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Clinical Trial Details

Trial ID: L1160
Source ID: NCT05254002
Associated Drug: Finerenone (Bay94-8862 ) 10 Mg
Title: A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Acronym: CONFIDENCE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Chronic Kidney Disease
Interventions: DRUG: Finerenone (BAY94-8862 ) 10 mg|DRUG: Empagliflozin|DRUG: Empagliflozin Placebo|DRUG: Finerenone (BAY94-8862 ) 20 mg|DRUG: Finerenone Placebo
Outcome Measures: Primary: Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone, Urinary albumin to-creatinine ratio (UACR), Up to 180 days|Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone, Up to 180 days|Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone, Upto 180 days|Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone, Up to 180 days | Secondary: Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210), Up to 210 days|Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1), Up to 210 days|Relative change in UACR category (>30%, >40%, >50%) at 180 days, Up to 180 days|Ratio of change from baseline in eGFR at 30 days, estimated glomerular filtration rate (eGRF), Up to 30 days|eGFR decline greater than 30% at 30 days from baseline, Up to 30 days|Ratio of change in eGFR at 180 days and 210 days from Day 30, Up to 210 days|Proportion of participants with of acute kidney injury (AKI) events, AKI is defined as any of the following: * An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or * An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * A urine volume less than 0.5 ml/kg/h for 6 hours, Up to 180 days|Total number of AKI events, Up to 180 days|Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]), serum/plasma potassium (k+), Up to 180 days|Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]), Up to 180 days|Change from baseline in K+, Up to 180 days|Proportion of participants with severe hypoglycemia events, Severe hypoglycemia is defined as glucose level of \<3.0 mmol/L (\<54 mg/dL)., Up to 180 days|Total number of events of severe hypoglycemia events, Up to 180 days|Proportion of participants with symptomatic hypotension events, Up to 180 days|Total number of symptomatic hypotension events, Up to 180 days|Proportion of participants with genital mycotic events, Up to 180 days|Total number of genital mycotic events, Up to 180 days|Proportion of participants with ketoacidosis events, Up to 180 days|Total number of ketoacidosis events, Up to 180 days|Proportion of participants with necrotizing fasciitis of the perineum events, Up to 180 days|Total number of necrotizing fasciitis of the perineum events, Up to 180 days|Proportion of participants with urosepsis and pyelonephritis events, Up to 180 days|Total number of urosepsis and pyelonephritis events, Up to 180 days
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 1664
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-23
Completion Date: 2025-03-14
Results First Posted:
Last Update Posted: 2025-03-18
Locations: Southwest Kidney Institute, PLC, Surprise, Arizona, 85374, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|Northridge Hospital, Northridge, California, 91325, United States|Olive View - UCLA Medical Center, Sylmar, California, 91342-1437, United States|Touro University California, Vallejo, California, 94592, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Florida Kidney Physicians - Delray Beach Nephrology, Delray Beach, Florida, 33445, United States|West Orange Endocrinology & Clinical Research, Ocoee, Florida, 34761-4547, United States|Innovative Research Institute, Port Charlotte, Florida, 33952, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401-3430, United States|Grady Memorial Hospital - Endocrinology, Atlanta, Georgia, 30303, United States|Southeast Kidney Associates, East Point, Georgia, 30344, United States|Velocity Clinical Research - Savannah, Savannah, Georgia, 31406, United States|Versailles Family Medicine, Versailles, Kentucky, 40383, United