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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)

StatusRecruiting
PhasePhase 3
Started2026-02-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Boehringer Ingelheim

Amendment history

2026-09-04
Study Status, Contacts/Locations v25
Trial sites expanded: 307 → 311 locations
Trial sites expanded: 306 → 309 locations
2026-08-19
Study Status, Contacts/Locations v24
Trial sites expanded: 302 → 306 locations
2026-08-05
Study Identification, Study Status, Contacts/Locations v23
Trial sites expanded: 296 → 302 locations
2026-07-22
Study Status, Contacts/Locations v22
Study sites294→296
2026-07-14
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v21
Primary endpoint(s) modified1 entry, revised
WasRelative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104
NowRelative change in 24-hour UPCR (measured in mg/g) from baseline to Week 104
Trial sites expanded: 287 → 294 locations
Eligibility criteria-33 characters
[...] on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the sc [...] sease epidemiology collaboration (CKD-EPI) formula based on combined serum creatinine plus cystatin C) at the screening visit (Visit 1) For adolescent participants (12 to <18 years);: ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using height and serum cystatin C at the screening visit (Visit 1) Further i [...] ene mutations) Clinical or histologic evidence of secondary maladaptiveadaptive or toxic forms of FSGS (based on Investigator's j [...]
Secondary endpointsdetails revised at 2 of 6 entries
2026-06-22
Study Status, Contacts/Locations v20
Trial sites expanded: 277 → 287 locations
Primary completion moved earlier: 2029-11-20 → 2028-12-27
Completion moved earlier: 2029-12-18 → 2029-01-24
2026-06-09
Study Status, Contacts/Locations v19
Trial sites expanded: 271 → 277 locations
2026-05-28
Study Status, Contacts/Locations v18
Trial sites expanded: 266 → 271 locations
2026-05-13
Study Status, Contacts/Locations v17
Trial sites expanded: 256 → 266 locations
2026-04-28
Study Status, Contacts/Locations v16
Study sites254→256
2026-04-14
Study Status, Contacts/Locations v15
Trial sites expanded: 251 → 254 locations
2026-03-31
Study Status, Contacts/Locations v14
Trial sites expanded: 243 → 251 locations
2026-03-18
Study Status, Contacts/Locations v13
Study sites231→243
2026-03-02
Study Status, Contacts/Locations v12
Study sites211→231
2026-02-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v11
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02-06→confirmed 2026-02-16
Study sites205→211
2026-02-03
Study Status, Contacts/Locations v10
Start date2026-01-31→2026-02-06
Study sites204→205
2026-01-27
Study Status, Contacts/Locations, IPDSharing, References v9
Start date2026-01-23→2026-01-31
Study sites194→204
2026-01-20
Study Status, Contacts/Locations v8
Study sites187→194
2026-01-08
Study Status, Contacts/Locations v7
Start date2025-12-19→2026-01-23
Study sites185→187
2025-12-19
Study Status, Contacts/Locations v6
Study sites183→185
2025-12-11
Study Status, Contacts/Locations v5
Study sitescontacts updated at 10 of 183 sites
2025-12-10
Study Status, Contacts/Locations v4
Start date2025-12-05→2025-12-19
Study sites178→183
2025-11-25
Study Status, Contacts/Locations v3
Study sites173→178
2025-11-11
Study Status, Contacts/Locations v2
Primary completion date2030-02-20→2029-11-20
Completion date2030-03-20→2029-12-18
Study sites156→173
2025-10-28
Study Status, Contacts/Locations v1
Study sites0→156
2025-10-22
Original filing
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.
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 2026-09-30