NCT05182840

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 714 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 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. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Kidney Disease, Chronic

Interventions

Type	Name	Description
DRUG	BI 690517	Film-coated tablets
DRUG	Placebo to BI 690517	Film-coated tablets
DRUG	Empagliflozin	Empagliflozin
DRUG	Placebo to empagliflozin	Placebo to empagliflozin

Timeline

• Start date: 2022-01-11
• Primary completion: 2023-06-19
• Completion: 2023-07-10
• First posted: 2022-01-10
• Last updated: 2024-10-22
• Results posted: 2024-08-29

Locations

203 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study