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

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

- Neither requires an 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 ;

- Receiving dual RAS inhibition (two of ACEi, ARB, DRI);

- Any immunosuppression therapy in last 3 months (except prednisolone ≤10 mg or
equivalent); or anyone currently on >10 mg prednisolone (or equivalent)

- 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;

- ALT or AST >3x ULN;

- Hypersensitivity to empagliflozin or other SGLT-2 inhibitor;

- Known to be poorly compliant with clinic visits or prescribed medication