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NCT05182840 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 714
- Enrollment target
NCT05182840: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05182840 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 714 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (437% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05182840, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 714 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation st
Interventions
- DRUG Empagliflozin
- DRUG BI 690517
- DRUG Placebo to BI 690517
- DRUG Placebo to empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 714 participants |
| Start Date | 2022-01-11 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 2 |
What the finished NCT05182840 record still lists
NCT05182840 is an interventional study that assigns participants to a tested intervention. The registered 714 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (437% higher).
The record links to 0 conditions, and to 4 interventions - of which Empagliflozin is the first listed.
NCT05182840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05182840 about?
NCT05182840 is a clinical study titled "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". 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 combinati...
What is the current status of trial NCT05182840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 714 participants. The study started on 2022-01-11. Estimated completion is 2023-07-10.
What interventions are being tested in trial NCT05182840?
The interventions under investigation include: Empagliflozin (DRUG), BI 690517 (DRUG), Placebo to BI 690517 (DRUG), Placebo to empagliflozin (DRUG).
Who is sponsoring clinical trial NCT05182840?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05182840's enrollment target sits among peer trials
714 45th of 2000 higher than 1,956 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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