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Study on Rituximab for Preventing Epstein-Barr Virus Infection and Lymphoproliferative Disorders in EBV-Negative Kidney Transplant Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Rituximab in patients who have undergone a kidney transplant. The study specifically looks at patients who are negative for the Epstein-Barr virus (EBV) and have received a kidney from a donor who is positive for EBV. The main goal is to see if early treatment with Rituximab can help prevent the initial infection of EBV and the development of a condition called post-transplant lymphoproliferative disorder (PTLD), which can occur after a transplant.

Participants in the study will be randomly assigned to one of two groups. One group will receive Rituximab, which is a type of medication known as a monoclonal antibody that targets specific cells in the immune system. The other group will receive a placebo. The study will monitor the participants over a period of time to observe the incidence of EBV infection and PTLD, as well as other health outcomes related to the transplant.

The study will track various health indicators over several years, including the presence of EBV in the blood, kidney function, and any other infections or complications that may arise. The aim is to gather information on how effective Rituximab is in preventing these issues in kidney transplant patients who are at risk of EBV infection. This research could provide valuable insights into improving the care and outcomes for transplant recipients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of transplant, and EBV status.

    Written informed consent is required, and a negative pregnancy test is necessary for participants of childbearing potential.

  2. Step 2

    Initial treatment

    The study involves the administration of Rituximab, a medication given through an intravenous infusion.

    The purpose of this treatment is to prevent primary infection with the Epstein-Barr virus (EBV) and related complications after a kidney transplant.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the incidence of EBV infection and other health parameters.

    Blood tests are performed at various intervals, such as 1, 2, 3, 6, 12, 24, 36, 48, and 60 months, to evaluate viral load and immune response.

  4. Step 4

    Evaluation of outcomes

    The primary outcome is measured by the incidence of EBV infection and related disorders within one year.

    Secondary outcomes include long-term monitoring of transplant health, immune function, and any additional infections or complications.

  5. Step 5

    Completion of study

    The study is expected to conclude by December 2029, with ongoing assessments throughout the duration.

    Participants are evaluated for any long-term effects or benefits from the treatment received during the study.

Who can join the trial?

7 criteria

  • Adult patients who are 18 years or older at the time of transplantation.
  • Patients receiving a kidney transplant or a kidney and pancreas transplant at the same time.
  • Patients who are **EBV seronegative**, meaning they do not have certain antibodies (IgG anti EBNA, IgG anti VCA, and IgM anti VCA) that show past infection with the **Epstein Barr Virus (EBV)**. This must be confirmed from 6 months before the transplant to the day of the transplant.
  • Children who are older than 2 years but younger than 18 years at the time of transplantation.
  • Patients who have provided written informed consent, which means they have agreed in writing to participate in the study after being informed about it.
  • Women must have a negative pregnancy test and agree to use contraception throughout the study or for 12 months after receiving **Rituximab**, a medication used in the study, if they stop participating early.
  • The donor of the kidney must be **EBV positive**, meaning they have been infected with the Epstein Barr Virus.

Who cannot join the trial?

5 criteria

  • Patients who have had a **kidney transplant** from a donor who is positive for the **Epstein Barr virus (EBV)** cannot participate. EBV is a common virus that can cause infections.
  • Patients who are already **positive for EBV** are not eligible. This means they have been infected with the virus before.
  • Patients who are not within the specified **age range** for the study cannot participate. The study has specific age requirements.
  • Patients who are not part of the specified **clinical trial group** are excluded. This refers to a specific group of people the study is focusing on.
  • Patients who are considered part of a **vulnerable population** are not eligible. This means people who might need special protection or care.
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Investigated drugs

Rituximab is a medication used in this study to prevent certain infections and disorders after a kidney transplant. It is given early to patients who have received a kidney from a donor with a specific virus, called EBV, to help stop the virus from causing problems. The study is looking at how well Rituximab works in stopping the virus from causing an infection or a type of disorder that can happen after a transplant.

What is already known about the treatment

Rituximab – This medication is administered through an intravenous infusion, meaning it is given directly into a vein. Rituximab is currently well-established in medical literature and is used in various clinical settings. It is primarily indicated for preventing Epstein-Barr virus (EBV) primary infection and post-transplant lymphoproliferative disorders (PTLD) in EBV-negative kidney transplant recipients. At the molecular level, Rituximab works by targeting and binding to a specific protein called CD20 found on the surface of certain immune cells, leading to their destruction. It is classified as a monoclonal antibody, which is a type of targeted therapy used to modulate the immune system.

Investigated diseases

  • Epstein-Barr Virus Primary Infection

    This infection occurs when a person is first exposed to the Epstein-Barr virus (EBV), which is a common virus that can cause infectious mononucleosis. The virus is typically spread through bodily fluids, primarily saliva. After the initial infection, the virus remains dormant in the body and can reactivate later. Symptoms of primary infection may include fatigue, fever, sore throat, and swollen lymph nodes. In some cases, the infection can be asymptomatic, especially in children. The virus can be detected through blood tests that identify EBV DNA or antibodies.

  • Post-Transplant Lymphoproliferative Disorder

    This disorder is a complication that can occur after an organ transplant, such as a kidney transplant, due to the immunosuppressive medications used to prevent organ rejection. It involves the abnormal growth of lymphoid cells, which can lead to the development of lymphomas. The condition is often associated with Epstein-Barr virus infection, as the virus can drive the proliferation of these cells. Symptoms may include fever, swollen lymph nodes, and organ dysfunction. The disorder can vary in severity, ranging from benign growths to aggressive lymphomas. Monitoring and early detection are crucial for managing the condition effectively.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515075-36-00Protocol code7678Estimated enrolment100 patientsSponsorLes Hopitaux Universitaires De Strasbourg

sourced from the EU Clinical Trials Register and site verification

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