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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
BK Viremia
Resolution of BK viremia by 3 months post-enrollment. Resolution is defined as a decrease in viral load of BKV in the plasma to \<1000 copies/mL.
Time frame: 3 Months
Donor specific anti-HLA antibodies
Prevention of new donor specific anti-HLA antibodies (DSA)
Time frame: 12 Months
Kidney graft survival
Time frame: 12 Months
Acute Cellular Rejection
Incidence of acute cellular rejection (Banff 2013 Criteria)
Time frame: 12 Months
BK Nephropathy
Proportion of BKV nephropathy
Time frame: 12 Months
Acute Antibody Mediated Rejection
Incidence of acute antibody mediated rejection
Time frame: 12 Months
Interstitial Fibrosis or Transplant Glomerulopathy
Incidence of interstitial fibrosis or transplant glomerulopathy
Time frame: 12 Months
Glomerular Filtrition Rate (GFR)
Proportion of delta decline in estimated glomerular filtration rate (MDRD) of \>20%
Time frame: 12 Months
BKV remission
Length of BKV remission (time from clearance of BK viremia to reappearance of BK viremia (plasma DNA load \>1000 copies/mL x 2 measures that are a 4weeks apart) or end of study
Time frame: Up to 24 Months
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