A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
A Phase II Randomised, Double-blind, Parallel-group, Multicentre, International Trial to Investigate the Safety and Efficacy of Vicadrostat and Empagliflozin Administered With Simultaneous vs Staggered Initiation in Participants With Chronic Kidney Disease at Risk of Kidney Disease Progression
3 other identifiers
interventional
416
24 countries
156
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
Shorter than P25 for phase_2
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 14, 2025
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 20, 2026
April 28, 2026
April 1, 2026
1.1 years
April 11, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
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
Study Arms (2)
Placebo followed by vicadrostat/empagliflozin
PLACEBO COMPARATORVicadrostat/empagliflozin
EXPERIMENTALInterventions
Empagliflozin
Placebo matching vicadrostat
Eligibility Criteria
You may qualify if:
- At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- 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.
- 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.
- 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.
You may not qualify if:
- Treatment with an SGLT2i within 4 weeks before Visit 2. Treatment with a sodium glucose co transporter 2 inhibitor (SGLT2i) should not be interrupted with the intention of enrolment into the trial.
- 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.
- Blood potassium of \>5.2 mmol/L at Visit 1.
- Blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>3x Upper limit of normal (ULN) at Visit 1.
- Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).
- On dialysis, functioning kidney transplant, or scheduled for transplant.
- Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.
- Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (156)
Apogee Clinical Research
Huntsville, Alabama, 35805, United States
Orange County Clinical Trials
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
ULB Hopital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centro de Pesquisa do Hospital Evangélico 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
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-031, Brazil
CEPIC - Centro Paulista de Investigacao Clinica
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 14, 2025
Study Start
July 18, 2025
Primary Completion (Estimated)
August 20, 2026
Study Completion (Estimated)
August 20, 2026
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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.