The EMPA-KIDNEY Study
Research type
Research Study
Full title
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
IRAS ID
236211
Contact name
William Herrington
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2017-002971-24
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
EMPA-KIDNEY is a clinical trial aiming to test whether taking a medication called empagliflozin lowers the risk of worsening kidney disease or heart disease in patients with kidney disease.
Empagliflozin was originally developed to treat people with diabetes. In a large clinical trial, empagliflozin reduced the number of deaths from heart disease in people who already had both heart disease and diabetes. The same clinical trial suggested that this medication could reduce the development or worsening of kidney disease. There is good reason to believe the medication could benefit people with kidney disease whether they have diabetes or not.
EMPA-KIDNEY aims to recruit about 5000 participants with chronic kidney disease internationally (of which about 1000 will be in the UK). Half of the participants will take empagliflozin 10mg once daily and half will receive a matching inactive pill (placebo). The trial 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 be followed in clinics 3 times over the first 6 months and then 6 monthly. At each visit they will have a measure of kidney function and blood pressure made and information about their health recorded. 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 C Research Ethics Committee
REC reference
18/SC/0155
Date of REC Opinion
29 Mar 2018
REC opinion
Favourable Opinion