EASi-KIDNEY participant documents
Prior to entry into the trial you will be required to read this Participant Information Leaflet and Data Protection Information Leaflet in order to enable you to be fully informed about the trial and complete the Informed Consent Form at your first Screening visit.
At your first Screening visit, in addition to a copy of the Informed Consent Form (if completed), you will be given the Study Treatment Information Leaflet, Dietary Potassium Leaflet and Participant Card which will provide important information for the duration of the trial.
Provided at Invitation:
1. Participant Invitation Letter: a letter providing a brief overview of this research study and inviting patients to participate.
2. Participant Information Leaflet: this leaflet provides detailed information about this study to help patients decide whether they want to take part.
3. Data Protection Information Leaflet: a leaflet explaining how data from EASi-KIDNEYTM are processed.
Provided at Screening:
4. Informed Consent Form: a form to make sure each patient understands the main points about taking part in this research study and provides a record of consent to participate.
5. Study Treatment Information Leaflet: a leaflet providing detailed information about the study pills (vicadrostat (BI 690517) or matching placebo and empagliflozin).
6. Dietary Potassium Leaflet: a leaflet providing dietary advice for participants if they have a high blood potassium level.
7. Participant Card: a card with contact details of the study team so that your clinical team can promptly report all hospitalisations and emergencies.