A phase I/II study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of FR104, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment in de novo renal transplant patients
This research study is looking at a new medication called FR104 for individuals who have just received a kidney transplant. When someone gets a new kidney, their body's immune system can sometimes try to reject it. This new medicine aims to help prevent that by working against a specific part of the immune system called CD28. Researchers are carefully checking if FR104 is safe to use and how well people's bodies tolerate it. They will also look at how the medicine moves through the body and if it has the desired effects. This study is an important early step (Phase I/II) to understand if FR104 could be a helpful new treatment option for kidney transplant patients.
At a glance
What is this study about?
This study is about people who have recently received a new kidney through a transplant. A kidney transplant is a life-changing operation, but after surgery, the body's immune system can sometimes see the new kidney as 'foreign' and try to attack it. This is called rejection, and doctors work hard to prevent it.
The new medicine being tested in this study is called FR104. It's designed to help protect the new kidney by calming down a specific part of the immune system. Think of it like a specialist guard dog that usually helps fight off bad things, but sometimes gets too excited and attacks something good, like a new kidney. FR104 aims to gently tell that guard dog to relax, so it doesn't harm the new kidney.
This is an important early study (called Phase I/II). This means doctors are carefully looking at several things: is FR104 safe to use? Does it cause any serious side effects? How does it behave inside the body? And does it seem to be doing what we hope it will do, which is to help prevent the body from rejecting the new kidney? Finding answers to these questions is a crucial step towards developing new and better treatments for people with kidney transplants.
Key takeaways
- This study is for adults who have recently had a kidney transplant.
- It's testing a new medicine, FR104, to prevent the body from rejecting the new kidney.
- The main focus is on the safety of FR104 and how well people tolerate it.
- It's an early-stage study (Phase I/II) to gather important information about this new treatment.
- Participation involves regular clinic visits for checks and tests.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. There is no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate.
Critically, you must have recently received a kidney transplant. This study is specifically for people who are in the early stages after their transplant operation.
The study team will review your complete medical history and current health to make sure that taking part is safe and appropriate for you. They will explain any other specific requirements or conditions that might make someone suitable or unsuitable for the study.
- Are you 18 years old or older?
- Have you recently received a kidney transplant?
- Are you willing to attend regular clinic visits for monitoring?
- Are you comfortable with the idea of taking a new, experimental medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the new medication, FR104. The study combines two early phases, meaning there will be careful monitoring. This would involve regular visits to the clinic for check-ups. During these visits, doctors and nurses will conduct various assessments, including blood tests, physical examinations, and other tests to keep track of your health and how your body is reacting to the treatment.
You would receive the study medication as instructed by the doctors. The exact number of visits, tests, and the total length of time you would be involved in the study would be explained in detail by the research team. This commitment is important to ensure we gather all the necessary information about the new medicine.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is the new medicine FR104?
FR104 is a new experimental medicine designed to help prevent your body from rejecting a new kidney after a transplant.
What is the main goal of this study?
The main goal is to find out if FR104 is safe, how your body handles it, and if it starts to show signs of being effective in kidney transplant patients.
Who can take part in this study?
Adults aged 18 and over who have recently had a kidney transplant are being considered for this study.
Will I know if I'm getting the new medicine?
The research team will explain exactly what treatment you would receive as part of the study design.
What does a 'Phase I/II' study mean?
This means it's an early stage of testing where we're looking very carefully at safety and initial effectiveness before moving to larger studies.
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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