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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518457-42-00 | Registry Identifier | CTIS | |
| U1111-1314-0083 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease.
In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine.
Participants are in the study for about 4.5 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine.
The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo followed by vicadrostat/empagliflozin | Placebo Comparator |
| |
| Vicadrostat/empagliflozin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicadrostat | Drug | Vicadrostat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14 and week 16 | At baseline, up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 12 | At baseline, up to week 12 | |
| Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 12 | At baseline, up to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apogee Clinical Research | Huntsville | Alabama | 35805 | United States | ||
| Orange County Clinical Trials |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
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| Empagliflozin | Drug | Empagliflozin |
|
| Placebo matching vicadrostat | Drug | Placebo matching vicadrostat |
|
| Relative change (ratio) in Urine Albumin Creatinine Ratio (UACR) from baseline to Week 6 | At baseline, up to week 6 |
| Absolute change in serum potassium (mmol/L) from baseline to Week 12 | At baseline, up to week 12 |
| Anaheim |
| California |
| 92801 |
| United States |
| North America Research Institute | San Dimas | California | 91773 | United States |
| Valiance Clinical Research-Tarzana-68237 | Tarzana | California | 91356 | United States |
| Amicis Research Center - Valencia | Valencia | California | 91355 | United States |
| Focus Clinical Research | West Hills | California | 91307 | United States |
| Clinical Research of Brandon LLC | Brandon | Florida | 33511 | United States |
| Hillcrest Medical Research | DeLand | Florida | 32720 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| Finlay Medical Research Corp | Miami | Florida | 33126 | United States |
| Total Research Group, LLC | Miami | Florida | 33126 | United States |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | United States |
| West Orange Endocrinology | Ocoee | Florida | 34761 | United States |
| Florida Kidney Physicians - Riverview/Brandon | Riverview | Florida | 33578 | United States |
| Masters of Clinical Research, Inc | Augusta | Georgia | 30909 | United States |
| Boise Kidney and Hypertension, PLLC | Boise | Idaho | 83706 | United States |
| Research by Design, LLC | Chicago | Illinois | 60643 | United States |
| Nephrology Associates of Northern Illinois and Indiana - Oak Brook | Hinsdale | Illinois | 60521 | United States |
| Nephrology Associates of Northern Illinois and Indiana - Fort Wayne | Fort Wayne | Indiana | 46804 | United States |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | United States |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | United States |
| Aa Mrc Llc | Flint | Michigan | 48504 | United States |
| Michigan Kidney Consultants | Pontiac | Michigan | 48341 | United States |
| Elixia MNA, LLC | City of Saint Peters | Missouri | 63376 | United States |
| Healor Primary Care | Las Vegas | Nevada | 89102 | United States |
| Endocrine Associates of Long Island | Smithtown | New York | 11787 | United States |
| Durham Nephrology Associates | Durham | North Carolina | 27704 | United States |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | United States |
| Brookview Hills Research Associates LLC | Winston-Salem | North Carolina | 27103 | United States |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Arlington Nephrology | Arlington | Texas | 76015 | United States |
| Endocrine Associates | Houston | Texas | 77004 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | United States |
| Javara Inc.-Stephenville-68996 | Stephenville | Texas | 76401 | United States |
| Utah Kidney Research Institute | Salt Lake City | Utah | 84115 | United States |
| Tidewater Physicians Multispecialty Group | Newport News | Virginia | 23606 | United States |
| IDIM - Instituto de Diagnostico e Investigaciones Metabolicas | Buenos Aires | 1012 | Argentina |
| CEDIC - Centro de Investigacion Clinica | CABA | C1060ABN | Argentina |
| Mautalen- Salud e Investigacion | CABA | C1128AAF | Argentina |
| Instituto Medico Catamarca - IMEC | Rosario | S2000AJU | Argentina |
| CEMEDIC - Centro de Especialidades Medicas | Villa Luro | 1407 | Argentina |
| John Hunter Hospital | New Lambton Heights | New South Wales | 2305 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Hopital Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centro de Pesquisa do Hospital Evangelico de Belo Horizonte | Belo Horizonte | 30220-420 | Brazil |
| Chronos Pesquisa Clinica | Brasília | 72145-450 | Brazil |
| Galileo Medical Research Ltda | Juiz de Fora | 36033-318 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Cpquali Pesquisa Clinica Ltda | São Paulo | 01228-000 | Brazil |
| Fundacao Oswaldo Ramos (Hospital do Rim) | São Paulo | 04038-031 | Brazil |
| CEPIC - Centro Paulista de Investigacao Clinica e Servicos | São Paulo | 04266-010 | Brazil |
| Centro de Pesquisa Clínica de Nefrologia do ICHC | São Paulo | 05403-000 | Brazil |
| Bluewater Clinical Research | Sarnia | Ontario | N7T 4X3 | Canada |
| Heart Health Institute (Scarborough) | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Diex Recherche (Trois-Rivieres) | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Beijing Tsinghua Changgung Hospital | Beijing | 100044 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| NanFang Hosptial | Guangzhou | 510515 | China |
