A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease
A Multicentre International Randomized Parallel Group Double-blind Placebo-controlled Clinical Trial of EMPAgliflozin Once Daily to Assess Cardio-renal Outcomes in Patients With Chronic KIDNEY Disease
The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).
Inclusion Criteria:
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
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;
Key Exclusion Criteria:
West Springfield, Massachusetts 01089, United States
Aichi, Nagoya, 455-8530, Japan
Fukuoka, Fukuoka, 814-0180, Japan
Gumma, Maebashi, 371-0046, Japan
Gunma, 371-0022, Japan
Gunma, 373-0861, Japan
Ibaraki, Tsukuba, 305-8576, Japan
Miyagi, Sendai, 980-8547, Japan
Okayama, Kurashiki, 701-0192, Japan
Okayama, Okayama, 700-8558, Japan
Shiga, Otsu, 520-2192, Japan
Tokyo, Bunkyo-ku, 113-8431, Japan
Tokyo, Bunkyo-ku, 113-8655, Japan
Tokyo, Ota-ku, 144-0051, Japan
Tokyo, Shinjuku-ku, 162-8555, Japan
Cheras, Kuala Lumpur, 56000, Malaysia
Georgetown, Pulau Pinang, 10450, Malaysia
Ipoh, Perak, 30450, Malaysia
Kajang, Selangor, 43000, Malaysia
Kajang, Selangor, 43000, Malaysia
Taiping, Perak, 34000, Malaysia