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
NCT ID: NCT05901831
Last Updated: 2025-10-21
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
PHASE3
241 participants
INTERVENTIONAL
2024-02-26
2025-09-15
Brief Summary
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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. An 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
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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 arm
Participants with eGFR ≥25 to \<60 mL/min/1.73 m\^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m\^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
Finerenone
Dose A, Dose B, oral
Placebo arm
Participants will take Finerenone matching placebo for 6 months.
Placebo
Oral
Interventions
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Finerenone
Dose A, Dose B, oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis.
* If the onset was after age 35, documentation of the presence of one or more of the following:
* Circulating T1D-associated autoantibodies
* Hospitalization for diabetic ketoacidosis
* Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dl).
* HbA1c at Screening \<10% (central assessment).
* Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
* K+ ≤ 4.8 mmol/L at Screening (local assessment)
* Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment):
* eGFR ≥25 and \<90 mL/min/1.73 m\^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit
* UACR ≥200 mg/g (22.6 mg/mmol) to \<5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements)
* Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.
Exclusion Criteria
* Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
* Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs).
* Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 (Glucagon-like peptide-1) receptor agonist.
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 - 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, Florida, United States
AdventHealth Translational Research Institute
Orlando, Florida, United States
Elixia Central Florida
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
Diabetes & Metabolism Associates
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
Washington University School of Medicine in St. Louis
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
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(RRDTC)
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
Centre de Recherche Clinique de Laval
Laval, Quebec, Canada
McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
Montreal, Quebec, Canada
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
Affiliated Hospital of Jiangsu University
JiangSu, Jiangsu, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Peking University People's Hospital
Beijing, , China
Southern Medical University - Nanfang Hospital (Southern Hospital)
Guangzhou, , China
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, , China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, , China
Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
Shanghai, , China
Central Hospital of Minhang District, Shanghai
Shanghai, , China
Zhongshan Hospital Fudan University, Qingpu Branch
Shanghai, , China
Hospital of South West Jutland | Department of Endocrinology Research
Esbjerg, , Denmark
Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department
Gistrup, , Denmark
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
Herlev, , Denmark
Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
Herning, , Denmark
Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
Hillerød, , Denmark
Odense University Hospital | Odense - Endocrinology Department
Odense, , Denmark
InnoDiab Forschung GmbH
Essen, North Rhine-Westphalia, Germany
Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
Bad Oeynhausen, , Germany
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete
Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia
Rome, Lazio, Italy
Careggi University Hospital - Diabetologia e Malattie del Metabolismo
Florence, Tuscany, Italy
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
Bergamo, , Italy
Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
Chieri, , Italy
Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
Chieti, , 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
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center - Oncology Department
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
A Coruña, A Coruña, Spain
Hospital Nisa Sevilla Aljarafe - Endocrinologia
Castilleja de la Cuesta, Sevilla, Spain
Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
Barcelona, , Spain
Hospital Gregorio Maranon | Endocrinology Department
Madrid, , Spain
Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia
Majadahonda, , Spain
Hospital Universitario Virgen De La Victoria - Endocrinologia
Málaga, , Spain
North Bristol NHS Trust | Southmead Hospital - Clinical Research Centre
Bristol, , United Kingdom
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, , United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust | Royal Derby Hospital - Renal Research
Derby, , United Kingdom
NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
Glasgow, , United Kingdom
Barts Health NHS Trust - Royal London Hospital - Nephrology
London, , United Kingdom
Manchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research Facility
Manchester, , United Kingdom
Walsall Healthcare NHS Trust | Manor Hospital - Nephrology
Walsall, , United Kingdom
Countries
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References
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Kugathasan L, Aronson Y, Sridhar VS, Ni H, Ouimet JP, Limonte CP, Sarma S, Cherney DZI. Advancing kidney protection in type 1 diabetes: insights from emerging therapies in type 2 diabetes and chronic kidney disease. Expert Rev Clin Immunol. 2025 Aug;21(8):1113-1134. doi: 10.1080/1744666X.2025.2537446. Epub 2025 Jul 24.
Heerspink HJL, Birkenfeld AL, Cherney DZI, Colhoun HM, Ji L, Mathieu C, Groop PH, Pratley RE, Rosas SE, Rossing P, Skyler JS, Tuttle KR, Lawatscheck R, Scott C, Edfors R, Scheerer MF, Kolkhof P, McGill JB. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes Res Clin Pract. 2023 Oct;204:110908. doi: 10.1016/j.diabres.2023.110908. Epub 2023 Oct 5.
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Other Identifiers
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2022-503024-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
22267
Identifier Type: -
Identifier Source: org_study_id
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