A study to investigate pharmacokinetics and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function.
This research is designed to carefully examine a medication called rupatadine, which is commonly prescribed for allergic conditions such as hay fever (allergic rhinitis) and itchy rashes (urticaria). The main goal is to understand how your body processes and gets rid of rupatadine, and its related active substances, if you have kidney problems. This will be compared to people with normal, healthy kidney function. By doing this, we hope to learn if people with kidney issues might need different doses or monitoring. This is an early-stage study, meaning it’s one of the first times this specific aspect of the medicine is being looked at in people, focusing on its safety and how it moves through the body.
At a glance
What is this study about?
This research study is about a medicine called rupatadine. You might know rupatadine as a treatment for common allergy symptoms, such as sneezing, runny nose, itchy eyes from hay fever (allergic rhinitis), or the itchy red bumps of hives (urticaria). When you take a medicine, your body breaks it down and eventually gets rid of it, often with the help of your kidneys.
We are particularly interested in how rupatadine works in people who have kidneys that aren't working as well as they should. Your kidneys play a vital role in cleaning your blood and removing medicines from your system. If your kidneys aren't fully healthy, it might change how long a medicine stays in your body or how much of it builds up. This study is trying to understand these differences.
The main purpose is to see how the amount of rupatadine and its active parts behave in the blood of people with kidney conditions, and to compare this to people with healthy kidneys. This helps us make sure the medicine is used safely and effectively for everyone, by understanding if we need to adjust how it's given to people with kidney problems. This type of study is an important early step in understanding any new or existing medication better.
Key takeaways
- This study investigates an allergy medicine called rupatadine.
- It focuses on how the body handles the medicine in people with kidney problems.
- The goal is to ensure safe and effective use for all patients.
- It's an early-stage study looking at how the medicine works in the body.
- Only adults aged 18 and over can participate.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. A key part of the study is comparing people with different kidney functions, so some participants will have healthy kidneys, while others will have varying degrees of kidney impairment.
Specifically, the healthcare team will check your kidney function through tests to work out which group you fit into. If you have severe kidney problems or other serious health conditions that could affect how the medicine works or make your participation unsafe, you might not be able to join.
It's important to discuss any health conditions you have and any medicines you are currently taking with the study team, as these could affect whether you are suitable for the study. The team will explain everything clearly and answer any questions you have about whether this study is right 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 allergic conditions like hay fever or hives?
- Are you willing to have your kidney function checked?
- Are you comfortable taking a study medication (rupatadine)?
- Are you able to attend clinic visits as required by the study?
What does participation involve?
If you decide to take part in this study, you would receive the study medication, rupatadine, specifically the 10 mg dose. This is an early-stage study focused on understanding how the body handles the medicine. You would attend several visits to the study clinic, where doctors and nurses would perform various health checks, such as blood and urine tests, to monitor your kidney function and measure the levels of the study drug in your body.
These visits might also include physical examinations and questions about your health. The total duration of your involvement in the study would be outlined by the research team, including the period you take the medication and any follow-up appointments. The team will carefully explain the schedule of visits and what each visit involves before you make a decision.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedPortugal
Common questions
What is rupatadine used for?
Rupatadine is a medicine commonly used to treat symptoms of allergies like hay fever (allergic rhinitis, causing sneezing and runny nose) and hives (urticaria, causing itchy rashes).
Why is this study looking at kidney problems?
The study is looking at how the body processes rupatadine in people with kidney problems to make sure the medicine can be used safely and effectively by everyone, by understanding if doses might need to be adjusted.
Will I get the medicine for free?
If you join the study, the study medication (rupatadine 10 mg) will be provided as part of your participation.
What does a 'Phase I' study mean?
Phase I means this is an early study, focusing on how a medicine moves through the body (pharmacokinetics) and its safety. It's usually done with a small group of people.
Can I leave the study if I change my mind?
Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and it will not affect your medical care.
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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