Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery.
This research study is looking at a new medicine called Ilofotase alfa. It's for people who are having open-heart surgery and might be at risk of their kidneys being damaged by the operation. The study wants to find out if this new medicine can help protect the kidneys. Participants will receive either the new medicine or a 'dummy' medicine (placebo), without knowing which one they have. This helps researchers fairly compare the effects. They will closely check kidney health using blood tests and look for any side effects. The goal is to see if Ilofotase alfa is both safe and effective in preventing kidney problems after surgery.
At a glance
What is this study about?
This study is called a 'clinical trial,' and it's a way for doctors and scientists to find out if a new medicine or treatment works well and is safe to use. Here, they are focusing on a medicine called Ilofotase alfa. The main aim is to see if this medicine can help protect the kidneys of people who are having open-heart surgery. Sometimes, after major operations like open-heart surgery, there's a risk that the kidneys can become damaged.
To find this out, some people in the study will receive the new medicine, Ilofotase alfa, while others will get a 'placebo.' A placebo looks just like the real medicine but has no active ingredients – it's like a dummy pill. Neither the patients nor their doctors will know who is getting the real medicine and who is getting the placebo. This is called 'double-blind' and it helps make sure the results are as fair and unbiased as possible. The researchers will be carefully measuring how well the kidneys are working after surgery using blood tests.
They will also be keeping a very close eye on everyone to make sure the medicine is safe and to spot any side effects. This type of study is an early-stage trial (Phase II), which means it's one of the first times this medicine is being tested in a larger group of people to see if it shows promise before moving on to bigger studies.
Key takeaways
- Tests a new medicine (Ilofotase alfa) for kidney protection.
- For adults having open-heart surgery with kidney risk.
- Compares the new medicine to a dummy medicine (placebo).
- Monitors kidney function closely with blood tests.
- Looks for safety and effectiveness over approximately two months.
- Aims to prevent kidney damage after surgery.
Who may be eligible?
This study is looking for adults aged 18 and older. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.
The most important thing is that you must be planning to have open-heart surgery and be considered by your medical team to be at risk for kidney problems afterwards. Your doctors will be able to tell you if you fit this specific health requirement.
There will also be other health checks and strict medical guidelines that you'll need to meet to make sure the study is right for you and safe for your health. For example, they will check your kidney function before the surgery.
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.
- Am I 18 years old or older?
- Am I planning to have open-heart surgery?
- Has my doctor said I might be at risk for kidney problems after surgery?
- Am I willing to have extra blood tests to check my kidney health?
- Can I commit to follow-up visits for about 2 months after surgery?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine (Ilofotase alfa) or a dummy medicine (placebo) around the time of your open-heart surgery. You won't know which one you're getting. Your doctors will carefully monitor your health and kidney function, especially in the days following your surgery.
This will involve regular blood tests to check an important marker for kidney health called creatine. They will compare these results to your kidney health before the surgery. You will also have follow-up checks for about two months (around 60-61 days) after your surgery to see how your kidneys are recovering and to make sure you're not having any unexpected problems. During this time, the research team will monitor for any side effects.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What is Ilofotase alfa?
It's a new medicine being tested to see if it can help protect kidneys after open-heart surgery.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you're getting the active medicine or a dummy medicine (placebo), to keep the study fair.
Why are blood tests important?
Blood tests help the doctors check how well your kidneys are working before and after your surgery.
How long will I be involved in the study?
You'll be monitored for around 60-61 days after your open-heart surgery.
Will I still get my usual medical care?
Yes, taking part in the study will not stop you from receiving all the standard care for your open-heart surgery and recovery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.