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)

June 16, 2026 updated by: Bayer

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1664

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • UZ Gent
      • Ieper, Belgium, 8900
        • Jan Yperman Ziekenhuis
      • 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
    • 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, H1M 1B1
        • GCP Research | Montreal
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clinical Research Inc. Montreal
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2400
        • Bispebjerg Hospital - Hjerteafdeling
      • Herlev, Capital Region, Denmark, 2730
        • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
    • Region Syddanmark
      • Esbjerg, Region Syddanmark, Denmark, 6700
        • Hospital of South West Jutland | Department of Endocrinology Research
  • France
      • Many Locations, France
        • Many Locations
    • Auvergne-Rhône-Alpes
      • La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, France, 38043
        • Center Hospitalier Michallon - Grenoble
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Hôpital Edouard Herriot - Lyon Cedex
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • CHU Dijon - Hopital Francois Miterrand
    • Occitanie
      • Nîmes, Occitanie, France, 30029
        • Hopital Carémeau - Nîmes
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • Hôpital Saint Joseph
  • Germany
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22041
        • Diabetes Zentrum Wandsbek
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • ClinPhenomics GmbH&Co. KG
    • North Rhine-Westphalia
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Diabetologische Schwerpunkt Praxis Dortmund
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67059
        • Zentrum für Diabetologie und Ernährungsmedizin
    • Saxony
      • Pirna, Saxony, Germany, 1796
        • Cardiologicum Pirna / Dresden-Seidnitz
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12203
        • Charité Campus Benjamin Franklin (CBF)
    • Thuringia
      • Jena, Thuringia, Germany, 7747
        • Friedrich-Schiller-Uni. Jena
  • India
      • Bengaluru, India, 560076
        • Dr. Bantwal's Clinic
      • Bengaluru, India
        • Bangalore Medical College & Research Institute
      • Cuttack, India
        • Sriram Chandra Bhanj Medical College & 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
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • King George Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Mavani Dialysis & Kidney Center
      • Vadodara, Gujarat, India, 390007
        • Vedanta Kidney Care
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
      • Mangalore, Karnataka, India, 575003
        • Vinaya Hospital and Research Centre (A Unit of KIMS)
      • Mysore, Karnataka, India, 570015
        • Manipal Hospital
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
      • Nagpur, Maharashtra, India, 440010
        • Asian Kidney Hospital and Medical Centre
      • Pune, Maharashtra, India, 411001
        • Grant Medical Foundation - Ruby Hall Clinic (RHC)
    • National Capital Territory of Delhi
      • Bhubaneswar, National Capital Territory of Delhi, India, 751019
        • All India Institute of Medical Sciences
      • New Delhi, National Capital Territory of Delhi, India, 110076
        • Indraprastha Apollo Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Sawami Man Singh (SMS) Medical College & Attached Hospitals
      • Jaipur, Rajasthan, India, 302020
        • Eternal Heart Care Centre (EHCC) and Research Institute
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600010
        • Government Kilpauk Medical College Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Nizam's Institute of Medical Sciences (NIMS)
      • Secunderabad, Telangana, India, 500003
        • Krishna Institute Of Medical Science
      • Telangana, Telangana, India, 500012
        • Osmania General Hospital
    • 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
      • Beersheba, Israel, 8410101
        • Clalit Health | Soroka Medical Center - Internal Medicine Department
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center | Internal Medicine Department
      • Jerusalem, Israel, 911200
        • Hadassah University Medical Center (HUMC)
      • Nahariya, Israel, 2210001
        • Health Corporation of Galilee Medical Center
      • Safed, Israel, 1311001
        • Health Corporation of the Ziv Medical Center (R.A.)
  • Italy
      • Chieti, Italy, 66100
        • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
      • Many Locations, Italy
        • Many Locations
    • Apulia
      • San Giovanni Rotondo, Apulia, Italy, 71013
        • Casa Sollievo della Sofferenza - Endocrinologia
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliero Universitaria Parma - SC Nefrologia
    • Liguria
      • Chiavari, Liguria, Italy, 16043
        • ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
      • Milan, Lombardy, Italy, 20142
        • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
      • Rho, Lombardy, Italy, 20017
        • Azienda Socio Sanitaria Territoriale Rhodense
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
    • Sardinia
      • Olbia, Sardinia, Italy, 07026
        • Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
  • Japan
      • Many Locations, Japan
        • Many Locations
    • Ehime
      • Matsuyama, Ehime, Japan, 791-8026
        • Saiseikai Matsuyama Hospital
    • Fukui
      • Fukui-shi, Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Fukuoka, Japan, 811-0213
        • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro 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, Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic
    • Ishikawa-ken
      • Hakusan, Ishikawa-ken, Japan, 924-8588
        • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
    • Osaka
      • Osaka, Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Osaka, Osaka, Japan, 530-0001
        • Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
  • Netherlands
    • Gelderland
      • Apeldoorn, Gelderland, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3818 TZ
        • Meander Medisch Centrum
  • South Korea
      • Gyeonggi-do, South Korea, 425-707
        • Ansan Hospital | Nephrology
      • Seoul, South Korea, 5278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, South Korea, 7442
        • Hallym University Kangnam Sacred Heart Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, South Korea, 31151
        • Soon Chun Hyang University Cheonan Hospital
    • Gang''Weondo
      • Wŏnju, Gang''Weondo, South Korea, 26426
        • Yonsei University Wonju Christian Hospital
    • Gyeonggi-do
      • Guri-si, Gyeonggi-do, South Korea, 471-701
        • Hanyang University Guri Hospital
    • Gyeonggido
      • Anyang-si, Gyeonggido, South Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Incheon Gwang''Yeogsi
      • Incheon, Incheon Gwang''Yeogsi, South Korea, 21431
        • The Catholic University of Korea, Incheon St.Mary's Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 3080
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center | Ophthalmology
  • Spain
      • Many Locations, Spain
        • Many Locations
    • A Coruña
      • A Coruña, A Coruña, Spain, 15006
        • Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
      • Ferrol, A Coruña, Spain, 15405
        • Area Sanitaria De Ferrol | Medicina Interna
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitari Vall D Hebron | Nefrologia
      • Barcelona, Barcelona, Spain, 8023
        • Hospital Quironsalud Barcelona | Internal Medicine Department
    • Granada
      • Granada, Granada, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves | Medicina Interna
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
        • Hospital Universitario Principe De Asturias | Nefrologia
      • Madrid, Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia
    • Málaga
      • Málaga, Málaga, Spain, 20910
        • Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spain, 41950
        • Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clinico Universitario De Valencia | Cardiologia
      • Valencia, Valencia, Spain, 46017
        • Hospital Universitario Dr Peset Aleixandre | Nefrologia
  • Taiwan
      • Many Locations, Taiwan
        • Many Locations
      • Taichung, Taiwan, 404327
        • China Medical University Hospital
    • Changhua
      • Changhua, Changhua, Taiwan, 50006
        • Changhua Christian Hospital
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital Kaohsiung
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital | Nephrology Department
      • New Taipei City, New Taipei, Taiwan, 23561
        • Taipei Medical University - Shuang Ho Hospital
    • Taichung
      • Taichung, Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
    • Taipei
      • Taipei, Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United States
    • Arizona
      • Surprise, Arizona, United States, 85374
        • Southwest Kidney Institute, PLC - Suprise
    • California
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Northridge, California, United States, 91325
        • Dignity Health Northridge Hospital Medical Center - Nephrology
      • Sylmar, California, United States, 91342-1437
        • Olive View - UCLA Medical Center
      • Vallejo, California, United States, 94592
        • Touro University California - Metabolic Research Center
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Florida Kidney Physicians - Delray Beach Nephrology
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology & Clinical Research
      • Port Charlotte, Florida, United States, 33952
        • Innovative Research Institute
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital - Endocrinology
      • East Point, Georgia, United States, 30344
        • Southeast Kidney Associates - East Point
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research - Savannah
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Nola Care Clinical Research
      • Metairie, Louisiana, United States, 70006
        • Omega Clinical Research - Metairie
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • South Shore Nephrology
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lake Michigan Nephrology
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center - Endocrinology
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants, a JCCT Company
      • St Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular, PC - Christian Hospital Office
      • St Louis, Missouri, United States, 63110
        • Center for Advanced Medicine - Diabetes Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Healor Primary Care / CCT Research
      • Las Vegas, Nevada, United States, 89119
        • CCT Research - Santa Rosa Medical Centers of Nevada
    • New York
      • Middletown, New York, United States, 10941
        • Circuit Clinical/Crystal Run
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Health Internal Medicine in Asheboro
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals Outpatient Center at Eastowne - Nephrology
      • 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 - Blue Ash
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Dunes Clinical Research LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • DarSalud Care / LifeDOC Research
      • Memphis, Tennessee, United States, 38163
        • The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology
    • Texas
      • Corpus Christi, Texas, United States, 78414
        • Office of Osvaldo A. Brusco, MD
      • Dallas, Texas, United States, 75208
        • Thyroid, Endocrinology, and Diabetes - Dallas
      • 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 Lewisville
      • McAllen, Texas, United States, 78503
        • Biopharma Informatic - McAllen, TX
      • San Antonio, Texas, United States, 78212
        • Clinical Advancement Center, PLLC
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio - Medical Arts & Research Center - Endocrinology
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone
Time Frame: Baseline and Day 180
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures. The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.
Baseline and Day 180
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone
Time Frame: Baseline and Day 180
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Baseline and Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180
Time Frame: Up to 210 days
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 210 (30 days after stopping the treatment) relative to Day 180, estimated using a mixed model for repeated measures. A ratio above 1 indicates an increase in UACR at Day 210 compared with Day 180. UACR is a measurement of albuminuria, a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Up to 210 days
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline
Time Frame: Baseline to Day 210 (30 days after End of Treatment)
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) relative to baseline, estimated using a mixed model for repeated measures. A ratio below 1 indicates a reduction in UACR relative to baseline. UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
Baseline to Day 210 (30 days after End of Treatment)
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
Time Frame: At Day 180
This outcome summarizes the number of participants whose relative change from baseline in urine albumin-to-creatinine ratio (UACR) at Day 180 met prespecified category thresholds (>30%, >40%, or >50%). Relative change was assessed based on baseline and post-baseline UACR measurements. Percentages were calculated using as denominator the number of participants with both a baseline and at least one post-baseline UACR assessment within the specified timeframe. Participants were classified independently within each category.
At Day 180
Change From Baseline in eGFR at 30 Days
Time Frame: At Day 30
Change from baseline to Day 30 in estimated glomerular filtration rate (eGFR) was evaluated for each treatment group. Change was calculated as the value at Day 30 minus the baseline value. Negative values indicate a decrease from baseline and positive values indicate an increase from baseline.
At Day 30
Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline
Time Frame: Up to 30 days
Up to 30 days
Change in eGFR at 180 Days and 210 Days From Day 30
Time Frame: At Day 180 and Day 210
Change in estimated glomerular filtration rate (eGFR) from Day 30 to Day 180 and Day 210 was evaluated for each treatment group. Change was calculated as the value at Day 180 or Day 210 minus the value at Day 30. Positive values indicate an increase from Day 30 and negative values indicate a decrease from Day 30.
At Day 180 and Day 210
Number of Participants With AKI Events
Time Frame: Up to 180 days

