A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
- Registration Number
- NCT06522997
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- Participant must be ≥18 years of age
- eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m^2 at Screening Note: One re-assessment of eGFR based on central laboratory values is allowed during the Screening period"
- UACR ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at Screening
- Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study
- If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist
- Systolic blood pressure (SBP) <100 mmHg at Visit 2 (baseline)
- Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator
- SBP ≥160 mmHg, unless treated with ≥3 blood pressure lowering medications, at Screening or at Visit 2 (baseline)
- History of secondary hypertension other than CKD
- Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening
- Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 BAY3283142 BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days Arm 1 Placebo Placebo OD and sham titration after 14 days and after 28 days Arm 2 BAY3283142 BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days Arm 4 BAY3283142 BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days Arm 6 BAY3283142 BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days Arm 5 BAY3283142 BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
- Primary Outcome Measures
Name Time Method Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR) From baseline to Week 16
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (169)
General Hospital of Athens LAIKO
🇬🇷Athens, Greece
University General Hospital of Heraklion - Department of Paediatrics
🇬🇷Heraklion, Greece
Kasugai Municipal Hospital
🇯🇵Kasugai, Aichi, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Nephrology Consultants, LLC
🇺🇸Huntsville, Alabama, United States
Balboa Research SMO+ - Chula Vista - West
🇺🇸Chula Vista, California, United States
Balboa Research SMO+ - La Mesa
🇺🇸La Mesa, California, United States
California Kidney Specialists - San Dimas
🇺🇸San Dimas, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Nova Clinical Research - Blake Medical Center
🇺🇸Bradenton, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Elixia Central Florida
🇺🇸Orlando, Florida, United States
Florida Institue for Clinical Research
🇺🇸Orlando, Florida, United States
Southeastern Clinical Research Institute, LLC
🇺🇸Augusta, Georgia, United States
Research by Design, LLC | Chicago, IL
🇺🇸Chicago, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - Hinsdale
🇺🇸Hinsdale, Illinois, United States
Triad Internal Medicine
🇺🇸Asheboro, North Carolina, United States
Eastern Nephrology Associates - New Bern
🇺🇸New Bern, North Carolina, United States
Brookview Hills Research Associates, LLC
🇺🇸Winston-Salem, North Carolina, United States
Knoxville Kidney Center, PLLC
🇺🇸Knoxville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Renal Disease Research Institute | Landry
🇺🇸Dallas, Texas, United States
Southwest Houston Research, Ltd.
🇺🇸Houston, Texas, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
DaVita Clinical Research | Westover Hills, San Antonio, TX
🇺🇸San Antonio, Texas, United States
DaVita Clinical Research | North Houston, TX
🇺🇸Shenandoah, Texas, United States
Utah Kidney Research Institute | Salt Lake City, UT
🇺🇸S. Salt Lake, Utah, United States
Peninsula Kidney Associates - Hampton
🇺🇸Hampton, Virginia, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Salem VA Medical Center - Cardiology
🇺🇸Salem, Virginia, United States
Mendez Center For Clinical Research | Woodbridge, VA
🇺🇸Woodbridge, Virginia, United States
Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina
🇦🇷Temperley, Buenos Aires, Argentina
The First People's Hospital - Foshan
🇨🇳Foshan, China
CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
🇦🇷Caba, Ciudad Auton. De Buenos Aires, Argentina
Centro de Especialidades Medicas (Cemedic) | Cardiology Department
🇦🇷Villa Luro, Ciudad Auton. De Buenos Aires, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
🇦🇷Buenos Aires, Argentina
Centro Privado San Vicente Diabetes
🇦🇷Córdoba, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
🇦🇷San Luis, Argentina
Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina
🇦🇷Santa Rosa, Argentina
Epicura / Nephrology
🇧🇪Baudour, Belgium
UZ Gent / Nephrology
🇧🇪Gent, Belgium
Jan Yperman Ziekenhuis / Nephrology
🇧🇪Ieper, Belgium
UZ Brussel Nephrology
🇧🇪Jette, Belgium
UZ Leuven / Nephrology
🇧🇪Leuven, Belgium
AZ Delta / Nephrology
🇧🇪Roeselare, Belgium
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou University of TCM
🇨🇳Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Huai'an First People's Hospital, Nanjing Medical University
🇨🇳Huai'An, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical university
🇨🇳Nanjing, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Sichuan University - West China Hospital
🇨🇳Chengdu, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
🇨🇳Chengdu, China
Southern Medical University - Nanfang Hospital (Southern Hospital)
🇨🇳Guangzhou, China
Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)
🇨🇳Nanjing, China
Renji Hospital Shanghai JiaoTong University of Medicine
🇨🇳Shanghai, China
Huadong Hospital, Affiliated to Fudan University
🇨🇳Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, China
University of Thessaly - General University Hospital of Larissa (UHL)
🇬🇷Larissa, Greece
University Hospital of Ioannina (UHI)
🇬🇷Nisos Ioanninon, Greece
University General Hospital of Patras | Nephrology Clinic
🇬🇷Patra, Greece
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki Papageorgiou
🇬🇷Thessaloniki, Greece
Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou)
🇬🇷Thessaloniki, Greece
Mavani Research Center
🇮🇳Ahmedabad, Gujarat, India
Marengo Asia Hospital, Gurugram
🇮🇳Gurugram, Haryana, India
Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))
🇮🇳Bangalore, India
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
🇮🇳Calcutta, India
Madras Diabetes Research Foundation
🇮🇳Chennai, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
🇮🇳New Delhi, India
Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)
🇮🇳New Delhi, India
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
🇮🇹Bologna, Emilia-Romagna, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
🇮🇹Brescia, Lombardia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di Rene
🇮🇹Milano, Lombardia, Italy
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
🇮🇹Bergamo, Italy
Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi
🇮🇹Messina, Italy
Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
🇮🇹Modena, Italy
Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
🇮🇹Pavia, Italy
Chubu Rosai Hospital
🇯🇵Nagoya, Aichi, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Chiba, Japan
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
Fukui Prefectural Hospital
🇯🇵Fukui-shi, Fukui, Japan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Hirohata Naika Clinic
🇯🇵Kitakyushu, Fukuoka, Japan
Steel Memorial Yawata Hospital
🇯🇵Kitakyusyu, Fukuoka, Japan
Jiyugaoka Yamada Internal Medicine Clinic
🇯🇵Obihiro, Hokkaido, Japan
Naka Kinen Clinic
🇯🇵Naka-shi, Ibaraki, Japan
JA Toride Medical Center
🇯🇵Toride, Ibaraki, Japan
Komatsu Municipal Hospital
🇯🇵Komatsu City, Ishikawa, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Saiseikai Yokohamashi Nanbu Hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Katta General Hospital
🇯🇵Shiroishi, Miyagi, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Japanese Red Cross Saitama Hospital
🇯🇵Saitama, Japan
Yonsei University Wonju Christian Hospital
🇰🇷Wonju, Gang''weondo, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggido, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoungbuk-gu, Seoul, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Garcia de Orta | Research Department
🇵🇹Almada, Lisboa, Portugal
Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
🇵🇹Carnaxide, Lisboa, Portugal
Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao
🇵🇹Vila Franca de Xira, Lisboa, Portugal
Hospital Pedro Hispano | Clinical Research Center
🇵🇹Matosinhos, Porto, Portugal
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
🇵🇹Torres Novas, Santarém, Portugal
Centro Clinico Academico Braga | Braga, Portugal
🇵🇹Braga, Portugal
CHUC- Hospitais da Universidade de Coimbra - Nephrology Department
🇵🇹Coimbra, Portugal
Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
🇵🇹Lisboa, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
🇵🇹Lisboa, Portugal
Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos
🇵🇹Lisbon, Portugal
National University Hospital Medical Centre
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
SingHealth Polyclinics - Pasir Ris
🇸🇬Singapore, Singapore
Changi General Hospital
🇸🇬Singapore, Singapore
Khoo Teck Puat Hospital
🇸🇬Singapore, Singapore
Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia
🇸🇰Bratislava, Slovakia
DIABEDA s.r.o.
🇸🇰Bratislava, Slovakia
MEDISPEKTRUM s.r.o.
🇸🇰Bratislava, Slovakia
B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia
🇸🇰Galanta, Slovakia
NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice
🇸🇰Kosice, Slovakia
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Biodial | Puchov, Slovakia
🇸🇰Puchov, Slovakia
DIAB s.r.o
🇸🇰Roznava, Slovakia
B. Braun Avium Nefrologicka ambulancia | Sala, Slovakia
🇸🇰Sala, Slovakia
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
🇪🇸A Coruna, A Coruña, Spain
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology Department
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario de Valencia | Nephrology Department
🇪🇸Missing, Valencia, Spain
Hospital Quironsalud Barcelona | Internal Medicine Department
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
🇪🇸Ferrol, Spain
Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
🇪🇸Madrid, Spain
Hospital Universitario Nuestra Senora de Valme | Internal Medicine Department
🇪🇸Sevilla, Spain
Hospital Universitario Doctor Peset | Nephrology Department
🇪🇸Valencia, Spain
Hospital Universitario Y Politecnico La Fe - Nefrologia
🇪🇸Valencia, Spain
Sahlgrenska Universitetssjukhuset - Njurkliniken
🇸🇪Gothenburg, Sweden
Universitetssjukhuset i Linköping
🇸🇪LInköping, Sweden
ProbareE Stockholm
🇸🇪Stockholm, Sweden
Center For Diabetes, Academic Specialist Center
🇸🇪Stockholm, Sweden
Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken
🇸🇪Uppsala, Sweden
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Chang Gung Memorial Hospital Kaohsiung
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei, Taiwan
Chi-Mei Medical Center, Liouyine
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Salford Royal Hospital
🇬🇧Salford, Manchester, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
🇬🇧Cardiff, United Kingdom
Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit
🇬🇧Carshalton, United Kingdom
Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department
🇬🇧Hull, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Royal Free London NHS Foundation Trust | Royal Free Hospital - Cancer Services
🇬🇧London, United Kingdom
King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Lakeside Healthcare Research Department
🇬🇧Northamptonshire, United Kingdom