2024-515075-36-00招募中4 期
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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomised and controlled Trial
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
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
次要结局
- 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
- CD19/CD20 reconstitution at M3, M6, M12, M24
- Number of patients with high EBV viral load who need Rituximab for preemptive therapy in each group
- Graft loss at M1, M2, M3, M6, M12, M24, M36, M48, M60
- Allograft kidney function evaluated by CKD-EPI formula or by Schwartz formula in pediatric patients at M1, M2, M3, M6, M12, M24, M36, M48, M60Recipient 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 XML File Identifier: BMpUWXavs2G+LuOr9Bi86K8SCls= Page 12/29 M24
- Treatment tolerance: allergic reaction, neutropenia, hospitalization for febrile neutropenia, hypogammaglobulinémia
- AE/SAE
- All these end points in specific pediatric and adult sub groups
研究者
Sophie CAILLARD
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (21)
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