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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
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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
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
Start Date
February 16, 2026
Primary Completion Date
November 20, 2029
Completion Date
December 18, 2029
Last Updated
March 19, 2026
286
ESTIMATED participants
BI 764198
DRUG
Placebo
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT06090227
NCT02235857
NCT06466135
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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