Trials / Completed
CompletedNCT03594110
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,609 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin | Taken daily with or without food |
| DRUG | Matching placebo | Taken daily with or without food |
Timeline
- Start date
- 2019-01-31
- Primary completion
- 2022-07-05
- Completion
- 2024-07-02
- First posted
- 2018-07-20
- Last updated
- 2025-07-20
- Results posted
- 2023-07-27
Locations
240 sites across 8 countries: United States, Canada, China, Germany, Italy, Japan, Malaysia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03594110. Inclusion in this directory is not an endorsement.