A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
NCT ID: NCT07220083
Last Updated: 2025-11-12
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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NOT_YET_RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2025-12-05
2029-12-18
Brief Summary
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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.
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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BI 764198 treatment
BI 764198
BI 764198
Placebo treatment
Placebo
Placebo matching BI 764198
Interventions
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BI 764198
BI 764198
Placebo
Placebo matching BI 764198
Eligibility Criteria
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Inclusion Criteria
2. Weight of ≥40 kg at the screening visit (Visit 1)
3. Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
4. 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)
5. Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
6. 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 combined serum creatinine plus cystatin C) at the screening visit (Visit 1)
Exclusion Criteria
2. Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator's judgement)
3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
4. A history of organ transplantation or planned organ transplantation during the course of the trial
12 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Alabama Kidney Research
Alabaster, Alabama, United States
Nephrology Consultants, LLC
Huntsville, Alabama, United States
Amicis Research Center - Balboa
Granada Hills, California, United States
Academic Medical Research Institute - Glendale
Los Angeles, California, United States
North America Research Institute
San Dimas, California, United States
Valiance Clinical Research-Tarzana-68237
Tarzana, California, United States
National Institute of Clinical Research - Victorville
Victorville, California, United States
Colorado Kidney Center
Denver, Colorado, United States
Total Research Group, LLC
Miami, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Panoramic Health
Riverview, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
St. Clair Nephrology Research, LLC - Shelby Township
Utica, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
DaVita Clinical Research-Las Vegas-67781
Las Vegas, Nevada, United States
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Clinical Renal Associates
Exton, Pennsylvania, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Texas Tech University Health Sciences Center-Amarillo-63885
Amarillo, Texas, United States
Provecta Researh Network
Houston, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Virginia Nephrology
Arlington, Virginia, United States
Terapia Renal Domiciliaria
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
CEMIC
CABA, , Argentina
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Privada Velez Sarfield
Córdoba, , Argentina
Hospital Universitario Austral
Pilar, , Argentina
CardioAlem Investigaciones
San Isidro, , Argentina
Nepean Hospital
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Griffith Health
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
AZORG Ziekenhuis
Aalst, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Synvia
Campinas, , Brazil
Universidade Federal do Ceará
Fortaleza, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Universidade Federal Pernambuco
Recife, , Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, , Brazil
Centro de Pesquisa Clínica de Nefrologia do ICHC
São Paulo, , Brazil
The First Affiliated Hospital of Baotou Medical College
Baotou, , China
Peking University First Hospital
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
People's Hospital of Sichuan Province
Chengdu, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Guizhou People's Hospital
Guiyang, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Lanzhou University Second Hospital
Lanzhou, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Zhongda Hospital Southeast University
Nanjing, , China
The First People's Hospital of Nanning
Nanning, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shanxi Provincial People's Hospital
Taiyuan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, , China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, , China
Clinical Hospital Sveti Duh
Zagreb, , Croatia
Poliklinika Bonifarm Zagreb
Zagreb, , Croatia
Copenhagen University Hospital, Rigshospitalet
København Ø, , Denmark
Zealand University Hospita; Roskilde
Roskilde, , Denmark
HOP Amiens-Picardie Sud
Amiens, , France
HOP Pellegrin
Bordeaux, , France
HOP de la Cavale Blanche
Brest, , France
Hôpital Henri Mondor
Créteil, , France
HOP Edouard Herriot
Lyon, , France
HOP Pasteur
Nice, , France
HOP Nîmes
Nîmes, , France
HOP Necker
Paris, , France
HOP Nancy
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universität Leipzig
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
University General Hospital of Heraklion
Heraklion, , Greece
Univ. Gen. Hosp. of Patras
Pátrai, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Aartham Multi Super Speciality Hospital
Ahmedabad, , India
Government Medical College
Kozhikode, , India
Noble Hospital Pvt Ltd
Pune, , India
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, , Italy
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Asst Santi Paolo E Carlo
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Fondazione Salvatore Maugeri
Pavia, , Italy
ASST dei Sette Laghi
Varese, , Italy
Kasugai Municipal Hospital
Aichi, Kasugai, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, , Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, , Japan
Saiseikai Yokohamashi Nanbu Hospital
Kanagawa, Yokohama, , Japan
Nara Prefecture General Medical Center
Nara, Nara, , Japan
Dokkyo Medical University Saitama Medical Center
Saitama, Koshigaya, , Japan
The Jikei University Hospital
Tokyo, Minato-ku, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Lembah Pantai, , Malaysia
Sunway Medical Centre
Subang Jaya, , Malaysia
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, , Mexico
Amsterdam UMC Locatie AMC
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Optimal Clinical Trials - Christchurch
Christchurch, , New Zealand
Akershus Universitetssykehus HF
Lørenskog, , Norway
Oslo Universitetssykehus HF, Ullevål sykehus
Oslo, , Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, , Norway
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, , Norway
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, , Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Pomorski Uniwersytet Medyczny w Szczecinie, Samodzielny Publiczny Szpital Kliniczny nr 2
Szczecin, , Poland
Centralny Szpital Kliniczny MON WIM
Warsaw, , Poland
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
Almada, , Portugal
ULS de Amadora/ Sintra, E.P.E. - Hospital Professor Doutor Fernando Fonseca
Amadora, , Portugal
ULS Braga
Braga, , Portugal
ULS de Coimbra, E.P.E.
Coimbra, , Portugal
ULS de São José
Lisbon, , Portugal
ULS de Santa Maria, E.P.E
Lisbon, , Portugal
Unidade Local de Saúde Lisboa Occidental, E.P.E
Lisbon, , Portugal
ULS de Loures-Odivelas, E.P.E
Loures, , Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, , Portugal
Unidade Local de Saúde da Arrábida,E.P.E
Setúbal, , Portugal
Fundeni Clinical Institute
Bucharest, , Romania
Cluj Napoca Clinical County Hospital
Cluj-Napoca, , Romania
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Univerzitna nemocnica L. Pasteura Kosice
Košice, , Slovakia
Univ. Hospital Martin
Martin, , Slovakia
Samsung Medical Center
Gangnam-gu, , South Korea
Inje University Ilsan Paik Hospital
Goyang-si, , South Korea
Complejo Hospitalario Torrecárdenas
Almería, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Danderyds Sjukhus
Danderyd, , Sweden
Universitetssjukhuset, Linköping
Linköping, , Sweden
Skånes universitetssjukhus
Lund, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
University Hospital Bern
Bern, , Switzerland
Buddhist Tzu Chi General Hospital-Hualien-20741
Hualien City, , Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Adana City Hospital
Adana, , Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Bursa Uludag University
Bursa, , Turkey (Türkiye)
İstanbul Çapa University
Istanbul, , Turkey (Türkiye)
Erciyes University
Melikgazi/Kayseri, , Turkey (Türkiye)
Clatterbridge Hospital
Bebington, , United Kingdom
NIHR Bradford and West Yorkshire CRDC
Bradford, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
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Related Links
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Related Info
Other Identifiers
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2025-522191-86
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1326-1647
Identifier Type: REGISTRY
Identifier Source: secondary_id
1434-0017
Identifier Type: -
Identifier Source: org_study_id