A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
NCT Number: NCT06522997
Acronym: ALPINE 1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Kidney Disease
Interventions: DRUG: BAY3283142|DRUG: Placebo
Sponsor: Bayer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2026-06-17
Locations: Nephrology Consultants, LLC, Huntsville, Alabama, 35805-4104, United States|California Institute of Renal Research - Chula Vista, Chula Vista, California, 91910, United States|Balboa Nephrology Medical Group, Inc. (BNMG) - La Mesa, La Mesa, California, 91942-3059, United States|California Kidney Specialists (CKS) - San Dimas, San Dimas, California, 91773-3538, 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 (NANI) - 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, 28562-5200, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Knoxville Kidney Center (KKC), 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, 78212-4740, United States|DaVita Clinical Research | Westover Hills, San Antonio, TX, San Antonio, Texas, 78251, United States|DaVita Clinical Research | North Houston, TX, Woodland Hills, 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, 24153-6404, United States|Mendez Center For Clinical Research | Woodbridge, VA, Woodbridge, Virginia, 22192, United States|Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina, Temperley, Buenos Aires, B1834GUK, Argentina|Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina, Buenos Aires, Ciudad Auton. De Buenos Aires, C1056ABJ, 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|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, 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, 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 (MSSH) - Saket, New Delhi, 110017, India|Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto, Bologna, Emilia-Romagna, 40138, Italy|A.O. Spedali Civili di Brescia, Brescia, Lombardia, 25123, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Lombardia, 20122, Italy|ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia, Bergamo, 24127, Italy|Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" - Messina, Messina, 98125, Italy|Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena, Modena, 41124, Italy|Fondazione Salvatore Maugeri - IRCCS - Istituto Scientifico di Pavia - Via Maugeri, 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|Severance Hospital, Yonsei University Health System, Seoul, 3722, Korea, Republic of|Asan Medical Center, Seoul, 5505, Korea, Republic of|Samsung Medical Center, Seoul, 6351, 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|Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos, Lisbon, 1250-189, Portugal|National University Hospital, Singapore, 119074, Singapore|Singapore General Hospital, Singapore, 169608, 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|Far Eastern Memorial Hospital, New Taipei, 220, Taiwan|Chi-Mei Medical Center, Liouyine, Tainan, 736, 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 - The Royal Free Hospital (RFH), London, NW3 2QG, United Kingdom|King's College Hospital (KCH) NHS Foundation Trust - King's College Hospital, London, SE5 9RJ, United Kingdom|Manchester Royal Infirmary, Manchester, M13 9WL, United Kingdom|Lakeside Healthcare Research Department, Northamptonshire, NN17 2UR, United Kingdom

Summary:
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A common sign of decreasing kidney function is the body losing too much of a protein called albumin in the urine. This condition is known as albuminuria. This can lead to a faster decline in kidney function. People who have high blood pressure and diabetes are more likely to have CKD and are at a higher risk of complications related to it.

BAY3283142 is a new drug that is being developed to treat people with CKD. It works by activating a protein that helps relax blood vessels and is thought to have beneficial effects in CKD.

In this study, researchers want to learn about how well different doses of BAY3283142 work when taken with standard treatment for CKD in reducing albumin in the urine of participants with CKD. They will compare the results of the change in the urine albumin-creatinine ratio (UACR) after 16 weeks for BAY3283142 with a placebo. A placebo looks like the study drug but does not have any medicine in it.

During the study, participants will take either of the following drugs:

* BAY3283142: Participants will take BAY3283142 as tablets by mouth.
* Placebo: Participants will take it in the same way as BAY3283142. Participants will continue taking the available standard treatment for CKD and other conditions they may have (for example, heart conditions and diabetes).

At the start of this study, the researchers will check the medical history and current medications of the participants. They will also perform a complete health check-up of all the participants. Researchers will take urine and blood samples from the participants at different time points to measure UACR and eGFR.

Participants will be divided equally into different groups. Only 1 group will receive placebo and the other groups will receive BAY3283142. Participants will take their assigned treatment for 16 weeks.

No one will know who receives which drug or dose of BAY3283142 during the study.

Participants will be in this study for around 23 weeks. This includes the time for screening before the start of treatment and follow-up with participants after treatment.

People can join this study if they:

* are 18 years of age or older and have been diagnosed with CKD
* have poor kidney function according to the eGFR test
* have abnormally high levels of albumin in the urine according to the UACR test
* have been taking certain drugs at a stable dose for management of high blood pressure, diabetes, kidney disease, etc. for at least 4 weeks before the start of the study

People cannot join this study if they:

* have low blood pressure
* have had a stroke or a heart attack, or were hospitalized because of heart failure in the 3 months before the start of the study
* have a serious liver disease
* have a kidney disease for which they need to take drugs that control the immune system The detailed requirements will be discussed between the study doctors and people considering joining this study.

Participants may or may not get the expected benefits of treatment with BAY3283142, but they will receive thorough medical check-ups during this study. These can help to improve individual treatment in the future and to identify unknown medical risks.

Some participants may experience medical problems during this study including pain and discomfort when blood samples are taken. Researchers will closely monitor and manage any medical problems the participants may have. They will not include people who should not take BAY3283142 due to known safety concerns.

The findings from this study may contribute to developing a new treatment option for people with CKD who have excess albumin in the urine.

Primary Outcome Measures: Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR), From baseline to Week 16
Secondary Outcome Measures: 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