States|Nola Care Clinical Research, Metairie, Louisiana, 70006, United States|Omega Clinical Research Center, Metairie, Louisiana, 70006, United States|South Shore Nephrology, Plymouth, Massachusetts, 02360, United States|Lake Michigan Nephrology, Saint Joseph, Michigan, 49085, United States|Clinical Research Consultants, Kansas City, Missouri, 64111, United States|Kansas City VA Medical Center - Endocrinology, Kansas City, Missouri, 64128, United States|Washington University School of Medicine in St. Louis, Saint Louis, Missouri, 63110-1010, United States|St. Louis Heart & Vascular, PC, Saint Louis, Missouri, 63136, United States|Somnos Clinical Research, Lincoln, Nebraska, 68510, United States|Meridian Clinical Research- Norfolk, Norfolk, Nebraska, 68701, United States|Healor Primary Care / CCT Research, Las Vegas, Nevada, 89102, United States|Santa Rosa Medical Centers of Nevada / CCT Research, Las Vegas, Nevada, 89119, United States|Circuit Clinical/Crystal Run, Middletown, New York, 10941, United States|Randolph Medical Associates, Asheboro, North Carolina, 27203, United States|University of North Carolina Kidney Center, Chapel Hill, North Carolina, 27599-7155, United States|Eastern Nephrology Associates - Greenville West, Greenville, North Carolina, 27834, United States|Blue Sky, MD/ Lamond Family Medicine, Hendersonville, North Carolina, 28792, United States|Eastern Nephrology Associates - Kinston, Kinston, North Carolina, 28504, United States|Velocity Clinical Research, Cincinnati, Cincinnati, Ohio, 45242, United States|Oakland Medical Center, Dakota Dunes, South Dakota, 48085, United States|Dunes Clinical Research LLC, Dakota Dunes, South Dakota, 57049, United States|DarSalud Care / LifeDOC Research, Memphis, Tennessee, 38119, United States|University of Tennessee Health Science Center, Memphis, Tennessee, 38163, United States|Office of Osvaldo A. Brusco, MD, Corpus Christi, Texas, 78414-4173, United States|Thyroid, Endocrinology, and Diabetes (TED) PA, Dallas, Texas, 75208-2362, United States|DaVita Clinical Research- El Paso, El Paso, Texas, 79925, United States|Global Kidney Center, Houston, Texas, 77008, United States|Victorium Clinical Research, Houston, Texas, 77024-2593, United States|North Texas Kidney Disease Associates, PLLC, Lewisville, Texas, 75057, United States|Biopharma Informatic - McAllen, TX, McAllen, Texas, 78503, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|University of Texas Health Science Center, San Antonio, Texas, 78249, United States|Olympus Family Medicine, Salt Lake City, Utah, 84117, United States|Salem VA Medical Center - Endocrinology, Salem, Virginia, 24153, United States|MultiCare Rockwood Clinic Diabetes & Endocrinology Center, Spokane, Washington, 99202, United States|CHU de Charleroi Hôpital civil, Lodelinsart, Hainaut, 6042, Belgium|Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst, Aalst, Oost-vlaanderen, 9300, Belgium|AZ St-Lucas Campus St-Lucas, Gent, 9000, Belgium|UZ Gent, Gent, 9000, Belgium|Regionaal ZH Jan Yperman Campus Mariaziekenhuis, Ieper, 8900, Belgium|AZ Groeninge Campus Kennedylaan, Kortrijk, 8500, Belgium|UZ Leuven Gasthuisberg, Leuven, 3000, Belgium|AZ Delta, Roeselare, 8800, Belgium|LMC Manna Research - Calgary, Calgary, Alberta, T2H 2G4, Canada|Hamilton Medical Research Group, Hamilton, Ontario, L8M 1K7, Canada|William Osler Health centre, Sakuara Medical, Mississauga, Ontario, L5H4K9, Canada|Bluewater Clinical Research Group, Sarnia, Ontario, N7T 4X3, Canada|Sameh Fikry Professional Corporation, Waterloo, Ontario, N2J 1C4, Canada|Clinical Research Solutions, Inc., Waterloo, Ontario, N2T 0C1, Canada|Recherche GCP Research, Montreal, Quebec, H2R 1V6, Canada|Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, H2X 3E4, Canada|LMC Clinical Research Inc. Montreal, Ville Saint-Laurent, Quebec, H4T 1Z9, Canada|Hospital of South West Jutland | Department of Endocrinology Research, Esbjerg, 6700, Denmark|Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department, Herlev, 