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Clinical Trial Details

Trial ID: L1128
Source ID: NCT05901831
Associated Drug: Finerenone
Title: 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
Acronym: FINE-ONE
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 1 Diabetes Mellitus
Interventions: DRUG: Finerenone|OTHER: Placebo
Outcome Measures: 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|Number of participants with Hyperkalaemia, Hyperkalemia will be an adverse events of special interest (AESI)., From baseline up to 7 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 220
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-26
Completion Date: 2025-09-26
Results First Posted:
Last Update Posted: 2025-03-25
Locations: Southwest Kidney Institute, PLC, Surprise, Arizona, 85374, United States|Stanford University | Endocrinology Department - Diabetes Research, Stanford, California, 94305, United States|Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California, Vallejo, California, 94592-1118, United States|University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center, Miami, Florida, 33136-1013, United States|AdventHealth Translational Research Institute, Orlando, Florida, 32804, United States|Elixia Central Florida, Orlando, Florida, 32806, United States|Hanson Clinical Research Center, Inc., Port Charlotte, Florida, 33952, United States|Jedidiah Clinical Research, Tampa, Florida, 33619, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Grady Memorial Hospital - Endocrinology, Atlanta, Georgia, 30303, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Northwestern University | Feinberg School of Medicine - Division of Endocrinology, Metabolism and Molecular Medicine, Chicago, Illinois, 60611, United States|The University of Chicago Medicine Kovler Diabetes Center, Chicago, Illinois, 60637, United States|University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States|Wichita Nephrology Group Pa, Wichita, Kansas, 67214, United States|Omega Clinical Research Center, Metairie, Louisiana, 70006, United States|MedStar Health Research Institute, Hyattsville, Maryland, 20782, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Missouri Health Care, Columbia, Missouri, 65212, United States|Washington University School of Medicine in St. Louis, Saint Louis, Missouri, 63110-1010, United States|University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne, Chapel Hill, North Carolina, 27514, United States|Physicians East, P.A. - Endocrinology, Greenville, North Carolina, 27834-5051, United States|Accellacare - Wilmington, Wilmington, North Carolina, 28401, United States|Cleveland Clinic - Main Campus, Cleveland, Ohio, 44195, United States|Oregon Health & Science University (OHSU), Portland, Oregon, 97239, United States|University of Texas Health San Antonio, San Antonio, Texas, 78229, United States|Consano Clinical Research, LLC., San Antonio, Texas, 79231, United States|EVMS Strelitz Diabetes Center, Norfolk, Virginia, 23510, United States|Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane, Spokane, Washington, 99204-2318, United States|Richmond Road Diagnostic and Treatment Centre - Clinical Trials Unit(RRDTC), Calgary, Alberta, T2T 5C7, Canada|Alberta Diabetes Institute - Clinical Research Unit (CRU), Edmonton, Alberta, T6G 2E1, Canada|Toronto General Hospital - University Health Network, Renal Physiology laboratory, Toronto, Ontario, M5G 2C4, Canada|Centre de Recherche Clinique de Laval, Laval, Quebec, H7T 2P5, Canada|McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM), Montreal, Quebec, H4A 3J1, Canada|Zhongshan People's Hospital, Zhongshan, Guangdong, 528499, China|The 4th Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The Central Hospital of Wuhan, Tongji Medl Collg Huazhong..., Wuhan, Hubei, 430014, China|Affiliated Hospital of Jiangsu University, JiangSu, Jiangsu, 212001, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 030032, China|Peking University People's Hospital, Beijing, 100032, China|Southern Medical University - Nanfang Hospital (Southern Hospital), Guangzhou, 510515, China|Nanjing Medical University (NMU) - Huai'an First People's Hospital, Huai An, 223300, China|Nanjing Medical University (NMU) - The Second Affiliated Hospital, Nanjing, 210011, China|Shanghai Jiao Tong University (SJTU) - Shanghai General Hospital (Shanghai First People's Hospital) - Northern Location, Shanghai, 200080, China|Central Hospital of Minhang District, Shanghai, Shanghai, 201100, China|Zhongshan Hospital Fudan University, Qingpu Branch, Shanghai, 201700, China|Hospital of South West Jutland | Department of Endocrinology Research, Esbjerg, 6700, Denmark|Region Nordjylland | Aalborg University Hospital - Endocrinology Department, Gistrup, 9260, Denmark|Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department, Herlev, 2730, Denmark|Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department, Herning, DK-7400, Denmark|Capital Region | Nordsjaellands Hospital - Hillerod - Endocrinology Ambulatory Research Unit, Hillerod, 3400, Denmark|Odense University Hospital | Odense - Endocrinology Department, Odense, 5000, Denmark|InnoDiab Forschung GmbH, Essen, Nordrhein-Westfalen, 45136, Germany|Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center), Bad Oeynhausen, 32545, Germany|Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Endocrinologia e prevenzione e cura del diabete, Bologna, Emilia-Romagna, 40138, Italy|Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Diabetologia, Roma, Lazio, 00168, Italy|Careggi University Hospital - Diabetologia e Malattie del Metabolismo, Firenze, Toscana, 50134, Italy|ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia, Bergamo, 24127, Italy|Azienda Sanitaria Locale di Chieri | TO5 - SC Diabetologia Territoriale, Chieri, 10023, Italy|Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia, Chieti, 66100, Italy|ASST Fatebenefratelli Sacco _Ospedale Sacco - Malattie Endocrine e Diabetologia, Milano, 20157, Italy|IRCCS Ospedale San Raffaele | Diabetologia Department - Cardio-Metabolic and Clinica Trials Unit, Milan, 20132, Italy|ASST Santi Paolo e Carlo | San Paolo Hospital - Haemostasis and Thrombosis Department, Milan, 20142, Italy|Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi, 03722, Korea, Republic of|Asan Medical Center, Seoul, Seoul Teugbyeolsi, 05505, Korea, Republic of|Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, 3080, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition, A Coruna, A Coruña, 15006, Spain|Hospital Vithas Sevilla | Endocrinology Department, Castilleja de la Cuesta, Sevilla, 41950, Spain|Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion, Barcelona, 08036, Spain|Hospital Gregorio Maranon | Endocrinology Department, Madrid, 28007, Spain|Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department, Majadahonda, 28222, Spain|Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department, Malaga, 29010, Spain|North Bristol NHS Trust - Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Cardiff and Vale University Health Board - University Hospital of Wales (UHW), Cardiff, CF14 4XW, United Kingdom|University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital, Derby, DE22 3NE, United Kingdom|NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI), Glasgow, G4 0SF, United Kingdom|Royal London Hospital, London, E1 1BB, United Kingdom|Wythenshawe Hospital, Manchester, M23 9LT, United Kingdom|Walsall Healthcare NHS Trust - Manor Hospital, Walsall, WS2 9PS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05901831