A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared with Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease (Stage 3b and 4)
Chronic kidney disease means the kidneys gradually lose their ability to filter blood properly over time. This can also put extra strain on the heart. Currently, a medicine called dapagliflozin (often sold as Forxiga) is used to help slow down kidney damage and protect the heart. This Phase III clinical trial tests whether combining dapagliflozin with a new medicine called balcinrenone works even better. The trial is open to adults living with moderate to advanced kidney disease (stages 3b and 4). Participants will take either the new drug combination or dapagliflozin with a dummy pill (placebo). Researchers want to find out if the new combination reduces the risk of kidney failure, the need for dialysis, or heart complications. By taking part, volunteers can help doctors find improved treatments for people living with long-term kidney conditions.
At a glance
What is this study about?
Healthy kidneys act like filters, clearing waste and extra fluid from your blood. In chronic kidney disease, these filters become damaged and work less effectively over time. As kidney health declines, the risk of serious complications—such as kidney failure or heart problems—can increase significantly.
Doctors currently prescribe a tablet called dapagliflozin to help protect the kidneys and heart. While this medicine helps, researchers are searching for ways to offer even stronger protection. This study is testing whether adding a new experimental drug, balcinrenone, can work alongside dapagliflozin to slow down kidney disease and prevent hospital visits for heart issues.
In this trial, half of the participants will receive both medicines, while the other half will receive dapagliflozin plus an inactive dummy tablet (a placebo). Because this is a "double-blind" study, neither you nor your study doctor will know which group you are in until the trial ends. This helps ensure that the results are completely fair and reliable.
The findings could help improve standard treatment guidelines across the UK and worldwide, potentially giving people with kidney disease more time before needing dialysis or a transplant.
Key takeaways
- Tests a new medicine combination (balcinrenone and dapagliflozin) for chronic kidney disease.
- Open to adults aged 18 and older with stage 3b or stage 4 kidney disease.
- Aims to delay kidney failure and lower the risk of heart problems.
- Involves taking daily tablets and attending regular hospital monitoring visits.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with chronic kidney disease at stage 3b or stage 4. Stage 3b and stage 4 mean that kidney function is moderately to severely reduced, but dialysis is not yet required.
Both men and women can take part. However, this trial is not suitable for people who are already having regular dialysis treatment or who have already received a kidney transplant.
Your study doctor will review your medical history and carry out standard blood and urine tests to check your kidney function and make sure it is safe for you to take part.
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.
- I am aged 18 or older.
- I have been diagnosed with chronic kidney disease (stage 3b or stage 4).
- I am not currently having regular kidney dialysis.
- I have not had a kidney transplant.
- I am able to attend regular clinic appointments and take daily tablets.
What does participation involve?
Taking part involves taking study tablets once a day by mouth and attending regular check-ups at a hospital clinic. During these visits, doctors will monitor your health by checking your blood pressure, taking routine blood samples, and testing your urine. These checks help the team see how well your kidneys and heart are doing and ensure you remain safe. The study usually lasts for a few years, and you will be supported by a dedicated research nurse and doctor throughout your time on the trial.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedGreece
Common questions
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers fairly compare the true effects of the new treatment.
Will I have to stop taking my regular medicines?
In most cases, you can continue taking your usual prescribed medicines. The study doctor will check all your current treatments to make sure they are safe to use alongside the study tablets.
Does it cost anything to join the trial?
No, the study medication and tests are provided free of charge. Many trials also offer support to cover reasonable travel expenses for hospital visits.
Can I leave the study if I change my mind?
Yes, you can leave at any point without giving a reason. Your standard NHS medical care will continue as normal.
How will I know if my kidneys are getting worse?
The research team will check your kidney function regularly using routine blood and urine tests. If your health changes, the doctors will discuss the best next steps with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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