EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease
3 other identifiers
interventional
11,000
19 countries
452
Brief Summary
This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2024
Typical duration for phase_3
452 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
April 29, 2026
April 1, 2026
4 years
July 29, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
Kidney disease progression is defined as kidney failure or a sustained decline of ≥40% in estimated Glomerular Filtration Rate (eGFR) from randomization
up to 4 years
Secondary Outcomes (7)
Key secondary outcome: Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope)
up to 4 years
Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death
up to 4 years
Time to kidney disease progression
up to 4 years
Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death
up to 4 years
Occurrences of hospitalizations from any cause (first and any subsequent, combined)
up to 4 years
- +2 more secondary outcomes
Study Arms (3)
Part 1: Run-in period (all participants)
OTHEREligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin.
Part 2: Randomized treatment, follow-up period, treatment group
EXPERIMENTALPart 2: Follow-up period, placebo group
PLACEBO COMPARATORInterventions
BI 690517
Placebo matching BI 690517
Empagliflozin
Eligibility Criteria
You may qualify if:
- Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires:
- Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m²; or
- 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.
You may not qualify if:
- Blood potassium of \>5.2 mmol/L at screening visit
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (452)
Apogee Clinical Research
Huntsville, Alabama, 35805-4104, United States
Southwest Kidney Institute
Surprise, Arizona, 85374-4840, United States
Florida Kidney Physicians LLC
Jacksonville Beach, Florida, 32250-4303, United States
Total Research Group, LLC
Miami, Florida, 33126, United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, 30033-4004, United States
East Coast Institute For Research LLC
Macon, Georgia, 31210-1359, United States
Kootenai Research Services
Coeur d'Alene, Idaho, 83814, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
Medstar Health Research Institute
Baltimore, Maryland, 21239, United States
Lake Michigan Nephrology
Saint Joseph, Michigan, 49085-8511, United States
St. Clair Nephrology Research, LLC
Shelby, Michigan, 48315, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
Great Plains Nephrology
North Platte, Nebraska, 69101-0614, United States
Sierra Nevada Specialty Care
Reno, Nevada, 89511, United States
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, 03801, United States
UNM Health Science Center
Albuquerque, New Mexico, 87106, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28208-0014, United States
Carolina Kidney Associates
Greensboro, North Carolina, 27405-3654, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania, 19114-1028, United States
Clinical Renal Associates
Upland, Pennsylvania, 19013, United States
Nephrology Associates, Inc
East Providence, Rhode Island, 02914-2641, United States
University of Tennessee
Memphis, Tennessee, 38104, United States
Dallas Nephrology Associates Medical Clinic
DeSoto, Texas, 75115-2011, United States
Academy Of Diabetes, Thyroid And Endocrine, PA
El Paso, Texas, 79935, United States
P&I Clinical Research, LLC
Lufkin, Texas, 75904, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, 75904, United States
Renal Specialists of Houston, PA
Pasadena, Texas, 77504-1944, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Kidney and Hypertension Specialists, PLLC
Manassas, Virginia, 20110, United States
Tidewater Physicians Multispecialty Group
Newport News, Virginia, 23606, United States
Salem VA Medical Center
Salem, Virginia, 24153, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
Fundacion INTECNUS
Bariloche, 8500, Argentina
Centro de Salud Renal Junín SRL
Buenos Aires, B6000, Argentina
Dres. Iribarren & Asoc. Consultario
Buenos Aires, C1061AAE, Argentina
Glenny Corp - Centro Médico Saavedra
Buenos Aires, C1430CKE, Argentina
Sanatario Pasteur
Catamarca, K4703AFI, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, C1431FWO, Argentina
CIMEL Chahin - Chahin S.A.
Lanús Este, B1824KAJ, Argentina
Centro Nefrológico del Mar
Mar del Plata, B7612, Argentina
Mains Bleues
Rafaela, S2300, Argentina
Hospital Privado de Rosario
Rosario, S2000GAP, Argentina
Sanatorio Parque S.A.
