Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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;

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Empagliflozin
  • Drug: Empagliflozin
    Taken daily with or without food
Placebo Comparator
Placebo
  • Drug: Matching placebo
    Taken daily with or without food

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.