Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Impact of dapagliflozin on vascular function in chronic kidney disease patients - (DAPA-VASC)

This study, called DAPA-VASC, is investigating the effects of a medicine called dapagliflozin on blood vessels in people who have chronic kidney disease (long-term kidney problems). The main goal is to find out if this medicine helps blood vessels relax and open up more easily. For 12 weeks, some participants will take dapagliflozin, while others will take a dummy pill (placebo). Researchers will measure how much a main artery in the arm (brachial artery) widens in response to a simple test. They will also look at other measures like how blood flows in the hand, certain substances in the blood that affect blood vessels, and how flexible the major arteries are. The study includes both men and women of all ages.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

Start

04 Sep 2024

chronic kidney disease patients

What is this study about?

This study is called DAPA-VASC, and it's looking into how a medicine called dapagliflozin might help people with chronic kidney disease. Chronic kidney disease means your kidneys aren't working as well as they should, which can sometimes affect your heart and blood vessels too. Researchers want to see if dapagliflozin can make blood vessels work better.

Blood vessels need to be able to relax and widen to allow blood to flow easily around your body. The study will mainly measure this by looking at an artery in your arm (the brachial artery) and seeing how much it opens up in a simple test. They'll compare people who take dapagliflozin with those who take a dummy pill (placebo) to see if there's a difference after 12 weeks.

The findings from this study could help doctors understand if dapagliflozin can improve the health of blood vessels in people with long-term kidney problems. This is important because healthier blood vessels can reduce the risk of other health issues.

Key takeaways

The study explores how dapagliflozin affects blood vessels in people with chronic kidney disease.
It examines if the medicine helps blood vessels relax and widen over 12 weeks.
Participants will take either dapagliflozin or a dummy pill.
Measurements of blood vessel health and other bodily functions will be taken.
The study aims to understand if this treatment could improve blood vessel health in patients with kidney problems.

Who may be eligible?

This study is looking for people who have been diagnosed with chronic kidney disease, which means they have long-term problems with their kidneys.

Both men and women are welcome to take part in the study, and there are no specific age limits mentioned, meaning people of all adult ages could potentially join.

To find out if you're a good fit, the study team will ask you some questions about your health and medical history. They will check if your kidney disease is at a suitable stage for the study and if there are any other health conditions or medications that might prevent you from taking part safely.

Quick self-check

Do you have a diagnosis of chronic kidney disease?
Are you comfortable taking a daily tablet for 12 weeks?
Are you able to attend regular clinic appointments for tests?
Are you willing to have blood tests and other examinations?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be asked to take study medication (either dapagliflozin or a dummy pill) every day for 12 weeks. You wouldn't know which one you are taking. You would have several visits to the clinic over this 12-week period, and potentially a follow-up visit afterward. At these visits, doctors and nurses will perform tests to measure your blood vessel function, such as how much your arm artery widens. They will also take blood samples to check certain substances and measure how flexible your main arteries are. They might also check your heart using tests like scans. The total duration of your active involvement in the study would be around 12 weeks, plus any initial screening and final follow-up.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as closely monitored medical care and access to a new treatment that might improve your blood vessel health. However, there are also potential risks, like experiencing side effects from the study medication, although these will be carefully monitored. The dummy pill (placebo) has no active medicine, so it won't cause drug-related side effects but also won't offer any direct medical benefit beyond the care you'd receive. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What is chronic kidney disease?

Chronic kidney disease means your kidneys are not working properly and this condition has been present for a long time.

What is dapagliflozin?

Dapagliflozin is a medicine that helps the kidneys remove sugar from the body. It is often used for diabetes, but doctors are also studying its effects on kidney and heart health.

What is a 'dummy pill'?

A 'dummy pill' (or placebo) looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is having an effect.

Will I know if I'm taking the real medicine or the dummy pill?

No, you won't know this during the study. This is to ensure the results are as fair and unbiased as possible.

What does 'blood vessel function' mean?

Blood vessel function refers to how well your blood vessels are working, including their ability to relax and widen to allow good blood flow.