Rosario, S2013, Argentina
Instituto de Nefrourología y Nutrición de Salta
Salta, A4400, Argentina
Clínica El Castaño
San Juan, J5400, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, 4000, Argentina
Centro Integral de Medicina Respiratória - CIMER
San Miguel de Tucumán, 4000, Argentina
Instituto de Investigaciones Clinicas de Rosario
Santa Fe, 2000, Argentina
CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial
Villa Domínico, B1872EEB, Argentina
Renal Research, Gosford
Gosford, New South Wales, 2250, Australia
Port Macquarie Base Hospital (PMBH)
Port Macquarie, New South Wales, 2444, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Austin Health
Heidelberg Heights, Victoria, 3081, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Macquarie University
New South Wales, 2019, Australia
Westmead Hospital
New South Wales, 2145, Australia
AZ Sint-Jan Brugge
Bruges, 8000, Belgium
Centro de Pesquisa Clínica do Coração
Aracaju, 49055-530, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, 30150-320, Brazil
Centro de Pesquisa do Hospital Evangélico de Belo Horizonte
Belo Horizonte, 30220-330, Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, 1291-6542, Brazil
CEG - Centro de Endocrinologia Geloneze
Campinas, 13073-350, Brazil
Instituto Cardiovascular de Linhares Ltda
Centro Linhares, 29900010, Brazil
PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PR
Curitiba, 80230-130, Brazil
Hospital Universitário Walter Cantídio - UFC
Fortaleza, 60416-000, Brazil
Centro de Pesquisas em Diabetes e Doencas Metabolicas
Fortaleza, 60430-350, Brazil
Clínica CENDI Endocrinologia e Diabetes
Goiânia, 74230-035, Brazil
Hospital Ruy Azeredo
Goiânia, 74453200, Brazil
Fundação Pró-Rim Joinville
Joinville, 89227-680, Brazil
Galileo Medical Research Ltda
Juiz de Fora, 36033-318, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, 57051-160, Brazil
Hospital Universitário Onofre Lopes
Natal, 59012300, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospitalar Moinhos de Vento
Porto Alegre, 90560-032, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
IMIP Pernambuco
Recife, 50070902, Brazil
AME Saúde
Recife, 50720110, Brazil
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, 50740900, Brazil
Fundação Bahiana de Infectologia
Salvador, 40110160, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090, Brazil
CIPES - Centro Internacional de Pesquisa Clínica
São José dos Campos, 12230-001, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
São Paulo, 0402-9001, Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, 04023900, Brazil
Hospital Universitário da Universidade Federal do Piauí
Teresina, 64049550, Brazil
Clínica Cardiológica
Votuporanga, 15505-189, Brazil
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2P4, Canada
Royal Inland Hospital
Kamloops, British Columbia, V2C 2T1, Canada
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2, Canada
Northern Health
Prince George, British Columbia, V2M 1S2, Canada
Fraser Health
Surrey, British Columbia, V3W 1J8, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V1Y 1S1, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
CIUSSS Nord de l'île de Montreal
Québec, Montréal, H4J 1C5, Canada
Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V7, Canada
Centricity Research (Brampton)
Brampton, Ontario, L6S 0C6, Canada
Centricity Research (Vaughan)
Concord, Ontario, L4K 4M2, Canada
Queen's University
Kingston, Ontario, K7L 3N6, Canada
London Regional Cancer Program - London Health Sciences Ctr.
