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Clinical Trial Details

Trial ID: L0156
Source ID: NCT06522997
Associated Drug: Bay3283142
Title: A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Acronym: ALPINE 1
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: BAY3283142|DRUG: Placebo
Outcome Measures: Primary: Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR), From baseline to Week 16 | Secondary: Change from baseline over time in estimated glomerular filtration rate (eGFR), From baseline to Week 16|Change from baseline over time in the logarithm of UACR, From baseline to Week 16|Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention, From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 700
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2026-03-17
Results First Posted:
Last Update Posted: 2025-04-11
Locations: Nephrology Consultants, LLC, Huntsville, Alabama, 35805-4104, United States|Balboa Research SMO+ - Chula Vista - West, Chula Vista, California, 91911, United States|Balboa Research SMO+ - La Mesa, La Mesa, California, 91942, United States|California Kidney Specialists - San Dimas, San Dimas, California, 91773, United States|Yale University School of Medicine, New Haven, Connecticut, 06510, United States|Nova Clinical Research | Brandenton, FL, Bradenton, Florida, 34209, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|Elixia Central Florida, Orlando, Florida, 32608, United States|Florida Institue for Clinical Research, Orlando, Florida, 32825, United States|Southeastern Clinical Research Institute, LLC, Augusta, Georgia, 30904, United States|Research by Design, LLC | Chicago, IL, Chicago, Illinois, 60643, United States|Nephrology Associates of Northern Illinois and Indiana - Hinsdale, Hinsdale, Illinois, 60521, United States|Triad Internal Medicine, Asheboro, North Carolina, 27203-5573, United States|Eastern Nephrology Associates - New Bern, New Bern, North Carolina, 28562, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Knoxville Kidney Center, PLLC, Knoxville, Tennessee, 37923-3624, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Renal Disease Research Institute | Landry, Dallas, Texas, 75246, United States|Southwest Houston Research, Ltd., Houston, Texas, 77099, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|DaVita Clinical Research | Westover Hills, San Antonio, TX, San Antonio, Texas, 78251, United States|DaVita Clinical Research | North Houston, TX, Shenandoah, Texas, 77384, United States|Utah Kidney Research Institute | Salt Lake City, UT, S. Salt Lake, Utah, 84115, United States|Peninsula Kidney Associates, Hampton, Virginia, 23666, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Salem VA Medical Center - Cardiology, Salem, Virginia, 24153, United States|Mendez Center For Clinical Research | Woodbridge, VA, Woodbridge, Virginia, 22192, United States|Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina, Ciudad Autónoma de Buenos Aire, Buenos Aires, C1056ABI, Argentina|Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina, Temperley, Buenos Aires, B1834GUK, Argentina|CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina, Caba, Ciudad Auton. De Buenos Aires, C1018DES, Argentina|Centro de Especialidades Medicas (Cemedic) | Cardiology Department, Villa Luro, Ciudad Auton. De Buenos Aires, C1440CFD, Argentina|Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC), Buenos Aires, C1431FWO, Argentina|Centro Privado San Vicente Diabetes, Córdoba, 5000, Argentina|Centro de Rehabilitacion Cardiovascular | San Luis, Argentina, San Luis, D5702AAX, Argentina|Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina, Santa Rosa, 0, Argentina|Epicura / Nephrology, Baudour, 7331, Belgium|UZ Gent / Nephrology, Gent, 9000, Belgium|Jan Yperman Ziekenhuis / Nephrology, Ieper, 8900, Belgium|UZ Brussel Nephrology, Jette, 1090, Belgium|UZ Leuven / Nephrology, Leuven, 3000, Belgium|AZ Delta / Nephrology, Roeselare, 8800, Belgium|The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China|The First Affiliated Hospital of Guangzhou University of TCM, Guangzhou, Guangdong, 510405, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China|Huai'an First People's Hospital, Nanjing Medical University, Huai'An, Jiangsu, 223300, China|The Second Affiliated Hospital of Nanjing Medical university, Nanjing, Jiangsu, 210000, China|The Second Hospital of Jilin University, Changchun, Jilin, 130000, China|Shandong Provincial Hospital, Jinan, Shandong, 250021, China|Shandong