A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease
- Interventions
- Registration Number
- NCT06926660
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 416
- 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.
- 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).
Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by vicadrostat + empagliflozin Vicadrostat - Placebo followed by vicadrostat + empagliflozin Empagliflozin - Placebo followed by vicadrostat + empagliflozin Placebo matching vicadrostat - Vicadrostat + empagliflozin Vicadrostat - Vicadrostat + empagliflozin Empagliflozin -
- Primary Outcome Measures
Name Time Method Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14 At baseline, up to week 14
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (83)
Internistische Gemeinschaftspraxis in Bünde
🇩🇪Bünde, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Synexus Clinical Research GmbH-Frankfurt-56626
🇩🇪Frankfurt, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
DaVita Clinical Research Germany GmbH Geilenkirchen
🇩🇪Geilenkirchen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
🇩🇪Hannover, Germany
Synexus Clinical Research GmbH-Leipzig-57914
🇩🇪Leipzig, Germany
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Synexus Clinical Research GmbH-Berlin-26285
🇩🇪Berlin, Germany
Klinikum Bielefeld
🇩🇪Bielefeld, Germany
Instituto Medico Catamarca - IMEC
🇦🇷Rosario, Argentina
Focus Clinical Research
🇺🇸West Hills, California, United States
Brookview Hills Research Associates LLC
🇺🇸Winston-Salem, North Carolina, United States
CEDIC - Centro de Investigacion Clinica
🇦🇷Caba, Argentina
Mautalen- Salud e Investigacion
🇦🇷Caba, Argentina
Sanatorio Güemes
🇦🇷Capital Federal, Argentina
IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
🇦🇷Ciudad Autonoma de Buenos Aires, 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
Northern Hospital Epping
🇦🇺Epping, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Humani - CHU Charleroi - Chimay
🇧🇪Lodelinsart, Belgium
Centro de Pesquisa do Hospital Evangélico de Belo Horizonte
🇧🇷Belo Horizonte, Brazil
Universidade Federal do Rio Grande do Sul
🇧🇷Porto Alegre, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, Brazil
Bluewater Clinical Research
🇨🇦Sarnia, Ontario, Canada
Heart Health Institute (Scarborough)
🇨🇦Scarborough, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Diex Recherche (Trois-Rivieres)
🇨🇦Trois-Rivieres, Quebec, Canada
West China Hospital
🇨🇳Chengdu, China
Zhejiang Province People's Hospital
🇨🇳Hangzhou, China
Center Hospital of Jinan
🇨🇳Jinan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
MILAN KVAPIL s.r.o.
🇨🇿Pribram, Czechia
Hospital Slany, Internal Department
🇨🇿Slany, Czechia
HOP Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
HOP Hôtel-Dieu
🇫🇷Nantes, France
HOP Civil
🇫🇷Strasbourg, France
Facharztpraxis für Innere Medizin, Nierenheilkunde und Bluthochdruckkrankheiten
🇩🇪Rotenburg, Germany
DKD Helios Klinik Wiesbaden
🇩🇪Wiesbaden, Germany
Ospedale SS Annunziata
🇮🇹Chieti, Italy
Università degli Studi di Perugia
🇮🇹Perugia, Italy
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
🇮🇹Ranica (BG), Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy
Kasugai Municipal Hospital
🇯🇵Aichi, Kasugai, Japan
Tsuchiura Kyodo General Hospital
🇯🇵Ibaraki, Tsuchiura, Japan
Saiseikai Yokohamashi Nanbu Hospital
🇯🇵Kanagawa, Yokohama, Japan
Osaka General Medical Center
🇯🇵Osaka, Osaka, Japan
Ageo Central General Hospital
🇯🇵Saitama, Ageo, Japan
Omihachiman Community Medical Center
🇯🇵Shiga, Omihachiman, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Tokyo, Hachioji, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Amsterdam UMC Locatie AMC
🇳🇱Amsterdam, Netherlands
Albert SchweitzerZiekenhuis
🇳🇱Dordrecht, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Bethesda Diabetes Research Center, Hoogeveen
🇳🇱Hoogeveen, Netherlands
Waikato Hospital
🇳🇿Hamilton, New Zealand
Philippine Heart Center
🇵🇭Quezon City, Philippines
Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
🇵🇱Bydgoszcz, Poland
Cardiovascular Centre of Malopolska
🇵🇱Chrzanow, Poland
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Poland
Pro Salus Sp. z o.o. sp.k.
🇵🇱Lodz, Poland
Szpitale Tczewskie S.A.
🇵🇱Tczew, Poland
Centro de Salud Milladoiro
🇪🇸A Coruña, Spain
C.A.P. Sardenya
🇪🇸Barcelona, Spain
Centro de Salud Cartagena Casco Antiguo
🇪🇸Cartagena, Spain
Eap Osona Sud Alt Congost S.L.P. Cap Centelles
🇪🇸Osona, Barcelona, Spain
Centro de Salud Naranco
🇪🇸Oviedo, Spain
Centro de Salud de San Juan
🇪🇸Salamanca, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Siriraj Hospital
🇹🇭Bangkok, Thailand
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom