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EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

NCT03594110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6609

Last updated 2025-07-20

Study results available
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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

DRUG

Empagliflozin

Taken daily with or without food

DRUG

Matching placebo

Taken daily with or without food

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2022-07-05
Completion
2024-07-02
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Germany
  • Italy
  • Japan
  • Malaysia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594110 on ClinicalTrials.gov