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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000695-15-FR

Enrollment

664

Registered

2020-01-27

Start date

2020-12-15

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation BKV infection

Interventions

Pharmaceutical Form: Solution for infusion in administration system

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: - 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 > 3.5 log10 copies/mL in at least two consecutive samples at D0, D10, D31, D52, M3, M6 and M12 - Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12 - Evolution of T and B-cell repertoire against BKV at D0, D31, D52, 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;Timepoint(s) of evaluation of this end point: Day of transplantation Days 10, 31 and 52 after transplantation Months 3, 6 and 12 after transplantation	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: - 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 > 3.5 log10 copies/mL in at least two consecutive samples at D0, D10, D31, D52, M3, M6 and M12 - Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12 - Evolution of T and B-cell repertoire against BKV at D0, D31, D52, 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;Timepoint(s) of evaluation of this end point: Day of transplantation Days 10, 31 and 52 after transplantation Months 3, 6 and 12 after transplantation

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Countries

France

Contacts

Public ContactEric DEMONSANT

Hôpitaux Universitaires de Strasbourg

dpidrci@chru-strasbourg.fr0033388115266

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026