AzTrials
AzTrials

Chronic Kidney DiseasePhase 2NCT06926660

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

A Phase 2 study testing Vicadrostat and Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 157 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Vicadrostat and Empagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
492 participants
Where
157 sitesin 24 countries
Study dates
18 Jul 2025to 14 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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).
  • Further exclusion criteria apply.

Trial locations and contacts

157 sites in 24 countries.

157 sites in 24 countries

United States37 sites

  • Orange County Clinical Trials

    Anaheim, California, 92801

  • Arlington Nephrology

    Arlington, Texas, 76015

  • Masters of Clinical Research, Inc

    Augusta, Georgia, 30909

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

  • Boise Kidney and Hypertension, PLLC

    Boise, Idaho, 83706

  • Clinical Research of Brandon LLC

    Brandon, Florida, 33511

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • Elixia MNA, LLC

    City of Saint Peters, Missouri, 63376

  • Hillcrest Medical Research

    DeLand, Florida, 32720

  • Durham Nephrology Associates

    Durham, North Carolina, 27704

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Nephrology Associates of Northern Illinois and Indiana - Fort Wayne

    Fort Wayne, Indiana, 46804

  • Nephrology Associates of Northern Illinois and Indiana - Oak Brook

    Hinsdale, Illinois, 60521

  • Encore Medical Research

    Hollywood, Florida, 33024

  • Endocrine Associates

    Houston, Texas, 77004

  • Apogee Clinical Research

    Huntsville, Alabama, 35805

  • Healor Primary Care

    Las Vegas, Nevada, 89102

  • Finlay Medical Research Corp

    Miami, Florida, 33126

  • Total Research Group, LLC

    Miami, Florida, 33126

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Tidewater Physicians Multispecialty Group

    Newport News, Virginia, 23606

  • West Orange Endocrinology, PA

    Ocoee, Florida, 34761

  • Michigan Kidney Consultants

    Pontiac, Michigan, 48341

  • Florida Kidney Physicians - Riverview/Brandon

    Riverview, Florida, 33578

  • Utah Kidney Research Institute

    Salt Lake City, Utah, 84115

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • North America Research Institute

    San Dimas, California, 91773

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Endocrine Associates of Long Island

    Smithtown, New York, 11787

  • Javara Inc.-Stephenville-68996

    Stephenville, Texas, 76401

  • Valiance Clinical Research-Tarzana-68237

    Tarzana, California, 91356

  • Amicis Research Center - Valencia

    Valencia, California, 91355

  • Focus Clinical Research

    West Hills, California, 91307

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

  • Brookview Hills Research Associates LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

China14 sites

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • NanFang Hosptial

    Guangzhou, 510515

  • Zhejiang Province People's Hospital

    Hangzhou, 310014

  • Center Hospital of Jinan

    Jinan, 250013

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011

  • The First People's Hospital of Nanning

    Nanning, 530000

  • Ningbo Second Hospital

    Ningbo, 315010

  • General Hospital of Ningxia Medical University

    Ningxia, 750004

  • Second Hospital Affiliated to Shantou Medical University

    Shantou, 515041

  • Shenzhen Second People's Hospital

    Shenzhen, 518035

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • Yibin Second People's Hospital

    Yibin, 644099

Other trials in China

Japan10 sites

  • Kasugai Municipal Hospital

    Aichi, Kasugai, 486-8510

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712

  • Tsuchiura Kyodo General Hospital

    Ibaraki, Tsuchiura, 300-0028

  • Saiseikai Yokohamashi Nanbu Hospital

    Kanagawa, Yokohama, 234-0054

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • OCROM Clinic

    Osaka, Suita, 565-0853

  • Ageo Central General Hospital

    Saitama, Ageo, 362-8588

  • Omihachiman Community Medical Center

    Shiga, Omihachiman, 523-0082

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998

  • ToCROM Clinic

    Tokyo, Shinjuku-ku, 160-0008

Other trials in Japan

Germany9 sites

  • Klinikum Bielefeld

    Bielefeld, 33604

  • Internistische Gemeinschaftspraxis in Bünde

    Bünde, 32257

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • DaVita Clinical Research Germany GmbH Geilenkirchen

    Geilenkirchen, 52511

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen

    Hanover, 30625

  • Nephrologische Gemeinschaftspraxis, Hamann/Bacinovic/Jacobsen

    Rotenburg (Wümme), 27356

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376

Other trials in Germany

Brazil8 sites

  • Centro de Pesquisa do Hospital Evangelico de Belo Horizonte

    Belo Horizonte, 30220-420

  • Chronos Pesquisa Clinica

    Brasília, 72145-450

  • Galileo Medical Research Ltda

    Juiz de Fora, 36033-318

  • Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000

  • Fundacao Oswaldo Ramos (Hospital do Rim)

    São Paulo, 04038-031

  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos

    São Paulo, 04266-010

  • Centro de Pesquisa Clínica de Nefrologia do ICHC

    São Paulo, 05403-000

Other trials in Brazil

United Kingdom8 sites

  • University Hospital Monklands

    Airdrie, ML6 0JS

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Belmont Health Centre

    Harrow, HA3 7LT

  • Velocity Clinical Research, High Wycombe

    High Wycombe, HP11 2QW

  • Richford Gate Medical Practice

    London, W6 7HY

  • Banbury Cross Health Centre

    Oxford, OX16 9AD

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

Other trials in United Kingdom

Mexico6 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20259

  • Unidad de Investigación Clinica y Atencion Medica HEPA SC

    Guadalajara, 44670

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Soltmed Smo

    Mexico City, 03650

  • Clinica Omega Diabetes

    Mexico City, 06700

  • Sociedad de Metabolismo y Corazón S.C.