London, Ontario, N6A 5W9, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4G 3E8, Canada
St. Michael's Hospital
Toronto, Ontario, M5C2T2, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H3G 1A4, Canada
CIUSSS de l Estrie-CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, H2X 0A9, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, G1R 2J6, Canada
Diex Recherche Québec
Québec, G1V 4T3, Canada
Ansteel Group General Hospital
Anshan, 114000, China
Beijing AnZhen Hospital, Capital Medical University
Beijing, 100029, China
Peking University Third Hospital
Beijing, 100029, China
Fuwai Hospital, CAMS&PUMC
Beijing, 100037, China
The Second Hospital of Chaoyang
Chaoyang, 122000, China
West China Fourth Hospital of Sichuan University
Chengdu, 610041, China
Linquan County People's Hospital
Fuyang, 236400, China
Gaozhou People's Hospital
Gaozhou, 525200, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Guangzhou Red Cross Hospital
Guangzhou, 510240, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, 510665, China
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, 510925, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, 528200, China
Hainan General Hospital
Haikou, 570311, China
Shulan(Hanghzhou) Hospital
Hanghzhou, 310022, China
Zhejiang Hospital
Hangzhou, 310030, China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, 150001, China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, 150066, China
The Second People's Hospital of Hefei
Hefei, 230011, China
International Mongolian Hospital of Inner Mongolia
Hohot, 010010, China
Jingzhou Central Hospital
Jingzhou, 434020, China
Henan Jiyuan People's Hospital
Jiyuan, 454650, China
Liuzhou People's Hospital
Liuchow, 545006, China
Luoyang Third People's Hospital
Luoyang, 471002, China
Luoyang Central Hospital
Luoyang, 471009, China
Luoyang Yanshi People's Hospital
Luoyang, 471900, China
Jiangxi Branch Hospital of Xiangya Hospital of Central South University
Nanchang, 330000, China
Qingdao Cardiovascular Hospital
Qingdao, 266034, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shantou Central Hospital
Shantou, 515031, China
Second Hospital Affiliated to Shantou Medical University
Shantou, 515041, China
Shaoguan First People's Hospital
Shaoguan, 512000, China
Shaoxing Second Hospital
Shaoxing, 312000, China
Shenzhen Nanshan People's Hospital
Shenzhen, 518052, China
Songyuan Jilin Oilfield Hospital
Songyuan, 138000, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
The Fourth Central Hospital of Tianjin
Tianjin, 300140, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 830054, China
Hubei Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Wuhan, 430015, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, 361006, China
Xinxiang Central Hospital
Xinxiang, 453000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, 453100, China
The Ninth People's Hospital of Zhengzhou
Zhengzhou, 450053, China
Zhuhai People's Hospital
Zhuhai, 519000, China
Zhumadian Central Hospital
Zhumadian, 463000, China
Zhuzhou Central Hospital
Zhuzhou, 412000, China
Zhuzhou Central Hospital
Zhuzhou, 412007, China
Aalborg Universitetsshospital
Aalborg, 9000, Denmark
Rigshospitalet, København
Copenhagen, 2100, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Kolding Hospital
Kolding, 6000, Denmark
Odense University Hospital
Odense, 5000, Denmark
Zealand University Hospita; Roskilde
Roskilde, 4000, Denmark
Universitätsklinikum Aachen, AöR
Aachen, 52074, Germany
KfH-Nierenzentrum Bad Kreuznach
Bad Kreuznach, 55543, Germany
Nephrologische Gemeinschaftspraxis Bad Nenndorf
Bad Nenndorf, 31542, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Praxis für Nierenkrankheiten und Dialyse Helle Mitte
Berlin, 12627, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
KfH Nierenzentrum Coburg
Coburg, 96450, Germany
Klinikum Dortmund gGmbH
Dortmund, 44137, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Dialysezentrum Elsenfeld
Elsenfeld, 63820, Germany
ClinPhenomics CVC GmbH
Frankfurt, 60596, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596, Germany
