A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Launched by BAYER · Jul 22, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called BAY3283142 to see how well it works and its safety for people with chronic kidney disease (CKD). CKD is a condition where the kidneys gradually lose their ability to function properly, often leading to high levels of a protein called albumin in the urine, which can worsen kidney health. The researchers want to find out if BAY3283142 can help reduce the amount of albumin in the urine when taken alongside standard treatments for CKD.
To participate in the study, individuals must be at least 18 years old, have been diagnosed with CKD, and have certain blood and urine test results indicating poor kidney function and high albumin levels. Participants will be assigned to either take the new drug or a placebo (a pill that looks like the drug but has no medicine). Throughout the trial, which lasts about 23 weeks, participants will receive regular health check-ups and blood and urine tests to monitor their condition. While the study aims to improve treatment options for CKD, it's important to note that not everyone will experience benefits, and some may face mild discomfort during tests.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
New Haven, Connecticut, United States
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Taipei, , Taiwan
Birmingham, , United Kingdom
Izumisano, Osaka, Japan
Osaka, , Japan
Hamamatsu, Shizuoka, Japan
Manchester, , United Kingdom
Manassas, Virginia, United States
Seoul, , Korea, Republic Of
Martin, , Slovakia
Athens, , Greece
Thessaloniki, , Greece
Jinan, Shandong, China
Chuo, Yamanashi, Japan
Kamakura, Kanagawa, Japan
Kaohsiung, , Taiwan
Gyeonggi Do, , Korea, Republic Of
Nagoya, Aichi, Japan
Singapore, , Singapore
Hampton, Virginia, United States
Seoul, , Korea, Republic Of
Kitakyushu, Fukuoka, Japan
Salford, Manchester, United Kingdom
Shinagawa Ku, Tokyo, Japan
Singapore, , Singapore
Winston Salem, North Carolina, United States
Houston, Texas, United States
New Taipei, , Taiwan
Heraklion, , Greece
Urayasu, Chiba, Japan
Xiamen, Fujian, China
Yokohama, Kanagawa, Japan
Athens, , Greece
Changsha, Hunan, China
Seoul, , Korea, Republic Of
Linköping, , Sweden
Bologna, Emilia Romagna, Italy
Changchun, Jilin, China
Seoul, , Korea, Republic Of
Ocala, Florida, United States
Xiamen, Fujian, China
London, , United Kingdom
Changhua, , Taiwan
Huai'an, Jiangsu, China
Saitama, , Japan
Thessaloniki, , Greece
Kasugai, Aichi, Japan
Coimbra, , Portugal
Guangzhou, Guangdong, China
Singapore, , Singapore
Augusta, Georgia, United States
San Antonio, Texas, United States
Cardiff, , United Kingdom
Matsuyama, Ehime, Japan
Nara, , Japan
Shanghai, , China
Fukuoka, , Japan
San Antonio, Texas, United States
Chengdu, , China
Chula Vista, California, United States
Matsuyama, , Japan
Nanjing, Jiangsu, China
Huntsville, Alabama, United States
Thessaloniki, , Greece
Toride, Ibaraki, Japan
Wonju, Gang''Weondo, Korea, Republic Of
Taizhou, Zhejiang, China
Kitakyushu, Fukuoka, Japan
Stockholm, , Sweden
New Bern, North Carolina, United States
Anyang Si, Gyeonggido, Korea, Republic Of
Roeselare, , Belgium
Patra, , Greece
Yokohama, Kanagawa, Japan
Knoxville, Tennessee, United States
Barcelona, , Spain
New Delhi, , India
Bradenton, Florida, United States
Torres Novas, Santarém, Portugal
Orlando, Florida, United States
Guangzhou, , China
Beijing, , China
Calcutta, , India
A Coruna, A Coruña, Spain
Obihiro, Hokkaido, Japan
New Delhi, , India
Hinsdale, Illinois, United States
Braga, , Portugal
Lisboa, , Portugal
Madrid, , Spain
Bergamo, , Italy
Lisboa, , Portugal
Taiyuan, , China
Almada, Lisboa, Portugal
Uppsala, , Sweden
Buenos Aires, , Argentina
Valencia, , Spain
Villa Luro, Ciudad Auton. De Buenos Aires, Argentina
Chicago, Illinois, United States
Shenandoah, Texas, United States
S. Salt Lake, Utah, United States
Woodbridge, Virginia, United States
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Caba, Ciudad Auton. De Buenos Aires, Argentina
Ahmedabad, Gujarat, India
Carnaxide, Lisboa, Portugal
L'hospitalet De Llobregat, Barcelona, Spain
Missing, Valencia, Spain
La Mesa, California, United States
Tainan, , Taiwan
Orlando, Florida, United States
Asheboro, North Carolina, United States
San Antonio, Texas, United States
Woodland Hills, Texas, United States
Salem, Virginia, United States
Córdoba, , Argentina
San Luis, , Argentina
Santa Rosa, , Argentina
Baudour, , Belgium
Gent, , Belgium
Ieper, , Belgium
Jette, , Belgium
Leuven, , Belgium
Beijing, , China
Chengdu, , China
Nanjing, , China
Shanghai, , China
Larissa, , Greece
Nisos Ioanninon, , Greece
Thessaloniki, , Greece
Gurugram, Haryana, India
Bangalore, , India
Chennai, , India
Brescia, Lombardia, Italy
Messina, , Italy
Modena, , Italy
Pavia, , Italy
Fukui Shi, Fukui, Japan
Kitakyusyu, Fukuoka, Japan
Naka Shi, Ibaraki, Japan
Komatsu City, Ishikawa, Japan
Shiroishi, Miyagi, Japan
Seoungbuk Gu, Seoul, Korea, Republic Of
Vila Franca De Xira, Lisboa, Portugal
Matosinhos, Porto, Portugal
Lisbon, , Portugal
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Galanta, , Slovakia
Kosice, , Slovakia
Puchov, , Slovakia
Roznava, , Slovakia
Sala, , Slovakia
Ferrol, , Spain
Madrid, , Spain
Sevilla, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Carshalton, , United Kingdom
Hull, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Northamptonshire, , United Kingdom
Temperley, Buenos Aires, Argentina
San Dimas, California, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Foshan, , China
Bologna, Emilia Romagna, Italy
Milan, Lombardia, Italy
Coimbra, , Portugal
Lisbon, , Portugal
Galanta, , Slovakia
Kosice, , Slovakia
Puchov, , Slovakia
Sala, , Slovakia
London, , United Kingdom
Salem, Virginia, United States
Salem, Virginia, United States
New Delhi, , India
Brescia, Lombardia, Italy
Milano, Lombardia, Italy
New Bern, North Carolina, United States
Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina
Chula Vista, California, United States
Messina, , Italy
Pavia, , Italy
La Mesa, California, United States
Chula Vista, California, United States
Singapore, , Singapore
San Dimas, California, United States
London, , United Kingdom
Thessaloniki, , Greece
Heraklion, , Greece
Hinsdale, Illinois, United States
Modena, , Italy
London, , United Kingdom
Chula Vista, California, United States
Bradenton, Florida, United States
Hampton, Virginia, United States
Valencia, , Spain
Salford, Manchester, United Kingdom
Cardiff, , United Kingdom
Ocala, Florida, United States
Madrid, , Spain
Birmingham, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Torres Novas, , Portugal
A Coruna, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported