Trial Condition(s):

Chronic Kidney Disease, Type 1 diabetes mellitus

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)

Bayer Identifier:

22267

ClinicalTrials.gov Identifier:

NCT05901831

EudraCT Number:

Not Available

EU CT Number:

2022-503024-27-00

Recruiting

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
220
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department

Herning, Denmark, DK-7400

Status
Recruiting
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Emory University School of Medicine

Atlanta, United States, 30322

Status
Not yet recruiting
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Stanford University | Endocrinology Department - Diabetes Research

Stanford, United States, 94305

Status
Not yet recruiting
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Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center

Norfolk, United States, 23510

Status
Recruiting
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Sydvestjysk Sygehus Esbjerg

Esbjerg, Denmark, 6700

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

Bergamo, Italy, 24127

Status
Recruiting
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Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale

Chieri, Italy, 10023

Status
Not yet recruiting
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Ospedale FBF e Oftalmico Milano

Milano, Italy, 20157

Status
Recruiting
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University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne

Chapel Hill, United States, 27514-2286

Status
Not yet recruiting
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Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department

Herlev, Denmark, 2730

Status
Recruiting
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Odense University Hospital | Odense - Endocrinology Department

Odense, Denmark, 5000

Status
Recruiting
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Region Nordjylland | Aalborg University Hospital - Endocrinology Department

Aalborg, Denmark, 9000

Status
Not yet recruiting
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A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

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

Milan, Italy, 20142

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

Milan, Italy, 20132

Status
Recruiting
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00161

Status
Not yet recruiting
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Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia

Chieti, Italy, 66100

Status
Not yet recruiting
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Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition

A Coruna, Spain, 15006

Status
Recruiting
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Jedidiah Clinical Research

Tampa, United States, 33617

Status
Recruiting
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Washington University School of Medicine in St. Louis

Saint Louis, United States, 63110-1010

Status
Not yet recruiting
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Elixia Central Florida

Orlando, United States, 32806

Status
Recruiting
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Hospital Gregorio Maranon | Endocrinology Department

Madrid, Spain, 28007

Status
Not yet recruiting
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Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department

Malaga, Spain, 29010

Status
Not yet recruiting
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Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department

Majadahonda, Spain, 28222

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

Barcelona, Spain, 08036

Status
Recruiting
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Hospital Vithas Sevilla | Endocrinology Department

Castilleja de la Cuesta, Spain, 41950

Status
Not yet recruiting
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Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit

Hillerod, Denmark, 3400

Status
Not yet recruiting
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Cleveland Clinic - Main Campus

Cleveland, United States, 44195-0001

Status
Not yet recruiting
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Northwestern University

Chicago, United States, 60611

Status
Not yet recruiting
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MedStar Health Research Institute

Hyattsville, United States, 20782

Status
Not yet recruiting
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Royal London Hospital

London, United Kingdom, E1 1BB

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

Bad Oeynhausen, Germany, 32545

Status
Recruiting
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InnoDiab Forschung GmbH

Essen, Germany, 45136

Status
Recruiting
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Korea University Anam Hospital

seoul, South Korea, 02841

Status
Recruiting
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Seoul National University Hospital

Seoul, South Korea, 3080

Status
Recruiting
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Asan Medical Center

Seoul, South Korea, 138-736

Status
Recruiting
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Hanson Clinical Research Center, Inc.

Port Charlotte, United States, 33952-6722

Status
Recruiting
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University of Iowa Hospitals & Clinics

Iowa City, United States, 52242

Status
Recruiting
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Omega Clinical Research Center

Metairie, United States, 70006

Status
Not yet recruiting
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A.O.U. Careggi

Firenze, Italy, 50134

Status
Recruiting
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Physicians East, P.A. - Endocrinology

Greenville, United States, 27834-5051

Status
Recruiting
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University of Missouri Health Care

Columbia, United States, 65212

Status
Not yet recruiting
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Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California

Vallejo, United States, 94592-1118

Status
Not yet recruiting
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Metabolic Research Institute, Inc.

West Palm Beach, United States, 33401-3430

Status
Not yet recruiting
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University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center

Miami, United States, 33136-1013

Status
Not yet recruiting
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Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC)

Calgary, Canada, T2T 5C7

Status
Recruiting
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Centre de Recherche Clinique de Laval (CRCL)

Laval, Canada, H7T 2P5

Status
Recruiting
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Toronto General Hospital - University Health Network, Renal Physiology laboratory

Toronto, Canada, M5G 2C4

Status
Not yet recruiting
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Southern Medical University - Nanfang Hospital (Southern Hospital)

Guangzhou, China, 510515

Status
Recruiting
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Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC)

Boston, United States, 02215-5306

Status
Not yet recruiting
Locations

University of Michigan Health System (UMHS) - Metabolism Endocrinology & Diabetes Clinic (MEND) at Domino's Farms

Ann Arbor, United States, 48105-9484

Status
Not yet recruiting
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Fudan University - Shanghai Minhang District Central Hospital

Shanghai, China, 201100

Status
Recruiting
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Nanjing Medical University (NMU) - Huai'an First People's Hospital

Huai An, China, 223300

Status
Recruiting
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Nanjing Medical University (NMU) - The Second Affiliated Hospital

Nanjing, China, 210011

Status
Recruiting
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Zhongshan People's Hospital

Zhongshan, China, 528499

Status
Not yet recruiting
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NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)

Glasgow, United Kingdom, G4 0SF

Status
Not yet recruiting
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Wythenshawe Hospital

Manchester, United Kingdom, M23 9LT

Status
Recruiting
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North Bristol NHS Trust - Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Recruiting
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Walsall Healthcare NHS Trust - Manor Hospital

Walsall, United Kingdom, WS2 9PS

Status
Not yet recruiting
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University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital

Derby, United Kingdom, DE22 3NE

Status
Recruiting
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Alberta Diabetes Institute Clinical Research Unit

Edmonton, Canada, T6G 2E1

Status
Not yet recruiting
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The 4th Affiliated Hospital of Harbin Medical University

Harbin, China, 150001

Status
Not yet recruiting
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Shanxi Bethune Hospital

Taiyuan, China, 030032

Status
Recruiting
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Peking University People's Hospital

Beijing, China, 100032

Status
Not yet recruiting
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McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)

Montreal, Canada, H4A 3J1

Status
Not yet recruiting
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Wichita Nephrology Group Pa

Wichita, United States, 67214

Status
Recruiting
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Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Not yet recruiting
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Zhongshan Hospital Fudan University, Qingpu Branch

shanghai, China, 201700

Status
Not yet recruiting
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The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...

Wuhan, China, 430014

Status
Recruiting
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Affiliated Hospital of Jiangsu University

JiangSu, China, 212001

Status
Not yet recruiting
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Consano Clinical Research, LLC.

San Antonio, United States, 79231

Status
Recruiting
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University of Texas Health San Antonio

San Antonio, United States, 78229

Status
Not yet recruiting
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Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane

Spokane, United States, 99204-2318

Status
Not yet recruiting
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AdventHealth Translational Research Institute

Orlando, United States, 32804

Status
Not yet recruiting
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Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location

Shanghai, China, 200080

Status
Not yet recruiting
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Oregon Health & Science University (OHSU)

Portland, United States, 97239

Status
Not yet recruiting
Locations

The University of Chicago Medicine Kovler Diabetes Center

Chicago, United States, 60637

Status
Not yet recruiting

Trial Design