Provincial Hospital, Jinan, Shandong, 250021, China|Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, 317099, China|Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH), Beijing, 100029, China|Peking University People's Hospital, Beijing, 100032, China|Sichuan University - West China Hospital, Chengdu, 610041, China|Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH), Chengdu, 610072, China|The First People's Hospital - Foshan, Foshan, 528000, China|Southern Medical University - Nanfang Hospital (Southern Hospital), Guangzhou, 510515, China|Jiangsu Province Hospital of Traditional Chinese Medicine (TCM), Nanjing, 210029, China|Renji Hospital Shanghai JiaoTong University of Medicine, Shanghai, 200001, China|Huadong Hospital, Affiliated to Fudan University, Shanghai, 200040, China|Shanxi Bethune Hospital, Taiyuan, 030032, China|General Hospital of Athens LAIKO, Athens, 11527, Greece|University General Hospital of Heraklion - Department of Paediatrics, Heraklion, 71110, Greece|University of Thessaly - General University Hospital of Larissa (UHL), Larissa, 41100, Greece|University Hospital of Ioannina (UHI), Nisos Ioanninon, 455 00, Greece|University General Hospital of Patras | Nephrology Clinic, Patra, 26504, Greece|Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit', Thessaloniki, 54642, Greece|General Hospital of Thessaloniki Papageorgiou, Thessaloniki, 56403, Greece|Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou), Thessaloniki, 570 10, Greece|Mavani Research Center, Ahmedabad, Gujarat, 380052, India|Marengo Asia Hospital, Gurugram, Gurugram, Haryana, 122011, India|Life Care Clinic (LifeCare Clinic & Research Centre (LCRC)), Bangalore, 560092, India|The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital), Calcutta, 700020, India|Madras Diabetes Research Foundation, Chennai, 600 086, India|All India Institute of Medical Sciences (AIIMS) - New Delhi, New Delhi, 110 029, India|Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited), New Delhi, 110017, India|Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto, Bologna, Emilia-Romagna, 40138, Italy|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia, Brescia, Lombardia, 25123, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di Rene, Milano, Lombardia, 20122, Italy|ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia, Bergamo, 24127, Italy|Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi, Messina, 98124, Italy|Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene, Modena, 41124, Italy|Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia, Pavia, 27100, Italy|Kasugai Municipal Hospital, Kasugai, Aichi, 486-8510, Japan|Chubu Rosai Hospital, Nagoya, Aichi, 455-8530, Japan|Juntendo University Urayasu Hospital, Urayasu, Chiba, 279-0021, Japan|Saiseikai Matsuyama Hospital, Matsuyama, Ehime, 791-8026, Japan|Fukui Prefectural Hospital, Fukui-shi, Fukui, 910-0846, Japan|Kokura Memorial Hospital, Kitakyushu, Fukuoka, 802-8555, Japan|Hirohata Naika Clinic, Kitakyushu, Fukuoka, 807-0857, Japan|Steel Memorial Yawata Hospital, Kitakyusyu, Fukuoka, 805-8508, Japan|Jiyugaoka Yamada Internal Medicine Clinic, Obihiro, Hokkaido, 080-0848, Japan|Naka Kinen Clinic, Naka-shi, Ibaraki, 311-0113, Japan|JA Toride Medical Center, Toride, Ibaraki, 302-0022, Japan|Komatsu Municipal Hospital, Komatsu City, Ishikawa, 923-8560, Japan|Shonan Kamakura General Hospital, Kamakura, Kanagawa, 247-8533, Japan|Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Kanagawa, 234-0054, Japan|Yokohama City University Hospital, Yokohama, Kanagawa, 236-0004, Japan|Katta General Hospital, Shiroishi, Miyagi, 989-0231, Japan|Rinku General Medical Center, Izumisano, Osaka, 598-0048, Japan|Hamamatsu University Hospital, Hamamatsu, Shizuoka, 431-3192, Japan|NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, 141-8625, Japan|University of Yamanashi Hospital, Chuo, Yamanashi, 409-3898, Japan|Japanese Red Cross Fukuoka Hospital, Fukuoka, 815-8555, Japan|Ehime Prefectural Central Hospital, Matsuyama, 790-0024, Japan|Nara Prefecture General Medical Center, Nara, 630-8581, Japan|Osaka General Medical Center, Osaka, 558-8558, Japan|Japanese Red Cross Saitama Hospital, Saitama, 330-8553, Japan|Yonsei University Wonju Christian Hospital, Wonju, Gang''weondo, 26426, Korea, Republic of|Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggido, 14068, Korea, Republic of|Korea University Anam Hospital, Seoungbuk-gu, Seoul, 02841, Korea, Republic of|Korea University