Investigating BI 764198 in kidney diseases
The PODOMOUNT-Basket study investigates the safety and efficacy of BI 764198 in several rare kidney diseases associated with protein loss in the urine. The study aims to evaluate whether the treatment can reduce proteinuria and help preserve kidney function.
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PODOMOUNT-Basket: BI 764198 in proteinuric kidney diseases
Study summary
PODOMOUNT-Basket is a Phase II, multicentre, randomized, double-blind, placebo-controlled basket trial evaluating BI 764198 across several rare proteinuric kidney diseases that share common disease mechanisms. Participants are randomized in a 2:1 ratio to receive BI 764198 or placebo in addition to standard of care for 20 weeks.
Which patients may be eligible?
Key inclusion criteria
- Age ≥18 years (≥12 years for treatment-resistant primary MCD)
- BMI ≤40 kg/m²
- Body weight ≥40 kg
- eGFR ≥25 mL/min/1.73 m²
- Controlled blood pressure (≤160 mmHg in adults)
- Confirmed diagnosis of one of the selected proteinuric kidney diseases
- Persistent proteinuria despite standard therapy
Key exclusion criteria
- Severe renal impairment (eGFR <25 mL/min/1.73 m²)
- Uncontrolled hypertension
- Clinically significant comorbidities that may compromise safety or study participation
- Kidney diseases or causes of proteinuria not in<cluded in the study cohorts
- Recent participation in another interventional clinical trial or use of prohibited investigational therapies
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To evaluate the safety and efficacy of BI 764198 in reducing proteinuria in patients with proteinuric kidney diseases, including sFSGS, treatment-resistant MCD, Alport syndrome, and treatment-resistant membranous nephropathy.
Intervention / treatment
BI 764198 (TRPC6-inhibitor)
Study design
Randomized, placebo-controlled, quadruple-blind, parallel-group basket trial evaluating a therapeutic intervention.
Trial duration per participant
20 weeks
Participating centres
Relevant links
Contact NEFRO-NL
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
