What happens at the first appointment?

At your first study appointment (called your screening visit), with your agreement, a trained study nurse (or research coordinator) will check your previous blood and urine test results and then explain the study to you. You will have plenty of time to ask questions.

You will then be asked to sign a consent form if you agree to take part. The study nurse will then ask some more details about your medical history and current medication. They will also take a fresh blood sample (about one teaspoonful) and collect a urine sample to be sent to the local laboratory for testing.

The study nurse will ask for a list of medications you are currently taking. If you are not currently taking empagliflozin, you will also be prescribed this and required to take empagliflozin for the duration of the study. If you are already taking a similar drug (another type of SGLT2 inhibitor which ends in -flozin), you will be required to stop taking this and switch to empagliflozin instead. Empagliflozin will be supplied as part of the trial for the full duration of the trial.

This first appointment is one of the longest appointments and could take up to an hour to complete. If you are willing and able to take part in EASi-KIDNEY^TM, the study research nurse will give you a supply of pills to take for two to three months to see if taking these extra pills every day is acceptable to you.

After this appointment you are then in what is called the run-in phase. During this time, you will be advised to start taking the second study medication called empagliflozin alongside the other treatment BI 690517 or placebo. If you are already prescribed an alternative SGLT2 inhibitor (-flozin) medication, you will be instructed to stop taking this and switch to empagliflozin after discussion with your doctor. The study nurse and doctor will give you clear instructions. The research team will also write to and inform your GP to let them know that you are planning to join the EASi-KIDNEY^TM trial.

You will be given a participant card with the contact details of the study team so that your clinical team can promptly report all hospitalisations and emergencies.