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 (FINE-ONE)

October 19, 2025 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC)
      • Edmonton, Alberta, Canada, T6G 2E1
        • Alberta Diabetes Institute - Clinical Research Unit (CRU)
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital - University Health Network, Renal Physiology laboratory
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Centre de Recherche Clinique de Laval
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
  • China
      • Beijing, China, 100032
        • Peking University People's Hospital
      • Guangzhou, China, 510515
        • Southern Medical University - Nanfang Hospital (Southern Hospital)
      • Huai'an, China, 223300
        • Huai'an First People's Hospital, Nanjing Medical University
      • Nanjing, China, 210011
        • Nanjing Medical University (NMU) - The Second Affiliated Hospital
      • Shanghai, China, 201700
        • Zhongshan Hospital Fudan University, Qingpu Branch
      • Shanghai, China, 200080
        • Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
      • Shanghai, China, 201100
        • Central Hospital of Minhang District, Shanghai
    • Guangdong
      • Zhongshan, Guangdong, China, 528499
        • Zhongshan People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The 4th Affiliated Hospital of Harbin Medical University
    • Hubei
      • Wuhan, Hubei, China, 430014
        • The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
    • Jiangsu
      • JiangSu, Jiangsu, China, 212001
        • Affiliated Hospital of Jiangsu University
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital
  • Denmark
      • Esbjerg, Denmark, 6700
        • Hospital of South West Jutland | Department of Endocrinology Research
      • Gistrup, Denmark, 9260
        • Region Nordjylland | Steno Diabetes Center Nordjylland - Endocrinology Department
      • Herlev, Denmark, 2730
        • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
      • Herning, Denmark, DK-7400
        • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
      • Hillerød, Denmark, 3400
        • Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
      • Odense, Denmark, 5000
        • Odense University Hospital | Odense - Endocrinology Department
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45136
        • InnoDiab Forschung GmbH
  • Italy
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
      • Chieri, Italy, 10023
        • Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
      • Chieti, Italy, 66100
        • Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit
      • Milan, Italy, 20142
        • ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department
      • Milan, Italy, 20157
        • ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Careggi University Hospital - Diabetologia e Malattie del Metabolismo
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center - Oncology Department
      • Seoul, Seoul Teugbyeolsi, South Korea, 3080
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
      • Madrid, Spain, 28007
        • Hospital Gregorio Maranon | Endocrinology Department
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta De Hierro De Majadahonda - Endocrinologia
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen De La Victoria - Endocrinologia
    • A Coruña
      • A Coruña, A Coruña, Spain, 15006
        • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spain, 41950
        • Hospital Nisa Sevilla Aljarafe - Endocrinologia
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • North Bristol NHS Trust | Southmead Hospital - Clinical Research Centre
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
      • Derby, United Kingdom, DE22 3NE
        • University Hospitals of Derby and Burton NHS Foundation Trust | Royal Derby Hospital - Renal Research
      • Glasgow, United Kingdom, G4 0SF
        • NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust - Royal London Hospital - Nephrology
      • Manchester, United Kingdom, M23 9LT
        • Manchester University NHS Foundation Trust | Wythenshawe Hospital - Clinical Research Facility
      • Walsall, United Kingdom, WS2 9PS
        • Walsall Healthcare NHS Trust | Manor Hospital - Nephrology
  • United States
    • Arizona
      • Surprise, Arizona, United States, 85374
        • Southwest Kidney Institute, PLC - Suprise
    • California
      • Stanford, California, United States, 94305
        • Stanford Endocrinology Clinic
      • Vallejo, California, United States, 94592
        • Touro University California - Metabolic Research Center
    • Florida
      • Miami, Florida, United States, 33136
        • UHealth Diabetes Research Center
      • Orlando, Florida, United States, 32804
        • AdventHealth Translational Research Institute
      • Orlando, Florida, United States, 32806
        • Elixia Central Florida
      • Port Charlotte, Florida, United States, 33952
        • Hanson Clinical Research Center, Inc.
      • Tampa, Florida, United States, 33619
        • Jedidiah Clinical Research
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital - Endocrinology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine
      • Chicago, Illinois, United States, 60637
        • UChicago Medicine Kovler Diabetes Center
    • Iowa
      • Iowa City, Iowa, United States, 52202
        • Preventive Intervention Center - Endocrinology
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wichita Nephrology Group Pa
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Diabetes & Metabolism Associates
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Medstar Health Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • MU Health Care - University Hospital - Endocrinology
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine in St. Louis
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Endocrinology, Diabetes, and Obesity Clinical Research Unit
      • Greenville, North Carolina, United States, 27834
        • Physicians East, P.A.- W. H. Smith - Endocrinology
      • Wilmington, North Carolina, United States, 28401
        • Accellacare - Wilmington
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Main Campus
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Physicians Pavillion - Endocrinology
    • Texas
      • San Antonio, Texas, United States, 79231
        • Consano Clinical Research, LLC.
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio - Medical Arts & Research Center - Endocrinology
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • EVMS Strelitz Diabetes Center
    • Washington
      • Spokane Valley, Washington, United States, 99204
        • Providence Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Finerenone
Dose A, Dose B, oral
Placebo Comparator: Placebo arm
Participants will take Finerenone matching placebo for 6 months.
Other: Placebo
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary albumin-to-creatinine ratio (UACR)
Time Frame: From baseline up to 6 months
UACR will be assessed by the Central laboratory.
From baseline up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
Time Frame: From baseline up to 7 months
From baseline up to 7 months
Number of participants with Hyperkalaemia
Time Frame: From baseline up to 7 months
Hyperkalemia will be an adverse events of special interest (AESI).
From baseline up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Actual)

August 20, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 19, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22267
  • 2022-503024-27-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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