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 (CONFIDENCE)

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.

Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.

In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.

Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.

The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.

The study team will:

• collect blood and urine samples
• check the participants' vital signs
• do a physical examination including height and weight
• check the participants' heart health by using an electrocardiogram (ECG)
• monitor the participants' blood pressure
• ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Empagliflozin; Drug: Finerenone (BAY94-8862 ) 10 mg; Drug: Finerenone (BAY94-8862 ) 20 mg; Drug: Empagliflozin Placebo; Drug: Finerenone Placebo

• Study Type: Interventional
• Enrollment (Actual): 1664
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Gent, Belgium, 9000
    • AZ St-Lucas Campus St-Lucas
  • Ieper, Belgium, 8900
    • Regionaal ZH Jan Yperman Campus Mariaziekenhuis
  • Kortrijk, Belgium, 8500
    • AZ Groeninge Campus Kennedylaan
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Roeselare, Belgium, 8800
    • AZ Delta
  • Hainaut
    • Lodelinsart, Hainaut, Belgium, 6042
      • CHU de Charleroi Hôpital civil
  • Oost-vlaanderen
    • Aalst, Oost-vlaanderen, Belgium, 9300
      • Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • LMC Manna Research - Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Medical Research Group
    • Mississauga, Ontario, Canada, L5H4K9
      • William Osler Health centre, Sakuara Medical
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group
    • Waterloo, Ontario, Canada, N2J 1C4
      • Sameh Fikry Professional Corporation
    • Waterloo, Ontario, Canada, N2T 0C1
      • Clinical Research Solutions, Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Montreal, Quebec, Canada, H2R 1V6
      • Recherche GCP Research
    • Ville Saint-Laurent, Quebec, Canada, H4T 1Z9
      • LMC Clinical Research Inc. Montreal
• Denmark
  • Esbjerg, Denmark, 6700
    • Hospital of South West Jutland | Department of Endocrinology Research
  • Herlev, Denmark, 2730
    • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
  • Herning, Denmark, DK-7400
    • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
  • København, Denmark, DK-2400
    • Bispebjerg Hospital - Hjerteafdeling
• France
  • Dijon, France, 21000
    • Hôpital François Mitterrand - Dijon
  • Grenoble Cedex 9, France, 38043
    • Center Hospitalier Michallon - Grenoble
  • Lyon Cedex, France, 69003
    • Hôpital Edouard Herriot - Lyon Cedex
  • Multiple Locations, France
    • Many Locations
  • Nîmes, France, 30029
    • Hopital Carémeau - Nîmes
  • Paris, France, 75014
    • Hopital Saint Joseph
• Germany
  • Berlin, Germany, 12203
    • Charité Campus Benjamin Franklin (CBF)
  • Hamburg, Germany, 22041
    • Diabetes Zentrum Wandsbek
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
      • St. Josefskrankenhaus
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • ClinPhenomics GmbH&Co. KG
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Diabetologische Schwerpunkt Praxis Dortmund
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
      • Zentrum für Diabetologie und Ernährungsmedizin
  • Sachsen
    • Pirna, Sachsen, Germany, 1796
      • Cardiologicum Pirna / Dresden-Seidnitz
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Friedrich-Schiller-Uni. Jena
• India
  • Bengaluru, India, 560076
    • Dr. Bantwal's Clinic
  • Bengaluru, India
    • Bangalore Medical College & Research Institute
  • Chennai, India
    • Government Kilpauk Medical College Hospital
  • Cuttack, India
    • Sriram Chandra Bhanj Medical College & Hospital
  • Hyderabad, India, 500082
    • Nizam's Institute of Medical Sciences (NIMS)
  • Jaipur, India, 302017
    • Sawami Man Singh (SMS) Medical College & Attached Hospitals
  • Kozhikode, India, 673008
    • Government Medical College
  • Mangalore, India, 575003
    • Vinaya Hospital and Research Centre (A Unit of KIMS)
  • Mumbai, India, 400 012
    • Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
  • Nagpur, India, 440009
    • Government Medical College and Hospital (GMCH) Nagpur
  • New Delhi, India, 110017
    • Max Super Speciality Hospital (MSSH) - Saket
  • Pune, India, 411057
    • Lifepoint Multispecialty Hospital
  • Pune, India, 411001
    • Grant Medical Foundation - Ruby Hall Clinic (RHC)
  • Secunderabad, India, 500003
    • Krishna Institute of Medical Science
  • Telangana, India, 500012
    • Osmania General Hospital
  • Vadodara, India
    • Vedanta Kidney Care
  • AP
    • Visakhapatnam, AP, India
      • King George Hospital
  • Delhi
    • Bhubaneswar, Delhi, India, 751019
      • All India Institute of Medical Sciences
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospital
  • GJ
    • Ahmedabad, GJ, India
      • Mavani Dialysis & Kidney Center
