2024-515243-37-00招募中4 期
Intravenous Immunoglobulins for Prevention of BKV Viremia in Kidney Transplant Recipients According to BKV genotype-specific Neutralizing Antibody Titers at the day of transplantation: A Multicenter Study -BKANIG
Les Hopitaux Universitaires De Strasbourg, Les Hopitaux Universitaires De Strasbourg18 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2024年7月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 664
- 试验地点
- 18
- 主要终点
- The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.
研究概览
简要总结
The main objective of the study is to investigate the impact of a preventive administration of IVIG on the incidence of BKV viremia (> 3 log10 copies/mL ) in patients with low titers of neutralizing antibodies (NAbs) against the donor's BKV strain at the time of transplantation.
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
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years)
- •Kidney transplant recipients, including multiple organ transplant patients
- •Patients able to understand the purpose and the risks of the study, fully informed and having written informed consent
- •Affiliated to a medical insurance scheme
排除标准
- •BKV nephropathy during a previous transplantation in the past 5 years
- •Patients with isolated IgA deficiency French
- •HLA and ABO-incompatible kidney transplant recipients undergoing desensitization with rituximab and/or plasmapheresis before transplantation or susceptible to receive such therapy after transplantation
- •Patients with high risk of post- transplant Focal Segmental glomerulosclerosis recurrence
- •Patient with hyperprolinemia
- •Contraindications to the use to IVIg: hypersensitivity to the active substance or to any excipients or human immunoglobulins, especially in patients with antibodies against IgA
- •Pregnant or breast feeding women
- •Adults under guardianship or limited guardianship
- •Currently participating in another clinical trial investigating drugs (observational studies are not considered as an exclusion criterion)
- •Patients with high risk of thrombosis
结局指标
主要结局
The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.
The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.
次要结局
- BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12
- Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12
- Incidence of BKV viremia > 3 log10 copies/mL in at least two
- Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12
- Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12
- Incidence of BKV nephropathy at M3, M6, and M12
- Time of occurrence and duration of viruria, viremia and BKVAN
- Genotype of replicative BKV
- The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation
- GFR evaluated by CKD EPI formula at M3, M6 and M12
- Percentage of patients with donor specific antibodies (DSA) at M3 and M12
- Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification
- Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification
- Patient and graft survival at M12
- Tolerance of IVIG, adverse and severe adverse effects
研究者
Sophie CAILLARD
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (18)
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