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The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose, Day 0 | Experimental | CMVIG 150 mg/kg x 1 at Day 0. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion. |
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| Two Doses, One Week | Experimental | CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 7. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion. |
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| Two Doses, Four Weeks | Experimental | CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 28. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytogam | Drug | Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CMV IgG antibody level: Day 0 | Measured with ELISA testing | Day 0, pre-infusion |
| Anti-CMV IgG antibody level: Day 7 | Measured with ELISA testing | Day 7 |
| Anti-CMV IgG antibody level: Day 14 | Measured with ELISA testing | Day 14 |
| Anti-CMV IgG antibody level: Day 21 | Measured with ELISA testing | Day 21 |
| Anti-CMV IgG antibody level: Day 28 | Measured with ELISA testing | Day 28 |
| Anti-CMV IgG antibody level: Day 56 | Measured with ELISA testing | Day 56 after last dose of CMVIG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Reed | Contact | 612-624-9695 | surgcto@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Humphreville, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| C045781 | cytomegalovirus-specific hyperimmune globulin |
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