BI 764198
Familial FSGS has been associated with gain-of-function variants of the transient receptor potential cation channel, subfamily C, member 6 (TRPC6) gene. the resulting overexpression and/or overactivity of TRPC6 leading to podocyte injury. BI 764198 is a novel, potent, selective oral TRPC6 inhibitor. In phase 1 studies, BI 764198 was generally well tolerated at single and multiple rising doses administered once daily for up to 14 days.
Enroll in this clinical study
How is BI 764198 being studied in FSGS?
B1 764198 is being studied in a multicenter, multinational, randomized, double-blind, parallel-group, placebo-controlled trial, which will assess the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 764198 administered for 12 weeks in patients with primary or TRPC6 monogenic FSGS. Eligible patients will be randomized 1:1:1:1 to receive 1 of 3 doses of BI 764198 (low, medium, or high) or placebo daily over a 12-week treatment period. The primary endpoint of the trial is the proportion of patients reaching a ≥25% decrease in 24-hour urinary protein:creatinine ratio from baseline at week 12. Secondary endpoints comprise change in 24-hour urinary protein:creatinine ratio from baseline at weeks 12 and 13, change in 24-hour urinary protein excretion from baseline at week 12, and steady-state trough BI 764198 concentration at weeks 4 and 12.
Eligibility Criteria
Age 18 years to 75 years
Biopsy proven primary FSGS or documented TRPC6 gene mutation causing FSGS prior to screening visit.
UPCR ≥ 1000 mg/g based on first morning void urine sample during screening.
Stable dose of corticosteroids for at least 4 weeks
Stable doses of ACEi/ARB, Finerenone or SGLT2i for at least 4 weeks
BMI of ≤ 40 kg/m² at screening visit.
Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control
Protocol publication link: Kidney International Reports Dec 2023