A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess Oral TRPC6 Inhibitor BI 764198 Over 104 Weeks in Adults and Adolescents With Primary or Genetic FSGS

What this Trial Is About

Researchers are studying whether the medicine BI 764198 helps adults and adolescents with a kidney condition called focal segmental glomerulosclerosis FSGS. This study is a phase 3 clinical trial that compares BI 764198 with a placebo to understand its effects on kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants. The study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes BI 764198 tablets once a day, and the other takes placebo tablets that look like BI 764198 but contain no medicine. All participants continue their standard treatment for FSGS during the study. The treatment period lasts up to 104 weeks 2 years. Participants visit the study site about every three months during the two-year period. They regularly collect urine samples to monitor kidney function, and doctors assess their health and record any side effects. The main outcome measured is the change in urinary protein-to-creatinine ratio over 104 weeks. Other assessments include kidney filtration rate and treatment response. The study carefully monitors safety and treatment effects throughout.

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