Human normal immunoglobulin for BK virus infection|Kidney transplantation

Inclusion criteria

• {"criterion_text":"- Adult patients (≥ 18 years)"}
• {"criterion_text":"- Kidney transplant recipients, including multiple organ transplant patients"}
• {"criterion_text":"- Patients able to understand the purpose and the risks of the study, fully informed and having written informed consent"}
• {"criterion_text":"- Affiliated to a medical insurance scheme"}

Exclusion criteria

• {"criterion_text":"- BKV nephropathy during a previous transplantation in the past 5 years"}
• {"criterion_text":"- Patients with isolated IgA deficiency French"}
• {"criterion_text":"- HLA and ABO-incompatible kidney transplant recipients undergoing desensitization with rituximab and/or plasmapheresis before transplantation or susceptible to receive such therapy after transplantation"}
• {"criterion_text":"- Patients with high risk of post- transplant Focal Segmental glomerulosclerosis recurrence"}
• {"criterion_text":"- Patient with hyperprolinemia"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnant or breast feeding women"}
• {"criterion_text":"- Adults under guardianship or limited guardianship"}
• {"criterion_text":"- Currently participating in another clinical trial investigating drugs (observational studies are not considered as an exclusion criterion)"}
• {"criterion_text":"- Patients with high risk of thrombosis"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.","definition_or_measurement_approach":"Incidence of BKV viremia defined as > 3 log10 copies/mL measured 6 months after transplantation."}

Secondary endpoints

• {"endpoint_text":"- BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12","definition_or_measurement_approach":"Measurement of BKV neutralizing antibody (NAb) titers at specified timepoints D0, D10, D31, D52, M3, M6, M12."}
• {"endpoint_text":"- Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12","definition_or_measurement_approach":"Incidence of BK viruria measured at timepoints D10, D31, D52, M3, M6, M12."}
• {"endpoint_text":"- Incidence of BKV viremia > 3 log10 copies/mL in at least two","definition_or_measurement_approach":"Incidence of BKV viremia > 3 log10 copies/mL measured at scheduled visits (J0, J10, J31, J52, M3, M6, M12)."}
• {"endpoint_text":"- Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12","definition_or_measurement_approach":"Incidence of TTV viremia measured at timepoints D0, D10, D31, D52, M3, M6, M12."}
• {"endpoint_text":"- Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12","definition_or_measurement_approach":"Assessment of T and B-cell repertoire changes against BKV at D0, M3, M6, M12."}
• {"endpoint_text":"- Incidence of BKV nephropathy at M3, M6, and M12","definition_or_measurement_approach":"Incidence of BKV nephropathy assessed at M3, M6, M12."}
• {"endpoint_text":"- Time of occurrence and duration of viruria, viremia and BKVAN","definition_or_measurement_approach":"Recording time of onset and duration for viruria, viremia and BK virus-associated nephropathy (BKVAN)."}
• {"endpoint_text":"- Genotype of replicative BKV","definition_or_measurement_approach":"Genotyping of replicative BK virus strains."}
• {"endpoint_text":"- The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation","definition_or_measurement_approach":"Evaluation of pre-transplant BKV NAb titers as predictors of post-transplant BKV replication."}
• {"endpoint_text":"- GFR evaluated by CKD EPI formula at M3, M6 and M12","definition_or_measurement_approach":"GFR estimated using the CKD-EPI formula at M3, M6, M12."}
• {"endpoint_text":"- Percentage of patients with donor specific antibodies (DSA) at M3 and M12","definition_or_measurement_approach":"Proportion of patients with donor-specific antibodies assessed at M3 and M12."}
• {"endpoint_text":"- Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification","definition_or_measurement_approach":"Incidence of biopsy-proven antibody-mediated rejection assessed at M3 and M12 using Banff classification."}
• {"endpoint_text":"- Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification","definition_or_measurement_approach":"Incidence of biopsy-proven acute cellular rejection assessed at M3 and M12 using Banff classification."}
• {"endpoint_text":"- Patient and graft survival at M12","definition_or_measurement_approach":"Assessment of patient and graft survival status at 12 months."}
• {"endpoint_text":"- Tolerance of IVIG, adverse and severe adverse effects","definition_or_measurement_approach":"Recording and assessment of adverse events and serious adverse events related to IVIG administration."}

France

Latest Decision Or Authorization Date

12-07-2024

Number Of Sites

20

Number Of Participants

664

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France