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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Treatment) | Active Comparator | Intravenous immune globulin (IVIg; Privigen®) 1g/kg monthly for 2 months with immunosuppression reduction. |
|
| Group 2 (Control) | Placebo Comparator | Placebo infusion monthly for 2 months with immunosuppression reduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIg | Biological |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Donor specific anti-HLA antibodies | Prevention of new donor specific anti-HLA antibodies (DSA) | 12 Months |
| Kidney graft survival | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Gilligan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02114 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41071936 | Derived | He KD, Gressens SB, Dadhania DM, Gilligan HM, Davis C, Edusei E, Ahn J, Lifton M, Pastrana DV, Kleiboeker S, Buck CB, Jost S, Wojciechowski D, Tan CS. Immune Responses to BK Virus in Renal Transplant Recipients Receiving Intravenous Immunoglobulin Treatment. J Infect Dis. 2026 Feb 18;233(2):e392-e403. doi: 10.1093/infdis/jiaf525. |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Other |
|
| Acute Cellular Rejection | Incidence of acute cellular rejection (Banff 2013 Criteria) | 12 Months |
| BK Nephropathy | Proportion of BKV nephropathy | 12 Months |
| Acute Antibody Mediated Rejection | Incidence of acute antibody mediated rejection | 12 Months |
| Interstitial Fibrosis or Transplant Glomerulopathy | Incidence of interstitial fibrosis or transplant glomerulopathy | 12 Months |
| Glomerular Filtrition Rate (GFR) | Proportion of delta decline in estimated glomerular filtration rate (MDRD) of >20% | 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 | Up to 24 Months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |