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
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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COMPLETED
PHASE2
1664 participants
INTERVENTIONAL
2022-06-23
2025-03-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Finerenone (BAY94-8862 ) 10 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2
Empagliflozin
oral administration, once daily
Finerenone (BAY94-8862 ) 20 mg
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.
Finerenone (BAY94-8862 ) 10 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \<60 mL/min/1.73 m2
Empagliflozin Placebo
Matching placebo to empagliflozin oral administration, once daily
Finerenone (BAY94-8862 ) 20 mg
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.
Empagliflozin
oral administration, once daily
Finerenone Placebo
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
Empagliflozin
oral administration, once daily
Empagliflozin Placebo
Matching placebo to empagliflozin oral administration, once daily
Finerenone (BAY94-8862 ) 20 mg
oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2
Finerenone Placebo
Matching Placebo to Finerenone oral administration once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Southwest Kidney Institute, PLC
Surprise, Arizona, United States
Academic Medical Research Institute
Los Angeles, California, United States
Northridge Hospital
Northridge, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Touro University California
Vallejo, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Florida Kidney Physicians - Delray Beach Nephrology
Delray Beach, Florida, United States
West Orange Endocrinology & Clinical Research
Ocoee, Florida, United States
Innovative Research Institute
Port Charlotte, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Grady Memorial Hospital - Endocrinology
Atlanta, Georgia, United States
Southeast Kidney Associates
East Point, Georgia, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, United States
Versailles Family Medicine
Versailles, Kentucky, United States
Nola Care Clinical Research
Metairie, Louisiana, United States
Omega Clinical Research Center
Metairie, Louisiana, United States
South Shore Nephrology
Plymouth, Massachusetts, United States
Lake Michigan Nephrology
Saint Joseph, Michigan, United States
Clinical Research Consultants
Kansas City, Missouri, United States
Kansas City VA Medical Center - Endocrinology
Kansas City, Missouri, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
St. Louis Heart & Vascular, PC
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Meridian Clinical Research- Norfolk
Norfolk, Nebraska, United States
Healor Primary Care / CCT Research
Las Vegas, Nevada, United States
Santa Rosa Medical Centers of Nevada / CCT Research
Las Vegas, Nevada, United States
Circuit Clinical/Crystal Run
Middletown, New York, United States
Randolph Medical Associates
Asheboro, North Carolina, United States
University of North Carolina Kidney Center
Chapel Hill, North Carolina, United States
Eastern Nephrology Associates - Greenville West
Greenville, North Carolina, United States
Blue Sky, MD/ Lamond Family Medicine
Hendersonville, North Carolina, United States
Eastern Nephrology Associates - Kinston
Kinston, North Carolina, United States
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio, United States
Oakland Medical Center
Dakota Dunes, South Dakota, United States
Dunes Clinical Research LLC
Dakota Dunes, South Dakota, United States
DarSalud Care / LifeDOC Research
Memphis, Tennessee, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Office of Osvaldo A. Brusco, MD
Corpus Christi, Texas, United States
Thyroid, Endocrinology, and Diabetes (TED) PA
Dallas, Texas, United States
DaVita Clinical Research- El Paso
El Paso, Texas, United States
Global Kidney Center
Houston, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
North Texas Kidney Disease Associates, PLLC
Lewisville, Texas, United States
Biopharma Informatic - McAllen, TX
McAllen, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
Salem VA Medical Center - Endocrinology
Salem, Virginia, United States
MultiCare Rockwood Clinic Diabetes & Endocrinology Center
Spokane, Washington, United States
CHU de Charleroi Hôpital civil
Lodelinsart, Hainaut, Belgium
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
Aalst, Oost-vlaanderen, Belgium
AZ St-Lucas Campus St-Lucas
Ghent, , Belgium
UZ Gent
Ghent, , Belgium
Regionaal ZH Jan Yperman Campus Mariaziekenhuis
Ieper, , Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
AZ Delta
Roeselare, , Belgium
LMC Manna Research - Calgary
Calgary, Alberta, Canada
Hamilton Medical Research Group
Hamilton, Ontario, Canada
William Osler Health centre, Sakuara Medical
Mississauga, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
Sameh Fikry Professional Corporation
Waterloo, Ontario, Canada
Clinical Research Solutions, Inc.
