Chronic kidney disease
Conditions
Interventions
investigational material(s)
Generic name etc : empagliflozin
INN of investigational material : Empagliflozin
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administrati
Sponsors
Boehringer Ingelheim(ICCC:PAREXEL International)
The Medical Research Council Population Health Research Unit at the University of Oxford is the academic lead of the trial and has been delegated the task of conducting and analyzing the trial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with evidence of chronic kidney disease at risk of kidney disease progression, which is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires that: (a) CKD-EPI eGFR >=20 =45 =200 mg/g (or protein:creatinine ratio >=300 mg/g) Note: the number of participants with or without diabetes mellitus (of any type) will be at least one-third of each, and the number of participants with an eGFR>45 mL/min/1.73m2 limited to about one-third. The Steering Committee will monitor these proportions and will limit recruitment of particular categories of participant in whom sufficient numbers have already been screened or randomized.
Exclusion criteria
Exclusion criteria: People fulfilling any of the following criteria will be excluded: (i) Currently receiving SGLT-2 or SGLT-1/2 inhibitor; (ii) Diabetes mellitus type 2 and prior atherosclerotic cardiovascular disease with an eGFR >60 mL/min/1.73m2 at Screening; (iii) Receiving combined ACEi and ARB treatment; (iv) Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant; (v) Polycystic kidney disease; (vi) Previous or scheduled bariatric surgery; (vii) Ketoacidosis in the past 5 years; (viii) Symptomatic hypotension, or systolic blood pressure 180 mmHg at Screening; (ix) ALT or AST >3x ULN at Screening; (x) Hypersensitivity to empagliflozin or other SGLT-2 inhibitor; (xi) Any intravenous immunosuppression therapy in last 3 months; or anyone currently on >45 mg prednisolone (or equivalent); (xii) Use of an investigational medicinal product in the 30 days prior to Screening visit; (xiii) Known to be poorly compliant with clinic visits or prescribed medication; (xiv) 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); (xv) Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception. (xvi) Type 1 diabetes mellitus. In addition, individuals will be excluded at the Randomization visit if the participant: (i) Does not adhere to Run-in treatment; (ii) Is no longer willing to be randomized and followed for at least 3 years; (iii) Is considered by a local investigator not to be suitable for randomization; or (iv) Experiences ketoacidosis, heart attack, stroke, or hospitalization for heart failure, or hospitalization for urinary tract infection or acute kidney injury during Run-in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The effects of allocation to empagliflozin versus placebo on the time to the first occurrence of: (i) Kidney disease progression (defined as ESKD, a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of greater than or equal to 40% in eGFR from randomization); or (ii) Cardiovascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Key secondary outcomes: -Time to first hospitalization for heart failure or cardiovascular death -Time to occurrences of all-cause hospitalization (first and recurrent combined) -Time to death from any cause Other secondary outcomes: -Time to kidney disease progression -Time to cardiovascular death -Time to cardiovascular death or ESKD | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed