Clinical trial NCT06522997: A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5+1 parallel-arm
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
timeFrame: From baseline to Week 16
Secondary outcomes:
measure: Change from baseline over time in estimated glomerular filtration rate (eGFR)
timeFrame: From baseline to Week 16
measure: Change from baseline over time in the logarithm of UACR
timeFrame: From baseline to Week 16
measure: Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention
timeFrame: From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Chula Vista
country: United States
facility: Balboa Research SMO+ - Chula Vista - West
state: California
city: La Mesa
country: United States
facility: Balboa Research SMO+ - La Mesa
state: California
city: San Dimas
country: United States
facility: California Kidney Specialists - San Dimas
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bradenton
country: United States
facility: Nova Clinical Research - Blake Medical Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research - Deerwood Clinic
state: Florida
city: Orlando
country: United States
facility: Elixia Central Florida
state: Florida
city: Orlando
country: United States
facility: Florida Institue for Clinical Research
state: Florida
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Chicago
country: United States
facility: Research by Design, LLC | Chicago, IL
state: Illinois
city: Hinsdale
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - Hinsdale
state: Illinois
city: Asheboro
country: United States
facility: Triad Internal Medicine
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates - New Bern
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Renal Disease Research Institute | Landry
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: San Antonio
country: United States
facility: DaVita Clinical Research | Westover Hills, San Antonio, TX
state: Texas
city: Shenandoah
country: United States
facility: DaVita Clinical Research | North Houston, TX
state: Texas
city: S. Salt Lake
country: United States
facility: Utah Kidney Research Institute | Salt Lake City, UT
state: Utah
city: Hampton
country: United States
facility: Peninsula Kidney Associates - Hampton
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center - Cardiology
state: Virginia
city: Woodbridge
country: United States
facility: Mendez Center For Clinical Research | Woodbridge, VA
state: Virginia
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
state: Buenos Aires
city: Temperley
country: Argentina
facility: Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina
state: Buenos Aires
city: Caba
country: Argentina
facility: CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
state: Ciudad Auton. De Buenos Aires
city: Villa Luro
country: Argentina
facility: Centro de Especialidades Medicas (Cemedic) | Cardiology Department
state: Ciudad Auton. De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
city: Córdoba
country: Argentina
facility: Centro Privado San Vicente Diabetes
city: San Luis
country: Argentina
facility: Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
city: Santa Rosa
country: Argentina
facility: Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina
city: Baudour
country: Belgium
facility: Epicura / Nephrology
city: Gent
country: Belgium
facility: UZ Gent / Nephrology
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis / Nephrology
city: Jette
country: Belgium
facility: UZ Brussel Nephrology
city: Leuven
country: Belgium
facility: UZ Leuven / Nephrology
city: Roeselare
country: Belgium
facility: AZ Delta / Nephrology
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of TCM
state: Guangdong
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Huai'An
country: China
facility: Huai'an First People's Hospital, Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical university
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chengdu
country: China
facility: Sichuan University - West China Hospital
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
city: Foshan
country: China
facility: The First People's Hospital - Foshan
city: Guangzhou
country: China
facility: Southern Medical University - Nanfang Hospital (Southern Hospital)
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)
city: Shanghai
country: China
facility: Renji Hospital Shanghai JiaoTong University of Medicine
city: Shanghai
country: China
facility: Huadong Hospital, Affiliated to Fudan University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
city: Athens
country: Greece
facility: General Hospital of Athens LAIKO
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion - Department of Paediatrics
city: Larissa
country: Greece
facility: University of Thessaly - General University Hospital of Larissa (UHL)
city: Nisos Ioanninon
country: Greece
facility: University Hospital of Ioannina (UHI)
city: Patra
country: Greece
facility: University General Hospital of Patras | Nephrology Clinic
city: Thessaloniki
country: Greece
facility: Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Papageorgiou
city: Thessaloniki
country: Greece
facility: Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou)
city: Ahmedabad
country: India
facility: Mavani Research Center
state: Gujarat
city: Gurugram
country: India
facility: Marengo Asia Hospital, Gurugram
state: Haryana
city: Bangalore
country: India
facility: Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))
city: Calcutta
country: India
facility: The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS) - New Delhi
city: New Delhi
country: India
facility: Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
state: Emilia-Romagna
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di Rene
state: Lombardia
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
city: Kasugai
country: Japan
facility: Kasugai Municipal Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital
state: Aichi
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukui Prefectural Hospital
state: Fukui
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Hirohata Naika Clinic
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Steel Memorial Yawata Hospital
state: Fukuoka
city: Obihiro
country: Japan
facility: Jiyugaoka Yamada Internal Medicine Clinic
state: Hokkaido
city: Naka-shi
country: Japan
facility: Naka Kinen Clinic
state: Ibaraki
city: Toride
country: Japan
facility: JA Toride Medical Center
state: Ibaraki
city: Komatsu City
country: Japan
facility: Komatsu Municipal Hospital
state: Ishikawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Shiroishi
country: Japan
facility: Katta General Hospital
state: Miyagi
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
city: Nara
country: Japan
facility: Nara Prefecture General Medical Center
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Christian Hospital
state: Gang''weondo
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggido
city: Seoungbuk-gu
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Almada
country: Portugal
facility: Hospital Garcia de Orta | Research Department
state: Lisboa
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
state: Lisboa
city: Vila Franca de Xira
country: Portugal
facility: Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao
state: Lisboa
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano | Clinical Research Center
state: Porto
city: Torres Novas
country: Portugal
facility: Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
state: Santarém
city: Braga
country: Portugal
facility: Centro Clinico Academico Braga | Braga, Portugal
city: Coimbra
country: Portugal
facility: CHUC- Hospitais da Universidade de Coimbra - Nephrology Department
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
city: Lisboa
country: Portugal
facility: Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
city: Lisbon
country: Portugal
facility: Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos
city: Singapore
country: Singapore
facility: National University Hospital Medical Centre
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: SingHealth Polyclinics - Pasir Ris
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Bratislava
country: Slovakia
facility: Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia
city: Bratislava
country: Slovakia
facility: DIABEDA s.r.o.
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Galanta
country: Slovakia
facility: B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia
city: Kosice
country: Slovakia
facility: NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Puchov
country: Slovakia
facility: Biodial | Puchov, Slovakia
city: Roznava
country: Slovakia
facility: DIAB s.r.o
city: Sala
country: Slovakia
facility: B. Braun Avium Nefrologicka ambulancia | Sala, Slovakia
city: A Coruna
country: Spain
facility: Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
state: A Coruña
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology Department
state: Barcelona
city: Missing
country: Spain
facility: Hospital Clinico Universitario de Valencia | Nephrology Department
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona | Internal Medicine Department
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal - Medicina Interna
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Senora de Valme | Internal Medicine Department
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset | Nephrology Department
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe - Nefrologia
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset - Njurkliniken
city: LInköping
country: Sweden
facility: Universitetssjukhuset i Linköping
city: Stockholm
country: Sweden
facility: ProbareE Stockholm
city: Stockholm
country: Sweden
facility: Center For Diabetes, Academic Specialist Center
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center, Liouyine
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology
state: Manchester
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department
city: London
country: United Kingdom
facility: Barts Health NHS Trust - Royal London Hospital - Nephrology
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust | Royal Free Hospital - Cancer Services
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care
city: Northamptonshire
country: United Kingdom
facility: Lakeside Healthcare Research Department
Study officials:
References: