A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
NCT ID: NCT06926660
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
416 participants
INTERVENTIONAL
2025-07-18
2027-01-08
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo followed by vicadrostat/empagliflozin
Vicadrostat
Vicadrostat
Empagliflozin
Empagliflozin
Placebo matching vicadrostat
Placebo matching vicadrostat
Vicadrostat/empagliflozin
Vicadrostat
Vicadrostat
Empagliflozin
Empagliflozin
Interventions
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Vicadrostat
Vicadrostat
Empagliflozin
Empagliflozin
Placebo matching vicadrostat
Placebo matching vicadrostat
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. For men, birth control is not required during the trial. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
4. Evidence of Chronic Kidney Disease (CKD) at risk of progression based on two Estimated Glomerular Filtration Rate (eGFR) measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each Estimated Glomerular Filtration Rate (eGFR) ≥20 and \<60 mL/min/1.73m2, irrespective of urine albumin creatinine ratio (UACR). The first of these measurements will be In Approval assessed from historical local laboratory results, and the second will be determined from serum creatinine analysed by the central laboratory at Visit 1.
5. Treatment with a clinically appropriate, stable dose of either Angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) (but not both together) for ≥4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial.
Exclusion Criteria
2. Treatment with an mineralocorticoid receptor antagonist (MRA), aldosterone synthase inhibitor (ASi), or potassium-sparing diuretic(s) within 14 days prior to Visit 1, or requiring such treatment before randomisation, or planned during the trial, based on the judgment of the investigator. Treatment with an MRA or ASi should not be interrupted with the intention of enrolment into the trial.
3. Blood potassium of \>5.2 mmol/L at Visit 1.
4. Blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>3x Upper limit of normal (ULN) at Visit 1.
5. Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).
6. On dialysis, functioning kidney transplant, or scheduled for transplant.
7. Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.
8. Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Apogee Clinical Research
Huntsville, Alabama, United States
Orange County Clinical Trials
Anaheim, California, United States
North America Research Institute
San Dimas, California, United States
Valiance Clinical Research-Tarzana-68237
Tarzana, California, United States
Amicis Research Center - Valencia
Valencia, California, United States
Focus Clinical Research
West Hills, California, United States
Western Nephrology, Arvada
Arvada, Colorado, United States
Clinical Research of Brandon LLC
Brandon, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Finlay Medical Research Corp
Miami, Florida, United States
Total Research Group, LLC
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Florida Kidney Physicians - Riverview/Brandon
Riverview, Florida, United States
Masters of Clinical Research, Inc
Augusta, Georgia, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Boise Kidney and Hypertension, PLLC
Boise, Idaho, United States
Research by Design, LLC
Chicago, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - Oak Brook
Hinsdale, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
Fort Wayne, Indiana, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Aa Mrc Llc
Flint, Michigan, United States
Michigan Kidney Consultants
Pontiac, Michigan, United States
Prime Health and Wellness
Fayette, Mississippi, United States
Elixia MNA, LLC
City of Saint Peters, Missouri, United States
Healor Primary Care
Las Vegas, Nevada, United States
Endocrine Associates of Long Island
Smithtown, New York, United States
Durham Nephrology Associates
Durham, North Carolina, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
Heritage Valley Medical Group
Beaver, Pennsylvania, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Arlington Nephrology
Arlington, Texas, United States
Endocrine Associates
Houston, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Javara Inc.-Stephenville-68996
Stephenville, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Tidewater Physicians Multispecialty Group
Newport News, Virginia, United States
IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
Buenos Aires, , Argentina
CEDIC - Centro de Investigacion Clinica
CABA, , Argentina
Mautalen- Salud e Investigacion
CABA, , Argentina
Sanatorio Güemes
Capital Federal, , Argentina
Instituto Medico Catamarca - IMEC
Rosario, , Argentina
CEMEDIC - Centro de Especialidades Medicas
Villa Luro, , Argentina
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
ULB Hopital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Humani - CHU Charleroi - Chimay
Lodelinsart, , Belgium
Centro de Pesquisa do Hospital Evangélico de Belo Horizonte
Belo Horizonte, , Brazil
Chronos Pesquisa Clinica
Brasília, , Brazil
Galileo Medical Research Ltda
Juiz de Fora, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, , Brazil
Cpquali Pesquisa Clinica Ltda
São Paulo, , Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, , Brazil
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, , Brazil
Centro de Pesquisa Clínica de Nefrologia do ICHC
São Paulo, , Brazil
Bluewater Clinical Research
Sarnia, Ontario, Canada
Heart Health Institute (Scarborough)
Scarborough Village, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Diex Recherche (Trois-Rivieres)
Trois-Rivières, Quebec, Canada
Beijing Tsinghua Changgung Hospital
Beijing, , China
West China Hospital of Sichuan University
Chengdu, , China
NanFang Hosptial
Guangzhou, , China
Zhejiang Province People's Hospital
Hangzhou, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Center Hospital of Jinan
Jinan, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
The First People's Hospital of Nanning
Nanning, , China
Ningbo Second Hospital
Ningbo, , China
General Hospital of Ningxia Medical University
Ningxia, , China
Second Hospital Affiliated to Shantou Medical University
Shantou, , China
Shenzhen Second People's Hospital
Shenzhen, , China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, , China
Yibin Second People's Hospital
Yibin, , China
DIKa centrum s.r.o.
