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

NCT ID: NCT05254002

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2025-03-14

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Finerenone and Empagliflozin

Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days.

Group Type EXPERIMENTAL

Finerenone (BAY94-8862 ) 10 mg

Intervention Type DRUG

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

Empagliflozin

Intervention Type DRUG

oral administration, once daily

Finerenone (BAY94-8862 ) 20 mg

Intervention Type DRUG

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

Finerenone and Empagliflozin placebo

Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.

Group Type EXPERIMENTAL

Finerenone (BAY94-8862 ) 10 mg

Intervention Type DRUG

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

Empagliflozin Placebo

Intervention Type DRUG

Matching placebo to empagliflozin oral administration, once daily

Finerenone (BAY94-8862 ) 20 mg

Intervention Type DRUG

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

Empagliflozin and Finerenone placebo

Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

oral administration, once daily

Finerenone Placebo

Intervention Type DRUG

Matching Placebo to Finerenone oral administration once daily

Interventions

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Finerenone (BAY94-8862 ) 10 mg

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

Intervention Type DRUG

Empagliflozin

oral administration, once daily

Intervention Type DRUG

Empagliflozin Placebo

Matching placebo to empagliflozin oral administration, once daily

Intervention Type 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

Intervention Type DRUG

Finerenone Placebo

Matching Placebo to Finerenone oral administration once daily

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwest Kidney Institute, PLC

Surprise, Arizona, United States

Site Status

Academic Medical Research Institute

Los Angeles, California, United States

Site Status

Northridge Hospital

Northridge, California, United States

Site Status

Olive View - UCLA Medical Center

Sylmar, California, United States

Site Status

Touro University California

Vallejo, California, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Florida Kidney Physicians - Delray Beach Nephrology

Delray Beach, Florida, United States

Site Status

West Orange Endocrinology & Clinical Research

Ocoee, Florida, United States

Site Status

Innovative Research Institute

Port Charlotte, Florida, United States

Site Status

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status

Grady Memorial Hospital - Endocrinology

Atlanta, Georgia, United States

Site Status

Southeast Kidney Associates

East Point, Georgia, United States

Site Status

Velocity Clinical Research - Savannah

Savannah, Georgia, United States

Site Status

Versailles Family Medicine

Versailles, Kentucky, United States

Site Status

Nola Care Clinical Research

Metairie, Louisiana, United States

Site Status

Omega Clinical Research Center

Metairie, Louisiana, United States

Site Status

South Shore Nephrology

Plymouth, Massachusetts, United States

Site Status

Lake Michigan Nephrology

Saint Joseph, Michigan, United States

Site Status

Clinical Research Consultants

Kansas City, Missouri, United States

Site Status

Kansas City VA Medical Center - Endocrinology

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Site Status

St. Louis Heart & Vascular, PC

St Louis, Missouri, United States

Site Status

Somnos Clinical Research

Lincoln, Nebraska, United States

Site Status

Meridian Clinical Research- Norfolk

Norfolk, Nebraska, United States

Site Status

Healor Primary Care / CCT Research

Las Vegas, Nevada, United States

Site Status

Santa Rosa Medical Centers of Nevada / CCT Research

Las Vegas, Nevada, United States

Site Status

Circuit Clinical/Crystal Run

Middletown, New York, United States

Site Status

Randolph Medical Associates

Asheboro, North Carolina, United States

Site Status

University of North Carolina Kidney Center

Chapel Hill, North Carolina, United States

Site Status

Eastern Nephrology Associates - Greenville West

Greenville, North Carolina, United States

Site Status

Blue Sky, MD/ Lamond Family Medicine

Hendersonville, North Carolina, United States

Site Status

Eastern Nephrology Associates - Kinston

Kinston, North Carolina, United States

Site Status

Velocity Clinical Research, Cincinnati

Cincinnati, Ohio, United States

Site Status

Oakland Medical Center

Dakota Dunes, South Dakota, United States

Site Status

Dunes Clinical Research LLC

Dakota Dunes, South Dakota, United States

Site Status

DarSalud Care / LifeDOC Research

Memphis, Tennessee, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Office of Osvaldo A. Brusco, MD

Corpus Christi, Texas, United States

Site Status

Thyroid, Endocrinology, and Diabetes (TED) PA

Dallas, Texas, United States

Site Status

DaVita Clinical Research- El Paso

El Paso, Texas, United States

Site Status

Global Kidney Center

Houston, Texas, United States

Site Status

Victorium Clinical Research

Houston, Texas, United States

Site Status

North Texas Kidney Disease Associates, PLLC

Lewisville, Texas, United States

Site Status

Biopharma Informatic - McAllen, TX

McAllen, Texas, United States

Site Status

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Site Status

University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Olympus Family Medicine

Salt Lake City, Utah, United States

Site Status

Salem VA Medical Center - Endocrinology

Salem, Virginia, United States

Site Status

MultiCare Rockwood Clinic Diabetes & Endocrinology Center

Spokane, Washington, United States

Site Status

CHU de Charleroi Hôpital civil

Lodelinsart, Hainaut, Belgium

Site Status

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

Aalst, Oost-vlaanderen, Belgium

Site Status

AZ St-Lucas Campus St-Lucas

Ghent, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Regionaal ZH Jan Yperman Campus Mariaziekenhuis

Ieper, , Belgium

Site Status

AZ Groeninge Campus Kennedylaan

Kortrijk, , Belgium

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UZ Leuven Gasthuisberg

Leuven, , Belgium

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AZ Delta

Roeselare, , Belgium

Site Status

LMC Manna Research - Calgary

Calgary, Alberta, Canada

Site Status

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Site Status

William Osler Health centre, Sakuara Medical

Mississauga, Ontario, Canada

Site Status

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Site Status

Sameh Fikry Professional Corporation

Waterloo, Ontario, Canada

Site Status

Clinical Research Solutions, Inc.

Waterloo, Ontario, Canada

Site Status

Recherche GCP Research

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

LMC Clinical Research Inc. Montreal

Saint-Laurent, Quebec, Canada

Site Status

Bispebjerg Hospital - Hjerteafdeling

Copenhagen, , Denmark

Site Status

Hospital of South West Jutland | Department of Endocrinology Research

Esbjerg, , Denmark

Site Status

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

Herlev, , Denmark

Site Status

Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

Herning, , Denmark

Site Status

Hôpital François Mitterrand - Dijon

Dijon, , France

Site Status

Center Hospitalier Michallon - Grenoble

Grenoble, , France

Site Status

Hôpital Edouard Herriot - Lyon Cedex

Lyon, , France

Site Status

Many Locations

Multiple Locations, , France

Site Status

Hopital Carémeau - Nîmes

Nîmes, , France

Site Status

Hôpital Saint Joseph

Paris, , France

Site Status

St. Josefskrankenhaus

Heidelberg, Baden-Wurttemberg, Germany

Site Status

ClinPhenomics GmbH&Co. KG

Frankfurt am Main, Hesse, Germany

Site Status

Diabetologische Schwerpunkt Praxis Dortmund

Dortmund, North Rhine-Westphalia, Germany

Site Status

Zentrum für Diabetologie und Ernährungsmedizin

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

Cardiologicum Pirna / Dresden-Seidnitz

Pirna, Saxony, Germany

Site Status

Friedrich-Schiller-Uni. Jena

Jena, Thuringia, Germany

Site Status

Charité Campus Benjamin Franklin (CBF)

Berlin, , Germany

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Diabetes Zentrum Wandsbek

Hamburg, , Germany

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King George Hospital

Visakhapatnam, Andhra Pradesh, India

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Mavani Dialysis & Kidney Center

Ahmedabad, Gujarat, India

Site Status

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

Belagavi, Karnataka, India

Site Status

Manipal Hospital

Mysore, Karnataka, India

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Asian Kidney Hospital and Medical Centre

Nagapur, Maharashtra, India

Site Status

All India Institute of Medical Sciences

Bhubaneswar, National Capital Territory of Delhi, India

Site Status

Indraprastha Apollo Hospital

New Delhi, National Capital Territory of Delhi, India

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Eternal Heart Care Centre (EHCC) and Research Institute

Jaipur, Rajasthan, India

Site Status

Osmania General Hospital

Telangana, Telangana, India

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G.S.V.M. Medical College

Kanpur, Uttar Pradesh, India

Site Status

Institute of Post-Graduate Medical Education and Research

Kolkata, West Bengal, India

Site Status

Dr. Bantwal's Clinic

Bengaluru, , India

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Bangalore Medical College & Research Institute

Bengaluru, , India

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Government Kilpauk Medical College Hospital

Chennai, , India

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Sriram Chandra Bhanj Medical College & Hospital

Cuttack, , India

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Nizam's Institute of Medical Sciences (NIMS)

Hyderabad, , India

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Sawami Man Singh (SMS) Medical College & Attached Hospitals

Jaipur, , India

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Government Medical College

Kozhikode, , India

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Vinaya Hospital and Research Centre (A Unit of KIMS)

Mangalore, , India

Site Status

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

Mumbai, , India

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Government Medical College and Hospital (GMCH) Nagpur

Nagpur, , India

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Max Super Speciality Hospital (MSSH) - Saket

New Delhi, , India

Site Status

Grant Medical Foundation - Ruby Hall Clinic (RHC)

