(21177) A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease
This important study is testing a new medication called Finerenone for individuals who have long-term kidney disease not linked to diabetes. Researchers want to understand if Finerenone, when added to the usual care, can help slow down the worsening of kidney function. They're also checking how safe the medication is to use. Some participants will receive Finerenone, while others will get a placebo (a dummy pill with no active medicine), without knowing which they are taking. This helps scientists fairly compare the effects of the new drug. The study is particularly looking at changes in kidney function over about 32 months and overall health outcomes like heart problems.
At a glance
What is this study about?
Imagine your kidneys are like a filter, cleaning your blood. When you have chronic kidney disease (CKD), this filter isn't working as well as it should. Over time, for some people, kidney disease can get worse. This study is for people who have CKD that isn't caused by diabetes – sometimes we call this non-diabetic CKD.
Researchers want to see if a new medication called Finerenone can help to protect the kidneys and slow down the progression of the disease. They will compare it to a 'placebo', which looks exactly like the study drug but doesn't contain any active medicine. This helps them understand if any changes seen are truly due to Finerenone or something else. All participants will also receive the standard care for their kidney condition.
Another important goal is to check how safe Finerenone is. The study will carefully monitor participants for any side effects. By finding out if Finerenone is both effective and safe, it could potentially become a new treatment option for people living with non-diabetic chronic kidney disease, helping them to maintain their kidney health for longer.
Key takeaways
- This study is for adults with long-term kidney disease not caused by diabetes.
- It's testing a new medication called Finerenone to see if it can slow down kidney disease.
- Some participants will receive Finerenone, others a dummy pill (placebo).
- Participation involves regular clinic visits and close health monitoring for about 32 months.
- The study aims to check both the effectiveness and safety of Finerenone.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women can take part.
You would be considered for this study if you have chronic kidney disease that is not caused by diabetes. The study team will check your medical history and do some tests to make sure you meet all the specific requirements for the study.
There will be other detailed criteria that the study doctors will check to make sure the study is right for you and that you can safely participate. These might include specific health conditions you have, or medications you are currently taking.
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 DUE TO a cause other than diabetes?
- Are you willing to attend regular clinic visits for about 32 months?
What does participation involve?
If you decide to take part in this study, you will be in it for about 32 months. You'll need to attend regular clinic visits where the study team will monitor your health, perform physical exams, and take blood and urine samples. You will be given either the study medication (Finerenone) or a placebo (a dummy pill) to take regularly, but neither you nor your study doctor will know which one you are receiving – this is called 'double-blind'. The study team will also keep track of any changes in your health and any side effects you might experience. Throughout the study, you'll continue to receive your usual medical care for your kidney condition.
Potential risks and benefits
Locations (9)
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Common questions
What is chronic kidney disease?
Chronic kidney disease (CKD) means your kidneys are damaged and can't filter blood as well as healthy kidneys. It's a long-term condition that can get worse over time.
What is Finerenone?
Finerenone is an investigational drug, meaning it's still being studied. It aims to help protect the kidneys in people with kidney disease.
What does 'placebo' mean?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real drug's effects accurately.
How long will I be in the study?
The study will last for approximately 32 months, which is about two and a half years.
Can I leave the study early?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your medical care.
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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