Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Established Atherosclerotic Cardiovascular and Chronic Kidney Disease

This research study is about a new medicine called AZD4144. It's designed for people who have two health conditions: chronic kidney disease (long-term kidney problems) and atherosclerotic cardiovascular disease (heart and blood vessel disease caused by a build-up in arteries). This is a 'Phase 1' study, which means it's one of the very first times this medicine is being tested in humans. The main goals are to check if the medicine is safe, if people can take it without too many problems, and how it affects the body. Some people will get the active medicine, while others will get a dummy medicine (placebo), and neither the patients nor the doctors will know who gets what. This helps us get clearer results. It's a multi-centre study, meaning it's happening in several different places.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

13 Feb 2025

Chronic Kidney disease Atherosclerotic Cardiovascular Disease

What is this study about?

This research study is looking at a new medicine called AZD4144. It's being developed for people who have two important health conditions at the same time: chronic kidney disease and atherosclerotic cardiovascular disease. Chronic kidney disease means your kidneys aren't working as well as they should, which can cause many health issues. Atherosclerotic cardiovascular disease is when your arteries, the blood vessels that carry blood from your heart, become narrow and hardened due to a build-up of fatty substances. This can lead to serious problems like heart attacks and strokes.

Because these two conditions often occur together and can make each other worse, scientists are keen to find new treatments that might help people who have both. This particular study is in its very early stages, called 'Phase 1'. This phase is crucial for understanding a new medicine. We need to see if it's safe for people to take, how well their bodies cope with it, and what effects it might have.

The study is 'randomised', which means people will be put into different groups by chance – some will get the new medicine and some will get a placebo (a dummy medicine that looks the same but contains no active drug). It's also 'double-blind', meaning neither the patient nor the doctor knows who is getting which treatment. Both these steps are taken to make sure the study results are as fair and accurate as possible, without anyone's expectations influencing the outcome. This research is a vital step in trying to find better ways to help people living with these health challenges.

Key takeaways

This study is testing a brand-new medicine, AZD4144, for safety and how it works.
It's for adults who have both long-term kidney problems and heart/artery disease.
Participation involves regular clinic visits and health checks.
You might receive the new medicine or a dummy medicine (placebo).
Your health and safety would be closely monitored by a medical team.
You can stop participating at any time you wish.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to take part. Both men and women can participate in this research.

Crucially, you would need to have specific medical diagnoses. This includes having both long-term kidney problems (chronic kidney disease) and heart or blood vessel disease caused by hardened arteries (atherosclerotic cardiovascular disease). The study doctors will need to review your medical records to confirm you meet these health requirements.

There will also be other specific health requirements or conditions that might prevent someone from joining, even if they have the main conditions. These are put in place to ensure the study is safe for everyone involved and that the results are clear. Your doctor or the study team will be able to explain all these details to you.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of chronic kidney disease (long-term kidney problems)?
Do you have a diagnosis of atherosclerotic cardiovascular disease (heart/blood vessel disease due to hardened arteries)?
Are you able to attend regular clinic appointments?
Are you willing to potentially receive either the new medicine or a dummy medicine?
Are you comfortable with regular health checks and blood tests?

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

What does participation involve?

If you decide to take part in this study, you will first have a screening visit where doctors will check if you meet all the requirements. If you do, you will then start the treatment phase. You will receive either the new study medicine, AZD4144, or a placebo (a dummy medicine). You will have regular visits to the clinic for health checks, blood tests, and to make sure you are feeling okay. The study team will explain how long you'll be involved and how many visits you'll need. There will also be follow-up appointments after you finish taking the medicine to monitor your health. The total time you'd be involved in the study, from start to finish, would be explained by the research team.

Potential risks and benefits

Participating in a study like this comes with potential benefits and risks. A potential benefit is that you might receive access to a new medicine that could help your conditions, though this is not guaranteed as it's an early-stage study and some participants will receive a placebo. You would also be closely monitored by a medical team, and you'd be contributing to valuable medical research that could help many others in the future. Potential risks include experiencing side effects from the new medicine, which could be mild or, in rare cases, more serious. There might also be discomfort from tests, like blood draws, or inconvenience due to clinic visits. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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Bulgaria
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Romania
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Hungary

Common questions

What is a 'Phase 1' study?

It's the first time a new medicine is tested in people. The main goals are to check if it's safe, how well people tolerate it, and what it does in the body.

What does 'randomised' mean?

It means you're put into a treatment group (either the new medicine or the dummy one) by chance, like flipping a coin. This helps make the study fair.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new medicine or the dummy medicine. This helps prevent bias.

What are 'chronic kidney disease' and 'atherosclerotic cardiovascular disease'?

Chronic kidney disease means kidneys aren't working well long-term. Atherosclerotic cardiovascular disease is when arteries harden and narrow, usually due to fatty build-up, affecting the heart and blood vessels.

Will I get paid to take part?

Some studies offer payment for time and travel, while others do not. The study team will provide details about any compensation available.