Clinical trial NCT06926660: A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-04-14
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14
timeFrame: At baseline, up to week 14
Secondary outcomes:
measure: Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 12
timeFrame: At baseline, up to week 12
measure: Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 12
timeFrame: At baseline, up to week 12
measure: Relative change (ratio) in Urine Albumin Creatinine Ratio (UACR) from baseline to Week 6
timeFrame: At baseline, up to week 6
measure: Absolute change in serum potassium (mmol/L) from baseline to Week 12
timeFrame: At baseline, up to week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: San Dimas
country: United States
facility: North America Research Institute
state: California
city: Tarzana
country: United States
facility: Valiance Clinical Research-Tarzana-68237
state: California
city: Valencia
country: United States
facility: Amicis Research Center - Valencia
state: California
city: West Hills
country: United States
facility: Focus Clinical Research
state: California
city: Arvada
country: United States
facility: Western Nephrology, Arvada
state: Colorado
city: Brandon
country: United States
facility: Clinical Research of Brandon LLC
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Miami
country: United States
facility: Total Research Group, LLC
state: Florida
city: Riverview
country: United States
facility: Florida Kidney Physicians - Riverview/Brandon
state: Florida
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Boise
country: United States
facility: Boise Kidney and Hypertension, PLLC
state: Idaho
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Hinsdale
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - Oak Brook
state: Illinois
city: Fort Wayne
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
state: Indiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Pontiac
country: United States
facility: Michigan Kidney Consultants
state: Michigan
city: Fayette
country: United States
facility: Sky Clinical Research
state: Mississippi
city: Saint Peters
country: United States
facility: Midwest Nephrology Associates
state: Missouri
city: Smithtown
country: United States
facility: Endocrine Associates of Long Island
state: New York
city: Durham
country: United States
facility: Durham Nephrology Associates
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates LLC
state: North Carolina
city: Beaver
country: United States
facility: Heritage Valley Medical Group
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Arlington Nephrology
state: Texas
city: Houston
country: United States
facility: Endocrine Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: Salt Lake City
country: United States
facility: Utah Kidney Research Institute
state: Utah
city: Newport News
country: United States
facility: Tidewater Physicians Multispecialty Group
state: Virginia
city: Caba
country: Argentina
facility: CEDIC - Centro de Investigacion Clinica
city: Caba
country: Argentina
facility: Mautalen- Salud e Investigacion
city: Capital Federal
country: Argentina
facility: Sanatorio Güemes
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
city: Rosario
country: Argentina
facility: Instituto Medico Catamarca - IMEC
city: Villa Luro
country: Argentina
facility: CEMEDIC - Centro de Especialidades Medicas
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Epping
country: Australia
facility: Northern Hospital Epping
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lodelinsart
country: Belgium
facility: Humani - CHU Charleroi - Chimay
city: Belo Horizonte
country: Brazil
facility: Centro de Pesquisa do Hospital Evangélico de Belo Horizonte
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: Sarnia
country: Canada
facility: Bluewater Clinical Research
state: Ontario
city: Scarborough
country: Canada
facility: Heart Health Institute (Scarborough)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Diex Recherche (Trois-Rivieres)
state: Quebec
city: Chengdu
country: China
facility: West China Hospital
city: Hangzhou
country: China
facility: Zhejiang Province People's Hospital
city: Jinan
country: China
facility: Center Hospital of Jinan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Havirov
country: Czechia
facility: DIKa centrum s.r.o.
city: Pribram
country: Czechia
facility: MILAN KVAPIL s.r.o.
city: Slany
country: Czechia
facility: Hospital Slany, Internal Department
city: Le Kremlin-Bicêtre
country: France
facility: HOP Bicêtre
city: Nantes
country: France
facility: HOP Hôtel-Dieu
city: Strasbourg
country: France
facility: HOP Civil
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Bünde
country: Germany
facility: Internistische Gemeinschaftspraxis in Bünde
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Geilenkirchen
country: Germany
facility: DaVita Clinical Research Germany GmbH Geilenkirchen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hannover
country: Germany
facility: Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
city: Rotenburg
country: Germany
facility: Facharztpraxis für Innere Medizin, Nierenheilkunde und Bluthochdruckkrankheiten
city: Wiesbaden
country: Germany
facility: DKD Helios Klinik Wiesbaden
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
city: Ranica (BG)
country: Italy
facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Aichi, Kasugai
country: Japan
facility: Kasugai Municipal Hospital
city: Chiba, Chiba
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
city: Ibaraki, Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
city: Osaka, Osaka
country: Japan
facility: Osaka General Medical Center
city: Saitama, Ageo
country: Japan
facility: Ageo Central General Hospital
city: Shiga, Omihachiman
country: Japan
facility: Omihachiman Community Medical Center
city: Tokyo, Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Wonju-si, Gangwon State
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
city: Kajang
country: Malaysia
facility: Hospital Sultan Idris Shah Serdang
city: Kangar
country: Malaysia
facility: Tuanku Fauziah Hospital
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Locatie AMC
city: Dordrecht
country: Netherlands
facility: Albert SchweitzerZiekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Hoogeveen
country: Netherlands
facility: Bethesda Diabetes Research Center, Hoogeveen
city: Kapiti
country: New Zealand
facility: Momentum Clinical Research - Kapiti Coast
state: Wellington Region
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Camiling
country: Philippines
facility: Senor Santo Nino Hospital
city: Cebu City
country: Philippines
facility: Norzel Medical and Diagnostic Clinic
city: Marikina City
country: Philippines
facility: Institute for Studies on Diabetes Foundation Inc.
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
city: Chrzanow
country: Poland
facility: Cardiovascular Centre of Malopolska
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. z o.o.
city: Lodz
country: Poland
facility: Pro Salus Sp. z o.o. sp.k.
city: Mayaguez
country: Puerto Rico
facility: FDI Clinical Research - Mayagüez
city: A Coruña
country: Spain
facility: Centro de Salud Milladoiro
city: Barcelona
country: Spain
facility: C.A.P. Sardenya
city: Cartagena
country: Spain
facility: Centro de Salud Cartagena Casco Antiguo
city: Osona, Barcelona
country: Spain
facility: Eap Osona Sud Alt Congost S.L.P. Cap Centelles
city: Oviedo
country: Spain
facility: Centro de Salud Naranco
city: Salamanca
country: Spain
facility: Centro de Salud de San Juan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakom Chiangmai Hospital
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
Study officials:
References: