A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
3 other identifiers
interventional
286
39 countries
288
Brief Summary
PODOMOUNT-pFSGS This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health 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 P50-P75 for phase_3
Started Feb 2026
Typical duration for phase_3
288 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
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 23, 2025
CompletedStudy Start
First participant enrolled
February 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2029
July 23, 2026
July 1, 2026
2.9 years
October 22, 2025
July 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104
24-hour urinary protein-to-creatinine ratio (24-hr UPCR)
Baseline and Week 104
Secondary Outcomes (6)
Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104
Baseline and Week 104
Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104
At Week 104
Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint)
At Week 104
Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104
At Week 104
Change from baseline across disease-specific clinical outcome assessment (COA) NS-SIM-PRO at Week 104
Baseline and Week 104
- +1 more secondary outcomes
Study Arms (2)
BI 764198 treatment
EXPERIMENTALPlacebo treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- Weight of ≥40 kg at the screening visit (Visit 1)
- Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
- Participants with a diagnosis prior to the screening visit (Visit 1) of either:
- Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
- Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
- Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- Estimated glomerular filtration rate (eGFR)
- For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)
You may not qualify if:
- Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
- FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
- A history of organ transplantation or planned organ transplantation during the course of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (296)
Alabama Kidney Research
Alabaster, Alabama, 35007, United States
Apogee Clinical Research
Huntsville, Alabama, 35805, United States
Southwest Kidney Institute
Surprise, Arizona, 85374-4840, United States
West Coast Kidney Institute
Fremont, California, 94538, United States
Kidney Disease Medical Group
Glendale, California, 91206, United States
Amicis Research Center - Balboa
Granada Hills, California, 91344, United States
Valiance Clinical Research
Huntington Park, California, 90255, United States
Academic Medical Research Institute - Glendale
Los Angeles, California, 90022, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, 90027, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Shasta Critical Care Specialists
Redding, California, 96001, United States
North America Research Institute
San Dimas, California, 91773, United States
Kaiser Permanente - French Campus
San Francisco, California, 94118, United States
Valiance Clinical Research-Tarzana-68237
Tarzana, California, 91356, United States
National Institute of Clinical Research - Victorville
Victorville, California, 92392, United States
Kidney Associates of Colorado - Denver
Denver, Colorado, 80210, United States
Colorado Kidney Care
Denver, Colorado, 80220, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, 33487, United States
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, Florida, 33316, United States
Total Research Group, LLC
Miami, Florida, 33126, United States
CTR Oakwater, LLC
Orlando, Florida, 32808, United States
Florida Kidney Physicians - Riverview/Brandon
Riverview, Florida, 33578, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Coastal Medical Research, LLC
Brunswick, Georgia, 31520, United States
Southeast Kidney Associates - East Point
East Point, Georgia, 30344, United States
Memorial Health University Hospital
Savannah, Georgia, 31404, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Endeavor Health
Evanston, Illinois, 60201, United States
Nephrology Physicians - Mishawaka
Mishawaka, Indiana, 46545, United States
Wichita Nephrology Group
Wichita, Kansas, 67214, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Paragon Health Nephrology Center - Kalamazoo
Kalamazoo, Michigan, 49007, United States
St. Clair Nephrology Research, LLC - Shelby Township
Utica, Michigan, 48315, United States
Elixia MNA, LLC
City of Saint Peters, Missouri, 63376, United States
DaVita Clinical Research-Las Vegas-67781
Las Vegas, Nevada, 89107, United States
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, New York, 12065, United States
NYU Langone Nephrology Associates-Mineola
Mineola, New York, 11501, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolina Kidney Associates
Greensboro, North Carolina, 27405-3654, United States
Cardinal Clinical Research, LLC - Shelby
Shelby, North Carolina, 28150, United States
The Kidney and Hypertension Center
Cincinnati, Ohio, 45212, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
Clinical Renal Associates
Exton, Pennsylvania, 19341, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Nephrology Associates, Inc
East Providence, Rhode Island, 02914-2641, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
Texas Tech University Health Sciences Center-Amarillo-63885
Amarillo, Texas, 79106, United States
Nephrotex Research Group
Dallas, Texas, 75231, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Provecta Researh Network
Houston, Texas, 77027, United States
Provecta Research Path Forward Ventures
Humble, Texas, 77338, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Utah Kidney Research Institute
Salt Lake City, Utah, 84115, United States
Virginia Nephrology
Arlington, Virginia, 22205, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, 22150, United States
Virginia Commonwealth University
Richmond, Virginia, 23233, United States
West Virginia University Medicine
Morgantown, West Virginia, 26506, United States
Terapia Renal Domiciliaria
Buenos Aires, 1407, Argentina
Hospital Italiano de Buenos Aires
CABA, C1199ABB, Argentina
CEMIC
CABA, C1431FWO, Argentina
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, C1425AGC, Argentina
Clinica Privada Velez Sarfield
Córdoba, 5000, Argentina
Hospital Universitario Austral
Pilar, B1629ODT, Argentina
CardioAlem Investigaciones
San Isidro, B1642DCD, Argentina
Centro Integral de Medicina Respiratória - CIMER
San Miguel de Tucumán, 4000, Argentina
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Griffith Health
Southport, Queensland, 4222, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
AZORG Ziekenhuis
Aalst, 9300, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Synvia
Campinas, 13087-567, Brazil
Universidade Federal do Ceara
Fortaleza, 60110-110, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, 50670-901, Brazil
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002, Brazil
Centro de Pesquisa Clínica de Nefrologia do ICHC
São Paulo, 05403-000, Brazil
Instituto da Crianca e do Adolescente
São Paulo, 05403-901, Brazil
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Pleven, 5809, Bulgaria
Medicinski Centar Hipokrat-N EOOD
Plovdiv, 4000, Bulgaria
Medical Center "Pulmovision"
Sofia, 1756, Bulgaria
Victoria Hospital (LHSC)
London, Ontario, N6A 5W9, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
The First Affiliated Hospital of Baotou Medical College
Baotou, 014010, China
Peking University First Hospital
Beijing, 100034, China
Beijing Tsinghua Changgung Hospital
Beijing, 102218, China
The Second Hospital of Jilin University
Changchun, 130041, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital, Sichuan University
Chengdu, 610041, China
People's Hospital of Sichuan Province
Chengdu, 610072, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The First People's Hospital of Nanning
Nanning, 530000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Shanghai General Hospital
Shanghai, 200080, China
Shanxi Provincial People's Hospital
Taiyuan, 030000, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, 361004, China
University Hospital Dubrava
Zagreb, 10 000, Croatia
Clinical Hospital Sveti Duh
Zagreb, 10000, Croatia
Poliklinika Bonifarm Zagreb
Zagreb, 10000, Croatia
Solmed Polyclinic
Zagreb, 10000, Croatia
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100, Denmark
Zealand University Hospita; Roskilde
Roskilde, 4000, Denmark
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419, Estonia
Helsinki University Central Hospital, Meilahti hospital
Helsinki, FI-00290, Finland
CHU Amiens-Picardie
Amiens, 80054, France
HOP Pellegrin
Bordeaux, 33076, France
HOP de la Cavale Blanche
Brest, 29200, France
Hopital Henri Mondor
Créteil, 94000, France
Hôpital Edouard Herriot
Lyon, 69437, France
Hopital Pasteur
Nice, 06000, France
CHU de Nîmes
Nîmes, 30029, France
Hopital Necker
Paris, 75015, France
HOP Nancy
Vandœuvre-lès-Nancy, 54500, France
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 112, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 144, Georgia
M.Iashvili Children's Hospital
Tbilisi, 159, Georgia
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universität Leipzig
Leipzig, 04103, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97080, Germany
University General Hospital of Heraklion
Heraklion, 71500, Greece
Univ. Gen. Hosp. of Patras
Pátrai, 26504, Greece
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Aartham Multi Super Speciality Hospital
Ahmedabad, 380015, India
Zydus Hospital - Ahmedabad
Ahmedabad, 380054, India
AIIMS Bhubaneshwar
Bhubaneswar, 751019, India
S.P. Medical College & Associated Group of Hospitals
Bikaner, 334003, India
Madras Medical College and Rajiv Gandhi Government General Hospital
Chennai, 600032, India
Sri Ramchandra Institute
Chennai, 600116, India
Shri Mahant Indiresh Hospital
Dehradun, 248001, India
Sir Gangaram Hospital
Delhi, 110060, India
Osmania Medical College & Hospital
Hyderabad, 500012, India
Nizam's Institute of Medical Sciences
Hyderabad, 500082, India
Government Medical College
Kozhikode, 673008, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226014, India
Kasturba Medical College and Hospital
Manipal, 576104, India
Nutema Hospital
Meerut, 250004, India
KEM Hospital and Seth G S Medical College
Mumbai, 400012, India
P.D. Hinduja National Hospital
Mumbai, 400016, India
JSS Medical College
Mysore, 570015, India
Noble Hospital Pvt Ltd
Pune, 411013, India
Galaxy Lifecare Services Pvt. Ltd.
