A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
This research is testing a new drug called Baxdrostat when used alongside an existing medication, Dapagliflozin. It's for adults in the UK with ongoing kidney disease and high blood pressure. The main goal is to find out if this new combination can more effectively protect the kidneys from further damage and reduce the risk of serious heart problems, compared to Dapagliflozin by itself. The study will follow participants over time to check how well the treatment works and if it's safe. It's designed to be 'double-blind', meaning neither you nor your doctor will know if you're getting Baxdrostat or a dummy pill alongside Dapagliflozin. This helps ensure fair results.
At a glance
What is this study about?
This study is investigating a new treatment approach for people living with chronic kidney disease and high blood pressure. These conditions, when present together, can put a significant strain on your kidneys and heart, increasing the risk of serious health issues over time. Researchers want to see if adding a new meditation, Baxdrostat, to an existing one, Dapagliflozin, can provide better protection for your kidneys and heart.
Dapagliflozin is a medicine that's already used for kidney disease and heart conditions. Baxdrostat is a newer medication that works differently to help manage blood pressure. By combining these two drugs, the study hopes to find a more effective way to slow down kidney damage and reduce the chance of heart-related complications, such as heart failure or death due to heart problems. The study will carefully compare the new combination therapy against Dapagliflozin alone (with a 'dummy' pill instead of Baxdrostat) to understand the benefits and risks.
This is a 'Phase 3' study, which means it's one of the final stages of testing before a new medicine might be considered for wider use. It's being conducted across many different locations internationally to gather a broad range of information. The results will help doctors understand if this combination treatment could offer a valuable new option for managing chronic kidney disease and high blood pressure.
Key takeaways
- Tests a new drug (Baxdrostat) with an existing one (Dapagliflozin).
- Aims to protect kidneys and heart in people with kidney disease and high blood pressure.
- It's a long-term study with regular check-ups.
- You might receive the new medicine or a dummy pill.
- Your health will be closely monitored throughout.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult aged 18 or over. You must have a diagnosis of chronic kidney disease and high blood pressure. The study has specific readings needed for your kidney function (eGFR and protein levels in your urine) and blood pressure that your doctor will check. You'll also need to be taking a specific type of blood pressure medication (an ACE inhibitor or ARB) at a stable, tolerated dose.
There are some conditions that would prevent you from taking part. For example, if your blood pressure is extremely high or if you have very high levels of potassium in your blood. If your sodium levels are too low, you also wouldn't be able to join. Generally, if you have Type 1 diabetes, you won't be eligible, with very specific exceptions for those in the US or Japan who have been on certain treatments for a while.
The study team will review all your medical information carefully to determine if this study is suitable and safe for you. They will explain all the criteria in detail.
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?
- Do you have both chronic kidney disease and high blood pressure?
- Do you take an ACE inhibitor or ARB medication for your blood pressure?
- Is your blood pressure not extremely high (over 180/110)?
- Are your blood potassium levels not too high?
- Are you generally not a Type 1 diabetic (with specific exceptions)?
What does participation involve?
If you join the study, you'll first have a four-week period where you'll take Dapagliflozin. After this, you'll either receive the combination of Baxdrostat and Dapagliflozin, or a placebo (a dummy pill) along with Dapagliflozin. Neither you nor your study doctor will know which one you're receiving – this is called 'double-blind'.
You'll have regular visits to the study clinic: at 2, 4, 8, 16, 34, and 52 weeks after starting your main study medicine. After the first year, visits will be scheduled about every four months. These visits will involve various checks, such as blood tests, blood pressure measurements, and asking about your health and any side effects. The study will continue until a certain number of combined kidney and heart events have occurred across all participants. You might continue for several years.
If you need to stop taking the study medication early for any reason, you'll still be asked to remain in the study and attend your scheduled follow-up visits. This is important so the researchers can continue to monitor your health and gather complete information. You can decide to leave the study at any time, for any reason, without it affecting your usual care.
Potential risks and benefits
Locations (761)
- Research SiteVerified postcodeFairhope, United States· Recruiting
- Research SiteVerified postcodeSurprise, United States· Recruiting
- Research SiteVerified postcodeTucson, United States· Recruiting
- Research SiteVerified postcodeBeverly Hills, United States· Recruiting
- Research SiteVerified postcodeCanoga Park, United States· Withdrawn
- Research SiteVerified postcodeConcord, United States· Recruiting
- Research SiteVerified postcodeFremont, United States· Recruiting
- Research SiteVerified postcodeFullerton, United States· Recruiting
- Research SiteVerified postcodeInglewood, United States· Withdrawn
- Research SiteVerified postcodeLos Alamitos, United States· Recruiting
- Research SiteVerified postcodeLos Angeles, United States· Recruiting
- Research SiteVerified postcodeSan Diego, United States· Withdrawn
Common questions
What is chronic kidney disease?
Chronic kidney disease (CKD) means your kidneys are damaged and can't filter your blood as well as they should. This is a long-term condition that usually gets worse over time.
What does 'high blood pressure' mean in this study?
High blood pressure, or hypertension, is when the force of your blood against your artery walls is consistently too high. In this study, specific blood pressure readings are required to be eligible.
What is a 'double-blind' study?
A 'double-blind' study means that neither the participants nor the research team know whether a person is receiving the active trial treatment or a dummy pill (placebo). This helps make sure the study results are fair and unbiased.
What is Dapagliflozin?
Dapagliflozin is an existing medication already approved for treating certain conditions, including chronic kidney disease and heart failure, as well as Type 2 diabetes.
Can I leave the study if I change my mind?
Yes, absolutely. Your participation is always voluntary. You can decide to leave the study at any time, for any reason, without needing to explain why, and it won't affect your future medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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