Induction Related BK Viremia in Renal Transplant Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients

Conditions
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Disease Due to BK Polyomavirus, Transplantation Infection, Disorder Related to Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo transplant Aged 18-75 Exclusion Criteria: Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol. Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basiliximab (Simulect) Induction<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Acute Rejection of Transplanted Kidney |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BK Polyomavirus, Transplantation, Kidney, Transplantation, Pancreas