check_circleStudy Completed

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

Trial summary

Enrollment Goal
1222
Trial Dates
August 2024 - November 2025
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nurandociguat (BAY3283142)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
SingHealth Polyclinics - Pasir RisSingapore, 519457, Singapore
Completed
Southern Medical University - Nanfang Hospital (Southern Hospital)Guangzhou, 510515, China
Completed
Centro de Especialidades Medicas (Cemedic) | Cardiology DepartmentVilla Luro, C1440CFD, Argentina
Completed
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e TrapiantoBologna, 40138, Italy
Completed
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-DiabetologiaBergamo, 24127, Italy
Completed
Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di ReneModena, 41124, Italy
Completed
Istituti Clinici Scientifici Maugeri S.p.A._Pavia - NefrologiaPavia, 27100, Italy
Completed
Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e DialisiMessina, 98124, Italy
Withdrawn
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - NefrologiaBrescia, 25123, Italy
Completed
Unidade Local De Saúde De Lisboa Ocidental E.P.E.Carnaxide, 2790-134, Portugal
Completed
Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research DepartmentAlmada, 2805-267, Portugal
Completed
Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology DepartmentLisboa, 1069-166, Portugal
Completed
Ippokratio General Hospital Of Thessaloniki- 1st Department of NephrologyThessaloniki, 54642, Greece
Completed
Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology DepartmentThessaloniki, 57010, Greece
Completed
Laiko General Hospital Of Athens_ Department of Nephrology and Renal TransplantationAthens, 11525, Greece
Completed
University General Hospital of Heraklion-Nephrology ClinicHeraklion, 71500, Greece
Completed
General University Hospital Of Larissa-Nephrology ClinicLarissa, 41100, Greece
Completed
University General Hospital Of Ioannina-Nephrology ClinicIoannina, 45500, Greece
Completed
University General Hospital of Patras | Nephrology ClinicPatra, 26504, Greece
Completed
General Hospital Of Thessaloniki Papageorgiou-Renal DepartmentEfkarpia, 56429, Greece
Completed
Centro Clinico Academico Braga | Braga, PortugalBraga, 4710-243, Portugal
Completed
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de NefrologiaCoimbra, 3000-075, Portugal
Completed
AZ Delta / NephrologyRoeselare, 8800, Belgium
Completed
UZ Gent / NephrologyGent, 9000, Belgium
Completed
Unidade Local de Saude do Estuario do Tejo | Hospital de Vila Franca de Xira - Departamento de Formacao e InvestigacaoVila Franca de Xira, 2600-009, Portugal
Completed
Hospital Pedro Hispano | Clinical Research CenterMatosinhos, 4464-513, Portugal
Completed
Centro de Rehabilitacion Cardiovascular | San Luis, ArgentinaSan Luis, D5700CGR, Argentina
Completed
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology DepartmentTorres Novas, 2350-754, Portugal
Completed
UZ Leuven / NephrologyLeuven, 3000, Belgium
Completed
CEDIC Centro de Investigación Clínica | Buenos Aires, ArgentinaCABA, C1018DES, Argentina
Completed
Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, ArgentinaCiudad Autónoma de Buenos Aire, C1056ABI, Argentina
Completed
Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, ArgentinaSanta Rosa, Argentina
Completed
DIAB s.r.oRoznava, 048 01, Slovakia
Completed
Barts Health NHS Trust - Royal London Hospital - NephrologyLondon, E1 1FR, United Kingdom
Completed
Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials UnitCarshalton, SM5 1AA, United Kingdom
Completed
Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research DepartmentHull, HU3 2JZ, United Kingdom
Completed
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and TransplantCardiff, CF14 4XW, United Kingdom
Completed
Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - NephrologySalford, M6 8HD, United Kingdom
Withdrawn
Royal Free London NHS Foundation Trust | Royal Free Hospital – Cancer ServicesLondon, NW3 2QG, United Kingdom
Completed
University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research FacilityBirmingham, B15 2TH, United Kingdom
Completed
King’s College Hospital NHS Foundation Trust | King's College Hospital - Renal Research DepartmentLondon, SE5 9RJ, United Kingdom
Completed
Lakeside Healthcare | Lakeside Surgery - Research DepartmentCorby, NN17 2UR, United Kingdom
Completed
Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal CareManchester, M13 9WL, United Kingdom
Completed
Balboa Research SMO+ - Chula VistaChula Vista, 91910, United States
Completed
Clinical Advancement Center, PLLCSan Antonio, 78212, United States