2730, Denmark|Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department, Herning, DK-7400, Denmark|Bispebjerg Hospital - Hjerteafdeling, København, DK-2400, Denmark|Hôpital François Mitterrand - Dijon, Dijon, 21000, France|Center Hospitalier Michallon - Grenoble, Grenoble Cedex 9, 38043, France|Hôpital Edouard Herriot - Lyon Cedex, Lyon Cedex, 69003, France|Many Locations, Multiple Locations, France|Hopital Carémeau - Nîmes, Nîmes, 30029, France|Hôpital Saint Joseph, Paris, 75014, France|St. Josefskrankenhaus, Heidelberg, Baden-Württemberg, 69115, Germany|ClinPhenomics GmbH&Co. KG, Frankfurt, Hessen, 60596, Germany|Diabetologische Schwerpunkt Praxis Dortmund, Dortmund, Nordrhein-Westfalen, 44137, Germany|Zentrum für Diabetologie und Ernährungsmedizin, Ludwigshafen, Rheinland-Pfalz, 67059, Germany|Cardiologicum Pirna / Dresden-Seidnitz, Pirna, Sachsen, 1796, Germany|Friedrich-Schiller-Uni. Jena, Jena, Thüringen, 07747, Germany|Charité Campus Benjamin Franklin (CBF), Berlin, 12203, Germany|Diabetes Zentrum Wandsbek, Hamburg, 22041, Germany|King George Hospital, Visakhapatnam, AP, India|All India Institute of Medical Sciences, Bhubaneswar, Delhi, 751019, India|Indraprastha Apollo Hospital, New Delhi, Delhi, 110076, India|Mavani Dialysis & Kidney Center, Ahmedabad, GJ, India|K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre, Belgaum, Karnataka, 590010, India|Manipal Hospital, Mysore, Karnataka, 5570 015, India|Asian Kidney Hospital and Medical Centre, Nagapur, MH, 440010, India|Eternal Heart Care Centre (EHCC) and Research Institute, Jaipur, Rajasthan, 302020, India|G.S.V.M. Medical College, Kanpur, Uttar Pradesh, 208002, India|Institute of Post-Graduate Medical Education and Research, Kolkata, West Bengal, 700020, India|Dr. Bantwal's Clinic, Bengaluru, 560076, India|Bangalore Medical College & Research Institute, Bengaluru, India|Government Kilpauk Medical College Hospital, Chennai, India|Sriram Chandra Bhanj Medical College & Hospital, Cuttack, India|Nizam's Institute of Medical Sciences (NIMS), Hyderabad, 500082, India|Sawami Man Singh (SMS) Medical College & Attached Hospitals, Jaipur, 302017, India|Government Medical College, Kozhikode, 673008, India|Vinaya Hospital and Research Centre (A Unit of KIMS), Mangalore, 575003, India|Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital, Mumbai, 400 012, India|Government Medical College and Hospital (GMCH) Nagpur, Nagpur, 440009, India|Max Super Speciality Hospital (MSSH) - Saket, New Delhi, 110017, India|Grant Medical Foundation - Ruby Hall Clinic (RHC), Pune, 411001, India|Lifepoint Multispecialty Hospital, Pune, 411057, India|Krishna Institute Of Medical Science, Secunderabad, 500003, India|Osmania General Hospital, Telangana, 500012, India|Vedanta Kidney Care, Vadodara, India|HaEmek Medical Center | Internal Medicine C Department - Research Unit, Afula, 1834111, Israel|Barzilai Medical Center | Department of Nephrology and Hypertension, Ashkelon, 7830604, Israel|Clalit Health | Soroka Medical Center - Internal Medicine Department, Beer Sheva, 8410101, Israel|Edith Wolfson Medical Center | Internal Medicine Department, Holon, 58100, Israel|Hadassah University Medical Center (HUMC), Jerusalem, 911200, Israel|Health Corporation of Galilee Medical Center, Nahariya, 2210001, Israel|Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department, Petach Tikva, 4941492, Israel|Health Corporation of the Ziv Medical Center (R.A.), Zefat, 1311001, Israel|Azienda Ospedaliero Universitaria Parma - SC Nefrologia, Parma, Emilia-Romagna, 43126, Italy|ASL 4 Chiavarese, Chiavari, Liguria, 16043, Italy|Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia, Bergamo, Lombardia, 24127, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia, Milano, Lombardia, 20122, Italy|Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico, Milano, Lombardia, 20132, Italy|Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica, Milano, Lombardia, 20142, Italy|Azienda Socio Sanitaria Territoriale