(22267) A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes
This research study is for people who have chronic kidney disease (long-term kidney problems) because of their type 1 diabetes. We are testing a new medicine called finerenone to see how well it works and if it's safe. Half of the participants will receive finerenone, and the other half will receive a dummy medicine (placebo), in addition to the treatments they usually take for their condition. Neither the participants nor the doctors will know who is getting which treatment. Over six months, we will be carefully watching to see if finerenone helps to protect the kidneys better than the dummy medicine by looking at how a specific marker in their urine changes. We will also be checking for any side effects.
At a glance
What is this study about?
This study is a big, important trial (called a Phase 3 study) looking into a new medicine called finerenone. It's designed for people who have long-term kidney disease, specifically when it's caused by their type 1 diabetes. The main goal is to find out if finerenone can help prevent or slow down further kidney damage.
Participants in the study will be divided into two groups by chance. One group will receive the new medicine, finerenone, while the other group will receive a 'placebo.' A placebo looks exactly like the real medicine but doesn't contain any active drug – it's often called a 'dummy pill.' This helps us to see if the effects are genuinely due to the new medicine or something else. Both groups will continue to receive their usual care for their kidney disease and diabetes.
The study will last for at least 6 months. During this time, the researchers will be carefully measuring a specific marker in your urine called UACR (Urine Albumin to Creatinine Ratio). This is a good indicator of how well your kidneys are working. By comparing the UACR levels before and after treatment, the researchers can tell if finerenone is helping to protect the kidneys more effectively than the placebo. They will also be meticulously tracking any side effects to make sure the medicine is safe.
Key takeaways
- This study is for adults with long-term kidney disease due to type 1 diabetes.
- It's testing a new medicine, finerenone, against a dummy pill (placebo).
- Participation involves regular clinic visits, blood, and urine tests over at least 6 months.
- The goal is to see if finerenone helps protect kidneys and is safe.
- You will continue to receive your standard medical care throughout the study.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to everyone, regardless of whether you are male or female.
The key requirement is that you have chronic kidney disease (long-term kidney problems) that is linked to your type 1 diabetes. This means your kidney issues are a complication of your diabetes.
There might be other specific health requirements or conditions that would mean you can't join, which your doctor will discuss with you. These are put in place to ensure the study is safe for everyone involved and that the results are clear.
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 chronic kidney disease?
- Is your kidney disease caused by your type 1 diabetes?
- Are you willing to attend regular clinic appointments and have tests?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new medicine, finerenone, or a dummy pill (placebo). Neither you nor your study doctor will know which you are getting, to keep the results fair. You will take this medicine every day, in addition to your usual treatment for diabetes and kidney disease.
You will need to attend several appointments over at least a 6-month period. These visits will involve regular check-ups, blood tests, and urine tests to monitor your kidney function and overall health. The main measurement will be a specific urine test to see how your kidneys are doing.
Throughout the study, you'll be closely monitored for any side effects or changes in your health. The total duration of your participation will depend on the study's plan, but the main focus for evaluating the treatment effectiveness is over 6 months.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedSpain
Common questions
What is finerenone?
Finerenone is a new investigational medication being tested to see if it can help protect the kidneys in people with chronic kidney disease and type 1 diabetes.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.
How long will the study last for me?
The main part of the study where we look at the treatment's effect is over 6 months, but your overall participation might be longer, as discussed by your doctor.
Will I still take my usual medicines?
Yes, you will continue to take your regular medications for your diabetes and kidney disease as prescribed by your doctor, in addition to the study medication.
What is UACR?
UACR (Urine Albumin to Creatinine Ratio) is a measurement from a urine test that helps doctors monitor how well your kidneys are working and if they are showing signs of damage.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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