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

Chronic Kidney Disease Clinical Trial

— FINE-ONE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901831
• Other study ID #: 22267
• Secondary ID: 2022-503024-27-0
• Status: Recruiting
• Phase: Phase 3
• Start date: February 26, 2024
• Est. completion date: October 2, 2025

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 2, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Finerenone
Dose A, Dose B, oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
Canada	Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC)	Calgary
Canada	Alberta Diabetes Institute Clinical Research Unit	Edmonton
Canada	Centre de Recherche Clinique de Laval (CRCL)	Laval
Canada	McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)	Montreal
Canada	Toronto General Hospital - University Health Network, Renal Physiology laboratory	Toronto
China	Peking University People's Hospital	Beijing
China	Southern Medical University - Nanfang Hospital (Southern Hospital)	Guangzhou
China	The 4th Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Nanjing Medical University (NMU) - Huai'an First People's Hospital	Huai An
China	Affiliated Hospital of Jiangsu University	JiangSu	Jiangsu
China	Nanjing Medical University (NMU) - The Second Affiliated Hospital	Nanjing
China	Fudan University - Shanghai Minhang District Central Hospital	Shanghai
China	Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location	Shanghai
China	Zhongshan Hospital Fudan University, Qingpu Branch	Shanghai
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...	Wuhan	Hubei
China	Zhongshan People's Hospital	Zhongshan	Guangdong
Denmark	Region Nordjylland | Aalborg University Hospital - Endocrinology Department	Aalborg
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg
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	Hillerod
Denmark	Odense University Hospital | Odense - Endocrinology Department	Odense
Germany	Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)	Bad Oeynhausen
Germany	InnoDiab Forschung GmbH	Essen	Nordrhein-Westfalen
Italy	ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia	Bergamo
Italy	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna
Italy	Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale	Chieri
Italy	Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia	Chieti
Italy	A.O.U. Careggi	Firenze	Toscana
Italy	ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department	Milan
Italy	IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit	Milan
Italy	Ospedale FBF e Oftalmico Milano	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Spain	Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition	A Coruna	A Coruña
Spain	Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion	Barcelona
Spain	Hospital Vithas Sevilla | Endocrinology Department	Castilleja de la Cuesta
Spain	Hospital Gregorio Maranon | Endocrinology Department	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	Malaga
United Kingdom	North Bristol NHS Trust - Southmead Hospital	Bristol
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital	Derby
United Kingdom	NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)	Glasgow
United Kingdom	Royal London Hospital	London
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Walsall Healthcare NHS Trust - Manor Hospital	Walsall
United States	University of Michigan Health System (UMHS) - Metabolism Endocrinology & Diabetes Clinic (MEND) at Domino's Farms	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC)	Aurora	Colorado
United States	Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC)	Boston	Massachusetts
United States	University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne	Chapel Hill	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	The University of Chicago Medicine Kovler Diabetes Center	Chicago	Illinois
United States	Cleveland Clinic - Main Campus	Cleveland	Ohio
United States	University of Missouri Health Care	Columbia	Missouri
United States	Physicians East, P.A. - Endocrinology	Greenville	South Carolina
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Omega Clinical Research Center	Metairie	Louisiana
United States	Tulane Medical Center (TMC) - Tulane Lakeside Specialty Clinic	Metairie	Louisiana
United States	University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center	Miami	Florida
United States	Carolina Health Specialists - Medical Complex - 82nd Parkway Location	Myrtle Beach	South Carolina
United States	Christiana Care Health System (Services)	Newark	Delaware
United States	Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center	Norfolk	Virginia
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	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Consano Clinical Research, LLC.	San Antonio	Texas
United States	University of Texas Health San Antonio	San Antonio	Texas
United States	Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane	Spokane	Washington
United States	Stanford University | Endocrinology Department - Diabetes Research	Stanford	California
United States	Jedidiah Clinical Research	Tampa	Florida
United States	Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California	Vallejo	California
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Wichita Nephrology Group Pa	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  China,  Denmark,  Germany,  Italy,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary albumin-to-creatinine ratio (UACR)	UACR will be assessed by the Central laboratory.	From baseline up to 6 months
Secondary	Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)		From baseline up to 7 months
Secondary	Number of participants with Hyperkalaemia	Hyperkalemia will be an adverse events of special interest (AESI).	From baseline up to 7 months

External Links

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