Completed
Eastern Nephrology Associates - New BernNew Bern, 28562, United States
Completed
Florida Institue for Clinical ResearchOrlando, 32825, United States
Completed
Knoxville Kidney Center, PLLCKnoxville, 37923, United States
Completed
Manassas Clinical Research CenterManassas, 20110, United States
Completed
Mendez Center For Clinical Research | Woodbridge, VAWoodbridge, 22192, United States
Completed
Nephrology Associates of Northern Illinois and Indiana - HinsdaleHinsdale, 60521, United States
Completed
Brookview Hills Research Associates, LLCWinston-Salem, 27103, United States
Active, not recruiting
Peninsula Kidney Associates - HamptonHampton, 23666, United States
Completed
Southeastern Clinical Research Institute, LLCAugusta, 30904, United States
Completed
Utah Kidney Research Institute | Salt Lake City, UTSouth Salt Lake, 84115, United States
Completed
Yale Nephrology Clinical Research ClinicNew Haven, 06510, United States
Completed
Nephrology Consultants, LLCHuntsville, 35805, United States
Completed
Balboa Research SMO+ - Chula VistaChula Vista, 91910, United States
Completed
Renal Disease Research Institute | LandryDallas, 75246, United States
Withdrawn
DaVita Clinical Research | North Houston, TXShenandoah, 77384, United States
Completed
Triad Internal Medicine - AsheboroAsheboro, 27203, United States
Active, not recruiting
Nova Clinical Research - Blake Medical CenterBrandenton, 34209, United States
Withdrawn
DaVita Clinical Research | Westover Hills, San Antonio, TXSan Antonio, 78251, United States
Completed
Renstar Medical Research - Deerwood ClinicOcala, 34471, United States
Not yet recruiting
Elixia Central FloridaOrlando, 32608, United States
Completed
Research by Design, LLC | Chicago, ILChicago, 60643, United States
Completed
California Kidney Specialists - San DimasSan Dimas, 91773, United States
Completed
Vanderbilt University Medical Center - Nephrology Clinical Trials CenterNashville, 37232, United States
Completed
Salem VA Medical Center - NephrologySalem, 24153, United States
Completed
Southwest Houston Research, Ltd.Houston, 77099, United States
Completed
Chubu Rosai HospitalNagoya, 455-8530, Japan
Completed
Ehime Prefectural Central HospitalMatsuyama, 790-0024, Japan
Completed
Fukui Prefectural HospitalFukui-shi, 910-0846, Japan
Withdrawn
JA Toride Medical CenterToride, 302-0022, Japan
Completed
Japanese Red Cross Fukuoka HospitalFukuoka, 815-8555, Japan
Completed
Japanese Red Cross Saitama HospitalSaitama, 330-8553, Japan
Completed
Jiyugaoka Yamada Internal Medicine ClinicObihiro, 080-0848, Japan
Completed
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Komatsu Municipal HospitalKomatsu City, 923-8560, Japan
Completed
Hirohata Naika ClinicKitakyushu, 807-0857, Japan
Completed
Naka Kinen ClinicNaka-shi, 311-0113, Japan
Completed
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Saiseikai Matsuyama HospitalMatsuyama, 791-8026, Japan
Completed
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-0054, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Completed
University of Yamanashi HospitalChuo, 409-3898, Japan
Completed
Yokohama City University HospitalYokohama, 236-0004, Japan
Completed
Katta General HospitalShiroishi, 989-0231, Japan
Completed
Kasugai Municipal HospitalKasugai, 486-8510, Japan
Completed
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Completed
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Completed
Rinku General Medical CenterIzumisano, 598-8577, Japan
Completed
Steel Memorial Yawata HospitalKitakyusyu, 805-8508, Japan
Completed
Hospital Universitario Virgen De Valme | Medicina InternaSevilla, 41014, Spain
Completed
Complexo Hospitalario Universitario A Coruna | Endocrinologia y NutricionA Coruña, 15006, Spain
Completed
Area Sanitaria De Ferrol | Medicina InternaFerrol, 15405, Spain
Completed
Hospital Quironsalud Barcelona | Internal Medicine DepartmentBarcelona, 8023, Spain
Completed
Hospital Universitario Y Politecnico La Fe | NefrologiaValencia, 46026, Spain
Completed
Hospital Universitario Dr Peset Aleixandre | NefrologiaValencia, 46017, Spain
Completed
Hospital Universitario Ramon Y Cajal | Medicina InternaMadrid, 28034, Spain
Completed
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension DepartmentMadrid, 28040, Spain
Completed
Bellvitge Hospital Universitari | NefrologiaL'Hospitalet de Llobregat, 08907, Spain
Completed
Hospital Clinico Universitario De Valencia | NefrologiaValencia, 46010, Spain
Completed
Epicura / NephrologyBaudour, 7331, Belgium
Completed
Jan Yperman Ziekenhuis / NephrologyIeper, 8900, Belgium
Completed
UZ Brussel NephrologyJette, 1090, Belgium
Completed
