We have published an academic article that describes why and how we set up the EMPA-KIDNEY trial and what we hope to find out. This is a short summary of the key points.
What do we know about this subject?
Chronic kidney disease (CKD) is long-term condition that often gets worse. If you have CKD, you have an increased risk of developing heart disease or having a stroke. Your condition may get worse, and you may need to have dialysis (a procedure to remove waste products from the blood when the kidneys stop working as they should). We need treatments that help to reduce the risk of this happening.
Clinical trials in people with CKD have shown that drugs like empagliflozin, called sodium-glucose co-transporter-2 (SGLT-2) inhibitors, help reduce the risk of kidney disease becoming worse in certain patients.
Having protein in your urine is a sign of kidney disease. Previous SGLT-2 trials have shown that these drugs reduce the risk of kidney disease becoming worse in people with type 2 diabetes who have protein in their urine, and they may also help patients with protein in their urine who don’t have diabetes.
What does this study add?
Previous trials studied a small number of patients without diabetes, and a small number of people with low levels of protein in the urine; the numbers were too small to be certain if empagliflozin would work for them. We needed to recruit more patients to find out whether empagliflozin will help these types of patients and other patients with CKD.
For example, of the 6609 EMPA-KIDNEY participants, just over one-half did not have diabetes when they were recruited, and about one-half had only mild or moderate levels of protein in their urine.
We recruited patients from the UK, Europe, North America and East Asia, to make sure that the results would apply to people across the world.
How will this change treatment of kidney disease patients?
EMPA-KIDNEY will provide new information about the benefits of empagliflozin in a wide range of people with CKD who are at risk of worsening disease, including those who have diabetes and those who do not. It will also provide additional information about the safety of the treatment.
We expect that the EMPA-KIDNEY trial results will be available at the end of 2022. We will tell people about the results so that doctors and patients are able to make informed decisions about treatments.
You can find out more about the trial in our Frequently Asked Questions.