Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
Sponsor: Bayer
Summary
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: * medical problems (also called treatment-emergent adverse events (TEAEs)) * serious TEAEs. A TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important * higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. 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, they will visit the study site at least 6 times. The study team will: * collect blood and urine samples * check the participants' vital signs such as blood pressure and heart rate * do a physical examination including height and weight * check the participants' heart health by using an electrocardiogram (ECG) * do pregnancy tests in women of childbearing potential
Official title: A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Addition to Standard of Care, in Participants With Chronic Kidney Disease and Type 1 Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2024-02-26
Completion Date
2025-09-15
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Finerenone
Dose A, Dose B, oral
Placebo
Oral
Locations (79)
Southwest Kidney Institute, PLC - Suprise
Surprise, Arizona, United States
Stanford Endocrinology Clinic
Stanford, California, United States
Touro University California - Metabolic Research Center
Vallejo, California, United States
UHealth Diabetes Research Center - Miami
Miami, Florida, United States
AdventHealth Translational Research Institute
Orlando, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Hanson Clinical Research Center, Inc.
Port Charlotte, Florida, United States
Jedidiah Clinical Research
Tampa, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Grady Memorial Hospital - Endocrinology
Atlanta, Georgia, United States
Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine
Chicago, Illinois, United States
UChicago Medicine Kovler Diabetes Center
Chicago, Illinois, United States
Preventive Intervention Center - Endocrinology
Iowa City, Iowa, United States
Wichita Nephrology Group, PA
Wichita, Kansas, United States
Omega Clinical Research - Metairie
Metairie, Louisiana, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
MU Health Care - University Hospital - Endocrinology
Columbia, Missouri, United States
Center for Advanced Medicine - Diabetes Center
St Louis, Missouri, United States
UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit
Chapel Hill, North Carolina, United States
Physicians East, P.A.- W. H. Smith - Endocrinology
Greenville, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Cleveland Clinic - Main Campus - Endocrinology
Cleveland, Ohio, United States
OHSU Physicians Pavillion - Endocrinology
Portland, Oregon, United States
UT Health San Antonio - Medical Arts & Research Center - Endocrinology
San Antonio, Texas, United States
Consano Clinical Research, LLC.
San Antonio, Texas, United States
EVMS Strelitz Diabetes Center
Norfolk, Virginia, United States
Providence Medical Research Center
Spokane Valley, Washington, United States
Richmond Road Diagnostic and Treatment Centre | Clinical Trials Unit
Calgary, Alberta, Canada
Alberta Diabetes Institute | Clinical Research Unit (CRU)
Edmonton, Alberta, Canada
Toronto General Hospital - University Health Network, Renal Physiology laboratory
Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre | McConnell Centre for Innovative Medicine
Montreal, Quebec, Canada
Centre hospitalier universitaire de Québec (CHUQ) | Cardiology
Québec, Quebec, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, China
Southern Medical University - Nanfang Hospital (Southern Hospital)
Guangzhou, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The 4th Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
Wuhan, Hubei, China
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
Shanghai, Shanghai Municipality, China
Central Hospital of Minhang District, Shanghai
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University, Qingpu Branch
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
Herlev, Capital Region / Region Hovedstaden, Denmark
Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
Hillerød, Capital Region / Region Hovedstaden, Denmark
Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
Herning, Central Denmark Region / Region Midtjylland, Denmark
Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department
Gistrup, North Denmark Region / Region Nordjylland, Denmark
Hospital of South West Jutland | Department of Endocrinology Research
Esbjerg, Region of Southern Denmark / Region Syddanmark, Denmark
Odense University Hospital | Odense - Endocrinology Department
Odense, Region of Southern Denmark / Region Syddanmark, Denmark
Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
Bad Oeynhausen, North Rhine-Westphalia, Germany
InnoDiab Forschung GmbH
Essen, North Rhine-Westphalia, Germany
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
Bergamo, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete
Bologna, Italy
Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
Chieri, Italy
Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
Chieti, Italy
Careggi University Hospital - Diabetologia e Malattie del Metabolismo
Florence, Italy
IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit
Milan, Italy
ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department
Milan, Italy
ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia
Roma, Italy
Anam Hospital | Endocrinology and Metabolism
Seongbuk, Seoul, South Korea
Seoul National University Hospital | Endocrinology and Metabolism
Seoul, Seoul, South Korea
Severance Hospital | Endocrinology and Metabolism
Seoul, Seoul, South Korea
Asan Medical Center | Endocrinology and Metabolism
Seoul, Seoul, South Korea
Complexo Hospitalario Universitario A Coruna | Endocrinologia
A Coruña, A Coruña, Spain
Hospital Clinic De Barcelona | Endocrinologia
Barcelona, Barcelona, Spain
Hospital General Universitario Gregorio Maranon | Endocrinologia
Madrid, Madrid, Spain
Hospital Universitario Puerta De Hierro De Majadahonda | Endocrinologia
Majadahonda, Madrid, Spain
Hospital Universitario Virgen De La Victoria | Endocrinologia
Málaga, Málaga, Spain
Hospital Nisa Sevilla Aljarafe | Endocrinologia
Castilleja de la Cuesta, Sevilla, Spain
Southmead Hospital | Clinical Research Centre
Bristol, Bristol, United Kingdom
Royal Derby Hospital | Renal Research
Derby, Derbyshire, United Kingdom
Royal London Hospital | Nephrology
London, Greater London, United Kingdom
Wythenshawe Hospital | Clinical Research Facility
Manchester, Greater Manchester, United Kingdom
Glasgow Royal Infirmary | Renal Unit
Glasgow, Scotland, United Kingdom
University Hospital of Wales | Nephrology and Transplant
Cardiff, Wales, United Kingdom
Manor Hospital | Nephrology
Walsall, West Midlands, United Kingdom