A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
Public ClinicalTrials.gov record NCT04750577. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Diabetic Kidney Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04750577
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 243 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 26, 2021
- Primary completion
- Nov 29, 2022
- Completion
- Dec 26, 2022
- Last update posted
- Jul 22, 2024
2021 – 2022
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kidney & Hypertension Center | Victorville | California | 92395 | — |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | — |
| Indago Research and Health Center | Hialeah | Florida | 33012 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Davita Clinical Research | Columbus | Georgia | 31904 | — |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | — |
| Research by Design, LLC | Chicago | Illinois | 60643 | — |
| DaVita Clinical Research | Las Vegas | Nevada | 89128 | — |
| Total Renal Research | The Bronx | New York | 10461 | — |
| Brookview Hills Research Associates LLC | Winston-Salem | North Carolina | 27103 | — |
| Knoxville Kidney Center PLLC | Knoxville | Tennessee | 37923 | — |
| DaVita Clinical Research | Houston | Texas | 77054 | — |
| Texas Institute for Kidney and Endocrine Disorders | Lufkin | Texas | 75904 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | — |
| DaVita Clinical Research | San Antonio | Texas | 78240 | — |
| Kidney Specialists of North Houston, PLLC | Shenandoah | Texas | 77384 | — |
| Tidewater Kidney Specialists | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04750577, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2024 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04750577 live on ClinicalTrials.gov.