CLEAR-AKI: A multi-center, randomized, double blinded, placebo-controlled, four arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants associated with sepsis- associated acute kidney injury (SA-AKI)
This study, called CLEAR-AKI, investigates a new medicine named TIN816 for people experiencing acute kidney injury (sudden kidney damage) caused by a serious infection called sepsis. Doctors want to understand if TIN816 is safe and how well it helps the kidneys recover. Participants will receive either the new medicine or a 'dummy' treatment (placebo) through an IV drip. This is a "Phase 2" study, meaning researchers are still in the earlier stages of testing to find the right dose and confirm it might help. Your kidney function will be closely monitored over several weeks to see if the treatment makes a difference in how well your kidneys are working.
At a glance
What is this study about?
Imagine your body is fighting a serious infection, like sepsis. Sometimes, this can put a lot of stress on your kidneys, causing them to suddenly stop working as well as they should. This is called 'sepsis-associated acute kidney injury' or SA-AKI. Researchers are running a study called CLEAR-AKI to explore a new treatment, a medicine named TIN816, that might help kidneys recover from this damage.
In this study, some people will receive the new medicine through an IV drip, while others will get a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients; it's like a dummy treatment. This helps doctors fairly compare if the new drug is actually making a difference. The goal is to see if TIN816 is safe to use and if it can help improve how well the kidneys are working.
Doctors will be carefully checking how your kidneys are functioning for several weeks after you receive the treatment. They'll look at things like how well your body is clearing waste products and whether you need other kidney support, such as dialysis. This will help them understand if TIN816 could be a helpful treatment for people with kidney damage from sepsis in the future.
Key takeaways
- Tests a new medicine (TIN816) for kidney damage caused by sepsis.
- Compares the new medicine with a dummy treatment (placebo).
- Looks at safety and how well the kidneys recover over 3 months.
- Involves a single IV infusion and regular check-ups.
- Aims to find better treatments for sepsis-related kidney problems.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you would need to have experienced acute kidney injury that is linked to a serious infection called sepsis. The medical team would check specific details about your current health to make sure the study is right for you and safe for you to take part.
There might be other health conditions or medicines that would prevent someone from joining, but the study doctors would discuss all of these with you in detail to see if you are a good fit.
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?
- Have you recently had a serious infection called sepsis?
- Has sepsis caused your kidneys to suddenly develop a problem (acute kidney injury)?
- Are you able to attend regular follow-up appointments for approximately 3 months?
What does participation involve?
If you decide to take part, you would receive a single IV infusion of either the study medicine (TIN816) or the placebo. This infusion involves a drip into your arm and will contain sterile salt water if you receive the placebo, which comes in a 100ml bag. After the infusion, the study team will closely monitor your kidney health and overall well-being for several weeks.
This will involve regular check-ups, blood and urine tests to see how your kidneys are working, and monitoring for any changes in your health. There will also be follow-up visits to track your progress. The total duration of your active participation, including check-ups and follow-up, will be around 90 days (about three months) from the time you receive the infusion.
Potential risks and benefits
Locations (8)
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is sepsis?
Sepsis is a very serious reaction to an infection. It happens when your body's immune system overreacts to an infection and starts to damage your own tissues and organs.
What does 'acute kidney injury' mean?
It means your kidneys have suddenly stopped working as well as they should. This can happen for different reasons, and in this study, it's linked to sepsis.
What is a 'placebo'?
A placebo is a 'dummy' treatment. It looks exactly like the real medicine but contains no active ingredients. We use it to fairly compare if the actual medicine is making a difference.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know during the study which treatment you are receiving. This is called 'double-blinded' and helps make the results as fair and unbiased as possible.
What is an 'IV infusion'?
An IV infusion means the medicine is given directly into your bloodstream through a drip, usually in your arm. This is a common way to give medicines in hospitals.
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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