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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
Sponsor: Bayer
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. 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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1664
Start Date
2022-06-23
Completion Date
2025-03-17
Last Updated
2026-07-13
Healthy Volunteers
No
Interventions
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
Locations (173)
Southwest Kidney Institute, PLC - Suprise
Surprise, Arizona, United States
Academic Medical Research Institute
Los Angeles, California, United States
Dignity Health Northridge Hospital Medical Center - Nephrology
Northridge, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Touro University California - Metabolic Research Center
Vallejo, California, 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
East Point, Georgia, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, United States
Nola Care Clinical Research
Metairie, Louisiana, United States
Omega Clinical Research - Metairie
Metairie, Louisiana, United States
South Shore Nephrology
Plymouth, Massachusetts, United States
Lake Michigan Nephrology
Saint Joseph, Michigan, United States
Oakland Medical Research
Troy, Michigan, United States
Clinical Research Consultants, a JCCT Company
Kansas City, Missouri, United States
Kansas City VA Medical Center - Endocrinology
Kansas City, Missouri, United States
Center for Advanced Medicine - Diabetes Center
St Louis, Missouri, United States
St. Louis Heart and Vascular, PC - Christian Hospital Office
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Healor Primary Care / CCT Research
Las Vegas, Nevada, United States
CCT Research - Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, United States
Circuit Clinical/Crystal Run
Middletown, New York, United States
Randolph Health Internal Medicine in Asheboro
Asheboro, North Carolina, United States
UNC Hospitals Outpatient Center at Eastowne - Nephrology
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 - Blue Ash
Cincinnati, Ohio, United States
Dunes Clinical Research LLC
Dakota Dunes, South Dakota, United States
DarSalud Care / LifeDOC Research
Memphis, Tennessee, United States
The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology
Memphis, Tennessee, United States
Office of Osvaldo A. Brusco, MD
Corpus Christi, Texas, United States
Thyroid, Endocrinology, and Diabetes - Dallas
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 Lewisville
Lewisville, Texas, United States
Biopharma Informatic - McAllen, TX
McAllen, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
UT Health San Antonio - Medical Arts & Research Center - Endocrinology
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
UZ Gent
Ghent, Belgium
Jan Yperman Ziekenhuis
Ieper, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
AZ Delta
Roeselare, Belgium
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
GCP Research | Montreal
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology
Montreal, Quebec, Canada
LMC Clinical Research Inc. Montreal
Saint-Laurent, Quebec, Canada
Bispebjerg Hospital - Hjerteafdeling
Copenhagen, Capital Region, Denmark
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
Herlev, Capital Region, Denmark
Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
Herning, Central Jutland, Denmark
Hospital of South West Jutland | Department of Endocrinology Research
Esbjerg, Region Syddanmark, Denmark
Center Hospitalier Michallon - Grenoble
La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, France
Hôpital Edouard Herriot - Lyon Cedex
Lyon, Auvergne-Rhône-Alpes, France
CHU Dijon - Hopital Francois Miterrand
Dijon, Bourgogne-Franche-Comté, France
Hopital Carémeau - Nîmes
Nîmes, Occitanie, France
Many Locations
Many Locations, France
Hôpital Saint Joseph
Paris, Île-de-France Region, France
Diabetes Zentrum Wandsbek
Hamburg, Free and Hanseatic City of Hamburg, 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
Charité Campus Benjamin Franklin (CBF)
Berlin, State of Berlin, Germany
Friedrich-Schiller-Uni. Jena
Jena, Thuringia, Germany
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Mavani Dialysis & Kidney Center
Ahmedabad, Gujarat, India
Vedanta Kidney Care
Vadodara, Gujarat, India
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, India
Vinaya Hospital and Research Centre (A Unit of KIMS)
Mangalore, Karnataka, India
Manipal Hospital
Mysore, Karnataka, India
Government Medical College
Kozhikode, Kerala, India
Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
Mumbai, Maharashtra, India
Asian Kidney Hospital and Medical Centre
Nagpur, Maharashtra, India
Grant Medical Foundation - Ruby Hall Clinic (RHC)
Pune, 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
Sawami Man Singh (SMS) Medical College & Attached Hospitals
Jaipur, Rajasthan, India
Eternal Heart Care Centre (EHCC) and Research Institute
Jaipur, Rajasthan, India
Government Kilpauk Medical College Hospital
Chennai, Tamil Nadu, India
Nizam's Institute of Medical Sciences (NIMS)
Hyderabad, Telangana, India
Krishna Institute Of Medical Science
Secunderabad, Telangana, 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