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

Phase 1

Conditions: Kidney Transplantation BKV infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2018-000695-15-FR

Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 664

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to investigate the impact of a preventive administration of IVIG on the incidence of BKV viremia (> 3.5 log10 copies/mL in at least two consecutive samples) in patients with low titers of neutralizing antibodies (NAbs) against the donor’s BKV strain at the time of transplantation. ;Secondary Objective: The secondary objectives of the study are to assess in a prospective cohort, the kinetics of BKV NAbs, the incidence of BKV diseases, graft rejection episodes, graft survival, the incidence of TTV viremia, the evolution of B and T-cell repertoire against BKV, the tolerance of IVIG; and assess BKV NAb concentration in administered IVIG.;Primary end point(s): The primary endpoint is the incidence of BKV viremia (> 3.5 log10 copies/mL in at least two consecutive samples) 6 months after transplantation.;Timepoint(s) of evaluation of this end point: 6 months after transplantation

Secondary Outcome Measures