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
    • Mysore, Karnataka, India, 5570 015
      • Manipal Hospital
  • MH
    • Nagapur, MH, India, 440010
      • Asian Kidney Hospital And Medical Centre
  • Rajasthan
    • Jaipur, Rajasthan, India, 302020
      • Eternal Heart Care Centre (EHCC) and Research Institute
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • G.S.V.M. Medical College
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Institute of Post-Graduate Medical Education and Research
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center | Internal Medicine C Department - Research Unit
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center | Department of Nephrology and Hypertension
  • Beer Sheva, Israel, 8410101
    • Clalit Health | Soroka Medical Center - Internal Medicine Department
  • Holon, Israel, 58100
    • Edith Wolfson Medical Center | Internal Medicine Department
  • Jerusalem, Israel, 911200
    • Hadassah University Medical Center (HUMC)
  • Nahariya, Israel, 2210001
    • Health Corporation of Galilee Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
  • Zefat, Israel, 1311001
    • Health Corporation of the Ziv Medical Center (R.A.)
• Italy
  • Chieti, Italy, 66100
    • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
  • Multiple Locations, Italy
    • Many Locations
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43126
      • Azienda Ospedaliero Universitaria Parma - SC Nefrologia
  • Liguria
    • Chiavari, Liguria, Italy, 16043
      • ASL 4 Chiavarese
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
    • Milano, Lombardia, Italy, 20132
      • Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
    • Milano, Lombardia, Italy, 20142
      • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
    • Milano, Lombardia, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
    • Rho, Lombardia, Italy, 20017
      • Azienda Socio Sanitaria Territoriale Rhodense
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
  • Puglia
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • Casa Sollievo della Sofferenza - Endocrinologia
  • Sardegna
    • Olbia, Sardegna, Italy, 07026
      • Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
  • Veneto
    • Verona, Veneto, Italy, 37134
      • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo
• Japan
  • Fukui, Japan, 918-8503
    • Fukui-ken Saiseikai Hospital
  • Fukuoka, Japan, 811-0213
    • Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Multiple Locations, Japan
    • Many Locations
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Japan, 530-0001
    • Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
  • Ehime
    • Matsuyama, Ehime, Japan, 791-8026
      • Saiseikai Matsuyama Hospital
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818-8502
      • Fukuoka University Chikushi Hospital
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
    • Kitakyushu, Fukuoka, Japan, 807-0857
      • Hirohata Naika Clinic
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0848
      • Jiyugaoka Yamada Internal Medicine Clinic
  • Ibaraki
    • Naka-shi, Ibaraki, Japan, 311-0113
      • Naka Kinen Clinic
  • Ishikawa
    • Hakusan, Ishikawa, Japan, 924-8588
      • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chung Nam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 425-707
    • Korea University Ansan Hospital
  • Seoul, Korea, Republic of, 5278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 7442
    • Hallym University Kangnam Sacred Heart Hospital
  • Chungcheongnamdo
    • Cheonan, Chungcheongnamdo, Korea, Republic of, 31151
      • Soon Chun Hyang University Cheonan Hospital
  • Gang''weondo
    • Wonju, Gang''weondo, Korea, Republic of, 26426
      • Yonsei University Wonju Christian Hospital
  • Gyeonggi
    • Guri-si, Gyeonggi, Korea, Republic of, 471-701
      • Hanyang University Guri Hospital
  • Gyeonggido
    • Anyang-si, Gyeonggido, Korea, Republic of, 14068
      • Hallym University Sacred Heart Hospital
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Incheon Gwang''yeogsi
    • Incheon, Incheon Gwang''yeogsi, Korea, Republic of, 21431
      • The Catholic University of Korea, Incheon St.Mary's Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
      • Seoul National University Hospital
• Netherlands
  • Amersfoort, Netherlands, 3818 TZ
    • Meander Medisch Centrum
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Ziekenhuizen
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
• Spain
  • Barcelona, Spain, 08035
    • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Barcelona, Spain, 8023
    • Hospital Quironsalud Barcelona | Internal Medicine Department
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
  • Multiple Locations, Spain
    • Many Locations
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • A Coruña
    • A Coruna, A Coruña, Spain, 15006
      • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
