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NCT06926660 | NOT YET RECRUITING | Chronic Kidney Disease

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

Boehringer Ingelheim

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 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.

Condition or disease

Chronic Kidney Disease

Intervention/treatment

Vicadrostat

Empagliflozin

Placebo matching vicadrostat

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 416 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06-16
Estimated Primary Completion Date : 2027-01-08
Estimated Study Completion Date : 2027-01-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Location Details

NCT06926660

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Focus Clinical Research

West Hills, California, United States, 91207

Not yet recruiting

Argentina,

CEED - Clinical Research Center

CABA, Argentina, C1060abn

Not yet recruiting

Argentina,

Mautalen- Health and Research

CABA, Argentina, C1128Aaf

Not yet recruiting

Argentina,

Güemes Sanatorium

Capital Federal, Argentina, C1180AAX

Not yet recruiting

Argentina,

IDIM - Institute of Diagnosis and Metabolic Research

Autonomous City of Buenos Aires, Argentina, 1012

Not yet recruiting

Argentina,

Catamarca Medical Institute - Imec

Rosario, Argentina, S2GI

Not yet recruiting

Argentina,

CEMEDIC - Medical Specialties Center

Villa Luro, Argentina, 1407

Not yet recruiting

Australia, New South Wales

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Not yet recruiting

Australia, Victoria

Northern Hospital Epping

Epping, Victoria, Australia, 3076

Not yet recruiting

Australia, Western Australia

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Not yet recruiting

Belgium,

ULB HOPITAL ERASME

Bruxelles, Belgium, 1070

Not yet recruiting

Belgium,

Brussels - UNIV Saint-Luc

Bruxelles, Belgium, 1200

Not yet recruiting

Belgium,

UZ Leuven

Leuven, Belgium, 3000

Not yet recruiting

Belgium,

Humiani - Chuup Charlarii - Chime

Lodelinous, Belgium, 6041

Not yet recruiting

Brazil,

Research Center of the Evangelical Hospital of Belo Horizonte

Belo Horizonte, Brazil, 30220-420

Not yet recruiting

Brazil,

Federal University of Rio Grande do Sul

Porto Alegre, Brazil, 90430-001

Not yet recruiting

Brazil,

Regional College of Medicine Foundation of São José do Rio Preto

São José do Rio Preto, Brazil, 15090-000

Not yet recruiting

Canada, Ontario

Bluewater Clinical Research

Sarnia, Ontario, Canada, N7T 4X3

Not yet recruiting

Canada, Ontario

Heart Health Institute (Scarborough)

Scarborough, Ontario, Canada, M1B 4Z8

Not yet recruiting

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4G 3E8

Not yet recruiting

Canada, Ontario

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Not yet recruiting

Canada, Quebec

Diex Research (Trois-Rivieres)

Trois-Rivieres, Quebec, Canada, G9A 4p3

Not yet recruiting

China,

West China Hospital

Chengdu, China, 610041

Not yet recruiting

China,

Zhejiang Province People's Hospital

Hangzhou, China, 310014

Not yet recruiting

China,

Center Hospital of Jinan

Women, China, 250013

Not yet recruiting

China,

The First Affiliated Hospital of Nanchang University

Nanchang, China, 330006

Not yet recruiting

Czechia,

Milan Kvapil s.r.o.

Reconciliations, Czechia, 26101

Not yet recruiting

Czechia,

Hospital Slany, Internal Department

Slany, Czechia, 274 01

Not yet recruiting

France,

Hop bicêtre

The Kremlin-Bicêtre, France, 94270

Not yet recruiting

France,

Hop Hôtel-Dieu

Nantes, France, 44000

Not yet recruiting

France,

HOP Civil

Strasbourg, France, 67091

Not yet recruiting

Germany,

Synexus Clinical Research GmbH-Berlin-26285

Berlin, Germany, 12627

Not yet recruiting

Germany,

Bielefeld Clinic

Bielefeld, Germany, 33604

Not yet recruiting

Germany,

Internist group practice in Bünde

Fründe, Germany, 32257

Not yet recruiting

Germany,

University Hospital Carl Gustav Carus Dresden

Dresden, Germany, 01307

Not yet recruiting

Germany,

Synexus Clinical Research GmbH-Frankfurt-56626

Frankfurt, Germany, 60313

Not yet recruiting

Germany,

University Hospital Frankfurt

Frankfurt, Germany, 60590

Not yet recruiting

Germany,

Davita Clinical Research Germany GmbH Geilenkirchen

Geilenkirchen, Germany, 52511

Not yet recruiting

Germany,

Medical University of Hanover

Hannover, Germany, 30625

Not yet recruiting

Germany,

Center for kidneys high pressure and metabolic diseases

Hannover, Germany, 30625

Not yet recruiting

Germany,

Synexus Clinical Research GmbH-Leipzig-57914

Leipzig, Germany, 04103

Not yet recruiting

Germany,

Specialist practice for internal medicine, kidney medicine and high blood pressure diseases

Rotenburg, Germany, 27356

Not yet recruiting

Germany,

DKD HELIOS Clinic Wiesbaden

Wiesbaden, Germany, 65191

Not yet recruiting

Italy,

SS Annunziata Hospital

Chieti, Italy, 66100

Not yet recruiting

Italy,

University of Perugia

Perugia, Italy, 06132

Not yet recruiting

Italy,

Institute of pharmacological research Mario Negri Iccs

Ranica (BG), Italy, 24020

Not yet recruiting

Italy,

University Polyclinic Foundation A. Gemelli IRCCS

Roma, Italy, 00168

Not yet recruiting

Japan,

Kasugai Municipal Hospital

Aichi, shi, Japan, 486-8510

Not yet recruiting

Japan,

Tsuchiura Kyodo Gene et al. supplemented by Spita l

Ibaraki, Tsuchiura, Japan, 300-0028

Not yet recruiting

Japan,

Saiseikai Yokohama City Southern Bin SpitaL

Kanagawa, Yokohama, Japan, 234-0054

Not yet recruiting

Japan,

Ageo Central General Hospital

Saitama, Ageo, Japan, 362-8588

Not yet recruiting

Japan,

Omihachiman Community Medical Center

Login, Omihacherman, Japan, 523-0082

Not yet recruiting

Japan,

Tokyo Medical University Hachioji Medical Center

Tokyo, 8th man, Japan, 193-0998

Not yet recruiting

Korea, Republic of,

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of, 13620

Not yet recruiting

Korea, Republic of,

Hanyang University Medical Center

Seoul, Korea, Republic of, 04763

Not yet recruiting

Netherlands,

Amsterdam UMC location AMC

Amsterdam, Netherlands, 1105 is

Not yet recruiting

Netherlands,

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands, 3318 AT

Not yet recruiting

Netherlands,

Catharina Hospital

Eindhoven, Netherlands, 5623 EJ

Not yet recruiting

Netherlands,

Bethesda Diabetes Research Center, Hoogeveen

Hoogeveen, Netherlands, 7909 AA

Not yet recruiting

New Zealand,

Dunedin Hospital

Dunedin, New Zealand, 9016

Not yet recruiting

New Zealand,

Waikato Hospital

Hamilton, New Zealand, 3204

Not yet recruiting

Philippines,

Philippine Heart Center

Quezon City, Philippines, 850

Not yet recruiting

Poland,

Medical Center "Hippocrates" S.C. Elżbieta and Grzegorz Grześk

Bydgoszcz, Poland, 85-092

Not yet recruiting

Poland,

Cardiovascular Center of Malopolska

Horseradish, Poland, 32-500

Not yet recruiting

Poland,

Pro family alter

Katowice, Poland, 40-648

Not yet recruiting

Poland,

For safety

Lodz, Poland, 91-743

Not yet recruiting

Poland,

Hospitals Tczewskie S.A.

Tczew, Poland, 83-110

Not yet recruiting

Spain,

MILLADOIRO HEALTH CENTER

A Coruña, Spain, 15895

Not yet recruiting

Spain,

STAMP. Sardial

Barcelona, Spain, 08025

Not yet recruiting

Spain,

Cartagena Casco Old Health Center

Cartagena, Spain, 30201

Not yet recruiting

Spain,

EAP Osona Sud Alt Congost S.L.P. No centelles

Osona, Barcelona, Spain, 08540

Not yet recruiting

Spain,

Naranco Health Center

Oviedo, Spain, 33012

Not yet recruiting

Spain,

San Juan Health Center

Salamanca, Spain, 37005

Not yet recruiting

Taiwan,

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Not yet recruiting

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10048

Not yet recruiting

Taiwan,

Mackay Memorial Hospital

Taipei, Taiwan, 25160

Not yet recruiting

Thailand,

Siriraj hospital

Bangkok, Thailand, 10700

Not yet recruiting

United Kingdom,

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Not yet recruiting

United Kingdom,

Royal Berkshire Hospital

Reading, United Kingdom, RG1 5an