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

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 - REPLY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000492-21-FR

Enrollment

120

Registered

2021-04-21

Start date

2021-06-11

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation Epstein Barr virus

Interventions

Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.;Secondary Objective: -The occurrence of PTLD during the 5 post-transplant years -The occurrence of post-transplant EBV primary infection during the 5 post-transplant years -The kinetics of post-transplant EBV replication -The clinical presentation of EBV primary infection -The incidence of post-transplant EBV seroconversion during the 5 post-transplant years -The post-transplant immune reconstitution kinetics -The kidney allograft function and graft survival during the 5 post-transplant years -The recipient survival during the 5 post-transplant years -The tolerance of Rituximab -The incidence of opportunistic infections and malignancies during the 5 years after transplantation -The incidence of BK virus and Cytomegalovirus (CMV) infections post-transplantation ;Primary end point(s): 1 year incidence of a composite criteria: EBV primary infection assessed by a positive blood EBV viral load and/or EBV seroconversion ; and/or occurrence of a post-transplant lymphoproliferative disorder;Timepoint(s) of evaluation of this end point: 1 year after transplantation	—

Measure

Time frame

Main Objective: 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 adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.;Secondary Objective: -The occurrence of PTLD during the 5 post-transplant years -The occurrence of post-transplant EBV primary infection during the 5 post-transplant years -The kinetics of post-transplant EBV replication -The clinical presentation of EBV primary infection -The incidence of post-transplant EBV seroconversion during the 5 post-transplant years -The post-transplant immune reconstitution kinetics -The kidney allograft function and graft survival during the 5 post-transplant years -The recipient survival during the 5 post-transplant years -The tolerance of Rituximab -The incidence of opportunistic infections and malignancies during the 5 years after transplantation -The incidence of BK virus and Cytomegalovirus (CMV) infections post-transplantation ;Primary end point(s): 1 year incidence of a composite criteria: EBV primary infection assessed by a positive blood EBV viral load and/or EBV seroconversion ; and/or occurrence of a post-transplant lymphoproliferative disorder;Timepoint(s) of evaluation of this end point: 1 year after transplantation

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Secondary

Measure	Time frame
Secondary end point(s): -1, 2, 3, 4 and 5 years incidence of PTLD after kidney transplantation -Incidence of primary EBV infection evaluated by EBV viremia (PCR blood test) at M1, M2, M3, M6, M12, M24, M36, M48, M60 and EBV seroconversion at M1, M3, M6, M12, M24, M36, M48, M60. -Delay of occurrence of primary EBV infection -Symptoms of EBV primary infection -CD19/CD20 reconstitution at M3, M6, M12, M24 -Graft loss at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Allograft kidney function evaluated by CKD-EPI formula at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Recipient survival at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Incidence of opportunistic infections and malignancies at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Incidence of BKV viremia (PCR blood test) M1, M3, M6, M12 and M24 -Delay of BKV viremia -Incidence of CMV viremia (PCR blood test) at M1, M3, M6, M12 and M24 -Delay of CMV viremia -Treatment tolerance: allergic reaction, neutropenia -AE/SAE ;Timepoint(s) of evaluation of this end point: at several diffents timepoint	—

Measure

Time frame

Secondary end point(s): -1, 2, 3, 4 and 5 years incidence of PTLD after kidney transplantation -Incidence of primary EBV infection evaluated by EBV viremia (PCR blood test) at M1, M2, M3, M6, M12, M24, M36, M48, M60 and EBV seroconversion at M1, M3, M6, M12, M24, M36, M48, M60. -Delay of occurrence of primary EBV infection -Symptoms of EBV primary infection -CD19/CD20 reconstitution at M3, M6, M12, M24 -Graft loss at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Allograft kidney function evaluated by CKD-EPI formula at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Recipient survival at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Incidence of opportunistic infections and malignancies at M1, M2, M3, M6, M12, M24, M36, M48, M60 -Incidence of BKV viremia (PCR blood test) M1, M3, M6, M12 and M24 -Delay of BKV viremia -Incidence of CMV viremia (PCR blood test) at M1, M3, M6, M12 and M24 -Delay of CMV viremia -Treatment tolerance: allergic reaction, neutropenia -AE/SAE ;Timepoint(s) of evaluation of this end point: at several diffents timepoint

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Countries

France

Contacts

Public ContactEric DEMONSANT

Les Hôpitaux Universitaires de Strasbourg

dpidrci@chru-strasbourg.fr0033388115266

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026