    • Ferrol, A Coruña, Spain, 15405
      • Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Hospital Príncipe de Asturias
  • Malaga
    • Marbella, Malaga, Spain, 29603
      • H. Costa del Sol (Marbella)
  • Sevilla
    • Castilleja de la Cuesta, Sevilla, Spain, 41950
      • Hospital Vithas Sevilla | Endocrinology Department
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 833
    • Chang Gung Memorial Hospital Kaohsiung
  • Multiple Locations, Taiwan
    • Many Locations
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University - Shuang Ho Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital | Nephrology Department
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404327
    • China Medical University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United States
  • Arizona
    • Surprise, Arizona, United States, 85374
      • Southwest Kidney Institute, PLC
  • California
    • Los Angeles, California, United States, 90022
      • Academic Medical Research Institute
    • Northridge, California, United States, 91325
      • Northridge Hospital
    • Sylmar, California, United States, 91342-1437
      • Olive View - UCLA Medical Center
    • Vallejo, California, United States, 94592
      • Touro University California
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Florida Kidney Physicians - Delray Beach Nephrology
    • Ocoee, Florida, United States, 34761-4547
      • West Orange Endocrinology & Clinical Research
    • Port Charlotte, Florida, United States, 33952
      • Innovative Research Institute
    • West Palm Beach, Florida, United States, 33401-3430
      • Metabolic Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital - Endocrinology
    • East Point, Georgia, United States, 30344
      • Southeast Kidney Associates
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research - Savannah
  • Kentucky
    • Versailles, Kentucky, United States, 40383
      • Versailles Family Medicine
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Omega Clinical Research Center
    • Metairie, Louisiana, United States, 70006
      • NOLA Care Clinical Research
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • South Shore Nephrology
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Lake Michigan Nephrology
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center - Endocrinology
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart & Vascular, PC
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University School of Medicine in St. Louis
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Clinical Research
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research- Norfolk
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Santa Rosa Medical Centers of Nevada / CCT Research
    • Las Vegas, Nevada, United States, 89102
      • Healor Primary Care / CCT Research
  • New York
    • Middletown, New York, United States, 10941
      • Circuit Clinical/Crystal Run
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Randolph Medical Associates
    • Chapel Hill, North Carolina, United States, 27599-7155
      • University of North Carolina Kidney Center
    • Greenville, North Carolina, United States, 27834
      • Eastern Nephrology Associates - Greenville West
    • Hendersonville, North Carolina, United States, 28792
      • Blue Sky, MD/ Lamond Family Medicine
    • Kinston, North Carolina, United States, 28504
      • Eastern Nephrology Associates - Kinston
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research, Cincinnati
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 48085
      • Oakland Medical Center
    • Dakota Dunes, South Dakota, United States, 57049
      • Dunes Clinical Research LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center
    • Memphis, Tennessee, United States, 38119
      • DarSalud Care / LifeDOC Research
  • Texas
    • Corpus Christi, Texas, United States, 78414-4173
      • Office of Osvaldo A. Brusco, MD
    • Dallas, Texas, United States, 75208-2362
      • Thyroid, Endocrinology, and Diabetes (TED) PA
    • El Paso, Texas, United States, 79925
      • DaVita Clinical Research- El Paso
    • Houston, Texas, United States, 77008
      • Global Kidney Center
    • Houston, Texas, United States, 77024-2593
      • Victorium Clinical Research
    • Lewisville, Texas, United States, 75057
      • North Texas Kidney Disease Associates, PLLC
    • McAllen, Texas, United States, 78503
      • Biopharma Informatic - McAllen, TX
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
    • San Antonio, Texas, United States, 78249
      • University of Texas Health Science Center
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Olympus Family Medicine
  • Virginia
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center - Endocrinology
  • Washington
    • Spokane, Washington, United States, 99202
      • MultiCare Rockwood Clinic Diabetes & Endocrinology Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:

