EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Empagliflozin; Matching placebo
Intervention description: Taken daily with or without food; Taken daily with or without food
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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