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A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
NCT04750577 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo matching BI 685509
- DRUG BI 685509
Study Locations (20)
Texas
- DaVita Clinical Research — Houston
- Texas Institute for Kidney and Endocrine Disorders — Lufkin
- Clinical Advancement Center, PLLC — San Antonio
- DaVita Clinical Research — San Antonio
- Kidney Specialists of North Houston, PLLC — Shenandoah
Other
- CEDIC - Centro de Investigacion Clinica — CABA
- Instituto Médico Especializado — Capital Federal
- Instituto Privado de Investigaciones Clínica Córdoba S.A. — Córdoba
Florida
- Indago Research and Health Center — Hialeah
- Panax Clinical Research — Miami Lakes
Georgia
- Davita Clinical Research — Columbus
- Meridian Clinical Research, LLC — Savannah
California
- Kidney & Hypertension Center — Victorville
Connecticut
- Chase Medical Research, LLC — Waterbury
Illinois
- Research by Design, LLC — Chicago
Nevada
- DaVita Clinical Research — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2022-12-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04750577
The ClinicalTrials.gov registry entry for NCT04750577 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Nephropathies appearing as the primary indexed condition, and to 2 interventions — of which Placebo matching BI 685509 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04750577 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04750577 about?
NCT04750577 is a clinical study titled "A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease". 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...
What is the current status of trial NCT04750577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2021-04-27. Estimated completion is 2022-12-27.
What conditions does trial NCT04750577 study?
This clinical trial studies the following conditions: Diabetic Nephropathies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04750577?
The interventions under investigation include: Placebo matching BI 685509 (DRUG), BI 685509 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04750577?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04750577 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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