PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
Start Date
3/23/2026
Completion Date
2/17/2028
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.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
BI 764198
Placebo matching BI 764198
Conditions
Locations
Nephrology Consultants, LLC
Huntsville, Alabama 35805
United States
Kidney Disease Medical Group
Glendale, California 91206
United States
Amicis Research Center - Balboa
Granada Hills, California 91344
United States
Academic Medical Research Institute - Glendale
Los Angeles, California 90022
United States
University of California Los Angeles
Los Angeles, California 90095
United States
Colorado Kidney Care
Denver, Colorado 80220
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 32806
United States
Florida Kidney Physicians - Riverview/Brandon
Riverview, Florida 33578
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Endeavor Health
Evanston, Illinois 60201
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
St. Clair Nephrology Research, LLC - Shelby Township
Shelby, Michigan 48315
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
Cleveland Clinic
Cleveland, Ohio 44195
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
United States
Southeast Renal Research Institute
Chattanooga, Tennessee 37404
United States
Nephrotex Research Group
Dallas, Texas 75231
United States
Provecta Researh Network
Houston, Texas 77027
United States
West Virginia University Medicine
Morgantown, West Virginia 26506
United States
Terapia Renal Domiciliaria
Buenos Aires, 1407
Argentina
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, C1425AGC
Argentina
Clinica Privada Velez Sarfield
Córdoba, 5000
Argentina
CardioAlem Investigaciones
San Isidro, B1642DCD
Argentina
Nepean Hospital
Kingswood, New South Wales 2747
Australia
John Hunter Hospital
New Lambton Heights, New South Wales 2305
Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
AZORG Ziekenhuis
Aalst, 9300
Belgium
Hopital Erasme
Brussels, 1070
Belgium
Az Maria Middelares Gent
Ghent, 9000
Belgium
UZ Leuven
Leuven, 3000
Belgium
Universidade Federal do Ceara
Fortaleza, 60110-110
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-000
Brazil
Instituto da Crianca e do Adolescente
São Paulo, 05403-901
Brazil
CaRe Clinic (Calgary)
Calgary, Alberta T2N 4L7
Canada
Victoria Hospital (LHSC)
London, Ontario N6A 5W9
Canada
Maisonneuve-Rosemont Hospital
Monteral, Quebec H1T 2M4
Canada
Peking University First Hospital
Beijing, 100034
China
Beijing Tsinghua Changgung Hospital
Beijing, 102218
China
West China Hospital, Sichuan University
Chengdu, 610041
China
Guangdong Provincial People's Hospital
Guangzhou, 510080
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
China
Shanghai General Hospital
Shanghai, 200080
China
People's Hospital of Sichuan Province
Sichuan, 610031
China
Renmin Hospital of Wuhan University
Wuhan, 430060
China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, 361004
China
Specijalna Bolnica Medico
Rijeka, 51000
Croatia
General Hospital Vinkovci
Vinkovci, 32100
Croatia
Clinical Hospital Sveti Duh
Zagreb, 10000
Croatia
Solmed Polyclinic
Zagreb, 10000
Croatia
University Hospital Dubrava
Zagreb, 10000
Croatia
Zealand University Hospita; Roskilde
Roskilde, 4000
Denmark
Tartu University Hospital
Tartu, 50406
Estonia
CHU Amiens-Picardie
Amiens, 80054
France
HOP Pellegrin
Bordeaux, 33076
France
Hopital Henri Mondor
Créteil, 94000
France
Hopital Pasteur
Nice, 06000
France
Hopital Necker
Paris, 75015
France
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
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675
Germany
University General Hospital of Heraklion
Heraklion, 71500
Greece
General University Hospital of Patras
Pátrai, 265 04
Greece
Aartham Multi Super Speciality Hospital
Ahmedabad, 380015
India
AIIMS Bhubaneshwar
Bhubaneswar, 751019
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
JSS Medical College
Mysore, 570015
India
Noble Hospital Pvt Ltd
Pune, 411013
India
Galaxy Lifecare Services Pvt. Ltd.
Varanasi, 201010
India
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
Italy
Policlinico S. Orsola-Malpighi
Bologna, 40138
Italy
A.O.U.Policlinico G.Martino
Messina, 98124
Italy
Asst Santi Paolo E Carlo
Milan, 20142
Italy
Fondazione Salvatore Maugeri
Pavia, 27100
Italy
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (FG), 71013
Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Italy
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510
Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, 466-8650
Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
Japan
Kobe University Hospital
Hyogo, Kobe, 650-0017
Japan
The Jikei University Hospital
Tokyo, Minato-ku, 105-8471
Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666
Japan
Hospital Selayang
Batu Caves, 68100
Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, 43000
Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, 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
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal
Monterrey, 64060
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Tlalpan, 14080
Mexico
Amsterdam UMC Locatie AMC
Amsterdam, 1105 AZ
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Pacific Clinical Research Network - Auckland
Auckland, 622
New Zealand
Waikato Hospital
Hamilton, 3204
New Zealand
Akershus Universitetssykehus HF
Lørenskog, 1478
Norway
Oslo Universitetssykehus HF, Ulleval sykehus
Oslo, 0450
Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011
Norway
Universitetssykehuset Nord-Norge, Tromso
Tromsø, 9019
Norway
Central Clinical Hospital of the Medical University of Lodz
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
Unidade Local de Saúde de Almada-Seixal E.P.E.
Almada, 2805-267
Portugal
ULS Braga
Braga, 4710-243
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
Institutul Clinic Fundeni
Bucharest, 022328
Romania
County Emergency Hospital "Pius Brinzeu" Timisoara
Timișoara, 300723
Romania
Singapore General Hospital
Singapore, 169608
Singapore
Tan Tock Seng Hospital
Singapore, 308433
Singapore
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 975 17
Slovakia
University Hospital and Comenius University in Bratislava, Derer´s Hospital
Bratislava, 833 05
Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, 04011
Slovakia
FMC Dialysis Services Kosice
Košice, 40190
Slovakia
Univerzitna Nemocnica Martin
Martin, 036 01
Slovakia
Kyung Hee University Hospital at Gangdong
Seoul, 05278
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
Spain
Danderyds Sjukhus
Danderyd, 182 88
Sweden
Universitetssjukhuset, Linköping
Linköping, 581 85
Sweden
Uppsala University Hospital
Uppsala, 751 85
Sweden
Klinik Hirslanden
Zurich, 8032
Switzerland
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 Taiwan University Hospital
Taipei, 100225
Taiwan
Adana City Hospital
Adana, 01220
Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06200
Turkey (Türkiye)
Bursa Uludag University
Bursa, 16110
Turkey (Türkiye)
Istanbul Capa University
Istanbul, 34093
Turkey (Türkiye)
Kocaeli University Faculty of Medicine Hospital
İzmit, 41000
Turkey (Türkiye)
Erciyes University
Melikgazi/Kayseri, 38039
Turkey (Türkiye)
Bradford Institute for Health Research
Bradford, BD9 6RJ
United Kingdom
The Royal London Hospital
London, E1 1BB
United Kingdom
King's College Hospital
London, SE5 9RS
United Kingdom
Salford Royal
Salford, M6 8HD
United Kingdom