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RECRUITING Phase 2 ClinicalTrials.gov

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07355296

Registry updated: 2026-10-13
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Description

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.

Interventions

  • BI 764198 (Drug)
    BI 764198
  • Placebo matching BI 764198 (Drug)
    Placebo matching BI 764198

Eligibility criteria

Inclusion Criteria: * 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. Further inclusion criteria apply. Exclusion Criteria: * 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.

Conditions

Proteinuric Kidney Diseases

Locations

  • Nephrology Consultants, LLC — Huntsville, Alabama, United States
  • Kidney Disease Medical Group — Glendale, California, United States
  • Amicis Research Center - Balboa — Granada Hills, 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 Care — 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
  • Total Research Group, LLC — Miami, Florida, United States
  • CTR Oakwater, LLC — Orlando, Florida, United States
  • Florida Kidney Physicians - Riverview/Brandon — 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
  • Queens Long Island Kidney Center — Fresh Meadows, 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
  • Terapia Renal Domiciliaria — Buenos Aires, Argentina
  • Centro Medico Dra Laura Maffei — Ciudad Autonoma Buenos Aires, Argentina
  • Clinica Privada Velez Sarfield — Córdoba, Argentina
  • CardioAlem Investigaciones — San Isidro, Argentina
  • Concord Repatriation General Hospital — Concord, New South Wales, Australia
  • Nepean Hospital — Kingswood, New South Wales, Australia
  • John Hunter Hospital — New Lambton Heights, New South Wales, Australia
  • Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia
  • Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
  • AZORG Ziekenhuis — Aalst, Belgium
  • Az Maria Middelares Gent — Ghent, Belgium
  • UZ Leuven — Leuven, Belgium
  • Universidade Federal do Ceara — Fortaleza, Brazil
  • Hospital de Clinicas de Porto Alegre — Porto Alegre, Brazil
  • Fundacao Oswaldo Ramos (Hospital do Rim) — São Paulo, Brazil
  • Hospital das Clinicas da Faculdade de Medicina da USP — São Paulo, Brazil
  • Instituto da Crianca e do Adolescente — São Paulo, Brazil
  • CaRe Clinic (Calgary) — Calgary, Alberta, Canada
  • Victoria Hospital (LHSC) — London, Ontario, 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
  • Sichuan Provincial People's Hospital — Sichuan, China
  • Renmin Hospital of Wuhan University — Wuhan, China
  • Zhongshan Hospital Affiliated to Xiamen University — Xiamen, China
  • Specijalna Bolnica 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
  • Hopital Henri Mondor — Créteil, France
  • Hopital Pasteur — Nice, France
  • Hopital Necker — Paris, France
  • Vivantes Klinikum im Friedrichshain — Berlin, Germany
  • Universitätsklinikum Köln (AöR) — Cologne, Germany
  • Universitätsklinikum Hamburg, Eppendorf — Hamburg, Germany
  • Universitätsklinikum Hamburg, Eppendorf — Hamburg, Germany
  • Medizinische Hochschule Hannover — Hanover, Germany
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Germany
  • Klinikum rechts der Isar der Technischen Universität München — München, Germany
  • General University Hospital of Patras — Pátrai, Greece
  • Aartham Multi Super Speciality Hospital — Ahmedabad, India
  • AIIMS Bhubaneshwar — Bhubaneswar, India
  • Osmania Medical College & Hospital — Hyderabad, India
  • Nizam's Institute of Medical Sciences — Hyderabad, India
  • Government Medical College — Kozhikode, India
  • Sanjay Gandhi Post Graduate Institute of Medical Sciences — Lucknow, India
  • JSS Medical College — Mysore, 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
  • Centenario Hospital Miguel Hidalgo — Aguascalientes, Mexico
  • Health Pharma Professional Research S.A. de C.V. — Mexico City, Mexico
  • Soltmed Smo — Mexico City, Mexico
  • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico
  • Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal — Monterrey, Mexico
  • Instituto Nacional de Cardiologia Ignacio Chavez — Tlalpan, Mexico
  • Amsterdam UMC Locatie AMC — Amsterdam, Netherlands
  • Universitair Medisch Centrum Groningen — Groningen, Netherlands
  • Pacific Clinical Research Network - Auckland — Auckland, New Zealand
  • Waikato Hospital — Hamilton, New Zealand
  • Akershus Universitetssykehus HF — Lørenskog, Norway
  • Oslo Universitetssykehus HF, Ulleval sykehus — Oslo, Norway
  • Universitetssykehuset Nord-Norge, Tromso — Tromsø, Norway
  • Central Clinical Hospital of the Medical University of Lodz — Lodz, Poland
  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu — Poznan, Poland
  • Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie — Szczecin, Poland
  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie — Warsaw, Poland
  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy — Warsaw, Poland
  • Unidade Local de Saúde de Almada-Seixal E.P.E. — Almada, Portugal
  • ULS de Braga, E.P.E — 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
  • Univerzitna Nemocnica 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 Sant Joan de Déu — Esplugues de Llobregat, 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)
  • Istanbul Capa 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 Hospital — Salford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record