    Veracruz, 91910

Other trials in Mexico

Spain6 sites

  • Centro de Salud Milladoiro

    A Coruña, 15895

  • EAP Sardenya

    Barcelona, 08025

  • Centro de Salud Cartagena Casco Antiguo

    Cartagena, 30201

  • Eap Osona Sud Alt Congost S.L.P. Cap Centelles

    Centelles, Barcelona, 08540

  • Centro de Salud Naranco

    Oviedo, 33012

  • Centro de Salud de San Juan

    Salamanca, 37005

Other trials in Spain

Argentina5 sites

  • IDIM - Instituto de Diagnostico e Investigaciones Metabolicas

    Buenos Aires, 1012

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Mautalen- Salud e Investigacion

    CABA, C1128AAF

  • Instituto Medico Catamarca - IMEC

    Rosario, S2000AJU

  • CEMEDIC - Centro de Especialidades Medicas

    Villa Luro, 1407

Other trials in Argentina

Canada5 sites

  • Bluewater Clinical Research

    Sarnia, Ontario, N7T 4X3

  • Heart Health Institute (Scarborough)

    Scarborough Village, Ontario, M1B 4Z8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4G 3E8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Diex Recherche (Trois-Rivieres)

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

South Korea5 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312

  • Hanyang University Medical Center

    Seoul, 04763

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon State, 26426

Other trials in South Korea

Australia4 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Italy4 sites

  • Azienda Sanitaria Locale 2 Lanciano Vasto Chieti

    Chieti, 66100

  • Università degli Studi di Perugia

    Perugia, 06132

  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS

    Ranica (BG), 24020

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

Other trials in Italy

Malaysia4 sites

  • Hospital Canselor Tuanku Muhriz

    Cheras, 56000

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000

  • Tuanku Fauziah Hospital

    Kangar, 01000

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

Other trials in Malaysia

Netherlands4 sites

  • Amsterdam UMC Locatie AMC

    Amsterdam, 1105 AZ

  • Albert SchweitzerZiekenhuis

    Dordrecht, 3318 AT

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Bethesda Diabetes Research Center, Hoogeveen

    Hoogeveen, 7909 AA

Other trials in Netherlands

Poland4 sites

  • Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk

    Bydgoszcz, 85-092

  • American Heart Of Poland Sp. Z O.O.

    Chrzanów, 32-500

  • Pro Familia Altera Sp. z o.o.

    Katowice, 40-648

  • Pro Salus Sp. z o.o. sp.k.

    Lodz, 91 473

Other trials in Poland

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10048

  • Mackay Memorial Hospital

    Taipei, 25160

Other trials in Taiwan

Thailand4 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200

Other trials in Thailand

Belgium3 sites

  • Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Czechia3 sites

  • DIKa centrum s.r.o.

    Havířov, 73601

  • MILAN KVAPIL s.r.o.

    Příbram, 26101

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

France3 sites

  • HOP Bicêtre

    Le Kremlin-Bicêtre, 94270

  • HOP Hôtel-Dieu

    Nantes, 44000

  • HOP Civil

    Strasbourg, 67091

Other trials in France

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3240

  • Momentum Clinical Research - Kapiti Coast

    Kapiti, Wellington Region, 5036

Other trials in New Zealand

Philippines3 sites

  • Norzel Medical and Diagnostic Clinic

    Cebu City, 6000

  • Institute for Studies on Diabetes Foundation Inc.

    Marikina City, 1810

  • Philippine Heart Center

    Quezon City, 850

Other trials in Philippines

Puerto Rico1 site

  • FDI Clinical Research - Mayagüez

    Mayagüez, 00680

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
Vicadrostat, Empagliflozin, Placebo matching vicadrostat
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VicadrostatDrug

    Vicadrostat

  • EmpagliflozinDrug

    Empagliflozin

  • Placebo matching vicadrostatDrug

    Placebo matching vicadrostat

Study groups in NCT06926660
Study groupRoleWhat they receive
Placebo followed by vicadrostat/empagliflozinPlacebo comparatorNot described
Receives: Drug: Vicadrostat; Drug: Empagliflozin; Drug: Placebo matching vicadrostat
Vicadrostat/empagliflozinExperimentalNot described
Receives: Drug: Vicadrostat; Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14 and week 16

    Measured: At baseline, up to week 16

Secondary outcomes (4)

  1. Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 12

    Measured: At baseline, up to week 12

  2. Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 12

    Measured: At baseline, up to week 12

  3. Relative change (ratio) in Urine Albumin Creatinine Ratio (UACR) from baseline to Week 6

    Measured: At baseline, up to week 6

  4. Absolute change in serum potassium (mmol/L) from baseline to Week 12

    Measured: At baseline, up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2025
  2. Study start18 Jul 2025
  3. Primary completion14 Aug 2026
  4. Study completion14 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926660
Sponsor's protocol ID
1378-0023
Other IDs
2024-518457-42-00, U1111-1314-0083
Status last verified
Sep 2026
First submitted
11 Apr 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vicadrostat and Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 157 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, China, Japan, Germany, Brazil and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14 and week 16 (time frame: At baseline, up to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT06926660 | AzTrials