AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 2CONFIDENCENCT05254002

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

A Phase 2 study testing Finerenone (BAY94-8862 ) 10 mg, Empagliflozin and Finerenone (BAY94-8862 ) 20 mg in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Bayer at 173 sites in 14 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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Finerenone (BAY94-8862 ) 10 mg, Empagliflozin and Finerenone (BAY94-8862 ) 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,664 participants
Where
173 sitesin 14 countries
Study dates
23 Jun 2022to 17 Mar 2025
Phase
Phase 2
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

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

173 sites in 14 countries.

173 sites in 14 countries

United States46 sites

  • Randolph Health Internal Medicine in Asheboro

    Asheboro, North Carolina, 27203

  • Grady Memorial Hospital - Endocrinology

    Atlanta, Georgia, 30303

  • UNC Hospitals Outpatient Center at Eastowne - Nephrology

    Chapel Hill, North Carolina, 27514

  • Velocity Clinical Research - Blue Ash

    Cincinnati, Ohio, 45242

  • Office of Osvaldo A. Brusco, MD

    Corpus Christi, Texas, 78414

  • Dunes Clinical Research LLC

    Dakota Dunes, South Dakota, 57049

  • Thyroid, Endocrinology, and Diabetes - Dallas

    Dallas, Texas, 75208

  • Florida Kidney Physicians - Delray Beach Nephrology

    Delray Beach, Florida, 33445

  • Southeast Kidney Associates - East Point

    East Point, Georgia, 30344

  • DaVita Clinical Research- El Paso

    El Paso, Texas, 79925

  • Eastern Nephrology Associates - Greenville West

    Greenville, North Carolina, 27834

  • Blue Sky, MD/ Lamond Family Medicine

    Hendersonville, North Carolina, 28792

  • Global Kidney Center

    Houston, Texas, 77008

  • Victorium Clinical Research

    Houston, Texas, 77024-2593

  • Clinical Research Consultants, a JCCT Company

    Kansas City, Missouri, 64111

  • Kansas City VA Medical Center - Endocrinology

    Kansas City, Missouri, 64128

  • Eastern Nephrology Associates - Kinston

    Kinston, North Carolina, 28504

  • Healor Primary Care / CCT Research

    Las Vegas, Nevada, 89102

  • CCT Research - Santa Rosa Medical Centers of Nevada

    Las Vegas, Nevada, 89119

  • North Texas Kidney Disease Associates Lewisville

    Lewisville, Texas, 75057

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Biopharma Informatic - McAllen, TX

    McAllen, Texas, 78503

  • DarSalud Care / LifeDOC Research

    Memphis, Tennessee, 38119

  • The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology

    Memphis, Tennessee, 38163

  • Nola Care Clinical Research

    Metairie, Louisiana, 70006

  • Omega Clinical Research - Metairie

    Metairie, Louisiana, 70006

  • Circuit Clinical/Crystal Run

    Middletown, New York, 10941

  • Dignity Health Northridge Hospital Medical Center - Nephrology

    Northridge, California, 91325

  • West Orange Endocrinology & Clinical Research

    Ocoee, Florida, 34761

  • South Shore Nephrology

    Plymouth, Massachusetts, 02360

  • Innovative Research Institute

    Port Charlotte, Florida, 33952

  • Lake Michigan Nephrology

    Saint Joseph, Michigan, 49085

  • Salem VA Medical Center - Endocrinology

    Salem, Virginia, 24153

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • UT Health San Antonio - Medical Arts & Research Center - Endocrinology

    San Antonio, Texas, 78229

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406

  • MultiCare Rockwood Clinic Diabetes & Endocrinology Center

    Spokane, Washington, 99202

  • Center for Advanced Medicine - Diabetes Center

    St Louis, Missouri, 63110

  • St. Louis Heart and Vascular, PC - Christian Hospital Office

    St Louis, Missouri, 63136

  • Southwest Kidney Institute, PLC - Suprise

    Surprise, Arizona, 85374

  • Olive View - UCLA Medical Center

    Sylmar, California, 91342-1437

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Touro University California - Metabolic Research Center