Havířov, , Czechia
MILAN KVAPIL s.r.o.
Příbram, , Czechia
Hospital Slany, Internal Department
Slaný, , Czechia
HOP Bicêtre
Le Kremlin-Bicêtre, , France
HOP Hôtel-Dieu
Nantes, , France
HOP Civil
Strasbourg, , France
Klinikum Bielefeld
Bielefeld, , Germany
Internistische Gemeinschaftspraxis in Bünde
Bünde, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
DaVita Clinical Research Germany GmbH Geilenkirchen
Geilenkirchen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
Hanover, , Germany
Nephrologische Gemeinschaftspraxis, Hamann/Bacinovic/Jacobsen
Rotenburg (Wümme), , Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, , Germany
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Chieti, , Italy
Università degli Studi di Perugia
Perugia, , Italy
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Ranica (BG), , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Kasugai Municipal Hospital
Aichi, Kasugai, , Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, , Japan
Tsuchiura Kyodo General Hospital
Ibaraki, Tsuchiura, , Japan
Saiseikai Yokohamashi Nanbu Hospital
Kanagawa, Yokohama, , Japan
Osaka General Medical Center
Osaka, Osaka, , Japan
Ageo Central General Hospital
Saitama, Ageo, , Japan
Omihachiman Community Medical Center
Shiga, Omihachiman, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, , Japan
Hospital Canselor Tuanku Muhriz
Cheras, , Malaysia
Tuanku Fauziah Hospital
Kangar, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Unidad de Investigación Clinica y Atencion Medica HEPA SC
Guadalajara, , Mexico
Soltmed Smo
Mexico City, , Mexico
Clinica Omega Diabetes
Mexico City, , Mexico
Medical Care & Research SA de CV
Mérida, , Mexico
Sociedad de Metabolismo y Corazón S.C.
Veracruz, , Mexico
Amsterdam UMC Locatie AMC
Amsterdam, , Netherlands
Albert SchweitzerZiekenhuis
Dordrecht, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Bethesda Diabetes Research Center, Hoogeveen
Hoogeveen, , Netherlands
Momentum Clinical Research - Kapiti Coast
Kapiti, Wellington Region, New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Senor Santo Nino Hospital
Camiling, , Philippines
Norzel Medical and Diagnostic Clinic
Cebu City, , Philippines
Institute for Studies on Diabetes Foundation Inc.
Marikina City, , Philippines
Philippine Heart Center
Quezon City, , Philippines
Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
Bydgoszcz, , Poland
American Heart Of Poland Sp. Z O.O.
Chrzanów, , Poland
Pro Familia Altera Sp. z o.o.
Katowice, , Poland
Pro Salus Sp. z o.o. sp.k.
Lodz, , Poland
FDI Clinical Research - Mayagüez
Mayagüez, , Puerto Rico
Korea University Ansan Hospital
Ansan-si, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wonju-si, Gangwon State, , South Korea
Centro de Salud Milladoiro
A Coruña, , Spain
C.A.P. Sardenya
Barcelona, , Spain
Centro de Salud Cartagena Casco Antiguo
Cartagena, , Spain
Eap Osona Sud Alt Congost S.L.P. Cap Centelles
Centelles, Barcelona, , Spain
Centro de Salud Naranco
Oviedo, , Spain
Centro de Salud de San Juan
Salamanca, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakom Chiangmai Hospital
Chiang Mai, , Thailand
University Hospital Monklands
Airdrie, , United Kingdom
Banbury Cross Health Centre
Banbury, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Belmont Health Centre
Harrow, , United Kingdom
Velocity Clinical Research, High Wycombe
High Wycombe, , United Kingdom
Richford Gate Medical Practice
London, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2024-518457-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1314-0083
Identifier Type: REGISTRY
Identifier Source: secondary_id
1378-0023
Identifier Type: -
Identifier Source: org_study_id