Investigating BI 764198 in FSGS
The PODOMOUNT-pFSGS study investigates the efficacy and safety of BI 764198 in adults and adolescents with primary focal segmental glomerulosclerosis (FSGS) or genetic FSGS associated with TRPC6 variants. The study aims to evaluate whether the treatment can reduce protein loss in urine and slow the progression of kidney disease.
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PODOMOUNT-pFSGS: BI 764198 in focal segmental glomerulosclerosis
Study summary
PODOMOUNT-pFSGS is a Phase III, multicentre, randomized, double-blind, placebo-controlled trial investigating the oral TRPC6 inhibitor BI 764198 in patients with primary FSGS (pFSGS) or genetic FSGS caused by TRPC6 variants. Participants receive BI 764198 or placebo in addition to standard of care for up to 104 weeks.
Which patients may be eligible?
Key inclusion criteria
- Age ≥12 years
- Body weight ≥40 kg
- BMI ≤40 kg/m²
- Biopsy-confirmed primary FSGS or genetic FSGS due to a TRPC6 gain-of-function mutation
- UPCR ≥1500 mg/g at screening
- eGFR ≥25 mL/min/1.73 m²
Key exclusion criteria
- Secondary forms of FSGS
- Severe renal impairment below study-defined eGFR threshold
- Other clinically significant conditions that may affect study participation or interpretation of results
- Use of prohibited concomitant medications or participation in another investigational study.
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To evaluate whether BI 764198 safely reduces proteinuria and slows kidney disease progression in adults and adolescents with primary FSGS or TRPC6-associated genetic FSGS.
Intervention / treatment
BI 764198 (TRPC6-inhibitor)
Study design
Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicentre interventional trial
Trial duration per participant
104 weeks
Participating centres
Relevant links
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How can we help you?
Would you like to learn more about NEFRO-NL, our research network or our services? Our project managers are happy to help. Contact us at info@nefro-nl.nl.
Antina de Boer
Project Manager
