Intravenous Immunoglobulins for Prevention of BKV Viremia in KidneyTransplant Recipients According to BKV genotype-specific NeutralizingAntibody Titers at the day of transplantation: A Multicenter Study
- Conditions
- Kidney TransplantationBKV infectionTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2024-515243-37-00
- Lead Sponsor
- es Hopitaux Universitaires De Strasbourg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 664
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method