Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg/m2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft
This study is investigating if a medicine called rituximab can help prevent health problems in adults after a kidney transplant. Some people haven't been infected with the Epstein-Barr Virus (EBV) in the past, but they might receive a kidney from someone who has. In these cases, there's a risk of the virus causing serious complications, such as post-transplant lymphoproliferative disorder (PTLD), which is a type of uncontrolled cell growth. The study aims to see if giving a single dose of rituximab shortly after transplant can stop these issues from developing. Researchers are trying to find a safe and effective way to protect these higher-risk patients, as current prevention methods aren't always consistent.
At a glance
What is this study about?
When you have a kidney transplant, your body's defence system (immune system) is deliberately weakened so it doesn't reject the new kidney. However, this also means you can be more vulnerable to infections.
Most people get infected with the Epstein-Barr Virus (EBV) during their lives, often without even knowing it, and the virus then stays inactive in their body. But if someone who has never had EBV (they are 'EBV negative') receives a kidney from a donor who has had EBV (they are 'EBV positive'), there's a risk. The new kidney can introduce the virus to the patient's body for the first time, and because their immune system is suppressed, the virus can sometimes cause serious problems, including a condition called post-transplant lymphoproliferative disorder (PTLD).
PTLD is a rare but serious complication where certain immune cells grow out of control. It can be life-threatening. Currently, there isn't a very clear or consistently effective way to prevent PTLD in these specific higher-risk patients. This study wants to find out if a medicine called rituximab, given as one dose, can be a safe and effective way to lower the chances of these problems happening.
Key takeaways
- This study evaluates rituximab to prevent EBV-related issues in kidney transplant patients.
- It targets patients who haven't had EBV but receive a kidney from an EBV-positive donor.
- The main goal is to prevent a serious complication called PTLD.
- One dose of rituximab is given, and patients are carefully monitored.
- Participation is voluntary, and patients can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) who is having a kidney or kidney-pancreas transplant. A key requirement is that you have never had the Epstein-Barr Virus (EBV) yourself, meaning your recent blood tests for EBV must be negative. Also, the kidney you are receiving must come from a donor who has had EBV.
There are also some reasons why you might not be able to join. For example, if you have a known severe heart problem, a serious immune deficiency, or a current active Hepatitis B infection. You also can't join if you are pregnant, breastfeeding, or allergic to the study medicine, rituximab. If you are taking part in another drug trial, you generally can't join this one either. The study team will check all these details carefully with 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 having a kidney or kidney-pancreas transplant?
- Have you never had the Epstein-Barr Virus (EBV) yourself (your recent test was negative)?
- Is the person donating the kidney EBV-positive (meaning they have had EBV)?
- Are you not currently pregnant or breastfeeding?
- Do you not have active Hepatitis B, severe heart failure, or a known allergy to rituximab?
What does participation involve?
This study involves a single dose of the medicine rituximab, given around the time of your transplant. During the study, you will have regular visits to the hospital for check-ups and blood tests. These tests will look for signs of the Epstein-Barr Virus and other health markers. The exact number and timing of visits will be explained by the study team, but they will be scheduled to fit in with your regular transplant follow-up care as much as possible. The total duration of your participation in the study, including follow-up visits, will depend on the study plan, but ongoing monitoring is important to see the long-term effects.
Potential risks and benefits
Locations (1)
- Les Hôpitaux Universitaires de StrasbourgVerified postcodeStrasbourg, France· Recruiting
Common questions
What is the Epstein-Barr Virus (EBV)?
EBV is a very common virus, most people get it at some point, often causing no symptoms or mild flu-like illness. It stays in your body for life but is usually inactive.
What is PTLD?
PTLD stands for Post-Transplant Lymphoproliferative Disorder. It's a rare but serious complication after a transplant where cells affected by the Epstein-Barr Virus can grow too much.
What is rituximab?
Rituximab is a medicine that works by targeting specific immune cells in your body. It's used for various conditions, including some cancers and autoimmune diseases, and is being tested here to prevent PTLD.
Why is this study important?
This study is important because it's looking for a better way to protect kidney transplant patients who are at higher risk of developing serious problems from the Epstein-Barr Virus after their transplant.
Will I still receive my normal transplant care?
Yes, taking part in this study will not affect the standard medical care you receive for your kidney transplant. The study treatments and visits are in addition to your usual care.
How to find out more
Sophie Ohlmann-Caillard
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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