(21839) A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes.
This study, called a Phase 2 trial, is investigating a new way to treat chronic kidney disease in people who also have type 2 diabetes. We are comparing two medicines: finerenone (known as Kerendia) and empagliflozin (known as Jardiance). We want to find out if taking both medicines together is more effective and safe than taking either one by itself. The main thing we're looking at is how these treatments affect a marker in your urine that tells us about kidney health over about six months. We're also checking for any side effects and how your kidneys are working overall. This research helps doctors understand the best ways to protect kidneys in people with these conditions.
At a glance
What is this study about?
This study is about finding better ways to help people who have both chronic kidney disease and type 2 diabetes. These conditions often go hand-in-hand and can cause serious health problems. We are focusing on two medicines that are already used to treat these conditions: finerenone, which you might know as Kerendia, and empagliflozin, also known as Jardiance.
In this research, we are comparing three different treatment approaches. Some participants will receive finerenone, some will receive empagliflozin, and others will receive both medicines together. We will also use 'placebos', which look exactly like the real medicine but don't contain any active drug. This helps us ensure that any improvements we see are truly due to the medicines and not just other factors.
The main goal of the study is to see if taking both finerenone and empagliflozin works better than taking either one alone to improve kidney health. We'll be doing this by measuring a specific marker in your urine called the Urinary Albumin to Creatinine Ratio (UACR). This marker helps doctors understand how well your kidneys are filtering waste. We'll be looking at changes in this marker over six months. We will also keep a close eye on any side effects to make sure the treatments are safe.
Key takeaways
- This study is for adults with both chronic kidney disease and type 2 diabetes.
- It compares two medicines, finerenone and empagliflozin, used alone or together.
- The main goal is to see which treatment best improves kidney health markers.
- Participants will take study medication and attend regular clinic visits for about six months.
- Safety and side effects will be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.
The most important conditions for joining are that you must have been diagnosed with both chronic kidney disease and type 2 diabetes.
There might be other detailed requirements, like specific results from your blood or urine tests, or whether you are taking certain other medications. These will be discussed with you by the study team to make sure the study is a good fit for your health situation.
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?
- Have you been diagnosed with chronic kidney disease?
- Do you also have type 2 diabetes?
- Are you able to attend regular clinic appointments for about six months?
- Are you willing to take study medication as prescribed?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of three groups by chance (like flipping a coin). You'll either receive finerenone, empagliflozin, or a combination of both. You won't know which treatment you're getting, nor will your study doctor, to keep the results unbiased. Some groups will also receive a placebo, which looks like the medicine but contains no active drug. You will take the study medication as prescribed, likely in tablet form.
Over a period of about six months (180 days), you will have regular visits to the clinic. During these visits, the study team will monitor your health closely. This will involve physical examinations, providing blood and urine samples (to check your kidney function and other health markers), and discussions about how you're feeling and any side effects you might be experiencing. We'll be especially interested in changes to a kidney health marker found in your urine.
After the main treatment period, there will be some follow-up visits to see how you are doing after stopping the study medication. The exact number of visits will be explained to you by the study team, along with the total expected time you'll be involved in the study.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedDenmark
Common questions
What is chronic kidney disease?
Chronic kidney disease means your kidneys are damaged and can't filter blood as well as they should. It often gets worse over time.
What is type 2 diabetes?
Type 2 diabetes is a condition where your body doesn't use insulin properly, leading to high blood sugar levels.
What are finerenone (Kerendia) and empagliflozin (Jardiance)?
These are prescription medicines used to treat kidney disease and/or type 2 diabetes, working in different ways to protect your kidneys and heart.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks like the study medicine but doesn't contain any active drug. It helps compare real drug effects.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is over. This helps ensure fair results.
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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