EMPA-KIDNEY (The study of heart and kidney protection with empagliflozin)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 5000

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; or
(b)CKD-EPI eGFR =45 <90 mL/min/1.73m2 with urinary albumin:creatinine ratio =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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500

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 <90 or >180 mmHg at Screening;
(ix)ALT or AST >3x ULN at Screening;
(x)Hypersensitivity to empagliflozin or other SGLT-2 inhibitor;
(xi)Any immunosuppression therapy in last 3 months (except prednisolone =10 mg or equivalent); or anyone currently on >10 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.

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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