Chronic Kidney Disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Jardiance
Product Name: Empagliflozin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >=18 years at Screening. Evidence of progressive CKD at risk of kidney disease progression 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 mL/min/1.73m² limited to about one-third. The Steering Committee will monitor these proportions and will limit recruitment of particular categories of participants in whom sufficient numbers have already been screened or randomized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1800
Exclusion criteria
Exclusion criteria: None of the following must be fulfilled: (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 inhibitors; (xi) Any 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. Note that individuals who do not fulfil one or more inclusion criteria, or who fulfil one or more exclusion criteria, may be re-screened and later become eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main question is whether taking an empagliflozin pill once a day compared to an inactive pill (placebo) prevents worsening of kidney disease or death from heart disease in people with kidney disease.;Secondary Objective: Secondary questions are whether taking empagliflozin pill once a day compared to an inactive pill (placebo) prevents: - hospitalization with heart failure or death from heart disease - death from any cause - hospitalization from any cause in people with kidney disease. Other questions include the safety and tolerability of empagliflozin compared to placebo.;Primary end point(s): Time to first occurrence of: • Kidney disease progression (end-stage kidney disease, a sustained eGFR <10 mL/min/1.73m², renal death, or a sustained =40% decline in eGFR from randomization) or • Cardiovascular death;Timepoint(s) of evaluation of this end point: After accrual of at least 1070 primary outcome events as defined in E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Time to first hospitalization for heart failure or cardiovascular death; b) Occurrences of all-cause hospitalizations (first and recurrent); c) Time to death from any cause.;Timepoint(s) of evaluation of this end point: After accrual of at least 1070 primary outcome events as defined in E.5.1 | — |
Countries
Canada, China, Germany, Italy, Japan, Malaysia, Norway, Sweden, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim
Outcome results
None listed