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PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. 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 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. 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.
Official title: PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-03-23
Completion Date
2028-01-21
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
BI 764198
BI 764198
Placebo matching BI 764198
Placebo matching BI 764198
Locations (145)
Nephrology Consultants, LLC
Huntsville, Alabama, United States
Kidney Disease Medical Group
Glendale, California, United States
Academic Medical Research Institute - Glendale
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Colorado Kidney Center
Denver, Colorado, United States
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, United States
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Panoramic Health
Riverview, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
St. Clair Nephrology Research, LLC - Shelby Township
Shelby, Michigan, United States
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, New York, United States
NYU Langone Nephrology Associates-Mineola
Mineola, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Nephrotex Research Group
Dallas, Texas, United States
Provecta Researh Network
Houston, Texas, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada Velez Sarfield
Córdoba, Argentina
CardioAlem Investigaciones
San Isidro, Argentina
Nepean Hospital
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
AZORG Ziekenhuis
Aalst, Belgium
ULB Hopital Erasme
Brussels, Belgium
Az Maria Middelares Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Universidade Federal do Ceará
Fortaleza, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil
Instituto da Criança e do Adolescente
São Paulo, Brazil
CaRe Clinic (Calgary)
Calgary, Alberta, Canada
Victoria Hospital (LHSC)
London, Ontario, Canada
Maisonneuve-Rosemont Hospital
Monteral, Quebec, Canada
Peking University First Hospital
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
Guangdong Provincial People's Hospital
Guangzhou, 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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai General Hospital
Shanghai, China
People's Hospital of Sichuan Province
Sichuan, China
Renmin Hospital of Wuhan University
Wuhan, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China
Specialty Hospital Medico
Rijeka, Croatia
General Hospital Vinkovci
Vinkovci, Croatia
Clinical Hospital Sveti Duh
Zagreb, Croatia
Solmed Polyclinic
Zagreb, Croatia
University Hospital Dubrava
Zagreb, Croatia
Zealand University Hospita; Roskilde
Roskilde, Denmark
Tartu University Hospital
Tartu, Estonia
CHU Amiens-Picardie
Amiens, France
HOP Pellegrin
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
Hôpital Pasteur
Nice, France
Hôpital Necker
Paris, France
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitätsklinikum Köln (AöR)
Cologne, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
University General Hospital of Heraklion
Heraklion, Greece
General University Hospital of Patras
Pátrai, Greece
Aartham Multi Super Speciality Hospital
Ahmedabad, India
AIIMS Bhubaneshwar
Bhubaneswar, India
Government Medical College
Kozhikode, India
Noble Hospital Pvt Ltd
Pune, India
Galaxy Lifecare Services Pvt. Ltd.
Varanasi, India
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, Italy
Policlinico S. Orsola-Malpighi
Bologna, Italy
A.O.U.Policlinico G.Martino
Messina, Italy
Asst Santi Paolo E Carlo
Milan, Italy
Fondazione Salvatore Maugeri
Pavia, Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (FG), Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Kasugai Municipal Hospital
Aichi, Kasugai, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, Japan
Kobe University Hospital
Hyogo, Kobe, Japan
The Jikei University Hospital
Tokyo, Minato-ku, Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, Japan
Hospital Selayang
Batu Caves, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, Malaysia
Amsterdam UMC Locatie AMC
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Pacific Clinical Research Network - Auckland
Auckland, New Zealand
Waikato Hospital
Hamilton, 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
Central Clinical Hospital of the Medical University of Lodz
Lodz, Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
Pomorski Uniwersytet Medyczny w Szczecinie, Samodzielny Publiczny Szpital Kliniczny nr 2
Szczecin, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
Warsaw, Poland
Central Clinical Hospital of the Ministry of National Defence - Military Institute of Medicine
Warsaw, Poland
Unidade Local de Saúde de Almada-Seixal E.P.E.
Almada, Portugal
ULS Braga
Braga, 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
Institutul Clinic Fundeni
Bucharest, Romania
County Emergency Hospital "Pius Brinzeu" Timisoara
Timișoara, Romania
Singapore General Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, Slovakia
University Hospital and Comenius University in Bratislava, Derer´s Hospital
Bratislava, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
FMC Dialysis Services Kosice
Košice, Slovakia
Univ. Hospital Martin
Martin, Slovakia
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Danderyds Sjukhus
Danderyd, Sweden
Universitetssjukhuset, Linköping
Linköping, Sweden
Uppsala University Hospital
Uppsala, Sweden
Klinik Hirslanden
Zurich, Switzerland
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, 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)
Kocaeli University Faculty of Medicine Hospital
İzmit, Turkey (Türkiye)
Erciyes University
Melikgazi/Kayseri, Turkey (Türkiye)
Bradford Institute for Health Research
Bradford, United Kingdom
The Royal London Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Salford Royal
Salford, United Kingdom