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

Prior treatment

• Currently receiving SGLT-2 or SGLT-1/2 inhibitor
• Receiving combined ACEi and ARB treatment
• Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
• Previous or scheduled bariatric surgery
• 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

Other illness

• Polycystic kidney disease
• Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
• 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)
• Type 1 diabetes mellitus

Lab values

• Diabetes mellitus type 2 and prior atherosclerotic cardiovascular disease with an eGFR \>60 mL/min/1.73m2 at Screening
• ALT or AST \>3x ULN at Screening

Other

• Ketoacidosis in the past 5 years
• Symptomatic hypotension, or systolic blood pressure \<90 or \>180 mmHg at Screening
• Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception

• 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;