Using Rituximab to prevent Epstein-Barr Virus infection in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of a single dose of Rituximab in preventing primary Epstein-Barr Virus (EBV) infection and post-transplant lymphoproliferative disorder (PTLD) in adult patients who are EBV seronegative and have received an EBV seropositive kidney transplant. The study focuses on immunocompromised individuals, as they are at a higher risk for severe complications from EBV. Participants will be monitored for the incidence of EBV infection and PTLD following treatment. The trial aims to provide insights into effective preventive strategies for this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (age ≥18 years at transplantation)
* Kidney and kidney pancreas simultaneous transplantation
* EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of transplantation, included)
* Patient who have given written informed consent
* Negative pregnancy test and use of contraception during all the study
* EBV positive donor
* Patient affiliated to a social security scheme

Exclusion criteria:

* Patient with known HBV active infection
* Allergy to Rituximab
* Severe Immune deficiency
* Severe cardiac insufficiency
* Pregnant or lactating women
* Women of child bearing potential unless they are using a birth control method
* Patient under judicial protection or under guardianship
* Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion
* Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study
* Unlikely to comply with the visits scheduled in the protocol.

Exclusion Criteria:

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Where it's running

• Les Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Sophie Ohlmann-Caillard
• Email: sophie.caillard@chru-strasboourg.fr
• Phone: 0369550511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.