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)

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: Recruiting
• Conditions: Chronic Kidney Disease; Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Placebo; Drug: Finerenone

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Canada
  • Calgary, Canada, T2T 5C7
    • Recruiting
    • Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC)
  • Edmonton, Canada, T6G 2E1
    • Not yet recruiting
    • Alberta Diabetes Institute Clinical Research Unit
  • Laval, Canada, H7T 2P5
    • Recruiting
    • Centre de Recherche Clinique de Laval (CRCL)
  • Montreal, Canada, H4A 3J1
    • Not yet recruiting
    • McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
  • Toronto, Canada, M5G 2C4
    • Not yet recruiting
    • Toronto General Hospital - University Health Network, Renal Physiology laboratory
• China
  • Beijing, China, 100032
    • Not yet recruiting
    • Peking University People's Hospital
  • Guangzhou, China, 510515
    • Recruiting
    • Southern Medical University - Nanfang Hospital (Southern Hospital)
  • Huai An, China, 223300
    • Recruiting
    • Nanjing Medical University (NMU) - Huai'an First People's Hospital
  • Nanjing, China, 210011
    • Not yet recruiting
    • Nanjing Medical University (NMU) - The Second Affiliated Hospital
  • Shanghai, China, 200080
    • Not yet recruiting
    • Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location
  • Shanghai, China, 201100
    • Not yet recruiting
    • Fudan University - Shanghai Minhang District Central Hospital
  • Shanghai, China, 201700
    • Not yet recruiting
    • Zhongshan Hospital Fudan University, Qingpu Branch
  • Guangdong
    • Zhongshan, Guangdong, China, 528499
      • Not yet recruiting
      • Zhongshan People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Not yet recruiting
      • The 4th Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430014
      • Not yet recruiting
      • The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
  • Jiangsu
    • JiangSu, Jiangsu, China, 212001
      • Not yet recruiting
      • Affiliated Hospital of Jiangsu University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Not yet recruiting
      • Shanxi Bethune Hospital
• Denmark
  • Aalborg, Denmark, 9000
    • Not yet recruiting
    • Region Nordjylland | Aalborg University Hospital - Endocrinology Department
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Sydvestjysk Sygehus Esbjerg
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
  • Herning, Denmark, DK-7400
    • Recruiting
    • Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
  • Hillerod, Denmark, 3400
    • Not yet recruiting
    • Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit
  • Odense, Denmark, 5000
    • Not yet recruiting
    • Odense University Hospital | Odense - Endocrinology Department
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Recruiting
    • Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Not yet recruiting
      • InnoDiab Forschung GmbH
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
  • Chieri, Italy, 10023
    • Not yet recruiting
    • Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale
  • Chieti, Italy, 66100
    • Not yet recruiting
    • Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia
  • Milan, Italy, 20142
    • Not yet recruiting
    • ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit
  • Milano, Italy, 20157
    • Not yet recruiting
    • Ospedale FBF e Oftalmico Milano
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Recruiting
      • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • Lazio
    • Roma, Lazio, Italy, 00161
      • Not yet recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Not yet recruiting
      • A.O.U. Careggi
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Not yet recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
      • Recruiting
      • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
  • Castilleja de la Cuesta, Spain, 41950
    • Not yet recruiting
    • Hospital Vithas Sevilla | Endocrinology Department
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Hospital Gregorio Maranon | Endocrinology Department
  • Majadahonda, Spain, 28222
    • Not yet recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
  • Malaga, Spain, 29010
    • Not yet recruiting
    • Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
  • A Coruña
    • A Coruna, A Coruña, Spain, 15006
      • Recruiting
      • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Recruiting
    • North Bristol NHS Trust - Southmead Hospital
  • Derby, United Kingdom, DE22 3NE
    • Recruiting
    • University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
  • Glasgow, United Kingdom, G4 0SF
    • Not yet recruiting
    • NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Royal London Hospital
  • Manchester, United Kingdom, M23 9LT
    • Not yet recruiting
    • Wythenshawe Hospital
  • Walsall, United Kingdom, WS2 9PS
    • Not yet recruiting
    • Walsall Healthcare NHS Trust - Manor Hospital
• United States
  • California
    • Stanford, California, United States, 94305
      • Not yet recruiting
      • Stanford University | Endocrinology Department - Diabetes Research
    • Vallejo, California, United States, 94592-1118
      • Not yet recruiting
      • Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California
  • Colorado
    • Aurora, Colorado, United States, 80045-2536
      • Withdrawn
      • University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC)
  • Delaware
    • Newark, Delaware, United States, 19718
      • Withdrawn
      • Christiana Care Health System (Services)
  • Florida
    • Miami, Florida, United States, 33136-1013
      • Not yet recruiting
      • University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Elixia Central Florida
    • Orlando, Florida, United States, 32804
      • Not yet recruiting
      • AdventHealth Translational Research Institute
    • Port Charlotte, Florida, United States, 33952-6722
      • Recruiting
      • Hanson Clinical Research Center, Inc.
    • Tampa, Florida, United States, 33617
      • Recruiting
      • Jedidiah Clinical Research
    • West Palm Beach, Florida, United States, 33401-3430
      • Not yet recruiting
      • Metabolic Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • The University of Chicago Medicine Kovler Diabetes Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • University of Iowa Hospitals & Clinics
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Wichita Nephrology Group Pa
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Not yet recruiting
      • Omega Clinical Research Center
    • Metairie, Louisiana, United States, 70001-1210
      • Withdrawn
      • Tulane Medical Center (TMC) - Tulane Lakeside Specialty Clinic
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Not yet recruiting
      • MedStar Health Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5306
      • Not yet recruiting
      • Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC)
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-9484
      • Not yet recruiting
      • University of Michigan Health System (UMHS) - Metabolism Endocrinology & Diabetes Clinic (MEND) at Domino's Farms
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Not yet recruiting
      • University of Missouri Health Care
    • Saint Louis, Missouri, United States, 63110-1010
      • Not yet recruiting
      • Washington University School of Medicine in St. Louis
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Not yet recruiting
      • Cleveland Clinic - Main Campus
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health & Science University (OHSU)
  • South Carolina
    • Chapel Hill, South Carolina, United States, 27514-2286
      • Not yet recruiting
      • University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne
    • Greenville, South Carolina, United States, 27834-5051
      • Not yet recruiting
      • Physicians East, P.A. - Endocrinology
    • Myrtle Beach, South Carolina, United States, 29572-4610
      • Withdrawn
      • Carolina Health Specialists - Medical Complex - 82nd Parkway Location
  • Texas
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • University of Texas Health San Antonio
    • San Antonio, Texas, United States, 79231
      • Recruiting
      • Consano Clinical Research, LLC.
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Recruiting
      • Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center
  • Washington
    • Spokane, Washington, United States, 99204-2318
      • Not yet recruiting
      • Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)		From baseline up to 7 months
Number of participants with Hyperkalaemia	Hyperkalemia will be an adverse events of special interest (AESI).	From baseline up to 7 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful 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.
• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 2, 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 (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 1
• 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