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

NCT05901831 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 222672022-503024-27-00
• Study Type: interventional
• Target: 241
• Locations: 9 countries
• Sites: 80

Brief 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. 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

Conditions

Chronic Kidney Disease; Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Urinary albumin-to-creatinine ratio (UACR)

  UACR will be assessed by the Central laboratory.

  From baseline up to 6 months

Secondary Outcomes (2)

• Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)

  From baseline up to 7 months

• Number of participants with Hyperkalaemia

  From baseline up to 7 months

Study Arms (2)

Finerenone arm

EXPERIMENTAL

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.

Drug: Finerenone

Placebo arm

PLACEBO COMPARATOR

Participants will take Finerenone matching placebo for 6 months.

Other: Placebo

Interventions

Finerenone DRUG

Dose A, Dose B, oral

Finerenone arm

Placebo OTHER

Oral

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
• 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.

You may not qualify if:

• Participant with T2D (Type 2 diabetes).
• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (80)

Southwest Kidney Institute, PLC - Suprise

Surprise, Arizona, 85374, United States

Location

Stanford Endocrinology Clinic

Stanford, California, 94305, United States

Location

Touro University California - Metabolic Research Center

Vallejo, California, 94592, United States

Location

UHealth Diabetes Research Center

Miami, Florida, 33136, United States

Location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Elixia Central Florida

Orlando, Florida, 32806, United States

Location

Hanson Clinical Research Center, Inc.

Port Charlotte, Florida, 33952, United States

Location

Jedidiah Clinical Research

Tampa, Florida, 33619, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Grady Memorial Hospital - Endocrinology

Atlanta, Georgia, 30303, United States

Location

Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine

Chicago, Illinois, 60611, United States

Location

UChicago Medicine Kovler Diabetes Center

Chicago, Illinois, 60637, United States

Location

Preventive Intervention Center - Endocrinology

Iowa City, Iowa, 52202, United States

Location

Wichita Nephrology Group Pa

Wichita, Kansas, 67214, United States

Location

Diabetes & Metabolism Associates

Metairie, Louisiana, 70006, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MU Health Care - University Hospital - Endocrinology

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110-1010, United States

Location

UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit

Chapel Hill, North Carolina, 27514, United States

Location

Physicians East, P.A.- W. H. Smith - Endocrinology

Greenville, North Carolina, 27834, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic - Main Campus

Cleveland, Ohio, 44195, United States

Location

OHSU Physicians Pavillion - Endocrinology

Portland, Oregon, 97239, United States

Location

UT Health San Antonio - Medical Arts & Research Center - Endocrinology

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research, LLC.

San Antonio, Texas, 79231, United States

Location

EVMS Strelitz Diabetes Center

Norfolk, Virginia, 23510, United States

Location

Providence Medical Research Center

Spokane Valley, Washington, 99204, United States

Location

Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)

Calgary, Alberta, T2T 5C7, Canada

Location

Alberta Diabetes Institute - Clinical Research Unit (CRU)

Edmonton, Alberta, T6G 2E1, Canada

Location

Toronto General Hospital - University Health Network, Renal Physiology laboratory

Toronto, Ontario, M5G 2C4, Canada

Location

Centre de Recherche Clinique de Laval

Laval, Quebec, H7T 2P5, Canada

Location

McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)

Montreal, Quebec, H4A 3J1, Canada

Location

Zhongshan People's Hospital

Zhongshan, Guangdong, 528499, China

Location

The 4th Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...

Wuhan, Hubei, 430014, China

Location

Affiliated Hospital of Jiangsu University

JiangSu, Jiangsu, 212001, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

Peking University People's Hospital

Beijing, 100032, China

Location

Southern Medical University - Nanfang Hospital (Southern Hospital)

Guangzhou, 510515, China

Location

Huai'an First People's Hospital, Nanjing Medical University

Huai'an, 223300, China

Location

Nanjing Medical University (NMU) - The Second Affiliated Hospital

Nanjing, 210011, China

Location

Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location

Shanghai, 200080, China

Location

Central Hospital of Minhang District, Shanghai

Shanghai, 201100, China

Location

Zhongshan Hospital Fudan University, Qingpu Branch

Shanghai, 201700, China

Location

Hospital of South West Jutland | Department of Endocrinology Research

Esbjerg, 6700, Denmark

Location

Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department

Gistrup, 9260, Denmark

Location

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

Herlev, 2730, Denmark

Location

Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

Herning, DK-7400, Denmark

Location

Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit

Hillerød, 3400, Denmark

Location

Odense University Hospital | Odense - Endocrinology Department

Odense, 5000, Denmark

Location

InnoDiab Forschung GmbH

Essen, North Rhine-Westphalia, 45136, Germany

Location

Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)

Bad Oeynhausen, 32545, Germany

Location

Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete

Bologna, Emilia-Romagna, 40138, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia

Rome, Lazio, 00168, Italy

Location

Careggi University Hospital - Diabetologia e Malattie del Metabolismo

Florence, Tuscany, 50134, Italy

Location

ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia

Bergamo, 24127, Italy

Location

Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale

Chieri, 10023, Italy

Location

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

Chieti, 66100, Italy

Location

IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit

Milan, 20132, Italy

Location

ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department

Milan, 20142, Italy

Location

ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia

Milan, 20157, Italy

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center - Oncology Department

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

A Coruña, A Coruña, 15006, Spain

Location

Hospital Nisa Sevilla Aljarafe - Endocrinologia

Castilleja de la Cuesta, Sevilla, 41950, Spain

Location

Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion

Barcelona, 08036, Spain

Location

Hospital Gregorio Maranon | Endocrinology Department

Madrid, 28007, Spain

Location

Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia

Majadahonda, 28222, Spain

Location

Hospital Universitario Virgen De La Victoria - Endocrinologia

Málaga, 29010, Spain

Location

North Bristol NHS Trust | Southmead Hospital - Clinical Research Centre

Bristol, BS10 5NB, United Kingdom

Location

Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant

Cardiff, CF14 4XW, United Kingdom

Location

University Hospitals of Derby and Burton NHS Foundation Trust | Royal Derby Hospital - Renal Research

Derby, DE22 3NE, United Kingdom

Location

NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)

Glasgow, G4 0SF, United Kingdom

Location

Barts Health NHS Trust - Royal London Hospital - Nephrology

London, E1 1BB, United Kingdom

Location

Manchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research Facility

Manchester, M23 9LT, United Kingdom

Location

Walsall Healthcare NHS Trust | Manor Hospital - Nephrology

Walsall, WS2 9PS, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40693871 DERIVED

• 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.

  PMID: 37805000 DERIVED

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 1

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: February 26, 2024
• Primary Completion: August 20, 2025
• Study Completion: September 15, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); DK (6); CN (12); ES (6); CA (5); US (28); IT (9); KR (5); GB (7)