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

Phase 1

• Conditions: Kidney transplantationEpstein Barr virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000492-21-FR
• Lead Sponsor: es Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-21
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Patient with known HBV active infection
-Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
-Active severe infection
-Severe Immune deficiency
-Severe cardiac insufficiency
-Pregnant or lactating women
-Women of child bearing potential unless they are using an acceptable birth control methods
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified