A Study of Heart and Kidney Protection with Empagliflozin

Overview

About this study

The primary purpose of this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Nabeel Aslam, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20461641

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