Using Rituximab to prevent Epstein-Barr Virus infection in kidney transplant patients
Multicenter Randomized Two Arms Study Evaluating the Efficacy of Prophylactic Rituximab in Adult EBV Negative Kidney Transplant Recipients on Incidence of EBV Primary Infection and Post-transplant Lymphoproliferative Disorders
This study is testing if a single dose of Rituximab can help prevent Epstein-Barr Virus infection in kidney transplant patients who are at risk for complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Rituximab |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04989491 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are EBV seronegative and have received an EBV seropositive kidney transplant.
Not a fit: Patients with known active HBV infection, severe immune deficiency, or those allergic to Rituximab may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of EBV infection and PTLD in kidney transplant recipients, improving patient outcomes.
How similar studies have performed: While few studies have explored preventive strategies for EBV in transplant patients, this approach using Rituximab is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Strasbourg
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sophie Ohlmann-Caillard
- Email: sophie.caillard@chru-strasboourg.fr
- Phone: 0369550511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.