What happens at appointments?
First appoIntment (Screening Visit)
At the first study appointment (called the Screening Visit), with participant agreement, a trained study nurse will check previous blood and urine test results and then explain the study. There will be plenty of time to ask questions.
Participants will then be asked to sign a Consent Form if they agree to take part.
The study nurse will then ask some more details about medical history and current medication. They will also take a fresh blood sample (about 1 teaspoonful) and collect a urine sample to be sent to the local laboratory for testing.
If a participant is willing and able to take part in EMPA-KIDNEY, the study research nurse will give them a supply of pills to take for 2-3 months to see if taking extra pills every day is acceptable.
The research team will write to and inform participants' GPs to let them know that they are planning to join the study.
This first appointment is the longest appointment and could take up to an hour to complete.
Second Appointment (Randomization Visit)
2-3 months after the first visit, will be the second appointment (called the Randomization Visit). At this appointment we will check how participants got on taking the study pills. They will also be asked if they remain willing to commit to the study for around 3-4 years.
If participants are happy to join, a study nurse will perform a short interview, collect another blood sample (about 6 teaspoons this time), ask for a urine sample, and give out the next set of study pills.
This appointment should only take 30-45 minutes to complete.
Other appointments (Follow-up Visits)
The next appointment (called a Follow-up Visit) will be 2 months after the Randomization Visit. After that appointment, the study research nurse will see participants 4 months later and then every 6 months.
At each Follow-up Visit, the study nurse will ask about any new medical problems since the last appointment, give the next supply of study pills and take a blood sample (between 3-6 teaspoons each time) and possibly a urine sample.
Each Follow-up Visit is designed to ideally take less than 30 minutes (although the time needed to collect blood samples and dispense study pills can vary from hospital to hospital).
Following the last study Follow-up Visit, participants will stop the study pills. About 4 weeks later, they will be asked to provide one further blood test (about 1 teaspoonful) and a urine sample.