NCT04750577

A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic 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 Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and 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 BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.

Conditions

• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	Placebo matching BI 685509	film-coated tablet
DRUG	BI 685509	film-coated tablet

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-11-30
• Completion: 2022-12-27
• First posted: 2021-02-11
• Last updated: 2024-07-23
• Results posted: 2024-07-23

Locations

78 sites across 16 countries: United States, Argentina, Australia, Canada, China, Denmark, Hong Kong, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study