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Phase III

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

  • Study HIC#:2000024575
  • Last Updated:07/15/2021

Brief 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

  • Age18 years and older
  • GenderBoth
  • Start Date11/07/2019
  • End Date06/01/2022

Trial Purpose and Description

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

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
  • 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

Principal Investigator

Sub-Investigators

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