A study to investigate the mechanistic effects of dapagliflozin alone or in combination with balcinrenone, compared to balcinrenone and placebo on body fluid and electrolyte handling and energy metabolism in participants over 50 years of age with chronic kidney disease (DapaBalci-Leap)
This research study, called DapaBalci-Leap, is designed for people over 50 years old who have moderate chronic kidney disease (Stage 3). We're investigating two potential medicines, dapagliflozin and balcinrenone, given alone or in combination. The main goal is to understand how these medicines affect the body's fluids, salts (electrolytes), and how it uses energy. We'll be looking closely at changes in how much sugar leaves the body in urine over 28 days. This will help us learn more about how these treatments could potentially help manage kidney conditions in the future. Participants will receive different combinations of the study medicines or a placebo (dummy drug) to compare their effects.
At a glance
What is this study about?
This study, called 'DapaBalci-Leap', is looking into new ways to help people over 50 who have moderate chronic kidney disease, also known as Stage 3 chronic kidney disease. This is a common condition where the kidneys don't work as well as they should to filter waste from the blood.
The main aim of this study is to understand how two medicines, dapagliflozin and balcinrenone, affect your body. This includes looking at how your body handles fluids and important salts (like sodium and potassium), and how it uses energy. We want to see if these medicines, used alone or together, can make a positive difference in these areas. The study compares these active medicines to a placebo, which looks like the medicine but contains no active drug, to help us understand the true effects of the treatments.
We are particularly interested in how much sugar is passed in your urine over 28 days, as this can tell us a lot about how your kidneys are working and how the medicines are affecting them. By carefully studying these changes, we hope to gain valuable information that could lead to better treatments for chronic kidney disease in the future. This is a Phase II study, meaning it's an early-stage study focusing on whether the treatments work and are safe.
Key takeaways
- This study is for people over 50 with moderate kidney disease (Stage 3).
- It tests two medicines, dapagliflozin and balcinrenone, to see how they affect the body.
- The study looks at fluids, salts, and energy use changes over 28 days.
- You might receive active medicine or a placebo (dummy pill).
- Participation involves regular clinic visits, blood/urine tests, and possibly MRI scans.
- Your health will be closely monitored for any side effects.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old – there's no upper age limit. We are welcoming both men and women to take part.
The most important health requirement is that you have chronic kidney disease classified as Stage 3. This means your kidneys are moderately affected and aren't working as well as they should.
There might be other health conditions or medicines you're taking that could mean this study isn't right for you. The study team will review all your health information carefully to make sure it's safe for you to participate.
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.
- Am I 18 years old or older?
- Do I have chronic kidney disease, specifically Stage 3?
- Am I over 50 years of age?
- Am I comfortable with regular clinic visits and tests?
- Have I discussed this study with my doctor?
What does participation involve?
If you join this study, you will have several appointments at the clinic over about a month. You will receive either dapagliflozin, balcinrenone, a combination of both, or a placebo (a dummy pill with no active medicine). You won't know which one you're getting, and neither will your study doctor, to keep the results fair.
Throughout the study, nurses and doctors will monitor your health closely. This will involve giving urine and blood samples often, especially at the beginning and end of the study, to check things like how much sugar is in your urine, your salt levels, and other markers of kidney health. You might also have special scans, like MRI scans, to look at your body's fluid and salt content at certain points.
Your vital signs (like blood pressure and heart rate) will be checked regularly, and you'll be asked about any side effects you experience. The total duration of active participation, including taking the medication and attending appointments, will be about 28 days, followed by some final assessments.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What is Stage 3 chronic kidney disease?
Stage 3 chronic kidney disease means your kidneys are moderately damaged and aren't filtering waste from your blood as well as they should be.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. It helps researchers understand the true effects of the actual medicine.
How long will I be in the study?
Active participation, including taking medication and clinic visits, will last for about 28 days.
Will I know which medicine I'm getting?
No, to keep the study fair, you won't know if you're getting the active medicine or the placebo. This is called 'blinding'.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, for any reason, without it affecting 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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