    Vallejo, California, 94592

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

India26 sites

  • Mavani Dialysis & Kidney Center

    Ahmedabad, Gujarat, 380052

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

    Belagavi, Karnataka, 590010

  • Dr. Bantwal's Clinic

    Bengaluru, 560076

  • Bangalore Medical College & Research Institute

    Bengaluru

  • All India Institute of Medical Sciences

    Bhubaneswar, National Capital Territory of Delhi, 751019

  • Government Kilpauk Medical College Hospital

    Chennai, Tamil Nadu, 600010

  • Sriram Chandra Bhanj Medical College & Hospital

    Cuttack

  • Nizam's Institute of Medical Sciences (NIMS)

    Hyderabad, Telangana, 500082

  • Sawami Man Singh (SMS) Medical College & Attached Hospitals

    Jaipur, Rajasthan, 302017

  • Eternal Heart Care Centre (EHCC) and Research Institute

    Jaipur, Rajasthan, 302020

  • G.S.V.M. Medical College

    Kanpur, Uttar Pradesh, 208002

  • Institute of Post-Graduate Medical Education and Research

    Kolkata, West Bengal, 700020

  • Government Medical College

    Kozhikode, Kerala, 673008

  • Vinaya Hospital and Research Centre (A Unit of KIMS)

    Mangalore, Karnataka, 575003

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

    Mumbai, Maharashtra, 400012

  • Manipal Hospital

    Mysore, Karnataka, 570015

  • Asian Kidney Hospital and Medical Centre

    Nagpur, Maharashtra, 440010

  • Government Medical College and Hospital (GMCH) Nagpur

    Nagpur, 440009

  • Indraprastha Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076

  • Max Super Speciality Hospital (MSSH) - Saket

    New Delhi, 110017

  • Grant Medical Foundation - Ruby Hall Clinic (RHC)

