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Multicenter randomized two arms study evaluating the efficacy of prophylactic Rituximab in EBV negative kidney transplant recipients on incidence of EBV primary infection and post-transplant lymphoproliferative disorders - REPLY
EU CTIS ID: 2024-515075-36-00
What this study is testing
The main objective of our study is to evaluate the efficacy of early infusion of Rituximab in the prevention of EBV primary infection and post-transplant lymphoproliferative disorder (PTLD) occurrence in EBV negative kidney transplant recipients transplanted with an EBV positive donor.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- Pediatric patients > 2 years and <18 years at transplantation
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study or during 12 months after the administration of rituximab in case of early discontinuation of study-EBV positive donor
You likely can't join if
- Patient with known HBV active infection
- Unlikely to comply with the visits scheduled in the protocol
- Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
- Active severe infection
- Severe Immune deficiency
- Pregnant or lactating women
See the full eligibility 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)
- Pediatric patients > 2 years and <18 years at transplantation
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study or during 12 months after the administration of rituximab in case of early discontinuation of study-EBV positive donor
- EBV positif donnor
- Patient with known HBV active infection
- Unlikely to comply with the visits scheduled in the protocol
- Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
- Active severe infection
- Severe Immune deficiency
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.