account_circleRecruiting

Chronic kidney disease

A study to learn about how well BAY3283142 works and its safety in participants with chronic kidney disease

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 Years
  • - 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

Trial summary

Enrollment Goal
700
Trial Dates
August 2024 - March 2026
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY3283142
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
SingHealth Polyclinics - Pasir RisSingapore, 519457, Singapore
Recruiting
Southern Medical University - Nanfang Hospital (Southern Hospital)Guangzhou, 510515, China
Recruiting
Centro de Especialidades Medicas (Cemedic) | Cardiology DepartmentVilla Luro, C1440CFD, Argentina
Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e TrapiantoBologna, 40138, Italy
Recruiting
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-DiabetologiaBergamo, 24127, Italy
Recruiting
Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di ModenaModena, 41124, Italy
Recruiting
Istituti Clinici Scientifici Maugeri S.p.A._Pavia - NefrologiaPavia, 27100, Italy
Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e DialisiMessina, 98124, Italy
Not yet recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - NefrologiaBrescia, 25123, Italy
Recruiting
Centro Hospitalar de Lisboa Ocidental | Clinical Research DepartmentCarnaxide, 2790-134, Portugal
Recruiting
Hospital Garcia de Orta | Research DepartmentAlmada, 2805-267, Portugal
Recruiting
Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology DepartmentLisboa, 1069-166, Portugal
Recruiting
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'Thessaloniki, 54642, Greece
Recruiting
Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou)Thessaloniki, 570 10, Greece
Recruiting
General Hospital of Athens LAIKOAthens, 11527, Greece
Recruiting
University General Hospital of Heraklion - Department of PaediatricsHeraklion, 71110, Greece
Not yet recruiting
University of Thessaly - General University Hospital of Larissa (UHL)Larissa, 41100, Greece
Recruiting
University Hospital of Ioannina (UHI)Nisos Ioanninon, 455 00, Greece
Recruiting
University General Hospital of Patras | Nephrology ClinicPatra, 26504, Greece
Not yet recruiting
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Recruiting
Centro Clinico Academico Braga | Braga, PortugalBraga, 4710-243, Portugal
Recruiting
CHUC- Hospitais da Universidade de Coimbra - Nephrology DepartmentCoimbra, 3000-075, Portugal
Recruiting
AZ Delta / NephrologyRoeselare, 8800, Belgium
Not yet recruiting
UZ Gent / NephrologyGent, 9000, Belgium
Recruiting
Hospital de Vila Franca de Xira | Centro de Desenvolvimento e InvestigacaoVila Franca de Xira, 2600-009, Portugal
Recruiting
Hospital Pedro Hispano | Clinical Research CenterMatosinhos, 4464-513, Portugal
Recruiting
Centro de Rehabilitacion Cardiovascular | San Luis, ArgentinaSan Luis, D5702AAX, Argentina
Recruiting
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology DepartmentTorres Novas, 2350-754, Portugal
Not yet recruiting
UZ Leuven / NephrologyLeuven, 3000, Belgium
Recruiting
CEDIC Centro de Investigación Clínica | Buenos Aires, ArgentinaCABA, C1018DES, Argentina
Recruiting
Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, ArgentinaCiudad Autónoma de Buenos Aire, C1056ABI, Argentina
Recruiting
Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, ArgentinaSanta Rosa, Argentina
Recruiting
DIAB s.r.oRoznava, 048 01, Slovakia
Recruiting
Royal London HospitalLondon, E1 1FR, United Kingdom
Recruiting
Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials UnitCarshalton, SM5 1AA, United Kingdom
Recruiting
Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research DepartmentHull, HU3 2JZ, United Kingdom
Recruiting
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)Cardiff, CF14 4XW, United Kingdom
Recruiting
Salford Royal HospitalSalford, M6 8HD, United Kingdom
Withdrawn
Royal Free London NHS Foundation Trust - The Royal Free Hospital (RFH)London, NW3 2QG, United Kingdom
Recruiting
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Not yet recruiting
King’s College Hospital NHS Foundation Trust | King's College Hospital - Renal Research DepartmentLondon, SE5 9RJ, United Kingdom
Recruiting
Lakeside Healthcare Research DepartmentNorthamptonshire, NN17 2UR, United Kingdom
Not yet recruiting
Manchester Royal InfirmaryManchester, M13 9WL, United Kingdom
Recruiting
Balboa Research SMO+ - Chula Vista - WestChula Vista, 91911, United States
Recruiting
Clinical Advancement Center, PLLCSan Antonio, 78212, United States
Recruiting
Eastern Nephrology Associates - New BernNew Bern, 28562, United States
Recruiting
Florida Institue for Clinical ResearchOrlando, 32825, United States
Recruiting
Knoxville Kidney Center, PLLCKnoxville, 37923-3624, United States
Recruiting
Manassas Clinical Research CenterManassas, 20110, United States
