A Phase IIb, Multicentre, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination with Dapagliflozin Compared with Dapagliflozin in Patients with Chronic Kidney Disease and Albuminuria
This research study is investigating a new medication called balcinrenone, used alongside an existing drug, dapagliflozin (also known as Forxiga). We are looking for people in the UK who have chronic kidney disease, which means their kidneys aren't working as well as they should, and also have albuminuria, where there's too much protein in their urine. The main goal is to find out if this combination of drugs can help improve kidney health and reduce the amount of protein in the urine, compared to just taking dapagliflozin alone. We also want to understand if the new drug is safe and well-tolerated. This is a Phase II study, meaning we're trying to find the best dose and check its early effects.
At a glance
What is this study about?
This study is about helping people who have chronic kidney disease and also have a condition called albuminuria. Chronic kidney disease means your kidneys are damaged and don't filter your blood as well as healthy kidneys should. Albuminuria means there's too much of a protein called albumin in your urine, which is a sign of kidney damage. Both of these conditions can get worse over time and lead to serious health problems.
We are looking at a new medication called balcinrenone. In this study, balcinrenone will be given together with an existing medication called dapagliflozin, which you might know as Forxiga. Forxiga is already used to help people with kidney disease. The main goal is to see if adding balcinrenone to Forxiga works better than Forxiga alone to protect the kidneys and reduce the amount of protein in the urine. We're also checking different doses of balcinrenone to find out what works best.
This is an important step in finding new ways to treat chronic kidney disease. By carefully studying these medications, we hope to find new treatments that can improve the health and well-being of people living with this condition. Your participation could help us learn vital information for future treatments.
Key takeaways
- Tests a new medicine (balcinrenone) with an existing one (dapagliflozin/Forxiga).
- Focuses on people with long-term kidney disease and protein in their urine.
- Aims to see if the combination helps slow kidney damage and reduce protein in urine.
- You might receive the new combination or just the existing medicine.
- Participation involves regular clinic visits for checks and tests.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or over. This study is open to both men and women. We are specifically looking for people who have been diagnosed with chronic kidney disease, which means you have ongoing problems with your kidneys.
You also need to have what's called albuminuria. This means that tests have shown there's too much protein (albumin) in your urine. Your doctor will be able to tell you if you have this condition.
There will also be some other health checks and tests to make sure that the study medication is safe for you and that you meet all the requirements. These will be explained in full detail by the study team.
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?
- Does your doctor say you have too much protein (albumin) in your urine (albuminuria)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part, you would receive either the new drug combination (balcinrenone with dapagliflozin) or dapagliflozin on its own. You won't know which one you are getting, and neither will your study doctor. This is done to make sure the results are fair.
You would have regular visits to the clinic for check-ups, blood tests, and urine tests. These tests help us to see how your kidneys are doing and if the medication is having an effect. We will also monitor your overall health throughout the study. The study involves taking medication and attending follow-up appointments over a period of time, which the study team will explain in detail. The main thing we'll be looking at is how your protein levels in urine change over 12 weeks.
Potential risks and benefits
Locations (5)
- —UnverifiedBulgaria
- —UnverifiedAustria
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is chronic kidney disease?
Chronic kidney disease means your kidneys are damaged and don't work as well as they should, usually for a long time.
What is albuminuria?
Albuminuria means there's too much protein (albumin) in your urine, which can be a sign of kidney damage.
What is dapagliflozin/Forxiga?
Dapagliflozin (also known as Forxiga) is a medication already used to help people with conditions like type 2 diabetes and kidney disease.
Will I know if I'm getting the new drug?
No, neither you nor your study doctor will know whether you are receiving the new drug combination or just the existing treatment. This is to ensure fair and unbiased results.
How long does the study last?
The main part of the study measures changes over 12 weeks, but the full duration of your participation will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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