Coming Soon
This study will begin recruiting soon.
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
About This Study
This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of BI 764198, an oral TRPC6 inhibitor, in adults and adolescents with primary FSGS or genetic FSGS related to TRPC6 variants. Participants are randomized to receive either BI 764198 or placebo once daily for 104 weeks as an adjunct to standard of care. The study assesses the drug's impact on disease progression and kidney function through regular monitoring of UPCR and adverse events. The primary objective is to determine if TRPC6 inhibition reduces proteinuria and stabilizes renal function over a long-term treatment period.
Who Can Participate?
✓ Inclusion Criteria
- •Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- •Weight of ≥40 kg at the screening visit (Visit 1)
- •Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
- •Participants with a diagnosis prior to the screening visit (Visit
- •of either:
- •Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
- •Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
- •Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- •Estimated glomerular filtration rate (eGFR)
- •For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease 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
- •Further inclusion criteria apply.
✗ Exclusion Criteria
- •Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- •Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator's judgement)
- •FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit
- •(based on Investigator's judgement)
- •A history of organ transplantation or planned organ transplantation during the course of the trial
- •Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit
- •Further exclusion criteria apply.