• About the DKD Studies

    The purpose of the FIDELIO-DKD and FIGARO-DKD studies is to evaluate whether adding an investigational medication to regular treatment may be safe and effective to help slow the progression of kidney disease in patients with DKD and type 2 diabetes. The studies will also look at whether the addition of the investigational medication to regular treatment may help reduce the more serious complications of DKD like heart disease or stroke.

    Overweight woman who could have type 2 diabetes and reduced kidney function

    Who can participate?

    You may be able to join either the FIDELIO-DKD study or the FIGARO-DKD study if you:

    • Are diagnosed with type 2 diabetes
    • Have reduced kidney function as a result of having diabetes
    • Are receiving treatment for high blood pressure
    • Are at least 18 years old

    There are other criteria you must meet to be eligible to participate. The study staff will discuss these with you in more detail.

     

    If you qualify and choose to participate, you will join either the FIDELIO-DKD study or the FIGARO-DKD study, depending on which study you are best qualified for. However, if you first join one study and your eligibility changes later, you may be transferred from one study to the other without having any additional study visits, tests, or procedures.

    What is the investigational medication?

    The FIDELIO-DKD and FIGARO-DKD studies are evaluating two different doses of a once-daily oral investigational medication in patients with DKD and type 2 diabetes. The investigational medication works by blocking the effects of aldosterone, a hormone that is associated with progression of kidney disease as well as heart disease, in individuals with type 2 diabetes mellitus. The studies will examine whether adding the investigational medication to regular treatment may be safe and effective to help slow the progression of kidney disease and reduce the more serious complications of DKD like heart disease or stroke.

     

    In the studies, the investigational medication is being compared to placebo, which looks similar to the investigational medication but contains no active ingredients. Study participants will be assigned randomly to receive either the investigational medication or placebo.

     

    Speak with the study staff for more information about the study investigational study medication.

    What will happen during the study?

    If you are eligible to participate in either the FIDELIO-DKD or FIGARO-DKD study, you will be required to attend all study visits and follow instructions from the study staff. Study visits will occur every four months for the majority of the study, though they may be more frequent at the beginning and end of the study. You may also be asked to occasionally visit the study site between regular study visits.

     

    Participants will be asked to remain in the study through the planned study end date.

     

    All study-related medications, tests, procedures, and evaluations will be provided at no cost during the study.

    What are the potential risks and benefits of study participation?

    Your health will be monitored by the study doctor and staff throughout the study, and you will continue to receive regular blood pressure and type 2 diabetes treatments. There is no guarantee that being in a study will help your DKD and type 2 diabetes. Before choosing to take part in one of the studies, please read all the information the study doctor provides and ask questions about the study.

     

    Talk with the study staff if you have any questions about the risks and benefits of study participation.