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:
EudraCT Number:
Not Available
EU CT Number:
2022-503024-27-00
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department Herning, Denmark, DK-7400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Morehouse School of Medicine | Clinical Research Centre Atlanta, United States, 30303-3031 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stanford University | Endocrinology Department - Diabetes Research Stanford, United States, 94305 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center Norfolk, United States, 23510 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydvestjysk Sygehus Esbjerg Esbjerg, Denmark, 6700 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia Bergamo, Italy, 24127 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale Chieri, Italy, 10023 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale FBF e Oftalmico Milano Milano, Italy, 20157 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne Chapel Hill, United States, 27514-2286 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department Herlev, Denmark, 2730 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense University Hospital | Odense - Endocrinology Department Odense, Denmark, 5000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Region Nordjylland | Aalborg University Hospital - Endocrinology Department Aalborg, Denmark, 9000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department Milan, Italy, 20142 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit Milan, Italy, 20132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00161 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia Chieti, Italy, 66100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition A Coruna, Spain, 15006 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jedidiah Clinical Research Tampa, United States, 33617 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Washington University School of Medicine in St. Louis Saint Louis, United States, 63110-1010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Elixia Central Florida Orlando, United States, 32806 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Gregorio Maranon | Endocrinology Department Madrid, Spain, 28007 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department Malaga, Spain, 29010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department Majadahonda, Spain, 28222 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion Barcelona, Spain, 08036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Vithas Sevilla | Endocrinology Department Castilleja de la Cuesta, Spain, 41950 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit Hillerod, Denmark, 3400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cleveland Clinic - Main Campus Cleveland, United States, 44195-0001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Chicago, United States, 60611 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MedStar Health Research Institute Hyattsville, United States, 20782 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal London Hospital London, United Kingdom, E1 1BB | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center) Bad Oeynhausen, Germany, 32545 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations InnoDiab Forschung GmbH Essen, Germany, 45136 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Anam Hospital Seongbuk, South Korea, 136-705 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 3080 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanson Clinical Research Center, Inc. Port Charlotte, United States, 33952-6722 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Iowa Hospitals & Clinics Iowa City, United States, 52242 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Omega Clinical Research Center Metairie, United States, 70006 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Physicians East, P.A. - Endocrinology Greenville, United States, 27834-5051 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Missouri Health Care Columbia, United States, 65212 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California Vallejo, United States, 94592-1118 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Metabolic Research Institute, Inc. West Palm Beach, United States, 33401-3430 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC) Calgary, Canada, T2T 5C7 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Recherche Clinique de Laval (CRCL) Laval, Canada, H7T 2P5 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toronto General Hospital - University Health Network, Renal Physiology laboratory Toronto, Canada, M5G 2C4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Medical University - Nanfang Hospital (Southern Hospital) Guangzhou, China, 510515 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC) Boston, United States, 02215-5306 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fudan University - Shanghai Minhang District Central Hospital Shanghai, China, 201100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nanjing Medical University (NMU) - Huai'an First People's Hospital Huai An, China, 223300 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nanjing Medical University (NMU) - The Second Affiliated Hospital Nanjing, China, 210011 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan People's Hospital Zhongshan, China, 528499 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI) Glasgow, United Kingdom, G4 0SF | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wythenshawe Hospital Manchester, United Kingdom, M23 9LT | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North Bristol NHS Trust - Southmead Hospital Bristol, United Kingdom, BS10 5NB | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Walsall Healthcare NHS Trust - Manor Hospital Walsall, United Kingdom, WS2 9PS | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital Derby, United Kingdom, DE22 3NE | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alberta Diabetes Institute Clinical Research Unit Edmonton, Canada, T6G 2E1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 4th Affiliated Hospital of Harbin Medical University Harbin, China, 150001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanxi Bethune Hospital Taiyuan, China, 030032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University People's Hospital Beijing, China, 100032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM) Montreal, Canada, H4A 3J1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wichita Nephrology Group Pa Wichita, United States, 67214 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 3722 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan Hospital Fudan University, Qingpu Branch shanghai, China, 201700 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Central Hospital of Wuhan, Tongji Medl Collg Huazhong... Wuhan, China, 430014 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Affiliated Hospital of Jiangsu University JiangSu, China, 212001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Consano Clinical Research, LLC. San Antonio, United States, 79231 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas Health San Antonio San Antonio, United States, 78229 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane Spokane, United States, 99204-2318 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AdventHealth Translational Research Institute Orlando, United States, 32804 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location Shanghai, China, 200080 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in Urinary albumin-to-creatinine ratio (UACR)UACR will be assessed by the Central laboratory.Timeframe: From baseline up to 6 months
Secondary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)Timeframe: From baseline up to 7 months
- Number of participants with HyperkalaemiaHyperkalemia will be an adverse events of special interest (AESI).Timeframe: From baseline up to 7 months
Additional Information
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