Proteinuric Kidney DiseasesPhase 2NCT07355296
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
A Phase 2 study testing BI 764198 in people with Proteinuric Kidney Diseases, run by Boehringer Ingelheim at 154 sites in 32 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Proteinuric Kidney Diseases
- What is being tested?
- BI 764198
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 154 sitesin 32 countries
- Study dates
- 23 Mar 2026to 17 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
- Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
- Weight of ≥40 kg at screening
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit
- For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit
- For adolescent participants (<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit
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- Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants <18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants <18)
- Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator
- If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)
- Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period
- Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.
- Further inclusion criteria apply.
Who cannot join
- A history of organ transplantation or planned transplantation during the course of the study
- Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
- Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
- Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
- Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit (Visit 1)
- Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit
- QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.
Trial locations and contacts
154 sites in 32 countries. Contact the study team or a site near you to ask about taking part.
154 sites in 32 countries
United States24 sites, 24 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, 33487
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
New York Nephrology and Dialysis Access Surgery, PC
Clifton Park, New York, 12065
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Colorado Kidney Care
Denver, Colorado, 80220
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, Florida, 33316
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Kidney Disease Medical Group
Glendale, California, 91206
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Amicis Research Center - Balboa
Granada Hills, California, 91344
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Provecta Researh Network
Houston, Texas, 77027
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Academic Medical Research Institute - Glendale
Los Angeles, California, 90022
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Total Research Group, LLC
Miami, Florida, 33126
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
NYU Langone Nephrology Associates-Mineola
Mineola, New York, 11501
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
West Virginia University Medicine
Morgantown, West Virginia, 26506
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
CTR Oakwater, LLC
Orlando, Florida, 32806
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Florida Kidney Physicians - Riverview/Brandon
Riverview, Florida, 33578
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
St. Clair Nephrology Research, LLC - Shelby Township
Shelby, Michigan, 48315
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
China12 sites, 12 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, 102218
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zhongda Hospital Southeast University
Nanjing, 210009
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First People's Hospital of Nanning
Nanning, 530000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Provincial People's Hospital
Sichuan, 610031
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, 430060
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, 361004
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
India8 sites, 8 recruiting
- Recruiting
Aartham Multi Super Speciality Hospital
Ahmedabad, 380015
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
AIIMS Bhubaneshwar
Bhubaneswar, 751019
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Osmania Medical College & Hospital
Hyderabad, 500012
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Nizam's Institute of Medical Sciences
Hyderabad, 500082
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Government Medical College
Kozhikode, 673008
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226014
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Noble Hospital Pvt Ltd
Pune, 411013
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Recruiting
Galaxy Lifecare Services Pvt. Ltd.
Varanasi, 201010
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Italy8 sites, 8 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Policlinico S. Orsola-Malpighi
Bologna, 40138
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
A.O.U.Policlinico G.Martino
Messina, 98124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Asst Santi Paolo E Carlo
Milan, 20142
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Salvatore Maugeri
Pavia, 27100
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
IRCCS Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo (FG), 71013
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Germany7 sites, 7 recruiting
- Recruiting
Vivantes Klinikum im Friedrichshain
Berlin, 10249
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Köln (AöR)
Cologne, 50937
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Klinikum rechts der Isar der Technischen Universität München
München, 81675
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan6 sites, 6 recruiting
- Recruiting
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Aichi, Nagoya, 466-8650
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kobe University Hospital
Hyogo, Kobe, 650-0017
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
The Jikei University Hospital
Tokyo, Minato-ku, 105-8471
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Mexico6 sites, 6 recruiting
- Not yet recruiting
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Soltmed Smo
Mexico City, 03650
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal
Monterrey, 64060
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Instituto Nacional de Cardiologia Ignacio Chavez
Tlalpan, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Turkey (Türkiye)6 sites, 6 recruiting
- Not yet recruiting
Adana City Hospital
Adana, 01220
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Ankara Etlik City Hospital
Ankara, 06200
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Bursa Uludag University
Bursa, 16110
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Istanbul Capa University
Istanbul, 34093
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Kocaeli University Faculty of Medicine Hospital
İzmit, 41000
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Erciyes University
Melikgazi/Kayseri, 38039
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
Australia5 sites, 5 recruiting
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Nepean Hospital
Kingswood, New South Wales, 2747
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Brazil5 sites, 5 recruiting
- Recruiting
Universidade Federal do Ceara
Fortaleza, 60110-110
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Instituto da Crianca e do Adolescente
São Paulo, 05403-901
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Croatia5 sites, 5 recruiting
- Recruiting
Specijalna Bolnica Medico
Rijeka, 51000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Recruiting
General Hospital Vinkovci
Vinkovci, 32100
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Recruiting
Clinical Hospital Sveti Duh
Zagreb, 10000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Recruiting
Solmed Polyclinic
Zagreb, 10000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Recruiting
University Hospital Dubrava
Zagreb, 10000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
France5 sites, 5 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Pellegrin
Bordeaux, 33076
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hopital Henri Mondor
Créteil, 94000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hopital Pasteur
Nice, 06000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hopital Necker
Paris, 75015
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Portugal5 sites, 5 recruiting
- Recruiting
Unidade Local de Saúde de Almada-Seixal E.P.E.
Almada, 2805-267
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de Braga, E.P.E
Braga, 4710-243
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Unidade Local de Saúde Lisboa Occidental, E.P.E
Lisbon, 2790-134
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de Loures-Odivelas, E.P.E
Loures, 2674-514
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Slovakia5 sites, 5 recruiting
- Not yet recruiting
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 975 17
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Not yet recruiting
University Hospital and Comenius University in Bratislava, Derer´s Hospital
Bratislava, 833 05
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Recruiting
Univerzitna nemocnica L. Pasteura Kosice
Košice, 04011
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Not yet recruiting
FMC Dialysis Services Kosice
Košice, 40190
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Recruiting
Univerzitna Nemocnica Martin
Martin, 036 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
Argentina4 sites, 4 recruiting
- Recruiting
Terapia Renal Domiciliaria
Buenos Aires, 1407
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, C1425AGC
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Privada Velez Sarfield
Córdoba, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
CardioAlem Investigaciones
San Isidro, B1642DCD
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Poland4 sites, 4 recruiting
- Not yet recruiting
Central Clinical Hospital of the Medical University of Lodz
Lodz, 92-213
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie
Warsaw, 02-091
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-141
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Taiwan4 sites, 4 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
China Medical University Hospital
Taichung, 40447
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
United Kingdom4 sites, 4 recruiting
- Recruiting
Bradford Institute for Health Research
Bradford, BD9 6RJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal London Hospital
London, E1 1BB
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
King's College Hospital
London, SE5 9RS
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Salford Royal Hospital
Salford, M6 8HD
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Belgium3 sites, 3 recruiting
- Recruiting
AZORG Ziekenhuis
Aalst, 9300
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Az Maria Middelares Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Selayang
Batu Caves, 68100
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Sultan Idris Shah Serdang
Kajang, 43000
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Sunway Medical Centre
Selangor Darul Ehsan, 47500
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
Norway3 sites, 3 recruiting
- Recruiting
Akershus Universitetssykehus HF
Lørenskog, 1478
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Oslo Universitetssykehus HF, Ulleval sykehus
Oslo, 0450
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Universitetssykehuset Nord-Norge, Tromso
Tromsø, 9019
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Sweden3 sites, 3 recruiting
- Recruiting
Danderyds Sjukhus
Danderyd, 182 88
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Universitetssjukhuset Linköping
Linköping, 581 85
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Canada2 sites, 2 recruiting
- Recruiting
CaRe Clinic (Calgary)
Calgary, Alberta, T2N 4L7
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Victoria Hospital (LHSC)
London, Ontario, N6A 5W9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Amsterdam UMC Locatie AMC
Amsterdam, 1105 AZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
New Zealand2 sites, 2 recruiting
- Recruiting
Pacific Clinical Research Network - Auckland
Auckland, 622
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
- Recruiting
Waikato Hospital
Hamilton, 3204
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
Romania2 sites, 2 recruiting
- Recruiting
Institutul Clinic Fundeni
Bucharest, 022328
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
County Emergency Hospital Pius Brinzeu Timisoara
Timișoara, 300723
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
South Korea2 sites, 2 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Ajou University Hospital
Suwon, 16499
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospita; Roskilde
Roskilde, 4000
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
Greece1 site, 1 recruiting
- Recruiting
General University Hospital of Patras
Pátrai, 265 04
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Switzerland1 site, 1 recruiting
- Recruiting
Klinik Hirslanden
Zurich, 8032
Boehringer Ingelheim, 0800005900, suisse@bitrialsupport.com
About this study
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
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.
- Conditions
- Proteinuric Kidney Diseases
- Being tested
- BI 764198, Placebo matching BI 764198
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764198Drug
Also called Apecotrep
BI 764198
Placebo matching BI 764198Drug
Placebo matching BI 764198
| Study group | Role | What they receive |
|---|---|---|
| Secondary focal segmental glomerulosclerosis (sFSGS) cohort | Experimental | Not described Receives: Drug: BI 764198 |
| Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort | Experimental | Not described Receives: Drug: BI 764198 |
| Alport Syndrome cohort | Experimental | Not described Receives: Drug: BI 764198 |
| Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort | Experimental | Not described Receives: Drug: BI 764198 |
| Placebo cohort | Placebo comparator | Not described Receives: Drug: Placebo matching BI 764198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
Measured: At baseline and week 20
Secondary outcomes (3)
Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20
Measured: At baseline and week 20
Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
Measured: At baseline and week 20
Absolute change in estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20
Measured: At baseline and week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start23 Mar 2026
- Primary completion20 Jan 2028 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteinuric Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- basket trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355296
- Sponsor's protocol ID
- 1434-0027
- Other IDs
- 2025-523425-17, U1111-1328-7108, 2025
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07355296
- Acronym / sponsor ID
- 1434-0027
- Conditions
- Proteinuric Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- basket trial
| Arm | Type | Receives |
|---|---|---|
| Secondary focal segmental glomerulosclerosis (sFSGS) cohort | Experimental | Drug: BI 764198 |
| Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort | Experimental | Drug: BI 764198 |
| Alport Syndrome cohort | Experimental | Drug: BI 764198 |
| Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort | Experimental | Drug: BI 764198 |
| Placebo cohort | Placebo comparator | Drug: Placebo matching BI 764198 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
- Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
- Weight of ≥40 kg at screening
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit
- Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants <18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants <18)
Key exclusion criteria (8 listed)
- A history of organ transplantation or planned transplantation during the course of the study
- Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
- Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
- Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
- Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764198Also: ApecotrepBI 764198 | Drug | Alport Syndrome cohort, Secondary focal segmental glomerulosclerosis (sFSGS) cohort, Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort, Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort |
| Placebo matching BI 764198Placebo matching BI 764198 | Drug | Placebo cohort |
Primary outcome
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
Time frame: At baseline and week 20
3 secondary outcomes
Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20
Time frame: At baseline and week 20
Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
Time frame: At baseline and week 20
Absolute change in estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20
Time frame: At baseline and week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Proteinuric Kidney Diseases
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Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
154 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 764198 in people with Proteinuric Kidney Diseases, run by Boehringer Ingelheim at 154 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 154 sites in United States, China, India, Italy, Germany and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR) (time frame: At baseline and week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.