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NCT04736628 · ClinicalTrials.gov registry record · Phase 2
A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 261
- Enrollment target
NCT04736628: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04736628 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 261 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04736628, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 261 participants
- Enrollment target
Study Summary
This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat 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 avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.
Primary Outcome
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as
Interventions
- DRUG Placebo
- DRUG Avenciguat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2023-09-21 |
| Phase | Phase 2 |
What the finished NCT04736628 record still lists
NCT04736628 is an interventional study that assigns participants to a tested intervention. The registered 261 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 (96% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04736628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04736628 about?
NCT04736628 is a clinical study titled "A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease". This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the th...
What is the current status of trial NCT04736628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 261 participants. The study started on 2021-04-27. Estimated completion is 2023-09-21.
What interventions are being tested in trial NCT04736628?
The interventions under investigation include: Placebo (DRUG), Avenciguat (DRUG).
Who is sponsoring clinical trial NCT04736628?
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 NCT04736628's enrollment target sits among peer trials
261 210th of 2000 higher than 1,791 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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