A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

To join this study, you need to be at least 18 years old and have been diagnosed with long-term kidney disease (CKD) at stage 3b or 4. Your kidney function, which doctors measure with a blood test called eGFR, should be between 15 and 45 ml/min/1.73 m2. We also look at how much protein is in your urine, which can be a sign of kidney damage. Before joining, your potassium levels in your blood must be within a safe range, and if you take blood pressure medicine like ACE inhibitors or ARBs, you need to be on a stable dose for at least four weeks, unless you can't take them for medical reasons.

There are also some reasons why you might not be able to join. For example, if you are currently on dialysis, or likely to need it within three months, you won't be eligible. Also, if you have very high or very low blood pressure, severe heart problems (like a recent heart attack or stroke), very advanced liver disease, or certain other kidney conditions like polycystic kidney disease, you might not be able to take part. People with uncontrolled diabetes (HbA1c over 9%) or specific types of diabetes like Type 1 diabetes (with some exceptions) are also generally not included.

If you decide to take part, you will be randomly assigned to one of two treatment groups, like flipping a coin. You'll either receive the new combination medicine (balcinrenone/dapagliflozin) or dapagliflozin alone. Both treatments are taken as one capsule and one tablet once a day. You won't know which treatment you are getting, and neither will your study doctor, which helps make the results fairer.

Throughout the study, you'll continue to receive your usual kidney care from your own doctors. The study will involve regular visits to the hospital or clinic for health checks, blood tests, urine tests, and to review your progress. These visits help the study team monitor how you're responding to the medicine and check for any side effects. The study is designed to follow people for a long time, potentially several years, to see the full effects of the treatments on kidney health and heart problems. The total duration of your participation will depend on how the study progresses, but you will always be kept informed.