Study to assess the plasma concentration of rilzabrutinib given as a tablet to adult participants with severe renal impairment compared to matched participants with normal renal function
This early-stage clinical trial is testing a tablet called rilzabrutinib. The kidneys filter and remove many medicines from the blood. When someone has severe kidney problems, their body might process medicines more slowly or differently than usual. In this study, researchers want to measure how much rilzabrutinib stays in the blood after taking a dose. They will compare blood levels in adults who have severe kidney disease with blood levels in adults who have healthy kidneys. The healthy volunteers will be carefully matched by things like age and sex to make the comparison fair. The trial will help researchers decide if people with kidney disease need a different dose of rilzabrutinib in the future. Participants will take the medicine and have regular blood tests to track how it moves through their bodies.
At a glance
What is this study about?
When doctors prescribe a new medicine, it is vital to know the right amount to give. The kidneys play a major role in filtering our blood and clearing medicines from the body. If your kidneys are not working as well as they should, a drug might stay in your bloodstream for longer, or build up to higher levels than expected. This study focuses on finding out how kidney health affects a medicine called rilzabrutinib.
Rilzabrutinib is an experimental tablet being developed for certain immune-related conditions. In this study, doctors want to measure its levels in the blood over time. To do this, they are inviting two groups of adults to take part: people with severe kidney problems, and people with normal kidney function. By comparing these two groups, scientists can clearly see what difference reduced kidney function makes.
Taking part in this kind of research is an important step in medicine safety. If the trial shows that people with kidney problems process the medicine differently, doctors can adjust the dose to ensure it remains safe and effective. It helps make sure that in the future, treatments can be tailored safely to each person's needs.
Key takeaways
- The study tests how severe kidney problems affect levels of the tablet rilzabrutinib in the blood.
- It compares adults with severe kidney disease against matched adults with healthy kidneys.
- Taking part involves taking the study tablet and having regular blood and urine tests.
- This study does not aim to cure kidney disease, but it helps make future treatments safer.
- Taking part is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older. The researchers are looking for two specific groups of volunteers: adults who have been diagnosed with severe kidney problems, and adults who have healthy, normal kidney function.
To make sure the study results are fair, the healthy volunteers will be 'matched' with the volunteers who have kidney conditions. This means they will share similar characteristics, such as age, biological sex, and weight.
Because this is an early safety trial, there are rules about who can join. People with certain other uncontrolled health problems, recent major illnesses, or those taking specific medicines that could interfere with the study drug may not be able to take part. The study team will run checks to confirm if you are suitable.
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.
- I am aged 18 or older.
- I either have diagnosed severe kidney problems OR I have completely normal, healthy kidneys.
- I am able to attend clinic visits for blood tests and monitoring.
- I am happy to take an experimental tablet under medical supervision.
- I can discuss my current medicines with the study team to check for clashes.
What does participation involve?
If you take part, you will be asked to visit a specialist clinic or hospital unit. At the start, the research team will explain the study, check your health history, and run some basic tests like blood pressure and blood tests to make sure it is safe for you to join.
During the study, you will take rilzabrutinib as a tablet by mouth. You will then have regular blood and urine tests over a set period. These tests measure exactly how much of the medicine is in your body and how quickly your kidneys and liver clear it.
You may need to stay at the clinic for a short period or return for several follow-up visits so the team can monitor your health. The study team will give you a clear schedule showing the exact number of appointments and follow-up checks before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is rilzabrutinib?
Rilzabrutinib is a medicine being tested for conditions where the immune system attacks healthy parts of the body.
Will this medicine treat my kidney condition?
No, this study is only designed to measure how the drug moves through the body, not to treat kidney disease.
Do I have to pay to take part?
No, clinical trials in the UK do not charge participants. Travel expenses are often covered by the study.
How is the medicine taken?
Rilzabrutinib is given as a tablet that you swallow with water.
Can I leave the study if I change my mind?
Yes, you can leave at any point without giving a reason, and your regular medical care will continue as normal.
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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