NCT04736628

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Avenciguat	Avenciguat
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-04-27
• Primary completion: 2023-08-15
• Completion: 2023-09-21
• First posted: 2021-02-03
• Last updated: 2024-09-04
• Results posted: 2024-09-04

Locations

110 sites across 18 countries: United States, Argentina, Australia, Canada, China, Denmark, Germany, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Poland, Portugal, Russia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study