Recruiting
Mendez Center For Clinical Research | Woodbridge, VAWoodbridge, 22192, United States
Recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI) - HinsdaleHinsdale, 60521, United States
Recruiting
Brookview Hills Research Associates, LLCWinston-Salem, 27103, United States
Recruiting
Peninsula Kidney AssociatesHampton, 23666, United States
Recruiting
Southeastern Clinical Research Institute, LLCAugusta, 30904, United States
Active, not recruiting
Utah Kidney Research Institute | Salt Lake City, UTSouth Salt Lake, 84115, United States
Not yet recruiting
Yale University School of MedicineNew Haven, 06510, United States
Recruiting
Nephrology Consultants, LLCHuntsville, 35805-4104, United States
Recruiting
Balboa Research SMO+ - La MesaLa Mesa, 91942, United States
Recruiting
Renal Disease Research Institute | LandryDallas, 75246, United States
Withdrawn
DaVita Clinical Research | North Houston, TXShenandoah, 77384, United States
Recruiting
Triad Internal MedicineAsheboro, 27203-5573, United States
Recruiting
Nova Clinical Research | Brandenton, FLBrandenton, 34209, United States
Withdrawn
DaVita Clinical Research | Westover Hills, San Antonio, TXSan Antonio, 78251, United States
Recruiting
Renstar Medical ResearchOcala, 34470, United States
Not yet recruiting
Elixia Central FloridaOrlando, 32608, United States
Recruiting
Research by Design, LLC | Chicago, ILChicago, 60643, United States
Recruiting
California Kidney Specialists - San DimasSan Dimas, 91773, United States
Not yet recruiting
Vanderbilt University Medical CenterNashville, 37232, United States
Recruiting
Salem VA Medical Center - CardiologySalem, 24153, United States
Active, not recruiting
Southwest Houston Research, Ltd.Houston, 77099, United States
Recruiting
Chubu Rosai HospitalNagoya, 455-8530, Japan
Not yet recruiting
Ehime Prefectural Central HospitalMatsuyama, 790-0024, Japan
Recruiting
Fukui Prefectural HospitalFukui-shi, 910-0846, Japan
Withdrawn
JA Toride Medical CenterToride, 302-0022, Japan
Not yet recruiting
Japanese Red Cross Fukuoka HospitalFukuoka, 815-8555, Japan
Recruiting
Japanese Red Cross Saitama HospitalSaitama, 330-8553, Japan
Recruiting
Jiyugaoka Yamada Internal Medicine ClinicObihiro, 080-0848, Japan
Not yet recruiting
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Recruiting
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Not yet recruiting
Komatsu Municipal HospitalKomatsu City, 923-8560, Japan
Recruiting
Hirohata Naika ClinicKitakyushu, 807-0857, Japan
Recruiting
Naka Kinen ClinicNaka-shi, 311-0113, Japan
Recruiting
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Recruiting
Osaka General Medical CenterOsaka, 558-8558, Japan
Recruiting
Saiseikai Matsuyama HospitalMatsuyama, 791-8026, Japan
Recruiting
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-0054, Japan
Recruiting
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Not yet recruiting
University of Yamanashi HospitalChuo, 409-3898, Japan
Recruiting
Yokohama City University HospitalYokohama, 236-0004, Japan
Recruiting
Katta General HospitalShiroishi, 989-0231, Japan
Recruiting
Kasugai Municipal HospitalKasugai, 486-8510, Japan
Not yet recruiting
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Not yet recruiting
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Recruiting
Rinku General Medical CenterIzumisano, 598-0048, Japan
Recruiting
Steel Memorial Yawata HospitalKitakyusyu, 805-8508, Japan
Recruiting
Hospital Universitario Nuestra Senora de Valme | Internal Medicine DepartmentSevilla, 41014, Spain
Recruiting
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and NutritionA Coruna, 15006, Spain
Recruiting
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialFerrol, 15405, Spain
Recruiting
Hospital Quironsalud Barcelona | Internal Medicine DepartmentBarcelona, 8023, Spain
Recruiting
La Fe University and Polytechnic Hospital | Nephrology DepartmentValencia, 46026, Spain
Recruiting
Hospital Universitario Doctor Peset | Nephrology DepartmentValencia, 46017, Spain
Recruiting
Hospital Universitario Ramon y Cajal | Departamento de Medicina InternaMadrid, 28034, Spain
Recruiting
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension DepartmentMadrid, 28040, Spain
Recruiting
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology DepartmentL'Hospitalet de Llobregat, 8907, Spain
Recruiting
Hospital Clinico Universitario de Valencia | Nephrology DepartmentMISSING, 46010, Spain
Not yet recruiting
Epicura / NephrologyBaudour, 7331, Belgium
Not yet recruiting
Jan Yperman Ziekenhuis / NephrologyIeper, 8900, Belgium
Not yet recruiting
UZ Brussel NephrologyJette, 1090, Belgium
Recruiting
Universitetssjukhuset i LinköpingLInköping, 581 85, Sweden
Recruiting
Sahlgrenska Universitetssjukhuset - NjurklinikenGothenburg, 413 45, Sweden
Recruiting
Akademiska sjukhuset (Uppsala University Hospital) - NjurklinikenUppsala, 751 85, Sweden
Recruiting
