Multiple Locations

"Albert Schweitzer Ziekenhuis , Dordwijk - Cardiology Department"

"Hospital Quironsalud Barcelona , Internal Medicine Department"

"Hospital Universitario Virgen de las Nieves , Servicio de Endocrinologia y Nutricion"

"Hospital Universitario Puerta de Hierro Majadahonda , Clinical Pharmacology Department"

"Hospital Universitario Virgen de la Victoria , Unidad de Investigacion Clinica - Endocrinology Department"

Many Locations, Multiple Locations

Many Locations, Multiple Locations

"Far Eastern Memorial Hospital , Nephrology Department"

07747

Friedrich-Schiller-Uni. Jena, Jena

5570 015

Manipal Hospital, Mysore

400 012

Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital, Mumbai

07026

Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia, Olbia

791-8026

Saiseikai Matsuyama Hospital, Matsuyama

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

802-8555

Kokura Memorial Hospital, Kitakyushu

807-0857

Hirohata Naika Clinic, Kitakyushu

080-0848

Jiyugaoka Yamada Internal Medicine Clinic, Obihiro

311-0113

Naka Kinen Clinic, Naka

Ishikawa-ken

"Public Central Hospital of Matto Ishikawa , Clinical Trial Management Office"

918-8503

Fukui-ken Saiseikai Hospital, Fukui

811-0213

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital, Fukuoka

861-8520

Japanese Red Cross Kumamoto Hospital, Kumamoto

530-0001

Medical Corporation Taifukukai, Osaka Nishiumeda Clinic, Osaka

558-8558

Osaka General Medical Center, Osaka

3818 TZ

Meander Medisch Centrum, Amersfoort

1091 AC

Onze Lieve Vrouwe Gasthuis, Amsterdam

7334 DZ

Gelre Ziekenhuizen, Apeldoorn

471-701

Hanyang University Guri Hospital, Guri-si

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

425-707

Korea University Ansan Hospital, Gyeonggi-do

A Coruña

"Gerencia de Gestion Integrada A Coruna , Department of Endocrinology and Nutrition"

"Complejo Hospitalario Universitario de Ferrol , Hospital Naval - Unidad de Hipertensión Arterial"

Sevilla

"Hospital Vithas Sevilla , Endocrinology Department"

08035

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY