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NCT06926660

PHASE2

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

492

Start Date

2025-07-18

Completion Date

2026-08-14

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Chronic Kidney Disease

Interventions

DRUG

Vicadrostat

DRUG

Empagliflozin

DRUG

Placebo matching vicadrostat

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.

Locations (157)

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

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, PA

Ocoee, Florida, United States

Florida Kidney Physicians - Riverview/Brandon

Riverview, Florida, United States

Masters of Clinical Research, Inc

Augusta, 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

Northwest Louisiana Nephrology

Shreveport, Louisiana, United States

Aa Mrc Llc

Flint, Michigan, United States

Michigan Kidney Consultants

Pontiac, Michigan, 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

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

Hopital Erasme

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Centro de Pesquisa do Hospital Evangelico de Belo Horizonte

Belo Horizonte, Brazil

Chronos Pesquisa Clinica

Brasília, Brazil

Galileo Medical Research Ltda

Juiz de Fora, Brazil

Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Cpquali Pesquisa Clinica Ltda

São Paulo, Brazil

Fundacao Oswaldo Ramos (Hospital do Rim)

São Paulo, Brazil

CEPIC - Centro Paulista de Investigacao Clinica e Servicos

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, Sichuan University

Chengdu, China

NanFang Hosptial

Guangzhou, China

Zhejiang Province People's Hospital

Hangzhou, 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

Nemocnice Slany

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 Agostino 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

And 57 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (157)