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

Conditions

Kidney Transplantation BKV infection

Brief summary

The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.

Detailed description

BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12, Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12, Incidence of BKV viremia > 3 log10 copies/mL in at least two, Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12, Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12, Incidence of BKV nephropathy at M3, M6, and M12, Time of occurrence and duration of viruria, viremia and BKVAN, Genotype of replicative BKV, The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation, GFR evaluated by CKD EPI formula at M3, M6 and M12, Percentage of patients with donor specific antibodies (DSA) at M3 and M12, Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification, Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification, Patient and graft survival at M12, Tolerance of IVIG, adverse and severe adverse effects

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Interventions

DRUGPrivigen 100 mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.	—

Secondary

Measure	Time frame
BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12, Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12, Incidence of BKV viremia > 3 log10 copies/mL in at least two, Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12, Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12, Incidence of BKV nephropathy at M3, M6, and M12, Time of occurrence and duration of viruria, viremia and BKVAN, Genotype of replicative BKV, The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation, GFR evaluated by CKD EPI formula at M3, M6 and M12, Percentage of patients with donor specific antibodies (DSA) at M3 and M12, Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification, Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification, Patient and graft survival at M12, Tolerance of IVIG, adverse and severe advers	—

Measure

Time frame

BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12, Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12, Incidence of BKV viremia > 3 log10 copies/mL in at least two, Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12, Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12, Incidence of BKV nephropathy at M3, M6, and M12, Time of occurrence and duration of viruria, viremia and BKVAN, Genotype of replicative BKV, The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation, GFR evaluated by CKD EPI formula at M3, M6 and M12, Percentage of patients with donor specific antibodies (DSA) at M3 and M12, Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification, Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification, Patient and graft survival at M12, Tolerance of IVIG, adverse and severe advers

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Countries

France

Outcome results

None listed