| Zhejiang Province People's Hospital | Hangzhou | 310014 | China |
| Center Hospital of Jinan | Jinan | 250013 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | 210011 | China |
| The First People's Hospital of Nanning | Nanning | 530000 | China |
| Ningbo Second Hospital | Ningbo | 315010 | China |
| General Hospital of Ningxia Medical University | Ningxia | 750004 | China |
| Second Hospital Affiliated to Shantou Medical University | Shantou | 515041 | China |
| Shenzhen Second People's Hospital | Shenzhen | 518035 | China |
| First Affiliated Hospital of Xi'an JiaoTong University | Xi'an | 710061 | China |
| Yibin Second People's Hospital | Yibin | 644099 | China |
| DIKa centrum s.r.o. | Havířov | 73601 | Czechia |
| MILAN KVAPIL s.r.o. | Příbram | 26101 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| HOP Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| HOP Hôtel-Dieu | Nantes | 44000 | France |
| HOP Civil | Strasbourg | 67091 | France |
| Klinikum Bielefeld | Bielefeld | 33604 | Germany |
| Internistische Gemeinschaftspraxis in Bünde | Bünde | 32257 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| DaVita Clinical Research Germany GmbH Geilenkirchen | Geilenkirchen | 52511 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen | Hanover | 30625 | Germany |
| Nephrologische Gemeinschaftspraxis, Hamann/Bacinovic/Jacobsen | Rotenburg (Wümme) | 27356 | Germany |
| Robert Bosch Gesellschaft für medizinische Forschung mbH | Stuttgart | 70376 | Germany |
| Azienda Sanitaria Locale 2 Lanciano Vasto Chieti | Chieti | 66100 | Italy |
| Università degli Studi di Perugia | Perugia | 06132 | Italy |
| Istituto di Ricerche Farmacologiche Mario Negri IRCCS | Ranica (BG) | 24020 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
| Kasugai Municipal Hospital | Aichi, Kasugai | 486-8510 | Japan |
| National Hospital Organization Chibahigashi National Hospital | Chiba, Chiba | 260-8712 | Japan |
| Tsuchiura Kyodo General Hospital | Ibaraki, Tsuchiura | 300-0028 | Japan |
| Saiseikai Yokohamashi Nanbu Hospital | Kanagawa, Yokohama | 234-0054 | Japan |
| Osaka General Medical Center | Osaka, Osaka | 558-8558 | Japan |
| OCROM Clinic | Osaka, Suita | 565-0853 | Japan |
| Ageo Central General Hospital | Saitama, Ageo | 362-8588 | Japan |
| Omihachiman Community Medical Center | Shiga, Omihachiman | 523-0082 | Japan |
| Tokyo Medical University Hachioji Medical Center | Tokyo, Hachioji | 193-0998 | Japan |
| ToCROM Clinic | Tokyo, Shinjyuku-ku | 160-0008 | Japan |
| Hospital Canselor Tuanku Muhriz | Cheras | 56000 | Malaysia |
| Hospital Sultan Idris Shah Serdang | Kajang | 43000 | Malaysia |
| Tuanku Fauziah Hospital | Kangar | 01000 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20259 | Mexico |
| Unidad de Investigación Clinica y Atencion Medica HEPA SC | Guadalajara | 44670 | Mexico |
| Soltmed Smo | Mexico City | 03650 | Mexico |
| Clinica Omega Diabetes | Mexico City | 06700 | Mexico |
| Medical Care & Research SA de CV | Mérida | 97070 | Mexico |
| Sociedad de Metabolismo y Corazón S.C. | Veracruz | 91910 | Mexico |
| Amsterdam UMC Locatie AMC | Amsterdam | 1105 AZ | Netherlands |
| Albert SchweitzerZiekenhuis | Dordrecht | 3318 AT | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Bethesda Diabetes Research Center, Hoogeveen | Hoogeveen | 7909 AA | Netherlands |
| Momentum Clinical Research - Kapiti Coast | Kapiti | Wellington Region | 5036 | New Zealand |
| Dunedin Hospital | Dunedin | 9016 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Norzel Medical and Diagnostic Clinic | Cebu City | 6000 | Philippines |
| Institute for Studies on Diabetes Foundation Inc. | Marikina City | 1810 | Philippines |
| Philippine Heart Center | Quezon City | 850 | Philippines |
| Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk | Bydgoszcz | 85-092 | Poland |
| American Heart Of Poland Sp. Z O.O. | Chrzanów | 32-500 | Poland |
| Pro Familia Altera Sp. z o.o. | Katowice | 40-648 | Poland |
| Pro Salus Sp. z o.o. sp.k. | Lodz | 91 473 | Poland |
| FDI Clinical Research - Mayagüez | Mayagüez | 00680 | Puerto Rico |
| Korea University Ansan Hospital | Ansan-si | 15355 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | 03312 | South Korea |
| Hanyang University Medical Center | Seoul | 04763 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wonju-si, Gangwon State | 26426 | South Korea |
| Centro de Salud Milladoiro | A Coruña | 15895 | Spain |
| C.A.P. Sardenya | Barcelona | 08025 | Spain |
| Centro de Salud Cartagena Casco Antiguo | Cartagena | 30201 | Spain |
| Eap Osona Sud Alt Congost S.L.P. Cap Centelles | Centelles, Barcelona | 08540 | Spain |
| Centro de Salud Naranco | Oviedo | 33012 | Spain |
| Centro de Salud de San Juan | Salamanca | 37005 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Mackay Memorial Hospital | Taipei | 25160 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Maharaj Nakom Chiangmai Hospital | Chiang Mai | 50200 | Thailand |
| University Hospital Monklands | Airdrie | ML6 0JS | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Belmont Health Centre | Harrow | HA3 7LT | United Kingdom |
| Velocity Clinical Research, High Wycombe | High Wycombe | HP11 2QW | United Kingdom |
| Richford Gate Medical Practice | London | W6 7HY | United Kingdom |
| Banbury Cross Health Centre | Oxford | OX16 9AD | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Sunderland Royal Hospital | Sunderland | SR4 7TP | 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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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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