A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events
This research study is investigating a new medication, GDC-8264, to see if it can help prevent kidney problems that can happen after heart surgery. Some people are at a higher risk of developing these kidney issues, often called acute kidney injury (AKI). The study is comparing GDC-8264 with a dummy treatment (placebo) to find out if the new medication is effective and safe. We want to understand how many people develop serious kidney-related problems within certain timeframes after their operation. Protecting your kidneys during and after surgery is really important, and this study aims to find better ways to do that for future patients. Participants will receive either the new drug or a placebo, and their kidney health will be carefully monitored.
At a glance
What is this study about?
When you have heart surgery, sometimes your kidneys can be affected, leading to what doctors call acute kidney injury (AKI). For some people, this risk is higher. This study is testing a new medication, GDC-8264, to see if it can help protect kidneys from this kind of damage during and after heart surgery.
The main aim is to find out if GDC-8264 can reduce the number of people who experience serious kidney problems within 90 days of their surgery. This includes things like needing dialysis, or a significant drop in kidney function. We're also looking at other aspects, such as how many people develop any kidney injury within a week of surgery, and changes in kidney function over 30, 60, and 90 days. This is a "Phase II" study, which means it's an important early step to see if the medication works well and is safe before it can be more widely used.
Finding ways to protect kidneys during and after heart surgery is really important. If successful, this research could lead to new treatments that help improve recovery and long-term health for many people undergoing these operations. We want to ensure that patients have the best possible outcomes, and this study contributes to that goal by investigating potential new therapies.
Key takeaways
- This study is testing a new medication (GDC-8264) to prevent kidney damage after heart surgery.
- It aims to protect kidneys in people at higher risk of complications.
- Participants will receive either the study drug or a dummy treatment (placebo).
- Your kidney health will be closely monitored for 3 months after surgery.
- This is an important step to find better ways of caring for patients undergoing heart operations.
Who may be eligible?
This study is looking for both men and women aged 18 or older. You would be considered if you are planning to have heart surgery and your doctors believe you are at a higher risk of developing kidney problems afterwards. Your medical team will help figure out if this applies to you.
There will be other specific medical reasons why someone might not be able to join, or certain conditions that would make it unsuitable. These details are checked carefully by the study team to make sure it's safe for you to take part and that the study can get clear results.
If you're unsure whether you might be eligible, it's always best to discuss it with your doctor or the study team. They can provide all the specific information and help you understand if this research is a good fit 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?
- Are you planning to have heart surgery?
- Has your doctor told you that you might be at a higher risk for kidney problems after surgery?
- Are you able to attend follow-up appointments for approximately 3 months after your surgery?
What does participation involve?
If you decide to take part, you'll be given either the new medication (GDC-8264) or a dummy treatment (placebo). No one, not even your doctors, will know which one you are receiving – this is to make sure the results are fair and unbiased. Both are given in a way that is suitable for you around the time of your surgery.
You will have regular check-ups and tests, including blood and urine tests, to monitor your kidney health closely before, during, and for up to 90 days after your heart surgery. This helps the study team keep track of how you're feeling and how your kidneys are working. The total study duration, including follow-up, will be around 3 months after your heart operation.
Potential risks and benefits
Locations (6)
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is 'acute kidney injury'?
It's when your kidneys suddenly stop working as well as they should, often for a short time. It can be serious and is sometimes linked to surgery.
What is a 'placebo'?
A placebo is adummy treatment that looks like the study drug but doesn't contain any active medication. It helps us see if the new medicine really makes a difference.
Will I know if I'm getting the drug or placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know which you're receiving. This ensures the study results are as reliable as possible.
How long will I be involved in the study?
You'll be monitored closely for about 90 days (roughly 3 months) after your heart surgery to track your kidney health.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, and your decision will not affect the care you receive for your heart condition.
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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