Induction Related BK Viremia in Renal Transplant Patients
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.
Disease Due to BK Polyomavirus
Disorder Related to Transplantation
|Study Design:||Observational Model: Case Control|
|Official Title:||The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients|
- BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR) [ Time Frame: One year ] [ Designated as safety issue: Yes ]BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.
- Incidence of Acute Rejection of Transplanted Kidney [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610961
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Herwig-Ulf Meier-Kriesche, MD||University of Florida|