NCT05213624

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

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of BI 764198 Administered Orally Once Daily for 12 Weeks in Patients With Focal Segmental Glomerulosclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Disease, Chronic

Interventions

Type	Name	Description
DRUG	BI 764198	One single capsule of 20 milligrams (mg), 40 mg, or 80 mg of BI 764198 orally, once a day.
DRUG	Placebo	One single capsule of placebo matching BI 764198 orally, once a day.

Timeline

• Start date: 2022-05-03
• Primary completion: 2025-01-03
• Completion: 2025-01-03
• First posted: 2022-01-28
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

54 sites across 10 countries: United States, Australia, Belgium, China, France, Germany, Italy, New Zealand, Spain, United Kingdom

Regulatory

• FDA-regulated drug study