    Pune, Maharashtra, 411001

  • Lifepoint Multispecialty Hospital

    Pune, 411057

  • Krishna Institute Of Medical Science

    Secunderabad, Telangana, 500003

  • Osmania General Hospital

    Telangana, Telangana, 500012

  • Vedanta Kidney Care

    Vadodara, Gujarat, 390007

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Italy13 sites

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

    Bergamo, Lombardy, 24127

  • ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche

    Chiavari, Liguria, 16043

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

    Chieti, 66100

  • Many Locations

    Many Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia

    Milan, Lombardy, 20122

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

    Milan, Lombardy, 20132

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

    Milan, Lombardy, 20142

  • Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia

    Olbia, Sardinia, 07026

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia

    Orbassano, Piedmont, 10043

  • Azienda Ospedaliero Universitaria Parma - SC Nefrologia

    Parma, Emilia-Romagna, 43126

  • Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia

    Pisa, Tuscany, 56124

  • Azienda Socio Sanitaria Territoriale Rhodense

    Rho, Lombardy, 20017

  • Casa Sollievo della Sofferenza - Endocrinologia

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

Spain13 sites

  • Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion

    A Coruña, A Coruña, 15006

  • Hospital Universitario Principe De Asturias | Nefrologia

    Alcalá de Henares, Madrid, 28805

  • Hospital Universitari Vall D Hebron | Nefrologia

    Barcelona, Barcelona, 08035

  • Hospital Quironsalud Barcelona | Internal Medicine Department

    Barcelona, Barcelona, 8023

  • Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion

    Castilleja de la Cuesta, Sevilla, 41950

  • Area Sanitaria De Ferrol | Medicina Interna

    Ferrol, A Coruña, 15405

  • Hospital Universitario Virgen De Las Nieves | Medicina Interna

    Granada, Granada, 18014

  • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department

    Madrid, Madrid, 28040

  • Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion

    Málaga, Málaga, 20910

  • Many Locations

    Many Locations

  • Hospital Clinico Universitario De Valencia | Cardiologia

    Valencia, Valencia, 46010

  • Hospital Universitario Dr Peset Aleixandre | Nefrologia

    Valencia, Valencia, 46017

Other trials in Spain

Japan12 sites

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502

  • Fukui-ken Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213

  • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

    Hakusan, Ishikawa-ken, 924-8588

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Hirohata Naika Clinic

    Kitakyushu, Fukuoka, 807-0857

  • Many Locations

    Many Locations

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime, 791-8026

  • Naka Kinen Clinic

    Naka, Ibaraki, 311-0113

  • Jiyugaoka Yamada Internal Medicine Clinic

    Obihiro, Hokkaido, 080-0848

  • Medical Corporation Taifukukai, Osaka Nishiumeda Clinic

    Osaka, Osaka, 530-0001

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

Other trials in Japan

South Korea12 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggido, 14068

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, Chungcheongnam-do, 31151

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 471-701

  • Ansan Hospital | Nephrology

    Gyeonggi-do, 425-707

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

    Incheon, Incheon Gwang''Yeogsi, 21431

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center | Ophthalmology

    Seoul, Seoul Teugbyeolsi, 05505

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080

  • Kyung Hee University Hospital at Gangdong

    Seoul, 5278

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 7442

  • Yonsei University Wonju Christian Hospital

    Wŏnju, Gang''Weondo, 26426

Other trials in South Korea

Canada8 sites

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • William Osler Health centre, Sakuara Medical

    Mississauga, Ontario, L5H4K9

  • GCP Research | Montreal

    Montreal, Quebec, H1M 1B1

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology

    Montreal, Quebec, H2X 0A9

  • LMC Clinical Research Inc. Montreal

    Saint-Laurent, Quebec, H4T 1Z9

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

  • Sameh Fikry Professional Corporation

    Waterloo, Ontario, N2J 1C4

  • Clinical Research Solutions, Inc.

    Waterloo, Ontario, N2T 0C1

Other trials in Canada

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, Changhua, 50006

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, Kaohsiung, 833

  • Many Locations

    Many Locations

  • Far Eastern Memorial Hospital | Nephrology Department

    New Taipei City, New Taipei, 220

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, New Taipei, 23561

  • Taichung Veterans General Hospital

    Taichung, Taichung, 40705

  • China Medical University Hospital

    Taichung, 404327

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217

Other trials in Taiwan

Belgium7 sites

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

    Aalst, Oost-vlaanderen, 9300

  • UZ Gent

    Ghent, 9000

  • Jan Yperman Ziekenhuis

    Ieper, 8900

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Charleroi Hôpital civil

    Lodelinsart, Hainaut, 6042

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Germany7 sites

  • Charité Campus Benjamin Franklin (CBF)

    Berlin, State of Berlin, 12203

  • Diabetologische Schwerpunkt Praxis Dortmund

    Dortmund, North Rhine-Westphalia, 44137

  • ClinPhenomics GmbH&Co. KG

    Frankfurt am Main, Hesse, 60596

  • Diabetes Zentrum Wandsbek

    Hamburg, Free and Hanseatic City of Hamburg, 22041

  • Friedrich-Schiller-Uni. Jena

    Jena, Thuringia, 7747

  • Zentrum für Diabetologie und Ernährungsmedizin

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • Cardiologicum Pirna / Dresden-Seidnitz

    Pirna, Saxony, 1796

Other trials in Germany

Israel7 sites

  • HaEmek Medical Center | Internal Medicine C Department - Research Unit

    Afula, 1834111

  • Barzilai Medical Center | Department of Nephrology and Hypertension

    Ashkelon, 7830604

  • Clalit Health | Soroka Medical Center - Internal Medicine Department

    Beersheba, 8410101

  • Edith Wolfson Medical Center | Internal Medicine Department

    Holon, 5822012

  • Hadassah University Medical Center (HUMC)

    Jerusalem, 911200

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001

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

    Safed, 1311001

Other trials in Israel

France6 sites

  • CHU Dijon - Hopital Francois Miterrand

    Dijon, Bourgogne-Franche-Comté, 21000

  • Center Hospitalier Michallon - Grenoble

    La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, 38043

  • Hôpital Edouard Herriot - Lyon Cedex

    Lyon, Auvergne-Rhône-Alpes, 69003

  • Many Locations

    Many Locations

  • Hopital Carémeau - Nîmes

    Nîmes, Occitanie, 30029

  • Hôpital Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

Denmark4 sites

  • Bispebjerg Hospital - Hjerteafdeling

    Copenhagen, Capital Region, 2400

  • Hospital of South West Jutland | Department of Endocrinology Research

    Esbjerg, Region Syddanmark, 6700

  • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department

    Herlev, Capital Region, 2730

  • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

    Herning, Central Jutland, 7400

Other trials in Denmark

Netherlands4 sites

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3818 TZ

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1091 AC

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland, 7334 DZ

  • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department

    Dordrecht, South Holland, 3318 AT

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.
Being tested
Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

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

  • Finerenone (BAY94-8862 ) 10 mgDrug

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

  • EmpagliflozinDrug

    oral administration, once daily

  • Empagliflozin PlaceboDrug

    Matching placebo to empagliflozin oral administration, once daily

  • Finerenone (BAY94-8862 ) 20 mgDrug

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

  • Finerenone PlaceboDrug

    Matching Placebo to Finerenone oral administration once daily

Study groups in NCT05254002
Study groupRoleWhat they receive
Finerenone and EmpagliflozinExperimentalParticipants will take Finerenone (10 or 20 mg once daily [OD]) and Empagliflozin (10 mg OD) for up to 180 days.
Receives: Drug: Finerenone (BAY94-8862 ) 10 mg; Drug: Empagliflozin; Drug: Finerenone (BAY94-8862 ) 20 mg
Finerenone and Empagliflozin placeboExperimentalParticipants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.
Receives: Drug: Finerenone (BAY94-8862 ) 10 mg; Drug: Empagliflozin Placebo; Drug: Finerenone (BAY94-8862 ) 20 mg
Empagliflozin and Finerenone placeboExperimentalParticipants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.
Receives: Drug: Empagliflozin; Drug: Finerenone Placebo

What is being measured

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

  1. 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

    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.

    Measured: Baseline and Day 180

  2. 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

    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.

    Measured: Baseline and Day 180

Secondary outcomes (20)

  1. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180

    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.

    Measured: Up to 210 days

  2. Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline

    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.

    Measured: Baseline to Day 210 (30 days after End of Treatment)

  3. Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)

    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.

    Measured: At Day 180

  4. Change From Baseline in eGFR at 30 Days

    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.

    Measured: At Day 30

  5. Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline

    Measured: Up to 30 days

  6. Change in eGFR at 180 Days and 210 Days From Day 30

    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.

    Measured: At Day 180 and Day 210

  7. Number of Participants With 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 Total number of AKI events Up to 180 days

    Measured: Up to 180 days

  8. Total Number of 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 Total number of AKI events Up to 180 days

    Measured: Up to 180 days

  9. Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])

    Moderate hyperkalemia was defined as K+ >5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ >6.0 mmol/L).

    Measured: Up to 180 days

  10. Change From Baseline in K+

    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.

    Measured: At baseline, day 14 and day 180

  11. Number of Participants With Symptomatic Hypotension Events

    Number of participants who experienced at least one symptomatic hypotension event during the study period

    Measured: Up to 180 days

  12. Total Number of Symptomatic Hypotension Events

    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.

    Measured: Up to 180 days

  13. Number of Participants With Genital Mycotic Events

    The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.

    Measured: Up to 180 days

  14. Total Number of Genital Mycotic Events

    Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.

