Clinical Trial

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 11 changes
notable Trial sites expanded: 296 -> 302 locations 2026-08-07
critical Primary endpoint(s) modified 2026-07-16
notable Trial sites expanded: 287 -> 294 locations 2026-07-16
notable Trial sites expanded: 277 -> 287 locations 2026-06-24
notable Primary completion moved earlier: 2029-11-20 -> 2028-12-27 2026-06-24
minor Completion moved earlier: 2029-12-18 -> 2029-01-24 2026-06-24
notable Trial sites expanded: 271 -> 277 locations 2026-06-11
notable Trial sites expanded: 266 -> 271 locations 2026-05-30
notable Trial sites expanded: 256 -> 266 locations 2026-05-15
notable Trial sites expanded: 251 -> 254 locations 2026-04-16
notable Trial sites expanded: 243 -> 251 locations 2026-04-02
Trial Details
NCT Number NCT07220083
Lead Sponsor Boehringer Ingelheim
Conditions Focal Segmental Glomerulosclerosis
Enrollment 286 participants
Start Date 2026-02-16
Primary Completion 2028-12-27 (estimated)
Study Completion 2029-01-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-06