A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
Status:
Recruiting
Trial end date:
2022-08-16
Target enrollment:
Participant gender:
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.