A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis

Phase 2

Completed

• Conditions: Kidney Disease, Chronic
• Interventions: Drug: BI 764198; Drug: Placebo

• Registration Number: NCT05213624
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of BI 764198 are tested in this study.

Participants are put into 4 groups randomly, which means by chance. Three of the groups receive different doses of BI 764198 and one group receives placebo. Participants are in the study for about 4 months. For about 3 months, they take BI 764198 or placebo as capsules once a day.

Placebo capsules look like BI 764198 capsules but do not contain any medicine. Participants visit the study site about 10 times. You can participate in this study from your home. In this case a research nurse will visit you for the study visits.

Kidney health is assessed based on the analysis of urine samples, which participants collect at home. At the end of the study, the results are compared between the different groups. During the study, the doctors also regularly check the general health of the participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-05-03
• Primary Completion: 2025-01-03
• Study Completion: 2025-01-03
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 764198 - low dose	BI 764198	BI 764198 - low dose
BI 764198 - medium dose	BI 764198	BI 764198 - medium dose
Placebo	Placebo	Placebo
BI 764198 - high dose	BI 764198	BI 764198 - high dose

Primary Outcome Measures

Name	Time	Method
Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in 24-hour UPCR relative to baseline at week 13	up to 13 weeks
If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4	up to 4 weeks
Change in 24-hour urinary protein excretion relative to baseline at week 12	up to 12 weeks
Change in 24-hour UPCR relative to visit 3 at week 12	up to 12 weeks
If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12	up to 12 weeks

Trial Locations

Locations (54)

Nephrology Consultants, LLC; 🇺🇸 Huntsville, Alabama, United States

Valiance Clinical Research-South Gate-67878; 🇺🇸 S. Gate, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Valiance Clinical Research-Tarzana-68237; 🇺🇸 Tarzana, California, United States

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Elixia Fort Lauderdale, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

South Florida Research Institute; 🇺🇸 Lauderdale Lakes, Florida, United States

Total Research Group, LLC; 🇺🇸 Miami, Florida, United States

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States

NANI Research, LLC; 🇺🇸 Oak Brook, Illinois, United States

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