IMLIFIDASE IN LIVING DONOR RENAL TRANSPLANTATION: HIGHLY SENSITIZED RECIPIENTS (LIVEDES STUDY)
This study, called LIVEDES, is testing a new treatment called imlifidase for adult patients needing a kidney transplant from a living donor. These patients often have a strong immune response, making it very difficult to find a compatible kidney. The main goal is to see if imlifidase can quickly reduce these strong immune reactions, making it possible for them to receive a transplant. Researchers will also look at how well the new kidney works, how safe imlifidase is, and if patients get infections or other problems after treatment and transplant over a year. The hope is that imlifidase could open up transplant opportunities for more people who currently struggle to find a suitable donor.
At a glance
What is this study about?
When someone needs a kidney transplant, their body's immune system naturally looks for differences between their own tissues and the donor's. If there are too many differences, the immune system can create powerful defenders called 'antibodies' that might attack the new kidney. This makes it very hard to find a donor whose kidney won't be immediately rejected, especially for people who have developed many strong antibodies, perhaps from previous transplants or pregnancies.
This study is looking at a new medicine called imlifidase. The idea is that imlifidase can quickly reduce these strong antibodies just before a transplant. This could make it possible for a patient to receive a kidney from a living donor, even if they previously had strong antibodies that would have caused a problem. Doctors want to see if imlifidase can quickly 'clear the way' for a transplant to happen safely.
The main thing doctors want to find out is if imlifidase successfully calms down these strong immune reactions within a few hours, allowing the transplant to go ahead. They will also be carefully checking other important things over a year, such as how well the new kidney works, whether the patient and kidney remain healthy, and if there are any side effects from the imlifidase treatment.
Key takeaways
- This study is for adults needing a living donor kidney transplant.
- It tests a new medicine, imlifidase, to help overcome strong immune reactions to a donor kidney.
- The main goal is to see if imlifidase allows for a safe transplant.
- Patients will be closely monitored for at least a year after the transplant.
- This could help more people receive a kidney when a transplant was previously difficult.
Who may be eligible?
This study is looking for adults aged 18 and over who need a kidney transplant. Both men and women can take part.
To be considered for this study, you must require a kidney transplant from a living donor. The key part is that your body must have a very strong immune reaction (called a 'positive virtual crossmatch') to the potential donor's kidney. This strong reaction is what often prevents a transplant from happening, and this study aims to see if imlifidase can overcome it.
Your medical team will perform specific tests to confirm if you meet these criteria and can be considered for the study. There will also be other health checks to make sure the study is a safe option 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?
- Do you need a kidney transplant from a living donor?
- Has your medical team told you that you have a strong immune reaction (antibodies) that makes a transplant difficult?
- Are you able to attend regular follow-up appointments for at least a year?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, imlifidase, just before your planned kidney transplant. Doctors will closely monitor your immune reaction for several hours after you receive the medicine to see if it has worked, and you might receive a second dose if needed.
After your transplant, you'll have regular hospital visits and tests for at least a year. These appointments will check how your new kidney is working, measure your antibody levels, and monitor for any side effects or infections. This involves blood tests and other routine checks. The total duration of active follow-up for the study is at least one year after your transplant to understand the long-term effects of the treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What is imlifidase?
Imlifidase is a new medicine being tested to temporarily reduce strong antibodies in transplant patients, potentially making a kidney transplant possible.
Why is this study needed?
Some people have very strong immune reactions to donor kidneys, making a transplant difficult. This study hopes to find a way to help these patients receive a life-changing transplant.
What is a 'living donor'?
A living donor is someone who donates a kidney while they are still alive, often a family member or close friend.
Will I still need other transplant medications?
Yes, you will still need to take regular anti-rejection medications after your transplant, as per standard care, to help your body accept the new kidney.
How long will I be followed in the study?
You will be followed and monitored for at least one year after your kidney transplant to check your health and the new kidney's function.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.