Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
With
University of Oxford
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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;
You may not be if
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 at Screening
Receiving combined ACEi and ARB 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 hypotension, 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