  • In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
  • In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
  • 100 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
• Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
• Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

Exclusion Criteria:

• Participants with type 1 diabetes (T1D).
• Participant with hepatic insufficiency classified as Child-Pugh C.
• Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg.
• Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
• Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
• Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
• Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone and Empagliflozin; Participants will take Finerenone (10 or 20 mg once daily [OD]) and Empagliflozin (10 mg OD) for up to 180 days.	Drug: Empagliflozin; oral administration, once daily; 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: Finerenone (BAY94-8862 ) 20 mg; oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2
Experimental: Finerenone and Empagliflozin placebo; Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.	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: 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: Empagliflozin Placebo; Matching placebo to empagliflozin oral administration, once daily
Experimental: Empagliflozin and Finerenone placebo; Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.	Drug: Empagliflozin; oral administration, once daily; Drug: Finerenone Placebo; Matching Placebo to Finerenone oral administration once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone	Urinary albumin to-creatinine ratio (UACR)	Up to 180 days
Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone		Up to 180 days
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone		Upto 180 days
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone		Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)		Up to 210 days
Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)		Up to 210 days
Relative change in UACR category (>30%, >40%, >50%) at 180 days		Up to 180 days
Ratio of change from baseline in eGFR at 30 days	estimated glomerular filtration rate (eGRF)	Up to 30 days
eGFR decline greater than 30% at 30 days from baseline		Up to 30 days
Ratio of change in eGFR at 180 days and 210 days from Day 30		Up to 210 days
Total number of AKI events		Up to 180 days
Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])		Up to 180 days
Total number of events of severe hypoglycemia events		Up to 180 days
Total number of symptomatic hypotension events		Up to 180 days
Total number of genital mycotic events		Up to 180 days
Total number of ketoacidosis events		Up to 180 days
Total number of necrotizing fasciitis of the perineum events		Up to 180 days
Total number of urosepsis and pyelonephritis events		Up to 180 days
Proportion of participants with of acute kidney injury (AKI) events	AKI is defined as any of the following: An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or; An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or; A urine volume less than 0.5 ml/kg/h for 6 hours	Up to 180 days
Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])	serum/plasma potassium (k+)	Up to 180 days
Change from baseline in K+		Up to 180 days
Proportion of participants with severe hypoglycemia events	Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).	Up to 180 days
Proportion of participants with symptomatic hypotension events		Up to 180 days
Proportion of participants with genital mycotic events		Up to 180 days
Proportion of participants with ketoacidosis events		Up to 180 days
Proportion of participants with necrotizing fasciitis of the perineum events		Up to 180 days
Proportion of participants with urosepsis and pyelonephritis events		Up to 180 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Diabetes Mellitus, Type 2; Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: 21839; 2021-003037-11 (EudraCT Number); 2023-506981-30-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers 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.vivli.org 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 member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No