BridgeMD
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
EU CTIS ID: 2024-515243-37-00
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.