Active not recruitingPHASE3INTERVENTIONAL

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

This research study is investigating a new treatment for adults who have chronic kidney disease (CKD) and high blood pressure. It combines a new medication called baxdrostat with an existing one, dapagliflozin. The main goal is to find out if this combination safely and effectively slows down the worsening of kidney disease. Participants will take either the new combination or dapagliflozin with a dummy pill (placebo) for two years, without knowing which they are receiving. This helps researchers compare the effects accurately. After this, everyone will take dapagliflozin alone for about three months. The study involves regular check-ups to monitor health and kidney function.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

2,554

Start

29 Mar 2024

Estimated completion

24 Feb 2028

Chronic Kidney Disease and Hypertension

What is this study about?

This research is looking into a new way to treat chronic kidney disease (CKD) when it is combined with high blood pressure. If you have CKD, it means your kidneys aren't working as well as they should, and high blood pressure can unfortunately make this worse. This study wants to see if a new drug, Baxdrostat, when given alongside an existing drug called Dapagliflozin, can help protect your kidneys and slow down the progress of CKD.

Researchers want to understand two main things: how well this new combination works (its 'efficacy') and whether it's safe to use. Dapagliflozin is already known to help people with kidney disease, and this study aims to discover if adding Baxdrostat can offer even more benefits. By taking part, you could be helping to find better treatments for people with these conditions in the future.

The study involves comparing the new combination against a standard treatment. This means some participants will receive Baxdrostat plus Dapagliflozin, while others will receive Dapagliflozin along with a 'placebo' (a dummy pill that looks like Baxdrostat but contains no active medicine). This comparison helps the researchers determine if Baxdrostat truly makes a difference beyond what Dapagliflozin can do on its own.

Key takeaways

Study explores a new treatment for chronic kidney disease and high blood pressure.
Combines a new drug (baxdrostat) with an existing one (dapagliflozin).
Aims to see if this combination safely slows kidney disease progression.
Participants will receive either the new combination or dapagliflozin with a dummy pill.
The study involves regular clinic visits and lasts over two years.
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 chronic kidney disease (CKD) that falls within a specific range of kidney function, and your urine tests should show a certain level of protein. You also need to have high blood pressure that is being treated with a specific type of medication (either an ACE inhibitor or an ARB). Your blood pressure and potassium levels need to be within a certain range at the start of the study.

There are some reasons why you might not be able to join. For example, if your blood pressure is too high, or you've had certain heart problems like a stroke or heart failure recently. Also, if you have uncontrolled diabetes (Type 2 diabetes with very high blood sugar levels) or severe Type 1 diabetes, you generally won't be able to take part. Researchers also check for other health issues or medications that could make the study unsafe for you.

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?
Are you currently taking an ACE inhibitor or an ARB for your blood pressure?
Do you have specific test results for your kidney function and urine protein levels?
Have you not had a stroke or heart attack in the last 3 months?
Do you not have uncontrolled diabetes or very high blood pressure (over 180/110 mmHg)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will begin with an initial screening to check if you meet all the requirements. If you do, you'll start a 4-week period where you take only dapagliflozin. After this, you'll enter the main part of the study, which lasts for about two years. During this time, you'll receive either the new drug combination (baxdrostat and dapagliflozin) or dapagliflozin with a dummy pill.

Throughout the study, you'll have regular visits to the clinic. These visits will be more frequent at the beginning (at 2, 4, 8, and 16 weeks), and then approximately every four months. At each visit, healthcare professionals will check your health, measure your blood pressure, take blood and urine samples, and monitor how your kidneys are working. After two years, you'll stop taking baxdrostat or the dummy pill and continue with dapagliflozin alone for about three more months. This final period helps researchers measure the main effect on your kidney function. If for any reason you need to stop the study treatment early, you'll usually continue taking dapagliflozin and remain in the study for monitoring, unless there's a specific medical reason to stop all treatments.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving close medical attention for your kidney disease and high blood pressure, and potentially gaining access to a new treatment that could help slow down your condition. However, there are also potential risks involved, similar to any medical treatment. These could include side effects from the study medications, or the need for frequent blood tests and clinic visits. Even if you participate, there's no guarantee that the new treatment will improve your health. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (565)

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

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Fairhope, United States
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Phoenix, United States
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Surprise, United States
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Tucson, United States
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Searcy, United States
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Beverly Hills, United States
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Canyon Country, United States
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Fremont, United States
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Fullerton, United States
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Lincoln, United States
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Los Alamitos, United States
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San Francisco, United States

Common questions

What is chronic kidney disease?

Chronic kidney disease (CKD) means your kidneys are damaged and can't filter blood as well as they should. Over time, it can get worse if not managed.

What is high blood pressure?

High blood pressure (hypertension) is when the force of your blood against the walls of your arteries is too high. It can put a strain on your kidneys and heart.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but contains no active drug. It helps researchers compare the effects of the active treatment accurately.

How long will the study last for me?

The main treatment part of the study lasts about two years, followed by another three months where you'll continue with one of the study drugs, making the total around 27 months.

Will I know which treatment I am receiving?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you are receiving baxdrostat or the placebo during the main two-year period.