A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery
This clinical trial is designed to investigate a new medicine called RMC-035. The purpose is to see if RMC-035 can help protect the kidneys of patients undergoing open-chest heart surgery. Sometimes, after this type of surgery, people can experience kidney problems. Researchers want to find out if this new medicine is effective at preventing these issues and if it is safe for patients. Participants will be randomly given either RMC-035 or a placebo (a dummy medicine with no active ingredients). The study will look at how kidney function changes over time, specifically for 90 days after the surgery, to understand the medicine's effects. This is a "Phase 2b" study, meaning it's an early stage of testing to learn more about the medicine's best dose and its potential benefits.
At a glance
What is this study about?
When people have open-chest heart surgery, there's a small chance that their kidneys might not work as well afterwards. This study is looking into a new medicine called RMC-035, which is hoped to help protect the kidneys and prevent these problems. The medicine is a clear, liquid solution.
The main goal of the study is to see how much kidney function changes 90 days after surgery in people who receive RMC-035 compared to those who get a dummy treatment (placebo). Kidney function will be measured using something called eGFR, which is a common way doctors assess how well your kidneys are filtering waste from your blood.
Researchers will also be checking to see if other kidney-related problems happen less often in people taking RMC-035. They will also be closely monitoring everyone for any side effects to make sure the medicine is safe. This type of study, called a Phase 2b trial, helps doctors understand if a new medicine works and what dose might be best before it's tested in larger groups of people.
Key takeaways
- This study is for people having open-chest heart surgery who are at risk of kidney problems.
- It's testing a new medicine, RMC-035, to see if it can protect kidneys and is safe.
- Participants will get either RMC-035 or a placebo (dummy medicine).
- Kidney function will be checked for 90 days after surgery.
- The study aims to find the best dose and understand the medicine's effects.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, people must be at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.
The most important requirement is that you are planning to have open-chest heart surgery. The study is specifically designed for people who are considered to have a higher chance of developing kidney problems after this type of operation.
There will be other detailed health checks to make sure the study is a good and safe fit for you. These will likely involve reviewing your medical history and current health conditions, but the core criteria are being an adult having this specific surgery and being considered at higher risk for kidney injury afterwards.
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 scheduled for open-chest heart surgery?
- Has your doctor told you that you might be at a higher risk for kidney problems after this surgery?
- Are you male or female?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance to either receive the new medicine, RMC-035, or a placebo (a dummy medicine with no active ingredients). You will not know which one you are getting, and neither will your doctors – this is called a 'double-blind' study. The study treatment will be given around the time of your heart surgery.
You will have several assessments throughout the study to monitor your kidney function and general health. This will involve blood tests to check your kidney function (eGFR based on SCr), especially on day 90 after your surgery. There will also be checks for any side effects or other health changes. The total duration of your active participation in the study will involve monitoring your health and kidney function up to 90 days after your heart surgery, with various appointments and checks during this period.
Potential risks and benefits
Locations (3)
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is RMC-035?
RMC-035 is a new liquid medicine being tested to see if it can protect kidneys during heart surgery.
What kind of kidney problems is this study looking at?
The study focuses on kidney problems that can sometimes develop after open-chest heart surgery.
Will I know if I'm getting the real medicine or the dummy one?
No, neither you nor your doctor will know if you're getting RMC-035 or the placebo; this helps ensure fair results.
How long will I be involved in the study?
Your kidney function and health will be monitored for 90 days after your heart surgery.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't 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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