EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
NCT ID: NCT06531824
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
11000 participants
INTERVENTIONAL
2024-08-13
2028-08-30
Brief Summary
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This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study.
The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: Run-in period (all participants)
Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin.
Placebo matching BI 690517
Placebo matching BI 690517
Empagliflozin
Empagliflozin
Part 2: Randomized treatment, follow-up period, treatment group
BI 690517
BI 690517
Empagliflozin
Empagliflozin
Part 2: Follow-up period, placebo group
Placebo matching BI 690517
Placebo matching BI 690517
Empagliflozin
Empagliflozin
Interventions
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BI 690517
BI 690517
Placebo matching BI 690517
Placebo matching BI 690517
Empagliflozin
Empagliflozin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m²; or
2. CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥200 mg/g (or protein-to-creatinine ratio ≥300 mg/g).
* Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.
Exclusion Criteria
* Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \>3x Upper Limit of Normal (ULN) at Screening visit
* Known liver cirrhosis
* On dialysis, functioning kidney transplant, or scheduled living donor transplant
* Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
* Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)
* Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Apogee Clinical Research
Huntsville, Alabama, United States
Southwest Kidney Institute
Surprise, Arizona, United States
Florida Kidney Physicians LLC
Jacksonville Beach, Florida, United States
Total Research Group, LLC
Miami, Florida, United States
East Coast Institute For Research LLC
Macon, Georgia, United States
Kootenai Research Services
Coeur d'Alene, Idaho, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
Lake Michigan Nephrology
Saint Joseph, Michigan, United States
St. Clair Nephrology Research, LLC
Shelby, Michigan, United States
Great Plains Nephrology
North Platte, Nebraska, United States
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania, United States
Clinical Renal Associates
Upland, Pennsylvania, United States
Nephrology Associates, Inc
East Providence, Rhode Island, United States
Dallas Nephrology Associates Medical Clinic
DeSoto, Texas, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, United States
Renal Specialists of Houston, PA
Pasadena, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Tidewater Physicians Multispecialty Group
Newport News, Virginia, United States
Providence Medical Research Center
Spokane, Washington, United States
Centro de Salud Renal Junín SRL
Buenos Aires, , Argentina
Glenny Corp - Centro Médico Saavedra
Buenos Aires, , Argentina
Mains Bleues
Rafaela, , Argentina
Clínica El Castaño
San Juan, , Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, , Argentina
Centro Integral de Medicina Respiratória - CIMER
San Miguel de Tucumán, , Argentina
Centro de Pesquisa do Hospital Evangélico de Belo Horizonte
Belo Horizonte, , Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, , Brazil
Hospital Universitário Walter Cantídio - UFC
Fortaleza, , Brazil
Clínica CENDI Endocrinologia e Diabetes
Goiânia, , Brazil
Hospital Ruy Azeredo
Goiânia, , Brazil
AME Saúde
Recife, , Brazil
Fundação Bahiana de Infectologia
Salvador, , Brazil
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
São Paulo, , Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, , Brazil
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
Royal Inland Hospital
Kamloops, British Columbia, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
Northern Health
Prince George, British Columbia, Canada
Fraser Health
Surrey, British Columbia, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
CIUSSS Nord de l'île de Montreal
Québec, Montréal, Canada
Centre for Clinical Research
Halifax, Nova Scotia, Canada
Centricity Research (Brampton)
Brampton, Ontario, Canada
Centricity Research (Vaughan)
Concord, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
London Regional Cancer Program - London Health Sciences Ctr.
London, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
CIUSSS de l Estrie-CHUS
Sherbrooke, Quebec, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, , Canada
CHU de Quebec-Universite Laval Research Centre
Québec, , Canada
Fuwai Hospital, CAMS&PUMC
Beijing, , China
The Second Hospital of Chaoyang
Chaoyang, , China
Guangzhou Red Cross Hospital
Guangzhou, , China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, , China
Zhejiang Hospital
Hangzhou, , China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, , China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
The Fourth Central Hospital of Tianjin
Tianjin, , China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Aalborg Universitetsshospital
Aalborg, , Denmark
Rigshospitalet, København
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Herlev, , Denmark
Steno Diabetes Center Copenhagen
Herlev, , Denmark
Kolding Hospital
Kolding, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospita; Roskilde
Roskilde, , Denmark
Universitätsklinikum Aachen, AöR
Aachen, , Germany
Nephrologische Gemeinschaftspraxis Bad Nenndorf
Bad Nenndorf, , Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, , Germany
Praxis für Nierenkrankheiten und Dialyse Helle Mitte
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Klinikum Dortmund gGmbH
Dortmund, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Dialysezentrum Elsenfeld
Elsenfeld, , Germany
ClinPhenomics CVC GmbH
Frankfurt, , Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Nierenzentrum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Universitätsklinikum Halle (Saale) AöR
Halle, , Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
Hanover, , Germany
BAG für Nephrologie und Dialyse
Heilbronn, , Germany
Ruhr-Universität Bochum
Herne, , Germany
Universität des Saarlandes
Homburg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Klinikum Konstanz
Konstanz, , Germany
Dr. Vehling-Kaiser MVZ GmbH
Landshut, , Germany
KfH Nierenzentrum Leipzig
Leipzig, , Germany
Nephrologisches Zentrum Emsland
Lingen, , Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinikum der Universität München - Campus Innenstadt
München, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Dialysezentrum Neckarsulm
Neckarsulm, , Germany
Universitätsmedizin Rostock
Rostock, , Germany
Dialysezentrum Rotenburg
Rotenburg (Wümme), , Germany
MVZ Dialysezentrum Schweinfurt
Schweinfurt, , Germany
Städtisches Klinikum Solingen gGmbH
Solingen, , Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, , Germany
KfH-Nierenzentrum Traunstein
Traunstein, , Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Nierenzentrum Wiesbaden
Wiesbaden, , Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Manipal Hospital
Bangalore, , India
St John's Medical College
Bangalore, , India
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Karnataka Medical college and research institute
Hubballi, , India
Osmania Medical College & Hospital
Hyderabad, , India
Amrita Institute of Medical Sciences and Research Centre
Kochi, , India
Nil Ratan Sircar Medical College & Hospital
Kolkata, , India
IQRAA International hospital & research centre.
