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

Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 664 人开始时间: 2020年1月27日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•- 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
•- Women of child bearing potential or intends to become pregnant, unless they are using an effective method of birth control* and a ßHCG blood test negative
•- Affiliated to a medical insurance 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 650
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•- BKV nephropathy during a previous transplantation in the past 5 years
•- 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
•Patients with isolated IgA deficiency

发起方

Hôpitaux Universitaires de Strasbourg