Nierenzentrum Freiburg
Freiburg im Breisgau, 79100, Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392, Germany
Universitätsklinikum Halle (Saale) AöR
Halle, 06097, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Zentrum Für Nieren Hochdruck und Stoffwechselerkrankungen
Hanover, 30625, Germany
BAG für Nephrologie und Dialyse
Heilbronn, 74076, Germany
Ruhr-Universität Bochum
Herne, 44625, Germany
Universität des Saarlandes
Homburg, 66421, Germany
Universitätsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Klinikum Konstanz
Konstanz, 78464, Germany
KfH-Nierenzentrum Kronach
Kronach, 96317, Germany
Dr. Vehling-Kaiser MVZ GmbH
Landshut, 84036, Germany
KfH Nierenzentrum Leipzig
Leipzig, 04129, Germany
Nephrologisches Zentrum Emsland
Lingen, 49808, Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, 39120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Klinikum der Universität München - Campus Innenstadt
München, 80336, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Dialysezentrum Neckarsulm
Neckarsulm, 74172, Germany
Universitätsklinikum Ruppin-Brandenburg
Neuruppin, 16816, Germany
Klinikum Nürnberg
Nuremberg, 90471, Germany
Universitätsmedizin Rostock
Rostock, 18057, Germany
Dialysezentrum Rotenburg
Rotenburg (Wümme), 27356, Germany
MVZ Dialysezentrum Schweinfurt
Schweinfurt, 97421, Germany
Städtisches Klinikum Solingen gGmbH
Solingen, 42653, Germany
Nephrologische Gemeinschaftspraxis Springe
Springe, 31832, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
KfH-Nierenzentrum Traunstein
Traunstein, 83278, Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052, Germany
Nierenzentrum Wiesbaden
Wiesbaden, 65191, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078, Germany
Manipal Hospital
Bangalore, 560017, India
St John's Medical College
Bangalore, 560034, India
Apollo Hospital - Bangalore
Bangalore, 560076, India
All India Institute of Medical Sciences, Bathinda
Bathinda, 151001, India
All India Institute of Medical Sciences Bhubaneswar
Bhubaneswar, 751019, India
All India Institute of Medical Sciences, Bilaspur
Bilāspur, 174001, India
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
Apollo Hospital - Chennai
Chennai, 600006, India
Apollo Speciality Hospitals, Vanagaram
Chennai, 600095, India
Aakash Healthcare Super Speciality Hospital
Dwārka, 110075, India
Accord Superspeciality Hospital
Faridabad, 121002, India
Amrita Hospital Faridabad
Faridabad, 121002, India
Marengo Asia Hospitals, Guhugram
Guhugram, 122011, India
Artemis Hospital
Gurugram, 122001, India
Karnataka Institute of Medical Sciences, Hubli
Hubli, 580021, India
Osmania Medical College & Hospital
Hyderabad, 500012, India
Apollo Hospitals Jubilee Hills
Hyderabad, 500033, India
Apollo DRDO Hospital
Hyderabad, 500058, India
All India Institute of Medical Sciences, Jodhpur
Jodhpur, 342005, India
Amrita Institute of Medical Sciences and Research Centre
Kochi, 682041, India
Nil Ratan Sircar Medical College & Hospital
Kolkata, 700014, India
IQRAA International hospital & research centre.
Kozhikode, 673009, India
Dr Ram Manohar Lohia Institute of Medical Sciences
Lucknow, 226010, India
Apollo Speciality Hospital
Madurai, K.K. Nagar, 625020, India
Kasturba Medical College and Hospital
Mangaluru, 575001, India
Apollo BGS Hospital
Mysore, 570023, India
Muljibhai Patel Urological Hospital
Nadiād, 387001, India
Max Super Specialty Hospital, Saket
New Delhi, 110017, India
Epitome Kidney Urology Institute and Lions Hospital
New Delhi, 110025, India
Maharaja Agrasen Hospital
New Delhi, 110026, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, 110070, India
Indira Gandhi Institute of Medical Sciences
Patna, 800014, India
Jawaharlal Institute of Postgraduate Medical Education
Puducherry, 605006, India
All India Institute of Medical Sciences
Raipur, 492099, India
Paras HEC, Ranchi
Ranchi, 834004, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001, India
Yashoda Hospitals - Secunderabad
Secunderabad, 500003, India
Kimshealth
Trivandrum, 695029, India
