PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
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
3 other identifiers
interventional
132
31 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2026
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedStudy Start
First participant enrolled
March 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 21, 2028
April 28, 2026
April 1, 2026
1.8 years
January 20, 2026
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
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
At baseline and week 20
Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
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
At baseline and week 20
Study Arms (5)
Secondary focal segmental glomerulosclerosis (sFSGS) cohort
EXPERIMENTALTreatment resistant primary Minimal Change Disease (TR-pMCD) cohort
EXPERIMENTALAlport Syndrome cohort
EXPERIMENTALTreatment resistant primary Membranous Nephropathy (TR-pMN) cohort
EXPERIMENTALPlacebo cohort
PLACEBO COMPARATORInterventions
BI 764198
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
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 Center
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
Panoramic Health
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
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
ULB Hopital Erasme
Brussels, 1070, Belgium
Az Maria Middelares Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Universidade Federal do Ceará
Fortaleza, 60110-110, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000, Brazil
Instituto da Criança 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, 100044, 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
Specialty Hospital 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, 51014, Estonia
CHU Amiens-Picardie
Amiens, 80054, France
HOP Pellegrin
Bordeaux, 33076, France
Hôpital Henri Mondor
Créteil, 94000, France
Hôpital Pasteur
Nice, 06000, France
Hôpital 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
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
Government Medical College
Kozhikode, 673008, 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
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, Ullevål sykehus
Oslo, 0450, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011, Norway
Universitetssykehuset Nord-Norge, Tromsø
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
Central Clinical Hospital of the Ministry of National Defence - Military Institute of Medicine
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, 041 90, Slovakia
FMC Dialysis Services Kosice
Košice, 40190, Slovakia
Univ. Hospital 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 Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, 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)
İstanbul Çapa 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
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
January 20, 2026
First Posted
January 21, 2026
Study Start
March 23, 2026
Primary Completion (Estimated)
December 24, 2027
Study Completion (Estimated)
January 21, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
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's publication 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.