What is BI 764198 studying for proteinuric kidney diseases?

BI 764198 is being studied to see if it helps people with certain kidney diseases that cause protein in the urine. This trial aims to assess its safety and how well it works in improving kidney function. The study is sponsored by Boehringer Ingelheim and includes several kidney conditions.

Who may be eligible for this proteinuric kidney disease clinical trial?

People aged 12 years and older with specific kidney conditions such as secondary focal segmental glomerulosclerosis or treatment-resistant primary minimal change disease may be eligible. Both males and females can participate. Key factors include stable kidney function, weight over 40 kg, and stable medication use. Please review eligibility criteria for more details.

Is there any cost to participate in this proteinuric kidney disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 12Years +

All Genders

ID07355296

Phase II Study to Evaluate Safety and Effectiveness of BI 764198 in Adults and Adolescents with Various Proteinuric Kidney Diseases

Led by Boehringer Ingelheim · Updated on 2026-08-06

132

Participants Needed

161

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a medicine called BI 764198 helps adults and adolescents with certain kidney conditions, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. The study is a Phase II, randomized, double-blind, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of BI 764198 in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups, with twice the chance of receiving BI 764198 compared to placebo. They take one tablet daily for 20 weeks while continuing their standard kidney disease medications. The study lasts about seven months, during which participants attend six in-person visits and have three phone calls. The trial includes multiple cohorts based on specific kidney conditions. During the study, doctors regularly collect urine samples to measure protein levels and blood samples to monitor kidney function. Researchers compare these results between the treatment and placebo groups to evaluate changes in proteinuria and kidney filtration rate. Participants health and any side effects are closely monitored throughout the trial.

CONDITIONS

Brief Title

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants 18 years or older (12 years or older for treatment-resistant primary minimal change disease) at consent
Body mass index of 40 kg/m2 or less at screening
Weight of 40 kg or more at screening
Estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m2 or higher at screening
Seated systolic blood pressure 160 mmHg or less for adults (18+) or 140 mmHg or less for adolescents (<18)
Stable optimized dose of ACE inhibitors or angiotensin receptor blockers for at least 8 weeks before screening with no planned changes during treatment
Stable dose of mineralocorticoid receptor antagonists, endothelin receptor antagonists, GLP-1 or SGLT2 inhibitors for at least 8 weeks before screening, preferably without planned changes
Stable dose of oral immunosuppressive drugs (except glucocorticoids) for at least 12 weeks before screening with no planned changes
Oral glucocorticoid dose 10 mg/day or less of prednisolone or equivalent for 4 weeks or more before screening with no planned increase during treatment

You will not qualify if you...

History of organ transplantation or planned transplantation during the study
Use of intravenous immunosuppressive drugs within 6 months before screening
Expected start of oral or IV immunosuppression during the trial
Treatment with metformin or dofetilide within one week before randomization through 5 days after end of treatment
Use of strong CYP3A4/5 inhibitors or inducers within one week or 5 half-lives before randomization
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 3 times the upper limit of normal at screening
Clinically significant lab abnormalities or medical conditions posing safety risks or interfering with trial objectives
QTc intervals over 450 ms in males or 470 ms in females, or other significant ECG findings at screening

Research Team

Boehringer Ingelheim

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Phase II Study to Evaluate Safety and Effectiveness of BI 764198 in Adults and Adolescents with Various Proteinuric Kidney Diseases

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria