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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Placebo; Drug: BAY3283142

• Study Type: Interventional
• Enrollment (Actual): 1222
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1431FWO
    • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
  • Córdoba, Argentina, 5000
    • Centro Privado San Vicente Diabetes
  • Santa Rosa, Argentina
    • Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1056ABI
      • Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
    • Temperley, Buenos Aires, Argentina, B1834GUK
      • Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina
  • Ciudad Auton. de Buenos Aires
    • CABA, Ciudad Auton. de Buenos Aires, Argentina, C1018DES
      • CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
    • Villa Luro, Ciudad Auton. de Buenos Aires, Argentina, C1440CFD
      • Centro de Especialidades Medicas (Cemedic) | Cardiology Department
  • San Luis Province
    • San Luis, San Luis Province, Argentina, D5700CGR
      • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
• Belgium
  • Baudour, Belgium, 7331
    • Epicura / Nephrology
  • Ghent, Belgium, 9000
    • UZ Gent / Nephrology
  • Ieper, Belgium, 8900
    • Jan Yperman Ziekenhuis / Nephrology
  • Jette, Belgium, 1090
    • UZ Brussel Nephrology
  • Leuven, Belgium, 3000
    • UZ Leuven / Nephrology
  • Roeselare, Belgium, 8800
    • AZ Delta / Nephrology
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100029
    • Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)
  • Chengdu, China, 610041
    • Sichuan University - West China Hospital
  • Chengdu, China, 610072
    • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
  • Foshan, China, 528000
    • The First People's Hospital - Foshan
  • Guangzhou, China, 510515
    • Southern Medical University - Nanfang Hospital (Southern Hospital)
  • Nanjing, China, 210029
    • Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)
  • Shanghai, China, 200040
    • Huadong Hospital, Affiliated to Fudan University
  • Shanghai, China, 200001
    • Renji Hospital Shanghai JiaoTong University of Medicine
  • Taiyuan, China, 030032
    • Shanxi Bethune Hospital
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The first affiliated hospital of xiamen university
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzhou University of TCM
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Huai'an First People's Hospital, Nanjing Medical University
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The Second Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
  • Zhejiang
    • Taizhou, Zhejiang, China, 317099
      • Taizhou Hospital of Zhejiang Province
• Greece
  • Athens, Greece, 11525
    • Laiko General Hospital Of Athens_ Department of Nephrology and Renal Transplantation
  • Heraklion, Greece, 71500
    • University General Hospital of Heraklion-Nephrology Clinic
  • Ioannina, Greece, 45500
    • University General Hospital Of Ioannina-Nephrology Clinic
  • Larissa, Greece, 41100
    • General University Hospital Of Larissa-Nephrology Clinic
  • Thessaloniki, Greece, 54642
    • Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology
  • Thessaloniki, Greece, 57010
    • Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department
  • Achaia
    • Pátrai, Achaia, Greece, 26504
      • University General Hospital of Patras | Nephrology Clinic
  • Thessaloniki
    • Efkarpia, Thessaloniki, Greece, 56429
      • General Hospital Of Thessaloniki Papageorgiou-Renal Department
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • Mavani Research Center
  • Karnataka
    • Bengaluru, Karnataka, India, 560092
      • Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110017
      • Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • All India Institute of Medical Sciences (AIIMS) - New Delhi
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600086
      • Madras Diabetes Research Foundation
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
  • Messina, Italy, 98124
    • Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi
  • Modena, Italy, 41124
    • Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
  • Pavia, Italy, 27100
    • Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
• Japan
  • Fukuoka, Japan, 815-8555
    • Japanese Red Cross Fukuoka Hospital
  • Nara, Japan, 630-8581
    • Nara Prefecture General Medical Center
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Saitama, Japan, 330-8553
    • Japanese Red Cross Saitama Hospital
  • Aichi-ken
    • Kasugai, Aichi-ken, Japan, 486-8510
      • Kasugai Municipal Hospital
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Chubu Rosai Hospital
  • Chiba
    • Urayasu, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-8026
      • Saiseikai Matsuyama Hospital
    • Matsuyama, Ehime, Japan, 790-0024
      • Ehime Prefectural Central Hospital
  • Fukui
    • Fukui-shi, Fukui, Japan, 910-0846
      • Fukui Prefectural Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
    • Kitakyushu, Fukuoka, Japan, 805-8508
      • Steel Memorial Yawata Hospital
    • Kitakyushu, Fukuoka, Japan, 807-0857
      • Hirohata Naika Clinic
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0848
      • Jiyugaoka Yamada Internal Medicine Clinic
  • Ibaraki
    • Naka, Ibaraki, Japan, 311-0113
      • Naka Kinen Clinic
  • Ishikawa-ken
    • Komatsu, Ishikawa-ken, Japan, 923-8560
      • Komatsu Municipal Hospital
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
    • Yokohama, Kanagawa, Japan, 234-0054
      • Saiseikai Yokohamashi Nanbu Hospital
  • Miyagi
    • Shiroishi, Miyagi, Japan, 989-0231
      • Katta General Hospital
  • Osaka
    • Izumisano, Osaka, Japan, 598-8577
      • Rinku General Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo
  • Yamanashi
    • Chūō, Yamanashi, Japan, 409-3898
      • University of Yamanashi Hospital
• Portugal
  • Braga, Portugal, 4710-243
    • Centro Clinico Academico Braga | Braga, Portugal
  • Coimbra, Portugal, 3000-075
    • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Nefrologia
  • Lisbon, Portugal, 1250-189
    • Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos
  • Lisbon, Portugal, 1500-650
    • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
  • Lisbon, Portugal, 1069-166
    • Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
  • Lisbon District
    • Carnaxide, Lisbon District, Portugal, 2790-134
      • Unidade Local De Saúde De Lisboa Ocidental E.P.E.
    • Vila Franca de Xira, Lisbon District, Portugal, 2600-009
      • Unidade Local de Saude do Estuario do Tejo | Hospital de Vila Franca de Xira - Departamento de Formacao e Investigacao
  • Porto District
    • Matosinhos Municipality, Porto District, Portugal, 4464-513
      • Hospital Pedro Hispano | Clinical Research Center
  • Santarém District
    • Torres Novas, Santarém District, Portugal, 2350-754
      • Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2805-267
      • Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
  • Singapore, Singapore, 519457
    • SingHealth Polyclinics - Pasir Ris
  • Singapore, Singapore, 119074
    • National University Hospital Medical Centre
• Slovakia
  • Bratislava, Slovakia, 83101
    • Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia
  • Bratislava, Slovakia, 83106
    • DIABEDA s.r.o.
  • Bratislava, Slovakia, 85101
    • MEDISPEKTRUM s.r.o.
  • Galanta, Slovakia, 924 22
    • B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia
  • Košice, Slovakia, 04011
    • NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice
  • Martin, Slovakia, 036 59
    • Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenie
  • Púchov, Slovakia, 02001
    • BIODIAL spol. s r.o.
  • Rožňava, Slovakia, 048 01
    • DIAB s.r.o
  • Šaľa, Slovakia, 92719
    • B. Braun Avitum Nefrologicka ambulancia | Sala, Slovakia
• Spain
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
  • Barcelona, Spain, 8023
    • Hospital Quironsalud Barcelona | Internal Medicine Department
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal | Medicina Interna
  • Seville, Spain, 41014
    • Hospital Universitario Virgen De Valme | Medicina Interna
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario De Valencia | Nefrologia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr Peset Aleixandre | Nefrologia
  • Valencia, Spain, 46026
    • Hospital Universitario Y Politecnico La Fe | Nefrologia
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Area Sanitaria De Ferrol | Medicina Interna
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Bellvitge Hospital Universitari | Nefrologia
• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 113 29
      • ProbareE Stockholm
    • Stockholm, Stockholm County, Sweden, 113 65
      • Center For Diabetes, Academic Specialist Center
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 85
      • Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 45
      • Sahlgrenska Universitetssjukhuset - Njurkliniken
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 581 85
      • Universitetssjukhuset i Linköping
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Memorial Hospital Kaohsiung
  • Tainan, Taiwan, 73657
    • Chi-Mei Medical Center, Liouyine
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Changhua
    • Changhua, Changhua, Taiwan, 50006
      • Changhua Christian Hospital
  • New Taipei
    • New Taipei City, New Taipei, Taiwan, 220
      • Far Eastern Memorial Hospital
• United Kingdom
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
      • Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department
  • Greater London
    • London, Greater London, United Kingdom, E1 1FR
      • Barts Health NHS Trust - Royal London Hospital - Nephrology
    • London, Greater London, United Kingdom, SE5 9RJ
      • King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Lakeside Healthcare | Lakeside Surgery - Research Department
  • Surrey
    • Carshalton, Surrey, United Kingdom, SM5 1AA
      • Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Nephrology Consultants, LLC
  • California
    • Chula Vista, California, United States, 91910
      • Balboa Research SMO+ - Chula Vista
    • San Dimas, California, United States, 91773
      • California Kidney Specialists - San Dimas
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Nephrology Clinical Research Clinic
  • Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research - Blake Medical Center
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research - Deerwood Clinic
    • Orlando, Florida, United States, 32608
      • Elixia Central Florida
    • Orlando, Florida, United States, 32825
      • Florida Institue for Clinical Research
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Southeastern Clinical Research Institute, LLC
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC | Chicago, IL
    • Hinsdale, Illinois, United States, 60521
      • Nephrology Associates of Northern Illinois and Indiana - Hinsdale
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Triad Internal Medicine - Asheboro
    • New Bern, North Carolina, United States, 28562
      • Eastern Nephrology Associates - New Bern
    • Winston-Salem, North Carolina, United States, 27103
      • Brookview Hills Research Associates, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Knoxville Kidney Center, PLLC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center - Nephrology Clinical Trials Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Renal Disease Research Institute | Landry
    • Houston, Texas, United States, 77099
      • Southwest Houston Research, Ltd.
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
  • Utah
    • South Salt Lake, Utah, United States, 84115
      • Utah Kidney Research Institute | Salt Lake City, UT
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Peninsula Kidney Associates - Hampton
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center - Nephrology
    • Woodbridge, Virginia, United States, 22192
      • Mendez Center For Clinical Research | Woodbridge, VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1; Placebo OD and sham titration after 14 days and after 28 days	Drug: Placebo; Matching with BAY3283142
Experimental: Arm 2; BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days	Drug: BAY3283142; Tablet, intake orally once daily
Experimental: Arm 3; BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days	Drug: BAY3283142; Tablet, intake orally once daily
Experimental: Arm 4; BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days	Drug: BAY3283142; Tablet, intake orally once daily
Experimental: Arm 5; BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days	Drug: BAY3283142; Tablet, intake orally once daily
Experimental: Arm 6; BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days	Drug: BAY3283142; Tablet, intake orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)	From baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 22040 (City of Hope Medical Center); 2023-505755-40-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No