Varanasi, 201010, India
Sunrise Hospital
Vijayawada, 520002, India
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124, Italy
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Asst Santi Paolo E Carlo
Milan, 20142, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione Salvatore Maugeri
Pavia, 27100, Italy
ASST dei Sette Laghi
Varese, 21100, Italy
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510, Japan
Daido Clinic
Aichi, Nagoya, 457-8511, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, 466-8650, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Kobe University Hospital
Hyogo, Kobe, 650-0017, Japan
Saiseikai Yokohamashi Nanbu Hospital
Kanagawa, Yokohama, 234-0054, Japan
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004, Japan
Nara Prefecture General Medical Center
Nara, Nara, 630-8581, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Dokkyo Medical University Saitama Medical Center
Saitama, Koshigaya, 343-8555, Japan
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, 193-0998, Japan
The Jikei University Hospital
Tokyo, Minato-ku, 105-8471, Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666, Japan
Hospital Sultan Idris Shah Serdang
Kajang, 43000, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, 88586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Lembah Pantai, 59100, Malaysia
Hospital Tuanku Ja'afar
Negeri Sembilan, 70300, Malaysia
Sunway Medical Centre
Subang Jaya, 47500, Malaysia
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259, Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100, Mexico
Soltmed Smo
Mexico City, 03650, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14080, Mexico
Servicios de Oncología Médica Integral, S.A. de C.V. Sucursal Renal
Monterrey, 64060, Mexico
Amsterdam UMC Locatie AMC
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Waikato Hospital
Hamilton, Waikato Region, 3204, New Zealand
New Zealand Clinical Research (NZCR) Christchurch
Christchurch, 8011, New Zealand
Taranaki Base Hospital
New Plymouth, 4310, New Zealand
Optimal Clinical Trials North
Rosedale, Auckland, 0632, New Zealand
Akershus Universitetssykehus HF
Lørenskog, N-1478, Norway
Oslo Universitetssykehus HF, Ulleval sykehus
Oslo, 450, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011, Norway
Universitetssykehuset Nord-Norge, Tromso
Tromsø, 9019, Norway
Manila Doctors Hospital
Manila, 1000, Philippines
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, 92-213, Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Szczecin, 70-111, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
Warsaw, 02-091, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-141, Poland
4th Military Clinical Hospital with a Polyclinic
Wroclaw, 50-981, Poland
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
Almada, 2801-951, Portugal
ULS de Amadora/ Sintra, E.P.E. - Hospital Professor Doutor Fernando Fonseca
Amadora, 2720-276, Portugal
ULS Braga
Braga, 4710-243, Portugal
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561, Portugal
ULS de São José
Lisbon, 1069-166, Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1649-035, Portugal
Unidade Local de Saúde Lisboa Occidental, E.P.E
Lisbon, 2790-134, Portugal
ULS de Loures-Odivelas, E.P.E
Loures, 2674-514, Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, 4099-001, Portugal
Unidade Local de Saúde da Arrábida,E.P.E
Setúbal, 2910-549, Portugal
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Clinic Judetean de urgenta Cluj
Cluj-Napoca, 400006, Romania
Spitalul Clinic Judetean de Urgenta Bihor
Oradea, 410469, Romania
County Emergency Hospital "Pius Brinzeu" Timisoara
Timișoara, 300723, Romania
King Fahad Specialist Hospital - Research Center
Dammam, 31444, Saudi Arabia
Imam Abdulrahman bin Faisal University
Dammam, 34221, Saudi Arabia
National University Hospital
Singapore, 117599, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, 97409, Slovakia
Faculty hospital with clinics F.D. Roosevelta
Banská Bystrica, 97409, Slovakia
University Hospital and Comenius University in Bratislava, Derer´s Hospital
Bratislava, 833 05, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, 040 11, Slovakia
Univerzitna Nemocnica Martin
Martin, 036 01, Slovakia
Pusan National University Hospital
Busan, 49241, South Korea
Samsung Medical Center
Gangnam-gu, 06351, South Korea
Inje University Ilsan Paik Hospital
Goyang, 411 706, South Korea
Severance Hospital
Seoul, 03722, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Complejo Hospitalario Torrecárdenas
Almería, 04009, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Sant Joan de Déu
Barcelona, 08950, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Universitetssjukhuset, Linköping
Linköping, 581 85, Sweden
Skånes universitetssjukhus
Lund, 221 85, Sweden
Karolinska Universitetssjukhuset
Stockholm, 141 86, Sweden
Danderyds Sjukhus
Stockholm, 182 88, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
University Hospital Bern
Bern, 3010, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Buddhist Tzu Chi General Hospital-Hualien-20741
Hualien City, 970, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Maharaj Nakom Chiangmai Hospital
Chiang Mai, 50200, Thailand
Adana City Hospital
Adana, 01220, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06200, Turkey (Türkiye)
Malatya Inonu University Hospital
Battalgazi / Malatya, 44280, Turkey (Türkiye)
Bursa Uludag University
Bursa, 16110, Turkey (Türkiye)
Istanbul Capa University
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Kocaeli University Faculty of Medicine Hospital
İzmit, 41000, Turkey (Türkiye)
Erciyes University
Melikgazi/Kayseri, 38039, Turkey (Türkiye)
Afyon Kocatepe University Hospital
Merkez / Afyonkarahisar, 03100, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
Sakarya Üniversitesi Tıp Fakültesi
Sakarya, 54187, Turkey (Türkiye)
Clatterbridge Hospital
Bebington, CH63 4JY, United Kingdom
Bradford Institute for Health Research
Bradford, BD9 6RJ, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Salford Royal
Salford, M6 8HD, United Kingdom
Related Links
MeSH Terms
Conditions
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
October 22, 2025
First Posted
October 23, 2025
Study Start
February 16, 2026
Primary Completion (Estimated)
December 27, 2028
Study Completion (Estimated)
January 24, 2029
Last Updated
July 23, 2026
Record last verified: 2026-07
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'spublication 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.