    Measured: Up to 180 days

  15. Number of Participants With Urosepsis and Pyelonephritis Events

    Measured: Up to 180 days

  16. Total Number of Urosepsis and Pyelonephritis Events

    Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.

    Measured: Up to 180 days

  17. Number of Participants With Ketoacidosis Events

    Measured: Up to 180 days

  18. Total Number of Ketoacidosis Events

    Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.

    Measured: Up to 180 days

  19. Number of Participants With Necrotizing Fasciitis of the Perineum Events

    Measured: Up to 180 days

  20. Number of Participants With Severe Hypoglycemia Events

    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.

    Measured: Up to 180 days

Timeline

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

  1. First posted24 Feb 2022
  2. Study start23 Jun 2022
  3. Primary completion14 Mar 2025
  4. Study completion17 Mar 2025

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254002
Sponsor's protocol ID
21839
Other IDs
2023-506981-30-00, 2021-003037-11, 2023
Acronym
CONFIDENCE
Status last verified
Jun 2026
First submitted
4 Feb 2022
Last updated
13 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, 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.

Publications

  • Agarwal R, Correa-Rotter R, Navaneethan SD, Heerspink HJL, Weir MR, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Brinker M, Kovesdy CP, Green JB, Mann JFE. Safety and Synergy of Finerenone and Empagliflozin in Lowering Blood Pressure. Hypertension. 2026 Jun 5. doi: 10.1161/HYPERTENSIONAHA.126.27036. Online ahead of print.

    PubMed 42244376

  • Agarwal R, Correa-Rotter R, Navaneethan SD, Fukami K, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Aldworth C, Green JB, Weir MR. Acute eGFR Changes and Their Mediation of Albuminuria Reduction with Empagliflozin and Finerenone. J Am Soc Nephrol. 2026 Mar 29. doi: 10.1681/ASN.0000001071. Online ahead of print.

    PubMed 41905767

  • Agarwal R, Green JB, Heerspink HJL, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Solis-Herrera C, Scott C, Li L, Brinker M, Aldworth C, Mann JFE. Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial. J Am Coll Cardiol. 2026 Feb 24;87(7):772-784. doi: 10.1016/j.jacc.2025.10.049. Epub 2025 Nov 7.

    PubMed 41493296

  • 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

  • Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl A, Osonoi T, Pal A, Rossing P, Rosenstock J, Vaduganathan M, Li L, Li N, Scott C, Manjrekar P, Yamashita S, Nangaku M. Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Urinary Albumin-to-Creatinine Ratio in Asia: Pre-Specified Analysis of CONFIDENCE. Clin J Am Soc Nephrol. 2026 Jan 1;21(1):72-82. doi: 10.2215/CJN.0000000865. Epub 2025 Sep 18.

    PubMed 40965042

  • Vaduganathan M, Green JB, Heerspink HJL, Kim SG, Mann JFE, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Rohwedder K, Scott C, Agarwal R. Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial. Nephrol Dial Transplant. 2025 Dec 23;41(1):161-170. doi: 10.1093/ndt/gfaf160.

    PubMed 40886054

  • Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.

    PubMed 40470996

  • Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE investigators. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics. Nephrol Dial Transplant. 2025 Aug 1;40(8):1559-1569. doi: 10.1093/ndt/gfaf022.

    PubMed 39916475

  • Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.

    PubMed 39078403

  • Zachariah T, Radhakrishnan J. Potential Role of Mineralocorticoid Receptor Antagonists in Nondiabetic Chronic Kidney Disease and Glomerular Disease. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1499-1512. doi: 10.2215/CJN.0000000000000540. Epub 2024 Jul 22.

    PubMed 39037799

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Finerenone (BAY94-8862 ) 10 mg, Empagliflozin and Finerenone (BAY94-8862 ) 20 mg in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Bayer at 173 sites in 14 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 6 inclusion and 7 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, India, Italy, Spain, Japan and 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Jul 2026). 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?

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). The study lists 2 primary outcomes in all. 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 NCT05254002, which also lists 10 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 13 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in