Center For Diabetes, Academic Specialist CenterStockholm, 113 65, Sweden
Recruiting
ProbareE StockholmStockholm, 113 29, Sweden
Recruiting
Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios ClinicosLisbon, 1250-189, Portugal
Recruiting
Centro Privado San Vicente DiabetesCórdoba, 5000, Argentina
Not yet recruiting
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)Buenos Aires, C1431FWO, Argentina
Recruiting
Centro de Investigaciones Medicas Temperley | Buenos Aires, ArgentinaTemperley, B1834GUK, Argentina
Recruiting
Biodial | Puchov, SlovakiaPuchov, 02001, Slovakia
Recruiting
NephroCare | FMC-dialyzacne sluzby s.r.o. - KosiceKosice, 04011, Slovakia
Recruiting
B. Braun Avitum Nefrologicka Ambulancia | Galanta, SlovakiaGalanta, 924 22, Slovakia
Recruiting
B. Braun Avium Nefrologicka ambulancia | Sala, SlovakiaSala, 92719, Slovakia
Recruiting
MEDISPEKTRUM s.r.o.Bratislava, 85101, Slovakia
Recruiting
DIABEDA s.r.o.Bratislava, 83106, Slovakia
Not yet recruiting
Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulanciaBratislava, 83101, Slovakia
Recruiting
Univerzitna nemocnica MartinMartin, 036 59, Slovakia
Recruiting
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Recruiting
The Second Affiliated Hospital of Nanjing Medical universitynanjing, 210000, China
Recruiting
Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)Nanjing, 210029, China
Recruiting
The Third Xiangya Hospital of Central South Universitychangsha, 410000, China
Recruiting
Shanxi Bethune HospitalTaiyuan, 030032, China
Recruiting
The First Affiliated Hospital of Xiamen UniversityXiamen, 361003, China
Recruiting
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)Beijing, 100029, China
Recruiting
Huadong Hospital, Affiliated to Fudan UniversityShanghai, 200040, China
Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)Chengdu, 610072, China
Recruiting
Sichuan University - West China HospitalChengdu, 610041, China
Recruiting
Shandong Provincial HospitalJinan, 250021, China
Recruiting
Peking University People's HospitalBeijing, 100032, China
Withdrawn
Shandong Provincial HospitalJinan, 250021, China
Recruiting
Renji Hospital Shanghai JiaoTong University of MedicineShanghai, 200001, China
Recruiting
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Not yet recruiting
The Second Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
Asan Medical CenterSeoul, 5505, Korea,_republic_of
Withdrawn
Korea University Anam HospitalSeoungbuk-gu, 02841, Korea,_republic_of
Withdrawn
Samsung Medical CenterSeoul, 06351, Korea,_republic_of
Withdrawn
Severance Hospital, Yonsei University Health SystemSeoul, 3722, Korea,_republic_of
Withdrawn
Korea University Ansan HospitalGyeonggi-do, 425-707, Korea,_republic_of
Withdrawn
Yonsei University Wonju Christian HospitalWonju, 26426, Korea,_republic_of
Withdrawn
Hallym University Sacred Heart HospitalAnyang-si, 14068, Korea,_republic_of
Withdrawn
Marengo Asia Hospital, GurugramGurugram, 122011, India
Recruiting
Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)New Delhi, 110017, India
Recruiting
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)Calcutta, 700020, India
Recruiting
Mavani Research CenterAhmedabad, 380052, India
Recruiting
Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))Bangalore, 560092, India
Not yet recruiting
All India Institute of Medical Sciences (AIIMS) - New DelhiNew Delhi, 110 029, India
Recruiting
Madras Diabetes Research FoundationChennai, 600 086, India
Recruiting
Singapore General HospitalSingapore, 169608, Singapore
Withdrawn
Khoo Teck Puat HospitalSingapore, 768828, Singapore
Recruiting
Changi General HospitalSingapore, 529889, Singapore
Recruiting
National University Hospital Medical CentreSingapore, 119074, Singapore
Recruiting
Tan Tock Seng HospitalSingapore, 308433, Singapore
Recruiting
The First People's Hospital - FoshanFoshan, 528000, China
Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di ReneMilano, 20122, Italy
Recruiting
Far Eastern Memorial HospitalNew Taipei, 220, Taiwan
Not yet recruiting
Chi-Mei Medical Center, LiouyineTainan, 736, Taiwan
Not yet recruiting
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Recruiting
National Heart Centre SingaporeSingapore, 169609, Singapore
Recruiting
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Not yet recruiting
Changhua Christian HospitalChanghua, 50006, Taiwan
Not yet recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Not yet recruiting
Taizhou Hospital of Zhejiang ProvinceTaizhou, 317099, China

Primary Outcome

  • Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
    date_rangeTime Frame:
    From baseline to Week 16

Secondary Outcome

  • Change from baseline over time in estimated glomerular filtration rate (eGFR)
    date_rangeTime Frame:
    From baseline to Week 16
  • Change from baseline over time in the logarithm of UACR
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
6