The EASi-KIDNEY trial
Research type
Research Study
Full title
Studies of Heart & Kidney Protection with BI 690517 - A multicenter international randomized double-blind placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease
IRAS ID
1009666
Contact name
William Herrington
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2024-511025-63
Clinicaltrials.gov Identifier
Research summary
EASi-KIDNEY is a health research study testing whether the new medication called BI 690517, taken in combination with a well-tested medication called empagliflozin, lowers the risk of worsening kidney disease or heart disease in patients with kidney disease. In a large clinical trial, empagliflozin reduced the need to start dialysis and lowered the risk of heart disease in people who had kidney disease and is now recommended for most adults with chronic kidney disease worldwide.
Empagliflozin improves outcomes in people with kidney disease but is not a cure and the health risks remain elevated for many people. BI 690517 is a newly developed medicine that could provide further health benefits to people with kidney disease. Early studies have shown that BI 690517 might protect the kidneys and heart but this needs to be tested in a large study.
EASi-KIDNEY aims to recruit about 11000 participants with kidney disease internationally (of which about 1250 will be in the UK). Half of the participants will take BI 695017 10mg with empagliflozin 10mg once daily and half will receive a matching inactive pill (placebo) with empagliflozin 10mg once daily.The study is designed to be simple to run: extra effort and work for volunteer participants and collaborating hospital teams will be kept to a minimum, and only essential information will be collected. Participants will have 4 study visits in the first 6 months and then follow-up visits every 6 months. At each visit (except the third visit that only involves a blood test) they will have information about their health recorded, a blood test (to measure kidney function among other things) and physical measurements taken such as blood pressure. Some visits will also include provision of a urine sample. These study clinics will be run by research staff trained on study procedures. The study will continue until the study-required number of clinical outcomes have occurred which is estimated to take about 3-4 years.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0147
Date of REC Opinion
3 Jul 2024
REC opinion
Further Information Favourable Opinion