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 Total number of AKI events Up to 180 days
Up to 180 days
Total Number of AKI Events
Time Frame: Up to 180 days

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 Total number of AKI events Up to 180 days
Up to 180 days
Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])
Time Frame: Up to 180 days
Moderate hyperkalemia was defined as K+ >5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ >6.0 mmol/L).
Up to 180 days
Change From Baseline in K+
Time Frame: At baseline, day 14 and day 180
Serum potassium values (mmol/L) were assessed at baseline and scheduled post-baseline visits. Results are presented as observed mean potassium concentrations at each time point.
At baseline, day 14 and day 180
Number of Participants With Symptomatic Hypotension Events
Time Frame: Up to 180 days
Number of participants who experienced at least one symptomatic hypotension event during the study period
Up to 180 days
Total Number of Symptomatic Hypotension Events
Time Frame: Up to 180 days
Symptomatic hypotension events were assessed at all study visits and were documented as adverse events. The outcome represents the total number of symptomatic hypotension events reported during the study period.
Up to 180 days
Number of Participants With Genital Mycotic Events
Time Frame: Up to 180 days
The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.
Up to 180 days
Total Number of Genital Mycotic Events
Time Frame: Up to 180 days
Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.
Up to 180 days
Number of Participants With Urosepsis and Pyelonephritis Events
Time Frame: Up to 180 days
Up to 180 days
Total Number of Urosepsis and Pyelonephritis Events
Time Frame: Up to 180 days
Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.
Up to 180 days
Number of Participants With Ketoacidosis Events
Time Frame: Up to 180 days
Up to 180 days
Total Number of Ketoacidosis Events
Time Frame: Up to 180 days
Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.
Up to 180 days
Number of Participants With Necrotizing Fasciitis of the Perineum Events
Time Frame: Up to 180 days
Up to 180 days
Number of Participants With Severe Hypoglycemia Events
Time Frame: Up to 180 days
Severe hypoglycemia was defined as glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia. In addition, severe hypoglycemia, as defined by the ADA denotes severe cognitive impairment requiring external assistance for recovery.
Up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 17, 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)

July 13, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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