A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease Who do Not Have Diabetes
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease Who do Not Have Diabetes
This study is open to adults who have kidney disease and do not have diabetes. 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 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date: April 27, 2021
Estimated Primary Completion Date: July 19, 2022
Estimated Study Completion Date: August 16, 2022
Arms:
- Experimental: Dose group 1: BI 685509
- Placebo Comparator: Dose group 1: Matching placebo
- Experimental: Dose group 2: BI 685509
- Placebo Comparator: Dose group 2: Matching placebo
- Experimental: Dose group 3: BI 685509
- Placebo Comparator: Dose group 3: Matching placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 240 |
| Actual Study start date | 27 April 2021 |
| Estimated Study Completion Date | 16 August 2022 |