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

Phase 1

Conditions: Chronic kidney disease
MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2017-002971-24-IT

Lead Sponsor: BOEHRINGER INGELHEIM INTERNATIONAL GMBH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 6000

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:
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 2500

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; 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 I 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>inactive pill (placebo) prevents:<br>- hospitalization with heart failure or death from heart disease<br>- death from any cause<br>- hospitalization from any cause<br>in people with kidney disease.<br>Other questions include the safety and tolerability of empagliflozin compared to<br>placebo.;Primary end point(s): Time to first occurrence of:<br>• Kidney disease progression (end-stage kidney disease, a sustained declined in eGFR to <10 mL/min/1.<br>73m², renal death, or a sustained decline >=40% in eGFR from randomization) or<br>• Cardiovascular death;Timepoint(s) of evaluation of this end point: After accrual of at least 1070 primary outcome events as defined in E5.1

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Time to first hospitalization for heart failure or cardiovascular death;<br>b) Occurrences of all-cause hospitalizations (first and recurrent);<br>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 E5.1

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