drugset / Trial / NCT02659891

IVIg to Treat BK Viremia in Kidney Transplant Recipients

NCT02659891

Phase 1 Completed 16 enrolled Massachusetts General Hospital
RandomizedSingle-groupTriple-blindTreatment

Summary

The overall goal of this study is to rapidly improve clearance of BK viremia with Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies in renal transplant recipients that have had immunosuppression reduction due to BK viremia. Our approach is to perform a prospective, randomized, placebo controlled trial intravenous immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney transplantation.

Timeline

Start
2016-05
Primary completion
2020-12-10
Completion
2021-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 1 g/kg Intravenous