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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Empagliflozin; Drug: Matching placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03594110

1245-0137

2017-002971-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 6,609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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 diseasee with an eGFR >60 mL/min/1.73m2 at Screening
• Receiving combined ACEi and ARBf 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 hypotensiond, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,609 participants in 2 patient groups, including a placebo group

Empagliflozin 10 mg

Experimental group

Description:

Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Description:

Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.

Treatment:

Drug: Matching placebo