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A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Sponsor: Boehringer Ingelheim
Summary
PODOMOUNT-pFSGS This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. 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 up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. 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: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
286
Start Date
2026-02-16
Completion Date
2029-01-24
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
BI 764198
BI 764198
Placebo
Placebo matching BI 764198
Locations (316)
Alabama Kidney Research
Alabaster, Alabama, United States
Apogee Clinical Research
Huntsville, Alabama, United States
Southwest Kidney Institute
Surprise, Arizona, United States
West Coast Kidney Institute
Fremont, California, United States
Kidney Disease Medical Group
Glendale, California, United States
Amicis Research Center - Balboa
Granada Hills, California, United States
Valiance Clinical Research
Huntington Park, California, United States
Academic Medical Research Institute - Glendale
Los Angeles, California, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Valley Renal Medical Group - Northridge
Northridge, California, United States
Shasta Critical Care Specialists
Redding, California, United States
North America Research Institute
San Dimas, California, United States
Kaiser Permanente - French Campus
San Francisco, California, United States
Valiance Clinical Research-Tarzana-68237
Tarzana, California, United States
National Institute of Clinical Research - Victorville
Victorville, California, United States
Kidney Associates of Colorado - Denver
Denver, Colorado, United States
Colorado Kidney Care
Denver, Colorado, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 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
Coastal Nephrology and Associates
Port Charlotte, Florida, United States
Florida Kidney Physicians - Riverview/Brandon
Riverview, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Coastal Medical Research, LLC
Brunswick, Georgia, United States
Southeast Kidney Associates - East Point
East Point, Georgia, United States
Memorial Health University Hospital
Savannah, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Kidney Care Center - Olympia Fields
Olympia Fields, Illinois, United States
Nephrology Physicians - Mishawaka
Mishawaka, Indiana, United States
EmVenio Research Inc. - Kansas City
Kansas City, Kansas, United States
Wichita Nephrology Group
Wichita, Kansas, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Paragon Health Nephrology Center - Kalamazoo
Kalamazoo, Michigan, United States
St. Clair Nephrology Research, LLC - Shelby Township
Utica, Michigan, United States
Nephrology Associates - Columbus
Columbus, Mississippi, United States
Nephrology & Hypertension Associates, Ltd.
Tupelo, Mississippi, United States
Voltaire St. Peters, LLC
City of Saint Peters, Missouri, United States
DaVita Clinical Research-Las Vegas-67781
Las Vegas, Nevada, 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
Carolina Kidney Associates
Greensboro, North Carolina, United States
Cardinal Clinical Research, LLC - Shelby
Shelby, North Carolina, United States
Americare Kidney Institute - Brunswick
Brunswick, Ohio, United States
The Kidney and Hypertension Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Clinical Renal Associates
Exton, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Nephrology Associates, Inc
East Providence, Rhode Island, United States
Palmetto Nephrology
Orangeburg, South Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Texas Tech University Health Sciences Center-Amarillo-63885
Amarillo, Texas, United States
The Healing Kidneys Institute
Conroe, Texas, United States
Advanced Dallas Hospital and Clinics
Dallas, Texas, United States
Nephrotex Research Group
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Sanmora Bespoke Clinical Research Solutions
Grand Prairie, Texas, United States
Provecta Researh Network
Houston, Texas, United States
Provecta Research Path Forward Ventures
Humble, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Virginia Nephrology
Arlington, Virginia, United States
Nephrology Associates of Northern Virginia
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
Terapia Renal Domiciliaria
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
CEMIC
CABA, Argentina
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada Velez Sarfield
Córdoba, Argentina
Hospital Universitario Austral
Pilar, Argentina
CardioAlem Investigaciones
San Isidro, Argentina
Centro Integral de Medicina Respiratoria - CIMER
San Miguel de Tucumán, Argentina
Grupo MIT - Medicina Interdisciplinaria y Trasplantes
Santa Fe, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Griffith Health
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
AZORG Ziekenhuis
Aalst, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Synvia
Campinas, Brazil
Universidade Federal do Ceara
Fortaleza, Brazil