Ansan Hospital, Gyeonggi-do, 425-707, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 3722, Korea, Republic of|Asan Medical Center, Seoul, 5505, Korea, Republic of|Hospital Garcia de Orta | Research Department, Almada, Lisboa, 2805-267, Portugal|Centro Hospitalar de Lisboa Ocidental | Clinical Research Department, Carnaxide, Lisboa, 2790-134, Portugal|Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao, Vila Franca de Xira, Lisboa, 2600-009, Portugal|Hospital Pedro Hispano | Clinical Research Center, Matosinhos, Porto, 4464-513, Portugal|Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department, Torres Novas, Santarém, 2350-754, Portugal|Centro Clinico Academico Braga | Braga, Portugal, Braga, 4710-243, Portugal|CHUC- Hospitais da Universidade de Coimbra - Nephrology Department, Coimbra, 3000-075, Portugal|Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department, Lisboa, 1069-166, Portugal|Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica, Lisboa, 1500-650, Portugal|Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos, Lisbon, 1250-189, Portugal|National University Hospital Medical Centre, Singapore, 119074, Singapore|Singapore General Hospital, Singapore, 169608, Singapore|National Heart Centre Singapore, Singapore, 169609, Singapore|Tan Tock Seng Hospital, Singapore, 308433, Singapore|SingHealth Polyclinics - Pasir Ris, Singapore, 519457, Singapore|Changi General Hospital, Singapore, 529889, Singapore|Khoo Teck Puat Hospital, Singapore, 768828, Singapore|Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia, Bratislava, 83101, Slovakia|DIABEDA s.r.o., Bratislava, 83106, Slovakia|MEDISPEKTRUM s.r.o., Bratislava, 85101, Slovakia|B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia, Galanta, 924 22, Slovakia|NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice, Kosice, 04011, Slovakia|Univerzitna nemocnica Martin, Martin, 036 59, Slovakia|Biodial | Puchov, Slovakia, Puchov, 02001, Slovakia|DIAB s.r.o, Roznava, 048 01, Slovakia|B. Braun Avium Nefrologicka ambulancia | Sala, Slovakia, Sala, 92719, Slovakia|Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition, A Coruna, A Coruña, 15006, Spain|Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology Department, L'Hospitalet de Llobregat, Barcelona, 8907, Spain|Hospital Clinico Universitario de Valencia | Nephrology Department, Missing, Valencia, 46010, Spain|Hospital Quironsalud Barcelona | Internal Medicine Department, Barcelona, 8023, Spain|Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial, Ferrol, 15405, Spain|Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna, Madrid, 28034, Spain|Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department, Madrid, 28040, Spain|Hospital Universitario Nuestra Senora de Valme | Internal Medicine Department, Sevilla, 41014, Spain|Hospital Universitario Doctor Peset | Nephrology Department, Valencia, 46017, Spain|La Fe University and Polytechnic Hospital | Nephrology Department, Valencia, 46026, Spain|Sahlgrenska Universitetssjukhuset - Njurkliniken, Gothenburg, 413 45, Sweden|Universitetssjukhuset i Linköping, LInköping, 581 85, Sweden|ProbareE Stockholm, Stockholm, 113 29, Sweden|Center For Diabetes, Academic Specialist Center, Stockholm, 113 65, Sweden|Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken, Uppsala, 751 85, Sweden|Changhua Christian Hospital, Changhua, 50006, Taiwan|Chang Gung Memorial Hospital Kaohsiung, Kaohsiung, 833, Taiwan|Far Eastern Memorial Hospital, New Taipei, 220, Taiwan|Chi-Mei Medical Center, Liouyine, Tainan, 736, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Salford Royal Hospital, Salford, Manchester, M6 8HD, United Kingdom|Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom|Cardiff and Vale University Health Board - University Hospital of Wales (UHW), Cardiff, CF14 4XW, United Kingdom|Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit, Carshalton, SM5 1AA, United Kingdom|Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department, Hull, HU3 2JZ, United Kingdom|Royal London Hospital, London, E1 1FR, United Kingdom|Royal Free London NHS Foundation Trust | Royal Free Hospital - Cancer Services, London, NW3 2QG, United Kingdom|King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department, London, SE5 9RJ, United Kingdom|Manchester Royal Infirmary, Manchester, M13 9WL, United Kingdom|Lakeside Healthcare Research Department, Northamptonshire, NN17 2UR, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06522997