If you’ve been diagnosed with or told you are at risk for diabetic kidney disease (DKD), or if you have been told that you have high protein levels in your urine, you may want to consider the FIDELIO-DKD and FIGARO-DKD clinical research studies.
Before choosing to participate in a clinical research study, you can speak to your doctor to find out more about clinical research.
Is the FIDELIO-DKD or FIGARO-DKD clinical research study an option for you?
Diabetic kidney disease (DKD), also called diabetic nephropathy, affects the kidneys, cardiovascular system, and the overall health of people who have type 2 diabetes. Usually DKD develops in those who have had diabetes for 10 to 20 or more years. DKD occurs when high blood sugar levels and other complications of diabetes begin to affect how the kidneys work. The kidneys filter blood and remove waste products from the body. DKD can damage the kidney’s filters, causing them to “leak” proteins. Over time, DKD can progress to kidney failure and can considerably increase the risk of heart disease and stroke.
Type 2 diabetes mellitus is a chronic disease in which the body is unable to correctly produce or use insulin (a hormone that regulates blood sugar levels in the body), leading to increased blood sugar levels and other complications. Over time, high blood sugar levels can slowly damage blood vessels in the body. This can cause narrowing, also known as “furring,” of the arteries, leading to poor circulation, high blood pressure, heart attacks, and strokes. The kidneys can also be affected by damaged blood vessels.
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.
You may be able to join either the FIDELIO-DKD study or the FIGARO-DKD study if you:
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.
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 investigational study medication.
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.
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.
Clinical research studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe and effective for their intended use. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.
Why do people participate in studies?
People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.
Are clinical studies safe?
Clinical research studies follow a specific set of standards and are closely regulated to ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is designed to make sure all study procedures are conducted correctly and safely.
What if I have questions during the study?
You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Can I leave the study once it has started?
Study participation is completely voluntary, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.
Can I see other doctors during the study?
You can visit any doctor to meet your needs during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.