Christian Medical College, Vellore
Vellore, 632517, India
Apollo Hospitals Health City
Visakhapatnam, 530040, India
Ospedale Civile Ss. Antonio e Biagio
Alessandria, 15121, Italy
Asti-Ospedale Cardinal Massaia
Asti, 14100, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera ARNAS G. Brotzu
Cagliari, 09100, Italy
Chieri-Ospedale Maggiore
Chieri, 10023, Italy
Ospedale SS Annunziata
Chieti, 66100, Italy
A.S.O. S. Croce e Carle
Cuneo, 12100, Italy
Firenze-Ospedale San Giovanni di Dio
Florence, 50124, Italy
A. O. Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
Ospedale di Imola S. Maria della Scaletta
Imola, 40026, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Asst Santi Paolo E Carlo
Milan, 20142, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900, Italy
Ospedale Maggiore della Carità
Novara, 28100, Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, 43126, Italy
Fondazione Salvatore Maugeri
Pavia, 27100, Italy
Azienda Ospedaliera di Perugia
Perugia, 06129, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Prato-Ospedale Santo Stefano
Prato, 59100, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189, Italy
Ospedale Sant'Anna di San Fermo della Battaglia
San Fermo della Battaglia, 22020, Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (Foggia), 71013, Italy
Azienda Sociosanitaria Ligure 2
Savona, 17100, Italy
IRCCS MultiMedica
Sesto San Giovanni, 20099, Italy
Todi-Nuovo Ospedale Media Valle del Tevere
Todi, 06059, Italy
Torino-Ospedale Oftalmico
Turin, 0100, Italy
Ospedale Castelli - Verbania
Verbania, 28922, Italy
Ospedale San Bortolo
Vicenza, 36100, Italy
Asahikawa Medical University Hospital
Asahikawa-Shi, 078-8510, Japan
University of Yamanashi Hospital
Chuo-Shi, 409-3898, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Tokai University Hospital
Isehara, 259-1193, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Kawasaki Medical School Hospital
Kurashiki-Shi, 701-0192, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kansai Electric Power Hospital
Osaka, 553-0003, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
The University of Tokyo Hospital
Tokyo, 113-8655, Japan
National Center for Global Health and Medicine
Tokyo, 162-8655, Japan
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Selayang
Batu Caves, 68100, Malaysia
Hospital Sultanah Nora Ismail
Batu Pahat, 83000, Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
George Town, 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, 43000, Malaysia
Hospital Kajang
Kajang, Selangor, 43000, Malaysia
Hospital Tengku Ampuan Rahimah
Klang, 41200, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, 15586, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, 88586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Tuanku Ampuan Najihah
Kuala Pilah, 72000, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Hospital Kulim
Kulim, 09090, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, 84000, Malaysia
Hospital Seberang Jaya
Perai, 13700, Malaysia
Hospital Sultan Abdul Aziz Shah
Serdang, 43400, Malaysia
Hospital Tuanku Ja'afar
Seremban, 70300, Malaysia
Hospital Taiping
Taiping, Malaysia
Hospital Teluk Intan
Teluk Intan, 36000, Malaysia
Hospital Sultan Haji Ahmad Shah
Temerluh, 28000, Malaysia
Instituto de investigación aplicado a la neurociencia
Durango, 34000, Mexico
Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
Guadalajara, 44340, Mexico
Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente
Guadalajara, 44340, Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100, Mexico
Soluciones Terapéuticas Médico Quirúrgicas S. de R.L. de C.V.
Mexico City, 03650, Mexico
Hospital Juárez de México
Mexico City, 07760, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Merida Investigación Clínica
Mérida, 97125, Mexico
Iecsi S.C.
Monterrey, 64310, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Centro de Investigación Clínica Chapultepec S.A. de C.V.
Morelia, 58260, Mexico
IMSS Regional General Hospital 180
Tlajomulco de Zúñiga, 45653, Mexico
FAICIC S de RL de C.V.
Veracruz, 91900, Mexico
Dunedin Hospital
Dunedin, Otago, 9016, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Middlemore Hospital
Auckland, 2025, New Zealand
North Shore Hospital
Auckland, Takapuna, 0620, New Zealand
Taranaki Base Hospital
New Plymouth, 4310, New Zealand
ULS da Região de Aveiro
Aveiro, 3814-501, Portugal
CHLO, EPE - Hospital de Santa Cruz
Carnaxide, 2790-134, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3004-561, Portugal
Unidade Local de Saúde do Algarve, E.P.E
Faro, 8000-386, Portugal
SESARAM
Funchal, 9004-514, Portugal
ULS de São José
Lisbon, 1069-166, Portugal
Unidade Local de Saúde Santa Maria
Lisbon, 1649-035, Portugal
Hospital Beatriz Ângelo
Loures, 2674-514, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319, Portugal
Unidade Local de Saúde de Matosinhos
Senhora da Hora, 4464-513, Portugal
Unidade Local De Saude Da Arrabida E.P.E.
Setúbal, 2910-549, Portugal
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan-si, 31151, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Keimyung University Dongsan Hospital
Deagu, 42601, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, 10380, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, 14353, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
CHA Bundang Medical Center
Seongnam-si, 13496, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
E-Da Hospital
Kaohsiung City, 824005, Taiwan
Lotung Poh-Ai Hospital
Luodong Township, 265, Taiwan
Taipei Tzu Chi Hospital
New Taipei City, 23142, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Fu Jen Catholic University Hospital
New Taipei City, 243089, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Hospital, Liouying
Tainan, 736402, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Cathay General Hospital
Taipei, 106, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111045, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, 11696, Taiwan
TaoYuan General Hospital
Taoyuan, 330, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Antrim Area Hospital
Antrim, BT41 2RL, United Kingdom
Basildon Hospital
Basildon, SS16 5NL, United Kingdom
Ulster Hospital
Belfast, BT16 1RH, United Kingdom
Beltfast City Hospital
Belfast, BT9 7AB, United Kingdom
Ridgacre House Surgery
Birmingham, B32 2TJ, United Kingdom
Oakenhurst Medical Practice
Blackburn, BB2 1AX, United Kingdom
Royal County Sussex Hospital
Brighton, BN2 1ES, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Coniston Medical Practice
Bristol, BS34 5TF, United Kingdom
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ, United Kingdom
Broomfield Hospital
Chelmsford, CM1 7ET, United Kingdom
Hathaway Medical Centre
Chippenham, SN14 6GT, United Kingdom
Clevedon Medical Centre
Clevedon, BS21 6DG, United Kingdom
Queen Alexandra Hospital
Cosham, PO6 3LY, United Kingdom
Daisy Hill Hospital
County Down, BT35 8DR, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Orchard Court Surgery
Darlington, DL3 6HZ, United Kingdom
Darent Valley Hospital
Dartford, DA2 8DA, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Russells Hall Hospital
Dudley, DY1 2HQ, United Kingdom
University Health Centre
Durham, DH1 3JX, United Kingdom
Highland Clinical Research Facility
Fulwood, PR2 9HT, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
James Paget University Hospital
Great Yarmouth, NR31 6LA, United Kingdom
The Garth Surgery
Guisborough, TS14 7DJ, United Kingdom
Hereford County Hospital
Hereford, HR1 2BN, United Kingdom
Ipswich Hospital (UK)
Ipswich, IP4 5PD, United Kingdom
The Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
Ryeland Surgery
Leominster, HR6 8HD, United Kingdom
St Luke's Hospital
Little Horton Lane, BD5 0NA, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
North Middlesex University Hospital
London, N18 1QX, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
Linthorpe Surgery
Middlesbrough, TS5 6HA, United Kingdom
Norfolk and Norwich University Hospital
Norfolk, NR4 7UY, United Kingdom
Banbury Cross Health Centre
Oxford, OX16 9AD, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Pickering Medical Practice
Pickering, YO18 8BL, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Alexandra Hospital
Redditch, B98 7UB, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Southend University Hospital
Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 1, 2024
Study Start
August 13, 2024
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
August 30, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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.