Pune, , India

Site Status

Lifepoint Multispecialty Hospital

Pune, , India

Site Status

Krishna Institute Of Medical Science

Secunderabad, , India

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Vedanta Kidney Care

Vadodara, , India

Site Status

HaEmek Medical Center | Internal Medicine C Department - Research Unit

Afula, , Israel

Site Status

Barzilai Medical Center | Department of Nephrology and Hypertension

Ashkelon, , Israel

Site Status

Clalit Health | Soroka Medical Center - Internal Medicine Department

Beersheba, , Israel

Site Status

Edith Wolfson Medical Center | Internal Medicine Department

Holon, , Israel

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Hadassah University Medical Center (HUMC)

Jerusalem, , Israel

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Health Corporation of Galilee Medical Center

Nahariya, , Israel

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Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department

Petah Tikva, , Israel

Site Status

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

Safed, , Israel

Site Status

Casa Sollievo della Sofferenza - Endocrinologia

San Giovanni Rotondo, Apulia, Italy

Site Status

Azienda Ospedaliero Universitaria Parma - SC Nefrologia

Parma, Emilia-Romagna, Italy

Site Status

ASL 4 Chiavarese

Chiavari, Liguria, Italy

Site Status

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

Bergamo, Lombardy, Italy

Site Status

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia

Milan, Lombardy, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

Azienda Socio Sanitaria Territoriale Rhodense

Rho, Lombardy, Italy

Site Status

Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia

Orbassano, Piedmont, Italy

Site Status

Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia

Olbia, Sardinia, Italy

Site Status

Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia

Pisa, Tuscany, Italy

Site Status

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

Verona, Veneto, Italy

Site Status

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

Chieti, , Italy

Site Status

Many Locations

Multiple Locations, , Italy

Site Status

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, Japan

Site Status

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Site Status

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Site Status

Hirohata Naika Clinic

Kitakyushu, Fukuoka, Japan

Site Status

Jiyugaoka Yamada Internal Medicine Clinic

Obihiro, Hokkaido, Japan

Site Status

Naka Kinen Clinic

Naka, Ibaraki, Japan

Site Status

Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

Hakusan, Ishikawa-ken, Japan

Site Status

Fukui-ken Saiseikai Hospital

Fukui, , Japan

Site Status

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, , Japan

Site Status

Japanese Red Cross Kumamoto Hospital

Kumamoto, , Japan

Site Status

Many Locations

Multiple Locations, , Japan

Site Status

Medical Corporation Taifukukai, Osaka Nishiumeda Clinic

Osaka, , Japan

Site Status

Osaka General Medical Center

Osaka, , Japan

Site Status

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status

Gelre Ziekenhuizen

Apeldoorn, , Netherlands

Site Status

Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department

Dordrecht, , Netherlands

Site Status

Soon Chun Hyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, South Korea

Site Status

Yonsei University Wonju Christian Hospital

Wŏnju, Gang''weondo, South Korea

Site Status

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggido, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Site Status

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

Incheon, Incheon Gwang''yeogsi, South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Asan Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Chung Nam National University Hospital

Daejeon, , South Korea

Site Status

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition

A Coruña, A Coruña, Spain

Site Status

Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial

Ferrol, A Coruña, Spain

Site Status

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status

H. Costa del Sol (Marbella)

Marbella, Malaga, Spain

Site Status

Hospital Vithas Sevilla | Endocrinology Department

Castilleja de la Cuesta, Sevilla, Spain

Site Status

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Quironsalud Barcelona | Internal Medicine Department

Barcelona, , Spain

Site Status

Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion

Granada, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

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

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department

Majadahonda, , Spain

Site Status

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

Málaga, , Spain

Site Status

Many Locations

Multiple Locations, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, , Taiwan

Site Status

Many Locations

Multiple Locations, , Taiwan

Site Status

Far Eastern Memorial Hospital | Nephrology Department

New Taipei City, , Taiwan

Site Status

Taipei Medical University - Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Belgium Canada Denmark France Germany India Israel Italy Japan Netherlands South Korea Spain Taiwan

References

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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. 2025 Sep 18. doi: 10.2215/CJN.0000000865. Online ahead of print. No abstract available.

Reference Type DERIVED
PMID: 40965042 (View on PubMed)

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 Aug 31:gfaf160. doi: 10.1093/ndt/gfaf160. Online ahead of print.

Reference Type DERIVED
PMID: 40886054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40470996 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39916475 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39078403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39037799 (View on PubMed)

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https://clinicaltrials.bayer.com/study/21839

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-506981-30-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-003037-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21839

Identifier Type: -

Identifier Source: org_study_id

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