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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.
Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.
Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.
Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).
Inductions in both groups was/is Standard of Care at a time of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basiliximab (Simulect) Induction | Prospective group: patients are scheduled to receive a kidney transplant; and will receive Simulect®, Myfortic® and Prograf® with or without steroids according to routine care (Standard of Care). | ||
| Thymoglobulin Induction | Retrospective (historical or control) group: patients have already received a kidney transplant and were treated with Thymoglobulin®, Myfortic®, and Prograf® with or without steroids. This treatment was Standard of Care at a time of transplant. |
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| Measure | Description | Time Frame |
|---|---|---|
| BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR) | BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Rejection of Transplanted Kidney | One year |
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Inclusion Criteria:
Exclusion Criteria:
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de novo renal or renal/pancrease transplant patients
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| Name | Affiliation | Role |
|---|---|---|
| Herwig-Ulf Meier-Kriesche, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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