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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Empagliflozin; Drug: Vicadrostat; Drug: Placebo matching vicadrostat

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1012
    • IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
  • CABA, Argentina, C1060ABN
    • CEDIC - Centro de Investigacion Clinica
  • CABA, Argentina, C1128AAF
    • Mautalen- Salud e Investigacion
  • Rosario, Argentina, S2000AJU
    • Instituto Medico Catamarca - IMEC
  • Villa Luro, Argentina, 1407
    • CEMEDIC - Centro de Especialidades Medicas
• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Brussels, Belgium, 1070
    • ULB Hopital Erasme
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Belo Horizonte, Brazil, 30220-420
    • Centro de Pesquisa do Hospital Evangelico de Belo Horizonte
  • Brasília, Brazil, 72145-450
    • Chronos Pesquisa Clinica
  • Juiz de Fora, Brazil, 36033-318
    • Galileo Medical Research Ltda
  • São José do Rio Preto, Brazil, 15090-000
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigacao Clinica
  • São Paulo, Brazil, 01228-000
    • Cpquali Pesquisa Clinica Ltda
  • São Paulo, Brazil, 05403-000
    • Centro de Pesquisa Clínica de Nefrologia do ICHC
  • São Paulo, Brazil, 04038-031
    • Fundacao Oswaldo Ramos (Hospital do Rim)
• Canada
  • Ontario
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research
    • Scarborough Village, Ontario, Canada, M1B 4Z8
      • Heart Health Institute (Scarborough)
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M4G 3E8
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Diex Recherche (Trois-Rivieres)
• China
  • Beijing, China, 100044
    • Beijing Tsinghua Changgung Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Guangzhou, China, 510515
    • NanFang Hosptial
  • Hangzhou, China, 310014
    • Zhejiang Province People's Hospital
  • Jinan, China, 250013
    • Center Hospital of Jinan
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210011
    • The Second Affiliated Hospital of Nanjing Medical University
  • Nanning, China, 530000
    • The First People's Hospital of Nanning
  • Ningbo, China, 315010
    • Ningbo Second Hospital
  • Ningxia, China, 750004
    • General Hospital of Ningxia Medical University
  • Shantou, China, 515041
    • Second Hospital Affiliated to Shantou Medical University
  • Shenzhen, China, 518035
    • Shenzhen Second People's Hospital
  • Xi'an, China, 710061
    • First Affiliated Hospital of Xi'an JiaoTong University
  • Yibin, China, 644099
    • Yibin Second People's Hospital
• Czechia
  • Havířov, Czechia, 73601
    • DIKa centrum s.r.o.
  • Příbram, Czechia, 26101
    • MILAN KVAPIL s.r.o.
  • Slaný, Czechia, 274 01
    • Nemocnice Slany
• France
  • Le Kremlin-Bicêtre, France, 94270
    • HOP Bicêtre
  • Nantes, France, 44000
    • HOP Hôtel-Dieu
  • Strasbourg, France, 67091
    • HOP Civil
• Germany
  • Bielefeld, Germany, 33604
    • Klinikum Bielefeld
  • Bünde, Germany, 32257
    • Internistische Gemeinschaftspraxis in Bünde
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Geilenkirchen, Germany, 52511
    • DaVita Clinical Research Germany GmbH Geilenkirchen
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hanover, Germany, 30625
    • Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
  • Rotenburg (Wümme), Germany, 27356
    • Nephrologische Gemeinschaftspraxis, Hamann/Bacinovic/Jacobsen
  • Stuttgart, Germany, 70376
    • Robert Bosch Gesellschaft für medizinische Forschung mbH
• Italy
  • Chieti, Italy, 66100
    • Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
  • Perugia, Italy, 06132
    • Università degli Studi di Perugia
  • Ranica (BG), Italy, 24020
    • Istituto di Ricerche Farmacologiche Mario Negri IRCCS
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Japan
  • Aichi, Kasugai, Japan, 486-8510
    • Kasugai Municipal Hospital
  • Chiba, Chiba, Japan, 260-8712
    • National Hospital Organization Chibahigashi National Hospital
  • Ibaraki, Tsuchiura, Japan, 300-0028
    • Tsuchiura Kyodo General Hospital
  • Kanagawa, Yokohama, Japan, 234-0054
    • Saiseikai Yokohamashi Nanbu Hospital
  • Osaka, Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Suita, Japan, 565-0853
    • OCROM Clinic
  • Saitama, Ageo, Japan, 362-8588
    • Ageo Central General Hospital
  • Shiga, Omihachiman, Japan, 523-0082
    • Omihachiman Community Medical Center
  • Tokyo, Hachioji, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
  • Tokyo, Shinjyuku-ku, Japan, 160-0008
    • ToCROM Clinic
• Malaysia
  • Cheras, Malaysia, 56000
    • Hospital Canselor Tuanku Muhriz
  • Kajang, Malaysia, 43000
    • Hospital Sultan Idris Shah Serdang
  • Kangar, Malaysia, 01000
    • Tuanku Fauziah Hospital
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
• Mexico
  • Aguascalientes, Mexico, 20259
    • Centenario Hospital Miguel Hidalgo
  • Guadalajara, Mexico, 44670
    • Unidad de Investigación Clinica y Atencion Medica HEPA SC
  • Mexico City, Mexico, 06700
    • Clinica Omega Diabetes
  • Mexico City, Mexico, 03650
    • Soltmed Smo
  • Mérida, Mexico, 97070
    • Medical Care & Research SA de CV
  • Veracruz, Mexico, 91910
    • Sociedad de Metabolismo y Corazón S.C.
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC Locatie AMC
  • Dordrecht, Netherlands, 3318 AT
    • Albert SchweitzerZiekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Hoogeveen, Netherlands, 7909 AA
    • Bethesda Diabetes Research Center, Hoogeveen
• New Zealand
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Wellington Region
    • Kapiti, Wellington Region, New Zealand, 5036
      • Momentum Clinical Research - Kapiti Coast
• Philippines
  • Cebu City, Philippines, 6000
    • Norzel Medical and Diagnostic Clinic
  • Marikina City, Philippines, 1810
    • Institute for Studies on Diabetes Foundation Inc.
  • Quezon City, Philippines, 850
    • Philippine Heart Center
• Poland
  • Bydgoszcz, Poland, 85-092
    • Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
  • Chrzanów, Poland, 32-500
    • American Heart Of Poland Sp. Z O.O.
  • Katowice, Poland, 40-648
    • Pro Familia Altera Sp. z o.o.
  • Lodz, Poland, 91 473
    • Pro Salus Sp. z o.o. sp.k.
• Puerto Rico
  • Mayagüez, Puerto Rico, 00680
    • FDI Clinical Research - Mayagüez
• South Korea
  • Ansan-si, South Korea, 15355
    • Korea University Ansan Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Medical Center
  • Seoul, South Korea, 03312
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Wonju-si, Gangwon State, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
• Spain
  • A Coruña, Spain, 15895
    • Centro de Salud Milladoiro
  • Barcelona, Spain, 08025
    • C.A.P. Sardenya
  • Cartagena, Spain, 30201
    • Centro de Salud Cartagena Casco Antiguo
  • Centelles, Barcelona, Spain, 08540
    • Eap Osona Sud Alt Congost S.L.P. Cap Centelles
  • Oviedo, Spain, 33012
    • Centro de Salud Naranco
  • Salamanca, Spain, 37005
    • Centro de Salud de San Juan
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taipei, Taiwan, 25160
    • Mackay Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakom Chiangmai Hospital
• United Kingdom
  • Airdrie, United Kingdom, ML6 0JS
    • University Hospital Monklands
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Harrow, United Kingdom, HA3 7LT
    • Belmont Health Centre
  • High Wycombe, United Kingdom, HP11 2QW
    • Velocity Clinical Research, High Wycombe
  • London, United Kingdom, W6 7HY
    • Richford Gate Medical Practice
  • Oxford, United Kingdom, OX16 9AD
    • Banbury Cross Health Centre
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Sunderland Royal Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Apogee Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Orange County Clinical Trials
    • San Dimas, California, United States, 91773
      • North America Research Institute
    • Tarzana, California, United States, 91356
      • Valiance Clinical Research-Tarzana-68237
    • Valencia, California, United States, 91355
      • Amicis Research Center - Valencia
    • West Hills, California, United States, 91307
      • Focus Clinical Research
  • Florida
    • Brandon, Florida, United States, 33511
      • Clinical Research of Brandon LLC
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research
    • Miami, Florida, United States, 33126
      • Total Research Group, LLC
    • Miami, Florida, United States, 33126
      • Finlay Medical Research Corp
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Ocoee, Florida, United States, 34761
      • West Orange Endocrinology
    • Riverview, Florida, United States, 33578
      • Florida Kidney Physicians - Riverview/Brandon
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research, Inc
  • Idaho
    • Boise, Idaho, United States, 83706
      • Boise Kidney and Hypertension, PLLC
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
    • Hinsdale, Illinois, United States, 60521
      • Nephrology Associates of Northern Illinois and Indiana - Oak Brook
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Kansas Nephrology Research Institute, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Northwest Louisiana Nephrology
  • Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc Llc
    • Pontiac, Michigan, United States, 48341
      • Michigan Kidney Consultants
  • Missouri
    • City of Saint Peters, Missouri, United States, 63376
      • Elixia MNA, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Healor Primary Care
  • New York
    • Smithtown, New York, United States, 11787
      • Endocrine Associates of Long Island
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Durham Nephrology Associates
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • Brookview Hills Research Associates Llc
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Southeast Renal Research Institute
  • Texas
    • Arlington, Texas, United States, 76015
      • Arlington Nephrology
    • Houston, Texas, United States, 77004
      • Endocrine Associates
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
    • Stephenville, Texas, United States, 76401
      • Javara Inc.-Stephenville-68996
  • Utah
    • Salt Lake City, Utah, United States, 84115
      • Utah Kidney Research Institute
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Tidewater Physicians Multispecialty Group

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.
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:

1. 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.
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).

Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo followed by vicadrostat/empagliflozin	Drug: Empagliflozin; Empagliflozin; Drug: Vicadrostat; Vicadrostat; Drug: Placebo matching vicadrostat; Placebo matching vicadrostat
Experimental: Vicadrostat/empagliflozin	Drug: Empagliflozin; Empagliflozin; Drug: Vicadrostat; Vicadrostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 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; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; empagliflozin
• Other Study ID Numbers: 1378-0023; 2024-518457-42-00 (Registry Identifier: CTIS); U1111-1314-0083 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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