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NCT03594110 · ClinicalTrials.gov registry record · Phase 3
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
A Phase 3 study of Chronic Kidney Disease, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,609
- Enrollment target
- 20
- Study locations
NCT03594110: Completed Phase 3 study of Chronic Kidney Disease, sponsored by Boehringer Ingelheim.
NCT03594110 is a Phase 3 study of Chronic Kidney Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 6,609 participants, above the 3,141-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594110, a Phase 3 study of Chronic Kidney Disease, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,609 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Time to first occurrence of kidney disease progression (KDP) or cardiovascular death is reported as incidence rate of first occurrence of KDP or adjudicated cardiovascular death. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)\*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk \[days\] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: * end stage kidney di
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Empagliflozin
Study Locations (20)
Florida
- Midland Florida Clinical Reearch Center, LLC - DeLand
- University of Florida - Gainesville
- East Coast Institute for Research, LLC - Jacksonville
- East Coast Clinical Research, Inc - Lake City
- Total Research Group, LLC - Miami
- Hanson Clinical Research Center, Inc. - Port Charlotte
California
- Southern California Permanente Medical Group - San Diego
- University of California Los Angeles - Sylmar
- University of California Los Angeles - Torrance
Connecticut
- Yale University School of Medicine - New Haven
- Chase Medical Research, LLC - Thomaston
Georgia
- Emory University - Atlanta
- The Jones Center for Diabetes and Endocrine Wellness - Macon
Illinois
- Cedar Crosse Research Center - Chicago
- Northwestern University - Chicago
Kentucky
- Saint Elizabeth Healthcare - Covington
- Lexington VA Health Care System - Troy Bowling Campus - Lexington
Alabama
- Nephrology Consultants, LLC - Huntsville
Arizona
- Aventiv Research, Inc - Mesa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,609 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2024-07-02 |
| Phase | Phase 3 |
What the finished NCT03594110 record still lists
NCT03594110 is an interventional study that assigns participants to a tested intervention. Its 6,609 participants enrollment target places it among the larger protocols in the corpus, above the 3,141-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (110% higher).
The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT03594110 names 20 study sites across 9 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03594110 about?
NCT03594110 is a clinical study titled "EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)". 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 com...
What is the current status of trial NCT03594110?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,609 participants. The study started on 2019-01-31. Estimated completion is 2024-07-02.
What conditions does trial NCT03594110 study?
This clinical trial studies the following conditions: Chronic Kidney Disease.
What interventions are being tested in trial NCT03594110?
The interventions under investigation include: Matching placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT03594110?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03594110 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03594110's enrollment target sits among peer trials
6,609 5th of 101 higher than 97 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease 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.
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