Waterloo, Ontario, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
LMC Clinical Research Inc. Montreal
Saint-Laurent, Quebec, Canada
Bispebjerg Hospital - Hjerteafdeling
Copenhagen, , Denmark
Hospital of South West Jutland | Department of Endocrinology Research
Esbjerg, , Denmark
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
Herlev, , Denmark
Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
Herning, , Denmark
Hôpital François Mitterrand - Dijon
Dijon, , France
Center Hospitalier Michallon - Grenoble
Grenoble, , France
Hôpital Edouard Herriot - Lyon Cedex
Lyon, , France
Many Locations
Multiple Locations, , France
Hopital Carémeau - Nîmes
Nîmes, , France
Hôpital Saint Joseph
Paris, , France
St. Josefskrankenhaus
Heidelberg, Baden-Wurttemberg, Germany
ClinPhenomics GmbH&Co. KG
Frankfurt am Main, Hesse, Germany
Diabetologische Schwerpunkt Praxis Dortmund
Dortmund, North Rhine-Westphalia, Germany
Zentrum für Diabetologie und Ernährungsmedizin
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Cardiologicum Pirna / Dresden-Seidnitz
Pirna, Saxony, Germany
Friedrich-Schiller-Uni. Jena
Jena, Thuringia, Germany
Charité Campus Benjamin Franklin (CBF)
Berlin, , Germany
Diabetes Zentrum Wandsbek
Hamburg, , Germany
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Mavani Dialysis & Kidney Center
Ahmedabad, Gujarat, India
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India
Manipal Hospital
Mysore, Karnataka, India
Asian Kidney Hospital and Medical Centre
Nagapur, Maharashtra, India
All India Institute of Medical Sciences
Bhubaneswar, National Capital Territory of Delhi, India
Indraprastha Apollo Hospital
New Delhi, National Capital Territory of Delhi, India
Eternal Heart Care Centre (EHCC) and Research Institute
Jaipur, Rajasthan, India
Osmania General Hospital
Telangana, Telangana, India
G.S.V.M. Medical College
Kanpur, Uttar Pradesh, India
Institute of Post-Graduate Medical Education and Research
Kolkata, West Bengal, India
Dr. Bantwal's Clinic
Bengaluru, , India
Bangalore Medical College & Research Institute
Bengaluru, , India
Government Kilpauk Medical College Hospital
Chennai, , India
Sriram Chandra Bhanj Medical College & Hospital
Cuttack, , India
Nizam's Institute of Medical Sciences (NIMS)
Hyderabad, , India
Sawami Man Singh (SMS) Medical College & Attached Hospitals
Jaipur, , India
Government Medical College
Kozhikode, , India
Vinaya Hospital and Research Centre (A Unit of KIMS)
Mangalore, , India
Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
Mumbai, , India
Government Medical College and Hospital (GMCH) Nagpur
Nagpur, , India
Max Super Speciality Hospital (MSSH) - Saket
New Delhi, , India
Grant Medical Foundation - Ruby Hall Clinic (RHC)
Pune, , India
Lifepoint Multispecialty Hospital
Pune, , India
Krishna Institute Of Medical Science
Secunderabad, , India
Vedanta Kidney Care
Vadodara, , India
HaEmek Medical Center | Internal Medicine C Department - Research Unit
Afula, , Israel
Barzilai Medical Center | Department of Nephrology and Hypertension
Ashkelon, , Israel
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, , Israel
Edith Wolfson Medical Center | Internal Medicine Department
Holon, , Israel
Hadassah University Medical Center (HUMC)
Jerusalem, , Israel
Health Corporation of Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
Petah Tikva, , Israel
Health Corporation of the Ziv Medical Center (R.A.)
Safed, , Israel
Casa Sollievo della Sofferenza - Endocrinologia
San Giovanni Rotondo, Apulia, Italy
Azienda Ospedaliero Universitaria Parma - SC Nefrologia
Parma, Emilia-Romagna, Italy
ASL 4 Chiavarese
Chiavari, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
Bergamo, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
Milan, Lombardy, Italy
Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Rhodense
Rho, Lombardy, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
Orbassano, Piedmont, Italy
Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
Olbia, Sardinia, Italy
Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
Pisa, Tuscany, Italy
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo
Verona, Veneto, Italy
Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
Chieti, , Italy
Many Locations
Multiple Locations, , Italy
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Hirohata Naika Clinic
Kitakyushu, Fukuoka, Japan
Jiyugaoka Yamada Internal Medicine Clinic
Obihiro, Hokkaido, Japan
Naka Kinen Clinic
Naka, Ibaraki, Japan
Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
Hakusan, Ishikawa-ken, Japan
Fukui-ken Saiseikai Hospital
Fukui, , Japan
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Many Locations
Multiple Locations, , Japan
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
Meander Medisch Centrum
Amersfoort, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
Dordrecht, , Netherlands
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea
Yonsei University Wonju Christian Hospital
Wŏnju, Gang''weondo, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Incheon Gwang''yeogsi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Chung Nam National University Hospital
Daejeon, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
A Coruña, A Coruña, Spain
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
Ferrol, A Coruña, Spain
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain
H. Costa del Sol (Marbella)
Marbella, Malaga, Spain
Hospital Vithas Sevilla | Endocrinology Department
Castilleja de la Cuesta, Sevilla, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital Quironsalud Barcelona | Internal Medicine Department
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion
Granada, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
Majadahonda, , Spain
Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
Málaga, , Spain
Many Locations
Multiple Locations, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
Many Locations
Multiple Locations, , Taiwan
Far Eastern Memorial Hospital | Nephrology Department
New Taipei City, , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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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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