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
Public ClinicalTrials.gov record NCT05182840. 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, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05182840
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 714 participants
Conditions and interventions
Conditions
Interventions
- BI 690517 Drug
- Placebo to BI 690517 Drug
- Empagliflozin Drug
- Placebo to empagliflozin Drug
Drug
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
- Jan 10, 2022
- Primary completion
- Jun 18, 2023
- Completion
- Jul 9, 2023
- Last update posted
- Oct 21, 2024
2022 – 2023
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Aventiv Research Inc. | Mesa | Arizona | 85206 | — |
| AKDHC Medical Research Services, LLC | Phoenix | Arizona | 85027 | — |
| Clearview Medical Research, LLC | Canyon Country | California | 91351 | — |
| Pacific Renal Associates | Long Beach | California | 90806 | — |
| Amicis Research Center | Northridge | California | 91324 | — |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | — |
| California Kidney Specialists | San Dimas | California | 91773 | — |
| Colorado Kidney Care | Denver | Colorado | 80230 | — |
| Clinical Research of Brandon LLC | Brandon | Florida | 33511 | — |
| Horizon Research Group | Coral Gables | Florida | 33134 | — |
| Elixia Fort Lauderdale, LLC | Fort Lauderdale | Florida | 33308 | — |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | — |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33014 | — |
| Total Research Group, LLC | Miami | Florida | 33126 | — |
| Horizon Research Group, LLC | Miami | Florida | 33150 | — |
| West Orange Endocrinology | Ocoee | Florida | 34761 | — |
| Pines Care Research Center | Pembroke Pines | Florida | 33024 | — |
| Elixia Tampa, LLC | Temple Terrace | Florida | 33637 | — |
| Boise Kidney and Hypertension PLLC | Nampa | Idaho | 83687 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | — |
| Aa Mrc Llc | Flint | Michigan | 48504 | — |
| Elite Research Center, LLC | Flint | Michigan | 48532 | — |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | — |
| Forte Family Practice | Las Vegas | Nevada | 89103 | — |
| New Mexico Clinical Research and Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | — |
| Triad Internal Medicine | Asheboro | North Carolina | 27203 | — |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | — |
| Diabetes & Endocrinology Associates of Stark County | Canton | Ohio | 44718 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | — |
| Elixia Upland, LLC | Upland | Pennsylvania | 19013 | — |
| Monument Health | Rapid City | South Dakota | 57701 | — |
| Knoxville Kidney Center PLLC | Knoxville | Tennessee | 37923 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Academy Of Diabetes, Thyroid And Endocrine, PA | El Paso | Texas | 79935 | — |
| PrimeCare Medical Group | Houston | Texas | 77024 | — |
| P&I Clinical Research, LLC | Lufkin | Texas | 75904 | — |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | — |
| Providence Medical Research Center | Spokane | Washington | 99204 | — |
| Universal Research Group, LLC | Tacoma | Washington | 98405 | — |
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 162 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05182840, 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 Oct 21, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05182840 live on ClinicalTrials.gov.