A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants with Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants
Doctors are studying a new medicine, AZD4144, to understand how it works in the body. They want to see how it's absorbed, used, and cleared, especially in people with kidney issues. The study involves three groups: healthy volunteers, people with severely reduced kidney function, and patients with end-stage kidney disease who are receiving dialysis. The main goals are to check if the medicine is safe and well-tolerated, and to see if kidney problems change how the body handles AZD4144. This is an early and important step in developing new medicines, helping researchers understand how best to use them in different patient groups.
At a glance
What is this study about?
This research study is about a new medicine called AZD4144. When a new medicine is developed, doctors need to understand exactly how it works inside the human body. This includes how much of the medicine gets into the bloodstream, how long it stays there, and how the body gets rid of it. This process is often different for people with certain health conditions, like kidney problems.
In this study, researchers want to see if kidney disease affects how a person's body handles AZD4144. They are comparing three different groups: healthy individuals, people who have severe kidney impairment (meaning their kidneys aren't working as well as they should), and people with end-stage kidney disease, often meaning they are on dialysis.
The main reasons for doing this study are to make sure the medicine is safe for people to take and to understand any side effects. It also helps doctors figure out if the dose of the medicine needs to be adjusted for people with kidney disease. This is a very important first step in making sure that if AZD4144 becomes a widely used medicine, it can be given safely and effectively to everyone who might benefit from it.
Key takeaways
- Tests a new medicine called AZD4144.
- Compares healthy people with those with kidney disease.
- Aims to understand how the body handles the medicine and if it's safe.
- Involves taking a single dose of the study medicine.
- Requires several follow-up visits for health checks.
- Is an early-stage study important for future drug development.
Who may be eligible?
This study is looking for adults aged 18 years and older. Both men and women are welcome to participate. You might be eligible if you are a healthy volunteer, meaning you don't have any major ongoing health problems.
They are also looking for people with kidney conditions. This includes individuals who have severe kidney impairment, where their kidneys are not functioning properly. Additionally, people with end-stage kidney disease who are receiving dialysis treatment are invited to take part.
To find out if you can join, the study team will need to do some checks to make sure you fit all the requirements for your specific group (healthy, severe kidney impairment, or end-stage kidney disease).
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 or older?
- Do you have severe kidney impairment?
- Do you have end-stage kidney disease and are on dialysis?
- Or are you a healthy adult with no major ongoing health issues?
- Are you willing to attend multiple study visits?
What does participation involve?
If you decide to take part in this study, you will be given a single dose of the study medicine, AZD4144. After you receive the medicine, the research team will monitor you closely. This will involve several visits to the study site over a period of time. During these visits, you will have various assessments, which may include blood tests to check how the medicine is moving through your body, urine tests, and checks of your vital signs (like blood pressure and heart rate).
The study is designed to observe how your body reacts to the medicine and how it processes it. The total duration of your involvement will depend on the monitoring schedule, but you will receive clear information about the number of visits and the time commitments involved before you agree to participate.
Potential risks and benefits
Locations (2)
- —UnverifiedBulgaria
- —UnverifiedRomania
Common questions
What is AZD4144?
AZD4144 is a new medicine being studied. This research aims to understand how it works in the body and if it's safe.
Why is this study important for people with kidney disease?
It helps doctors learn if the new medicine works differently in people with kidney problems, so they can use it safely and effectively if it becomes available.
Do I have to take the medicine?
Yes, if you join, you will receive one dose of the study medicine, AZD4144, as part of the research.
What does 'non-randomised' mean?
It means the study team decides which group you join (healthy, severe kidney issues, or end-stage kidney disease) based on your health condition, rather than by chance.
Will I know if I'm getting the real medicine or a dummy pill?
This study is 'open-label', meaning both you and the study team will know that you are receiving the study medicine, AZD4144.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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