A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
This research study is for adults aged 18 to 70 who are having their first kidney transplant and are at a low to moderate risk of their body rejecting the new kidney. The main goal is to find out if a new medicine, frexalimab, given as an injection under the skin, is as safe and effective as a common medicine called tacrolimus (given as capsules) in preventing the body from rejecting the transplanted kidney. The study will last for up to five years, and participants will have around 38 visits to the clinic during that time. Researchers want to see if frexalimab can help transplanted kidneys last longer and work better.
At a glance
What is this study about?
When someone receives a kidney transplant, their body's immune system naturally tries to fight off what it sees as 'foreign', which is the new kidney. This is called rejection. To stop this from happening, people need to take special medicines that calm down their immune system. This study is testing a new medicine called frexalimab to see how well it works compared to a medicine that's often used now, called tacrolimus.
Researchers want to understand if frexalimab can prevent kidney rejection effectively and safely. If it does, it could offer a new and potentially better way to help people with kidney transplants keep their new kidney working well for longer. This is important because preventing rejection helps improve the long-term success of kidney transplants and the quality of life for people who have them.
This study will carefully watch how participants' bodies react to the new kidney and to the study medicines over several years. By comparing frexalimab against tacrolimus, doctors hope to gather important information that could help future kidney transplant patients.
Key takeaways
- New medicine (frexalimab) compared to standard medicine (tacrolimus).
- Aims to prevent kidney transplant rejection.
- For adults having their first kidney transplant.
- Study lasts up to 5 years, with regular check-ups.
- You will know which treatment you are receiving.
- Could help find better long-term care for transplant patients.
Who may be eligible?
This study is for adults aged 18 to 70 who are planning to have their first kidney transplant. You would need to be at a low to moderate risk of your body rejecting the new kidney.
There are some reasons why you might not be able to join. For example, if you're getting a kidney from a donor who died and the kidney is considered 'expanded criteria', or if you've already had another organ transplant. Also, if you have certain serious health conditions like active tuberculosis, HIV, or hepatitis, or if your kidney failure was caused by specific rare diseases, you wouldn't be able to take part. The research team will carefully check all health information to make sure it's safe for you to join.
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 between 18 and 70 years old?
- Are you scheduled for your first kidney transplant?
- Are you considered by your doctor to have a low to moderate risk of transplant rejection?
- Do you currently have active tuberculosis, HIV, or hepatitis?
- Have you had another organ transplant before this one?
What does participation involve?
If you decide to take part in this study, you will be given either the new medicine, frexalimab, which is an injection under the skin, or the standard medicine, tacrolimus, which is taken as capsules. You will also receive other common medicines used after a kidney transplant. The study will last for a long time, up to about five years after your transplant. During this period, you will have regular check-ups, about 38 visits in total, to see how you are doing, how the medicine is working, and to monitor your kidney and general health. You will undergo various assessments, blood tests, and other procedures as needed during these visits. The research team will explain everything you need to do and be available to answer any questions.
Potential risks and benefits
Locations (16)
- Investigational Site Number : 0360001Verified postcodeParkville, Australia· Recruiting
- Investigational Site Number : 0360003Verified postcodeSydney, Australia· Recruiting
- Investigational Site Number : 1520004Verified postcodeSantiago, Chile· Recruiting
- Investigational Site Number : 1560003Verified postcodeChengdu, China· Recruiting
- Investigational Site Number : 1560012Verified postcodeJinan, China· Recruiting
- Investigational Site Number : 1560017Verified postcodeNanchang, China· Recruiting
- Investigational Site Number : 1560008Verified postcodeNanning, China· Recruiting
- Investigational Site Number : 1560001Verified postcodeShanghai, China· Recruiting
- Investigational Site Number : 1560006Verified postcodeWuhan, China· Recruiting
- Investigational Site Number : 2080001Verified postcodeAarhus, Denmark· Recruiting
- Investigational Site Number : 3760002Verified postcodeRamat Gan, Israel· Recruiting
- Investigational Site Number : 7240001Verified postcodeBarcelona, Spain· Recruiting
Common questions
What is the main goal of this study?
The main goal is to see if a new medicine, frexalimab, is safe and works well to prevent kidney transplant rejection in adults, compared to a standard medicine called tacrolimus.
How long will I need to be in the study?
The study will last for up to five years, with regular check-ups during that time.
Will I know if I'm getting the new medicine or the standard one?
Yes, this is an 'open-label' study, meaning you and the study team will know which medicine you are receiving.
Who can join this study?
Adults aged 18 to 70 who are having their first kidney transplant and are at a low to moderate risk of rejection may be eligible.
What typically happens if my body starts to reject the new kidney?
If your body shows signs of rejection, doctors have treatments to try and reverse it. This study aims to find ways to prevent rejection from happening in the first place.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.