Rhodense, Rho, Lombardia, 20017, Italy|Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia, Orbassano, Piemonte, 10043, Italy|Casa Sollievo della Sofferenza - Endocrinologia, San Giovanni Rotondo, Puglia, 71013, Italy|Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia, Olbia, Sardegna, 07026, Italy|Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia, Pisa, Toscana, 56124, Italy|Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo, Verona, Veneto, 37134, Italy|Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia, Chieti, 66100, Italy|Many Locations, Multiple Locations, Italy|Saiseikai Matsuyama Hospital, Matsuyama, Ehime, 791-8026, Japan|Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, 818-8502, Japan|Kokura Memorial Hospital, Kitakyushu, Fukuoka, 802-8555, Japan|Hirohata Naika Clinic, Kitakyushu, Fukuoka, 807-0857, Japan|Jiyugaoka Yamada Internal Medicine Clinic, Obihiro, Hokkaido, 080-0848, Japan|Naka Kinen Clinic, Naka-shi, Ibaraki, 311-0113, Japan|Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office, Hakusan, Ishikawa, 924-8588, Japan|Fukui-ken Saiseikai Hospital, Fukui, 918-8503, Japan|Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital, Fukuoka, 811-0213, Japan|Japanese Red Cross Kumamoto Hospital, Kumamoto, 861-8520, Japan|Many Locations, Multiple Locations, Japan|Medical Corporation Taifukukai, Osaka Nishiumeda Clinic, Osaka, 530-0001, Japan|Osaka General Medical Center, Osaka, 558-8558, Japan|Soon Chun Hyang University Cheonan Hospital, Cheonan, Chungcheongnamdo, 31151, Korea, Republic of|Yonsei University Wonju Christian Hospital, Wonju, Gang''weondo, 26426, Korea, Republic of|Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggido, 14068, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, 13620, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Gyeonggi, 471-701, Korea, Republic of|The Catholic University of Korea, Incheon St.Mary's Hospital, Incheon, Incheon Gwang''yeogsi, 21431, Korea, Republic of|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|Chung Nam National University Hospital, Daejeon, 35015, Korea, Republic of|Korea University Ansan Hospital, Gyeonggi-do, 425-707, Korea, Republic of|Kyung Hee University Hospital at Gangdong, Seoul, 5278, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, 7442, Korea, Republic of|Meander Medisch Centrum, Amersfoort, 3818 TZ, Netherlands|Onze Lieve Vrouwe Gasthuis, Amsterdam, 1091 AC, Netherlands|Gelre Ziekenhuizen, Apeldoorn, 7334 DZ, Netherlands|Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department, Dordrecht, 3318 AT, Netherlands|Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition, A Coruna, A Coruña, 15006, Spain|Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial, Ferrol, A Coruña, 15405, Spain|Hospital Principe de Asturias, Alcalá de Henares, Madrid, 28805, Spain|H. Costa del Sol (Marbella), Marbella, Malaga, 29603, Spain|Hospital Vithas Sevilla | Endocrinology Department, Castilleja de la Cuesta, Sevilla, 41950, Spain|Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, 08035, Spain|Hospital Quironsalud Barcelona | Internal Medicine Department, Barcelona, 8023, Spain|Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion, Granada, 18014, Spain|Hospital Clinico San Carlos, Madrid, 28040, Spain|Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD), Madrid, 28040, 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|Many Locations, Multiple Locations, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Dr. Peset, Valencia, 46017, Spain|Changhua Christian Hospital, Changhua, 50006, Taiwan|Chang Gung Memorial Hospital Kaohsiung, Kaohsiung, 833, Taiwan|Many Locations, Multiple Locations, Taiwan|Far Eastern Memorial Hospital | Nephrology Department, New Taipei City, 220, Taiwan|Taipei Medical University - Shuang Ho Hospital, New Taipei City, 23561, Taiwan|China Medical University Hospital, Taichung, 404327, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT05254002

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress