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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505755-40-00 | Registry Identifier | CTIS (EU) |
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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:
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:
People cannot join this study if they:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Placebo OD and sham titration after 14 days and after 28 days |
|
| Arm 2 | Experimental | BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days |
|
| Arm 3 | Experimental | BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days |
|
| Arm 4 | Experimental | BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days |
|
| Arm 5 | Experimental | BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days |
|
| Arm 6 | Experimental | BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY3283142 | Drug | Tablet, intake orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR) | From baseline to Week 16 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants, LLC | Huntsville | Alabama | 35805 | United States | ||
| Balboa Research SMO+ - Chula Vista |
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.
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5+1 parallel-arm
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In this double-blind study, participants will be randomly assigned to receive study intervention. Investigators, participants and study personnel will remain blinded to each participant's assigned study intervention throughout the course of the study
|
| Placebo | Drug | Matching with BAY3283142 |
|
| 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 |
| Chula Vista |
| California |
| 91910 |
| United States |
| California Kidney Specialists - San Dimas | San Dimas | California | 91773 | United States |
| Yale Nephrology Clinical Research Clinic | New Haven | Connecticut | 06510 | United States |
| Nova Clinical Research - Blake Medical Center | Bradenton | Florida | 34209 | United States |
| Renstar Medical Research - Deerwood Clinic | Ocala | Florida | 34471 | United States |
| Elixia Central Florida | Orlando | Florida | 32608 | United States |
| Florida Institue for Clinical Research | Orlando | Florida | 32825 | United States |
| Southeastern Clinical Research Institute, LLC | Augusta | Georgia | 30904 | United States |
| Research by Design, LLC | Chicago, IL | Chicago | Illinois | 60643 | United States |
| Nephrology Associates of Northern Illinois and Indiana - Hinsdale | Hinsdale | Illinois | 60521 | United States |
| Triad Internal Medicine - Asheboro | Asheboro | North Carolina | 27203 | United States |
| Eastern Nephrology Associates - New Bern | New Bern | North Carolina | 28562 | United States |
| Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Knoxville Kidney Center, PLLC | Knoxville | Tennessee | 37923 | United States |
| Vanderbilt University Medical Center - Nephrology Clinical Trials Center | Nashville | Tennessee | 37232 | United States |
| Renal Disease Research Institute | Landry | Dallas | Texas | 75246 | United States |
| Southwest Houston Research, Ltd. | Houston | Texas | 77099 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | United States |
| Utah Kidney Research Institute | Salt Lake City, UT | South Salt Lake | Utah | 84115 | United States |
| Peninsula Kidney Associates - Hampton | Hampton | Virginia | 23666 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Salem VA Medical Center - Nephrology | Salem | Virginia | 24153 | United States |
| Mendez Center For Clinical Research | Woodbridge, VA | Woodbridge | Virginia | 22192 | United States |
| Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina | Ciudad Autónoma de Buenos Aire | Buenos Aires | C1056ABI | Argentina |
| Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina | Temperley | Buenos Aires | B1834GUK | Argentina |
| CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina | CABA | Ciudad Auton. de Buenos Aires | C1018DES | Argentina |
| Centro de Especialidades Medicas (Cemedic) | Cardiology Department | Villa Luro | Ciudad Auton. de Buenos Aires | C1440CFD | Argentina |
| Centro de Rehabilitacion Cardiovascular | San Luis, Argentina | San Luis | San Luis Province | D5700CGR | Argentina |
| Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Buenos Aires | C1431FWO | Argentina |
| Centro Privado San Vicente Diabetes | Córdoba | 5000 | Argentina |
| Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina | Santa Rosa | 0 | Argentina |
| Epicura / Nephrology | Baudour | 7331 | Belgium |
| UZ Gent / Nephrology | Ghent | 9000 | Belgium |
| Jan Yperman Ziekenhuis / Nephrology | Ieper | 8900 | Belgium |
| UZ Brussel Nephrology | Jette | 1090 | Belgium |
| UZ Leuven / Nephrology | Leuven | 3000 | Belgium |
| AZ Delta / Nephrology | Roeselare | 8800 | Belgium |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| The First Affiliated Hospital of Guangzhou University of TCM | Guangzhou | Guangdong | 510405 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Huai'an First People's Hospital, Nanjing Medical University | Huai'an | Jiangsu | 223300 | China |
| The Second Affiliated Hospital of Nanjing Medical university | Nanjing | Jiangsu | 210011 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317099 | China |
| Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) | Beijing | 100029 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Sichuan University - West China Hospital | Chengdu | 610041 | China |
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH) | Chengdu | 610072 | China |
| The First People's Hospital - Foshan | Foshan | 528000 | China |
| Southern Medical University - Nanfang Hospital (Southern Hospital) | Guangzhou | 510515 | China |
| Jiangsu Province Hospital of Traditional Chinese Medicine (TCM) | Nanjing | 210029 | China |
| Renji Hospital Shanghai JiaoTong University of Medicine | Shanghai | 200001 | China |
| Huadong Hospital, Affiliated to Fudan University | Shanghai | 200040 | China |
| Shanxi Bethune Hospital | Taiyuan | 030032 | China |
| University General Hospital of Patras | Nephrology Clinic | Pátrai | Achaia | 26504 | Greece |
| General Hospital Of Thessaloniki Papageorgiou-Renal Department | Efkarpia | Thessaloniki | 56429 | Greece |
| Laiko General Hospital Of Athens_ Department of Nephrology and Renal Transplantation | Athens | 11525 | Greece |
| University General Hospital of Heraklion-Nephrology Clinic | Heraklion | 71500 | Greece |
| University General Hospital Of Ioannina-Nephrology Clinic | Ioannina | 45500 | Greece |
| General University Hospital Of Larissa-Nephrology Clinic | Larissa | 41100 | Greece |
| Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology | Thessaloniki | 54642 | Greece |
| Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department | Thessaloniki | 57010 | Greece |
| Mavani Research Center | Ahmedabad | Gujarat | 380052 | India |
| Life Care Clinic (LifeCare Clinic & Research Centre (LCRC)) | Bengaluru | Karnataka | 560092 | India |
| Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited) | New Delhi | National Capital Territory of Delhi | 110017 | India |
| All India Institute of Medical Sciences (AIIMS) - New Delhi | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600086 | India |
| The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital) | Kolkata | West Bengal | 700020 | India |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto | Bologna | Emilia-Romagna | 40138 | Italy |
| ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia | Bergamo | 24127 | Italy |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi | Messina | 98124 | Italy |
| Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene | Modena | 41124 | Italy |
| Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia | Pavia | 27100 | Italy |
| Kasugai Municipal Hospital | Kasugai | Aichi-ken | 486-8510 | Japan |
| Chubu Rosai Hospital | Nagoya | Aichi-ken | 455-8530 | Japan |
| Juntendo University Urayasu Hospital | Urayasu | Chiba | 279-0021 | Japan |
| Ehime Prefectural Central Hospital | Matsuyama | Ehime | 790-0024 | Japan |
| Saiseikai Matsuyama Hospital | Matsuyama | Ehime | 791-8026 | Japan |
| Fukui Prefectural Hospital | Fukui-shi | Fukui | 910-0846 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Steel Memorial Yawata Hospital | Kitakyushu | Fukuoka | 805-8508 | Japan |
| Hirohata Naika Clinic | Kitakyushu | Fukuoka | 807-0857 | Japan |
| Jiyugaoka Yamada Internal Medicine Clinic | Obihiro | Hokkaido | 080-0848 | Japan |
| Naka Kinen Clinic | Naka | Ibaraki | 311-0113 | Japan |
| Komatsu Municipal Hospital | Komatsu | Ishikawa-ken | 923-8560 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Saiseikai Yokohamashi Nanbu Hospital | Yokohama | Kanagawa | 234-0054 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Katta General Hospital | Shiroishi | Miyagi | 989-0231 | Japan |
| Rinku General Medical Center | Izumisano | Osaka | 598-8577 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| NTT Medical Center Tokyo | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| University of Yamanashi Hospital | Chūō | Yamanashi | 409-3898 | Japan |
| Japanese Red Cross Fukuoka Hospital | Fukuoka | 815-8555 | Japan |
| Nara Prefecture General Medical Center | Nara | 630-8581 | Japan |
| Osaka General Medical Center | Osaka | 558-8558 | Japan |
| Japanese Red Cross Saitama Hospital | Saitama | 330-8553 | Japan |
| Unidade Local De Saúde De Lisboa Ocidental E.P.E. | Carnaxide | Lisbon District | 2790-134 | Portugal |
| Unidade Local de Saude do Estuario do Tejo | Hospital de Vila Franca de Xira - Departamento de Formacao e Investigacao | Vila Franca de Xira | Lisbon District | 2600-009 | Portugal |
| Hospital Pedro Hispano | Clinical Research Center | Matosinhos Municipality | Porto District | 4464-513 | Portugal |
| Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department | Torres Novas | Santarém District | 2350-754 | Portugal |
| Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department | Almada | Setúbal District | 2805-267 | Portugal |
| Centro Clinico Academico Braga | Braga, Portugal | Braga | 4710-243 | Portugal |
| Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Nefrologia | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department | Lisbon | 1069-166 | Portugal |
| Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos | Lisbon | 1250-189 | Portugal |
| Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica | Lisbon | 1500-650 | Portugal |
| National University Hospital Medical Centre | Singapore | 119074 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| National Heart Centre Singapore | Singapore | 169609 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| SingHealth Polyclinics - Pasir Ris | Singapore | 519457 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |
| Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia | Bratislava | 83101 | Slovakia |
| DIABEDA s.r.o. | Bratislava | 83106 | Slovakia |
| MEDISPEKTRUM s.r.o. | Bratislava | 85101 | Slovakia |
| B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia | Galanta | 924 22 | Slovakia |
| NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice | Košice | 04011 | Slovakia |
| Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenie | Martin | 036 59 | Slovakia |
| BIODIAL spol. s r.o. | Púchov | 02001 | Slovakia |
| DIAB s.r.o | Rožňava | 048 01 | Slovakia |
| B. Braun Avitum Nefrologicka ambulancia | Sala, Slovakia | Šaľa | 92719 | Slovakia |
| Area Sanitaria De Ferrol | Medicina Interna | Ferrol | A Coruña | 15405 | Spain |
| Bellvitge Hospital Universitari | Nefrologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion | A Coruña | 15006 | Spain |
| Hospital Quironsalud Barcelona | Internal Medicine Department | Barcelona | 8023 | Spain |
| Hospital Universitario Ramon Y Cajal | Medicina Interna | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department | Madrid | 28040 | Spain |
| Hospital Universitario Virgen De Valme | Medicina Interna | Seville | 41014 | Spain |
| Hospital Clinico Universitario De Valencia | Nefrologia | Valencia | 46010 | Spain |
| Hospital Universitario Dr Peset Aleixandre | Nefrologia | Valencia | 46017 | Spain |
| Hospital Universitario Y Politecnico La Fe | Nefrologia | Valencia | 46026 | Spain |
| ProbareE Stockholm | Stockholm | Stockholm County | 113 29 | Sweden |
| Center For Diabetes, Academic Specialist Center | Stockholm | Stockholm County | 113 65 | Sweden |
| Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken | Uppsala | Uppsala County | 751 85 | Sweden |
| Sahlgrenska Universitetssjukhuset - Njurkliniken | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Universitetssjukhuset i Linköping | Linköping | Östergötland County | 581 85 | Sweden |
| Changhua Christian Hospital | Changhua | Changhua | 50006 | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | New Taipei | 220 | Taiwan |
| Chang Gung Memorial Hospital Kaohsiung | Kaohsiung City | 833 | Taiwan |
| Chi-Mei Medical Center, Liouyine | Tainan | 73657 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department | Hull | East Riding Of Yorkshire | HU3 2JZ | United Kingdom |
| Barts Health NHS Trust - Royal London Hospital - Nephrology | London | Greater London | E1 1FR | United Kingdom |
| King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department | London | Greater London | SE5 9RJ | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care | Manchester | Greater Manchester | M13 9WL | United Kingdom |
| Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology | Salford | Greater Manchester | M6 8HD | United Kingdom |
| Lakeside Healthcare | Lakeside Surgery - Research Department | Corby | Northamptonshire | NN17 2UR | United Kingdom |
| Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit | Carshalton | Surrey | SM5 1AA | United Kingdom |
| Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant | Cardiff | Wales | CF14 4XW | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility | Birmingham | West Midlands | B15 2TH | United Kingdom |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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