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

Trial status: Authorised Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104, Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104, Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint), Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104, Change from baseline across disease-specific COA NS-SIM-PRO at Week 104, Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104 Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104

Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104, Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104, Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint), Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104, Change from baseline across disease-specific COA NS-SIM-PRO at Week 104, Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104

Age group: 18-64 years, 0-17 years, 65+ years Gender: Female, Male Target enrollment: 105 participants