RecruitingPHASE2INTERVENTIONAL

A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

This study is for people in the UK who have ongoing kidney disease and high blood pressure. We are testing a new approach by combining two medicines: baxdrostat and dapagliflozin. We want to see if taking these two medicines together can help reduce the amount of a protein called albumin in the urine. High levels of albumin in the urine can indicate kidney damage. The study will compare this combination treatment against baxdrostat with a dummy pill (placebo). We will also be checking how safe these treatments are. This is a "Phase IIb" study, meaning we are looking for the right dose and how well the treatment works in a larger group of people before potentially moving to bigger studies.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

218

Start

05 Dec 2025

Estimated completion

24 May 2027

Chronic Kidney Disease and Hypertension

What is this study about?

This research study is looking for better ways to help people who have both chronic kidney disease (CKD) and high blood pressure. Chronic kidney disease means your kidneys aren't working as well as they should over a long period. High blood pressure can put extra strain on your kidneys and make kidney disease worse.

The main aim of this study is to see if a combination of two medicines, called baxdrostat and dapagliflozin, can help protect your kidneys. We're particularly interested in whether this combination can lower the amount of a protein called albumin in your urine. Having too much albumin in your urine is a key sign that your kidneys might be under stress or damaged. By reducing this protein, we hope to show that the treatment can help slow down the progression of kidney disease.

Participants in the study will either receive combination of baxdrostat and dapagliflozin, or baxdrostat along with a 'dummy' pill (called a placebo). A placebo looks like the real medicine but contains no active ingredients. This helps us find out if the study medicine is truly responsible for any changes we see. The study will also carefully check for any side effects to make sure the treatments are safe.

Key takeaways

Tests a new combination treatment for chronic kidney disease and high blood pressure.
Aims to reduce protein (albumin) in urine, a sign of kidney damage.
Compares two groups: one gets the new combination, the other gets one drug plus a dummy pill.
Participation involves regular clinic visits for monitoring.
Strict eligibility criteria, including kidney function and blood pressure levels.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with chronic kidney disease. Your kidney function, measured by something called eGFR, needs to be within a specific range, and you should have a certain amount of albumin protein in your urine.

You also need to have high blood pressure, and typically be taking a stable dose of either an ACE inhibitor or an ARB medicine for your blood pressure, unless your doctor has advised against it. Your blood potassium levels also need to be within a specific healthy range.

There are some reasons why you couldn't join. For example, if your blood pressure is too high, if you have certain types of diabetes (Type 1, or very uncontrolled Type 2), or if you’ve had particular heart or brain conditions recently. Also, if you’re taking certain other medications that affect potassium or kidney function, you might not be able to participate. The study team will check all these details carefully to make sure it's safe and appropriate for you to join.

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 chronic kidney disease and high blood pressure?
Is your kidney function (eGFR) between 30 and 90?
Do you have more than 200mg/g of albumin in your urine?
Are you currently on a stable dose of an ACE inhibitor or ARB (if medically suitable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey will start with some checks to make sure the study is right for you. This might involve blood tests, urine tests, and blood pressure measurements. If you’re already taking a specific type of kidney medicine (SGLT2i), you might need to stop it for a short time before starting the study.

Once you're approved, you'll be randomly assigned to one of two groups: either you'll receive the combination of baxdrostat and dapagliflozin, or you'll receive baxdrostat with a dummy pill (placebo). You won't know which group you're in, and neither will the study doctors (this is called 'double-blind'). You'll take the study medication regularly, and you'll have regular visits to the clinic for check-ups, which will include blood tests, urine tests, and blood pressure readings. These visits will help us monitor your kidney health, blood pressure, and check for any side effects. The study will continue until the last participant has completed all their follow-up appointments.

Potential risks and benefits

By taking part, you might benefit from close medical monitoring of your kidney health and blood pressure. There's also a chance that the study medication could help improve your kidney function and lower your albumin levels more effectively than your current treatment. However, as with any medication, there's a risk of side effects, which the study team will carefully monitor. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (71)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Surprise, United States· Recruiting
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Hollywood, United States· Recruiting
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Port Charlotte, United States· Recruiting
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Port Orange, United States· Recruiting
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Atlanta, United States· Recruiting
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Champaign, United States· Recruiting
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Wichita, United States· Recruiting
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Eatontown, United States· Recruiting
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Greenville, United States· Recruiting
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Jacksonville, United States· Recruiting
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New Bern, United States· Recruiting
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Columbus, United States· Recruiting

Common questions

What is 'albuminuria'?

Albuminuria means there's too much of a protein called albumin in your urine. It can be a sign that your kidneys aren't working as well as they should.

What does 'double-blind' mean?

It means neither you nor your study doctor will know whether you're receiving the actual study drug combination or the group with the dummy pill. This helps us get unbiased results.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but doesn't contain any active ingredients. It helps us compare the effects of the actual study drug.

Why is it important to lower albumin in the urine?

Lowering albumin in the urine is important because it can help protect your kidneys from further damage and potentially slow down the progression of chronic kidney disease.

Do I need to stop any of my current medications?

If you are on certain kidney medications called SGLT2 inhibitors, you might need to stop them for a short time before starting the study. The study team will advise you on this.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.