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

Kidney Disease, Chronic Clinical Trial

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

Status Recruiting

Clinical Trial Summary

This study is open to adults with a type of kidney disease called primary 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal Segmental
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT05213624
• Study type: Interventional
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: [email protected]
• Status: Recruiting
• Phase: Phase 2
• Start date: March 10, 2022
• Completion date: August 21, 2023