A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
ALPINE 1
A Phase 2b Dose-finding, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of BAY 3283142 on Top of Standard of Care in Reducing Albuminuria in Patients With Chronic Kidney Disease
2 other identifiers
interventional
1,222
15 countries
153
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Shorter than P25 for phase_2
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
August 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2025
CompletedApril 13, 2026
April 1, 2026
1.2 years
July 22, 2024
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
From baseline to Week 16
Secondary Outcomes (3)
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
Study Arms (6)
Arm 1
PLACEBO COMPARATORPlacebo OD and sham titration after 14 days and after 28 days
Arm 2
EXPERIMENTALBAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days
Arm 3
EXPERIMENTALBAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days
Arm 4
EXPERIMENTALBAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days
Arm 5
EXPERIMENTALBAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
Arm 6
EXPERIMENTALBAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (153)
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
Balboa Research SMO+ - Chula Vista
Chula Vista, California, 91910, United States
California Kidney Specialists - San Dimas
San Dimas, California, 91773, United States
Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510, United States
Nova Clinical Research - Blake Medical Center
Bradenton, Florida, 34209, United States
Renstar Medical Research - Deerwood Clinic
Ocala, Florida, 34471, 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
Asheboro, North Carolina, 27203, 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, United States
Vanderbilt University Medical Center - Nephrology Clinical Trials 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
Utah Kidney Research Institute | Salt Lake City, UT
South Salt Lake, Utah, 84115, United States
Peninsula Kidney Associates - Hampton
Hampton, Virginia, 23666, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Salem VA Medical Center - Nephrology
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 Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, San Luis Province, D5700CGR, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
Centro Privado San Vicente Diabetes
Córdoba, 5000, Argentina
Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina
Santa Rosa, 0, Argentina
Epicura / Nephrology
Baudour, 7331, Belgium
UZ Gent / Nephrology
Ghent, 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, 410013, 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, 210011, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, 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, 100044, 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
University General Hospital of Patras | Nephrology Clinic
Pátrai, Achaia, 26504, Greece
General Hospital Of Thessaloniki Papageorgiou-Renal Department
Efkarpia, Thessaloniki, 56429, Greece
Laiko General Hospital Of Athens_ Department of Nephrology and Renal Transplantation
Athens, 11525, Greece
University General Hospital of Heraklion-Nephrology Clinic
Heraklion, 71500, Greece
University General Hospital Of Ioannina-Nephrology Clinic
Ioannina, 45500, Greece
General University Hospital Of Larissa-Nephrology Clinic
Larissa, 41100, Greece
Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology
Thessaloniki, 54642, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department
Thessaloniki, 57010, Greece
Mavani Research Center
Ahmedabad, Gujarat, 380052, India
Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))
Bengaluru, Karnataka, 560092, India
Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)
New Delhi, National Capital Territory of Delhi, 110017, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi, 110029, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, West Bengal, 700020, India
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
Bologna, Emilia-Romagna, 40138, 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-ken, 486-8510, Japan
Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, 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
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508, Japan
Hirohata Naika Clinic
Kitakyushu, Fukuoka, 807-0857, Japan
Jiyugaoka Yamada Internal Medicine Clinic
Obihiro, Hokkaido, 080-0848, Japan
Naka Kinen Clinic
Naka, Ibaraki, 311-0113, Japan
Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, 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, 598-8577, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555, 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
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Carnaxide, Lisbon District, 2790-134, Portugal
Unidade Local de Saude do Estuario do Tejo | Hospital de Vila Franca de Xira - Departamento de Formacao e Investigacao
Vila Franca de Xira, Lisbon District, 2600-009, Portugal
Hospital Pedro Hispano | Clinical Research Center
Matosinhos Municipality, Porto District, 4464-513, Portugal
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
Torres Novas, Santarém District, 2350-754, Portugal
Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
Almada, Setúbal District, 2805-267, Portugal
Centro Clinico Academico Braga | Braga, Portugal
Braga, 4710-243, Portugal
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Nefrologia
Coimbra, 3000-075, Portugal
Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
Lisbon, 1069-166, Portugal
Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos
Lisbon, 1250-189, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650, 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
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
Košice, 04011, Slovakia
Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenie
Martin, 036 59, Slovakia
BIODIAL spol. s r.o.
Púchov, 02001, Slovakia
DIAB s.r.o
Rožňava, 048 01, Slovakia
B. Braun Avitum Nefrologicka ambulancia | Sala, Slovakia
Šaľa, 92719, Slovakia
Area Sanitaria De Ferrol | Medicina Interna
Ferrol, A Coruña, 15405, Spain
Bellvitge Hospital Universitari | Nefrologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
A Coruña, 15006, Spain
Hospital Quironsalud Barcelona | Internal Medicine Department
Barcelona, 8023, Spain
Hospital Universitario Ramon Y Cajal | Medicina Interna
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, 28040, Spain
Hospital Universitario Virgen De Valme | Medicina Interna
Seville, 41014, Spain
Hospital Clinico Universitario De Valencia | Nefrologia
Valencia, 46010, Spain
Hospital Universitario Dr Peset Aleixandre | Nefrologia
Valencia, 46017, Spain
Hospital Universitario Y Politecnico La Fe | Nefrologia
Valencia, 46026, Spain
ProbareE Stockholm
Stockholm, Stockholm County, 113 29, Sweden
Center For Diabetes, Academic Specialist Center
Stockholm, Stockholm County, 113 65, Sweden
Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken
Uppsala, Uppsala County, 751 85, Sweden
Sahlgrenska Universitetssjukhuset - Njurkliniken
Gothenburg, Västra Götaland County, 413 45, Sweden
Universitetssjukhuset i Linköping
Linköping, Östergötland County, 581 85, Sweden
Changhua Christian Hospital
Changhua, Changhua, 50006, Taiwan
Far Eastern Memorial Hospital
New Taipei City, New Taipei, 220, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833, Taiwan
Chi-Mei Medical Center, Liouyine
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department
Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom
Barts Health NHS Trust - Royal London Hospital - Nephrology
London, Greater London, E1 1FR, United Kingdom
King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
London, Greater London, SE5 9RJ, United Kingdom
Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care
Manchester, Greater Manchester, M13 9WL, United Kingdom
Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology
Salford, Greater Manchester, M6 8HD, United Kingdom
Lakeside Healthcare | Lakeside Surgery - Research Department
Corby, Northamptonshire, NN17 2UR, United Kingdom
Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit
Carshalton, Surrey, SM5 1AA, United Kingdom
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, Wales, CF14 4XW, United Kingdom
University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility
Birmingham, West Midlands, B15 2TH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In this double-blind study, participants will be randomly assigned to receive study intervention. Investigators, participants and study personnel will remain blinded to each participant's assigned study intervention throughout the course of the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
July 26, 2024
Study Start
August 8, 2024
Primary Completion
October 24, 2025
Study Completion
November 20, 2025
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers' patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.