A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511706-23-00

Acronym

1434-0004

Enrollment

Registered

2024-05-21

Start date

2022-05-31

Completion date

2024-12-23

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal segmental glomerulosclerosis

Brief summary

Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12

Detailed description

Change in 24-hour UPCR relative to visit 3 at week 12, Change in 24-hour UPCR relative to baseline at week 13, Change in 24-hour urinary protein excretion relative to baseline at week 12, Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4, Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12

Interventions

DRUGBI 764198

DRUGPlacebo to match BI 764198

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12	—

Secondary

Measure	Time frame
Change in 24-hour UPCR relative to visit 3 at week 12, Change in 24-hour UPCR relative to baseline at week 13, Change in 24-hour urinary protein excretion relative to baseline at week 12, Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4, Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12	—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026