Universitetssjukhuset i LinköpingLInköping, 581 85, Sweden
Completed
Sahlgrenska Universitetssjukhuset - NjurklinikenGöteborg, 413 45, Sweden
Completed
Akademiska sjukhuset (Uppsala University Hospital) - NjurklinikenUppsala, 751 85, Sweden
Completed
Center For Diabetes, Academic Specialist CenterStockholm, 113 65, Sweden
Completed
ProbareE StockholmStockholm, 113 29, Sweden
Completed
Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios ClinicosLisboa, 1250-189, Portugal
Completed
Centro Privado San Vicente DiabetesCórdoba, 5000, Argentina
Completed
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)Buenos Aires, C1431FWO, Argentina
Completed
Centro de Investigaciones Medicas Temperley | Buenos Aires, ArgentinaTemperley, B1834GUK, Argentina
Completed
BIODIAL spol. s r.o.Puchov, 02001, Slovakia
Completed
NephroCare | FMC-dialyzacne sluzby s.r.o. - KosiceKosice, 04011, Slovakia
Completed
B. Braun Avitum Nefrologicka Ambulancia | Galanta, SlovakiaGalanta, 924 22, Slovakia
Completed
B. Braun Avitum Nefrologicka ambulancia | Sala, SlovakiaSala, 92719, Slovakia
Completed
MEDISPEKTRUM s.r.o.Bratislava, 85101, Slovakia
Completed
DIABEDA s.r.o.Bratislava, 83106, Slovakia
Completed
Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulanciaBratislava, 83101, Slovakia
Completed
Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenieMartin, 036 59, Slovakia
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Completed
The Second Affiliated Hospital of Nanjing Medical universitynanjing, 210011, China
Completed
Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)Nanjing, 210029, China
Completed
The Third Xiangya Hospital of Central South Universitychangsha, 410013, China
Completed
Shanxi Bethune HospitalTaiyuan, 030032, China
Completed
The First Affiliated Hospital of Xiamen UniversityXiamen, 361003, China
Completed
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)Beijing, 100029, China
Completed
Huadong Hospital, Affiliated to Fudan UniversityShanghai, 200040, China
Completed
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)Chengdu, 610072, China
Completed
Sichuan University - West China HospitalChengdu, 610041, China
Completed
Shandong Provincial HospitalJinan, 250021, China
Completed
Peking University People's HospitalBeijing, 100044, China
Withdrawn
Shandong Provincial HospitalJinan, 250021, China
Completed
Renji Hospital Shanghai JiaoTong University of MedicineShanghai, 200001, China
Completed
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Completed
The Second Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
Asan Medical Center | OphthalmologySeoul, 5505, Korea,_republic_of
Withdrawn
Anam Hospital | Endocrinology and MetabolismSeongbuk, 02841, Korea,_republic_of
Withdrawn
Samsung Medical Center - Oncology DepartmentSeoul, 06351, Korea,_republic_of
Withdrawn
Severance Hospital, Yonsei University Health SystemSeoul, 3722, Korea,_republic_of
Withdrawn
Ansan Hospital | NephrologyGyeonggi-do, 425-707, Korea,_republic_of
Withdrawn
Yonsei University Wonju Christian HospitalWonju-si, 26426, Korea,_republic_of
Withdrawn
Hallym University Sacred Heart HospitalAnyang-si, 14068, Korea,_republic_of
Withdrawn
Marengo Asia Hospital, GurugramGurugram, 122011, India
Completed
Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)New Delhi, 110017, India
Completed
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)Calcutta, 700020, India
Completed
Mavani Research CenterAhmedabad, 380052, India
Completed
Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))Bengaluru, 560092, India
Completed
All India Institute of Medical Sciences (AIIMS) - New DelhiNew Delhi, 110029, India
Completed
Madras Diabetes Research FoundationChennai, 600086, India
Completed
Singapore General HospitalSingapore, 169608, Singapore
Withdrawn
Khoo Teck Puat HospitalSingapore, 768828, Singapore
Completed
Changi General HospitalSingapore, 529889, Singapore
Completed
National University Hospital Medical CentreSingapore, 119074, Singapore
Completed
Tan Tock Seng HospitalSingapore, 308433, Singapore
Completed
The First People's Hospital - FoshanFoshan, 528000, China
Withdrawn
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di ReneMilano, 20122, Italy
Completed
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Completed
Chi-Mei Medical Center, LiouyineTainan, 73657, Taiwan
Completed
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Completed
National Heart Centre SingaporeSingapore, 169609, Singapore
Completed
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Completed
Changhua Christian HospitalChanghua City, 50006, Taiwan
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
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