Kozhikode, , India
Dr Ram Manohar Lohia Institute of Medical Sciences
Lucknow, , India
Apollo Speciality Hospital
Madurai, K.K. Nagar, , India
Apollo BGS Hospital
Mysore, , India
Muljibhai Patel Urological Hospital
Nadiād, , India
Max Super Specialty Hospital, Saket
New Delhi, , India
Epitome Kidney Urology Institute and Lions Hospital
New Delhi, , India
All India Institute of Medical Sciences
New Delhi, , India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, , India
Indira Gandhi Institute of Medical Sciences
Patna, , India
Jawaharlal Institute of Postgraduate Medical Education
Puducherry, , India
All India Institute of Medical Sciences
Raipur, , India
Yashoda Hospitals - Secunderabad
Secunderabad, , India
Kimshealth
Trivandrum, , India
Christian Medical College, Vellore
Vellore, , India
Ospedale Civile Ss. Antonio e Biagio
Alessandria, , Italy
Asti-Ospedale Cardinal Massaia
Asti, , Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera ARNAS G. Brotzu
Cagliari, , Italy
Chieri-Ospedale Maggiore
Chieri, , Italy
A.S.O.S. Croce e Carle
Cuneo, , Italy
Firenze-Ospedale San Giovanni di Dio
Florence, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera San Martino
Genova, , Italy
Asst Santi Paolo E Carlo
Milan, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
Ospedale Maggiore della Carità
Novara, , Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, , Italy
Fondazione Salvatore Maugeri
Pavia, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Prato-Ospedale Santo Stefano
Prato, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Ospedale Sant'Anna di San Fermo della Battaglia
San Fermo della Battaglia, , Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (Foggia), , Italy
Azienda Sociosanitaria Ligure 2
Savona, , Italy
IRCCS MultiMedica
Sesto San Giovanni, , Italy
Todi-Nuovo Ospedale Media Valle del Tevere
Todi, , Italy
Torino-Ospedale Oftalmico
Turin, , Italy
Ospedale Castelli - Verbania
Verbania, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Hospital Ampang
Ampang, , Malaysia
Hospital Selayang
Batu Caves, , Malaysia
Hospital Sultanah Nora Ismail
Batu Pahat, , Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
George Town, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Hospital Kajang
Kajang, Selangor, , Malaysia
Hospital Tengku Ampuan Rahimah
Klang, , Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, , Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tuanku Ampuan Najihah
Kuala Pilah, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Hospital Kulim
Kulim, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, , Malaysia
Hospital Seberang Jaya
Perai, , Malaysia
Hospital Sultan Abdul Aziz Shah
Serdang, , Malaysia
Hospital Tuanku Ja'afar
Seremban, , Malaysia
Hospital Taiping
Taiping, , Malaysia
Hospital Teluk Intan
Teluk Intan, , Malaysia
Hospital Sultan Haji Ahmad Shah
Temerluh, , Malaysia
Instituto de investigación aplicado a la neurociencia
Durango, , Mexico
ULS da Região de Aveiro
Aveiro, , Portugal
Unidade Local de Saúde do Algarve, E.P.E
Faro, , Portugal
SESARAM
Funchal, , Portugal
Unidade Local de Saúde Santa Maria
Lisbon, , Portugal
Hospital Beatriz Ângelo
Loures, , Portugal
ULS de São João
Porto, , Portugal
Unidade Local de Saúde de Matosinhos
Senhora da Hora, , Portugal
Unidade Local De Saude Da Arrabida E.P.E.
Setúbal, , Portugal
Korea University Ansan Hospital
Ansan-si, , South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan-si, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Keimyung University Dongsan Hospital
Deagu, , South Korea
Inje University Ilsan Paik Hospital
Goyang-si, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, , South Korea
CHA Bundang Medical Center
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
E-Da Hospital
Kaohsiung City, , Taiwan
Lotung Poh-Ai Hospital
Luodong Township, , Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Hospital, Liouying
Tainan, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Taipei Municipal Wanfang Hospital
Taipei, , Taiwan
Basildon Hospital
Basildon, , United Kingdom
South Eastern Health & Social Care Trust
Belfast, , United Kingdom
Belfast Health and Social Care Trust
Belfast, , United Kingdom
Oakenhurst Medical Practice
Blackburn, , United Kingdom
University Hospitals Sussex NHS Foundation Trusts
Brighton, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
Hathaway Medical Centre
Chippenham, , United Kingdom
Clevedon Medical Centre
Clevedon, , United Kingdom
Queen Alexandra Hospital
Cosham, , United Kingdom
Daisy Hill Hospital
County Down, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorset, , United Kingdom
Highland Clinical Research Facility
Fulwood, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Hereford County Hospital
Hereford, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
King's College Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Altnagelvin Area Hospital
Londonderry, , United Kingdom
Norfolk and Norwich University Hospital
Norfolk, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Pickering Medical Practice
Pickering, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Alexandra Hospital
Redditch, , United Kingdom
The Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2024-511025-63-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-5049
Identifier Type: REGISTRY
Identifier Source: secondary_id
1378-0006
Identifier Type: -
Identifier Source: org_study_id