An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
This study, called FINEROD, is looking at how a new medicine called finerenone is used in real life. It's for people who have both chronic kidney disease (long-term kidney problems) and type 2 diabetes. Doctors are already prescribing finerenone to these patients as part of their usual care. Instead of asking people to do new tests, researchers will look at existing health records from parts of Asia and the United States. They want to understand more about who is taking finerenone, how safe it is, and how well it's working for them. This helps doctors and researchers learn more about new medicines after they've been approved and are being used by patients.
At a glance
What is this study about?
This study, called FINEROD, is designed to understand more about a new medicine called finerenone. This medicine has recently become available for doctors to prescribe to people who have both long-term kidney problems (chronic kidney disease, or CKD) and a common type of diabetes called type 2 diabetes. When you have type 2 diabetes, your body either doesn't make enough of a hormone called insulin or doesn't use it properly. This can lead to high blood sugar levels, which can damage your kidneys over time.
Finerenone works by blocking certain proteins in the body, which might help to protect the kidneys, heart, and blood vessels from further damage. Because it's a new treatment, doctors and researchers want to gather more information about how it's being used in everyday medical practice. They want to see how safe it is and how well it works for people under normal conditions, rather than in a strict research setting.
To do this, the study isn’t asking people to take new medicines or have extra doctor visits. Instead, researchers will look at existing health information that doctors and hospitals already collect. This includes details like a person's age, gender, kidney health, any heart problems, and other medicines they might be taking. By studying these records, they hope to get a clearer picture of who is taking finerenone and what their experiences are like.
Key takeaways
- This study looks at a medicine called finerenone for kidney disease and type 2 diabetes.
- It uses existing patient health records, so no new appointments or tests are needed.
- The goal is to understand how finerenone works and if it's safe in real-world settings.
- It includes adults aged 18+ with specific stages of kidney disease and type 2 diabetes.
- The information gathered helps improve future care for similar patients.
Who may be eligible?
This study looks at information from people aged 18 or older who are already receiving finerenone as part of their regular medical care. To be included, their health records must show they have chronic kidney disease (long-term kidney problems) and type 2 diabetes. Specifically, their kidney problems should be at stages 2, 3, or 4.
Also, your health records need to show that you've been continuously getting medical care for at least 12 months before you started finerenone. This helps the researchers make sure they have a good, long-term picture of your health.
People would likely not be included if their kidney disease is very severe (stage 5 kidney failure), if they are on dialysis (a treatment for kidney failure), or if they have had a kidney transplant. The study is only looking at people whose medical records show they started finerenone after July 1st, 2021.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have type 2 diabetes?
- Do you have chronic kidney disease (stages 2 to 4)?
- Are you currently taking finerenone, prescribed by your doctor?
- Have you been getting regular medical care for at least 12 months?
What does participation involve?
If you are already taking finerenone and meet the study criteria, you wouldn't need to do anything extra to take part in this study. Researchers won't ask you for any new information, tests, or visits. You won't be given any new or different medication. They will simply look at your existing health records, which already contain information about your health conditions and the medicines you take, including finerenone.
Potential risks and benefits
Locations (4)
- Many LocationsUnverifiedMultiple Locations, United States· Completed
- BayerVerified postcodeBerlin, Germany· Recruiting
- Many LocationsUnverifiedMultiple Locations, Japan· Completed
- Many LocationsUnverifiedMultiple Locations, Taiwan· Completed
Common questions
What is finerenone?
Finerenone is a new medicine used for people with long-term kidney problems and type 2 diabetes.
Do I need to do anything to join this study?
No, if your records are included, you won't need to do anything extra. This study only looks at existing health information.
Will I get any new medicine or tests?
No, this study is 'observational,' meaning researchers only observe existing data. No new medicines or tests are involved.
Why is this study important?
It helps doctors learn more about how finerenone works and if it's safe for people in regular care after it's been approved.
Who is eligible for this study?
It includes adults aged 18 or over taking finerenone for chronic kidney disease (stages 2-4) and type 2 diabetes, based on their health records.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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