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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Cfcaba Hlvurircdim Umnwegopivoet Rmkoe Reims France
Cgheoo Hwrrqpcofuv Rcmdywni Dejysopdipbmur Angers France
Cuybvg Htzsmkipqim Ec Uouadkjanbpzs Dc Ljlsuop Limoges France
Cwudto Hviqghncqjs Rfcbysmk Ugwlndqcrqejq Dy Tupuk Tours France
Ctaq Do Nhssd Vandoeuvre Les Nancy France
Ikhonbtq do Cthpydidrqvl Hmewathccwb Unphchuqpibxh dm Skusx Eexhzor (vkeczph Saint Priest En Jarez France
Hvhhgxww Ucjudwetglvkll Svfdufiumm &aavyxv Hqyfzzl dv Hrivvgbuqrw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.12.2021

Trial locations

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.

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 ID:
2024-515075-36-00
Protocol code:
7678
NCT ID:
NCT04989491
Trial Phase:
Therapeutic confirmatory (Phase III)

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