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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT03594110

Run by

Boehringer Ingelheim

People needed

6609

Starts

2019-01-31

Expected to finish

2024-07-02

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years or at "full age" as required by local regulation
• Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit
• CKD-EPI eGFR ≥20 to <45 mL/min/1.73m² or
• CKD-EPI eGFR ≥45 to <90 mL/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g);
• Clinically appropriate doses of single agent RAS-inhibition with either ACEi or ARB unless such treatment is either not tolerated or not indicated
• A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT-1/2 inhibitor), nor that such treatment is inappropriate;
• Key Exclusion Criteria:
• Currently receiving SGLT-2 or SGLT-1/2 inhibitor
• Diabetes mellitus type 2 and prior atherosclerotic cardiovascular disease with an eGFR >60 mL/min/1.73m2 at Screening
• Receiving combined ACEi and ARB treatment
• Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
• Polycystic kidney disease
• Previous or scheduled bariatric surgery
• Ketoacidosis in the past 5 years
• Symptomatic hypotension, or systolic blood pressure <90 or >180 mmHg at Screening
• ALT or AST >3x ULN at Screening
• Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
• Any intravenous immunosuppression therapy in last 3 months; or anyone currently on >45 mg prednisolone (or equivalent)
• Use of an investigational medicinal product in the 30 days prior to Screening visit
• Known to be poorly compliant with clinic visits or prescribed medication
• Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
• Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception
• Type 1 diabetes mellitus

Where it is running

• Aventiv Research, Inc — Mesa, Arizona, United States
• Southern California Permanente Medical Group — San Diego, California, United States
• University of California Los Angeles — Sylmar, California, United States
• University of California Los Angeles — Torrance, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Chase Medical Research, LLC — Thomaston, Connecticut, United States
• Midland Florida Clinical Reearch Center, LLC — DeLand, Florida, United States
• University of Florida — Gainesville, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• East Coast Clinical Research, Inc — Lake City, Florida, United States
• Total Research Group, LLC — Miami, Florida, United States
• Hanson Clinical Research Center, Inc. — Port Charlotte, Florida, United States
• Emory University — Atlanta, Georgia, United States
• The Jones Center for Diabetes and Endocrine Wellness — Macon, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Saint Elizabeth Healthcare — Covington, Kentucky, United States
• Lexington VA Health Care System - Troy Bowling Campus — Lexington, Kentucky, United States
• Medstar Health Research Institute — Baltimore, Maryland, United States
• Kidney Care and Transplant Services of New England, PC — West Springfield, Massachusetts, United States
• Saint Clair Specialty Physicians — Roseville, Michigan, United States
• Clinical Research Consultants, LLC — Kansas City, Missouri, United States
• VA Southern Nevada Healthcare System — North Las Vegas, Nevada, United States
• Nephrology Consultants, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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