Induction Related BK Viremia in Renal Transplant Patients (BK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00610961|
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : September 27, 2011
|Condition or disease||Phase|
|Disease Due to BK Polyomavirus Transplantation Infection Disorder Related to Transplantation||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients|
|Study Start Date :||October 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||November 2009|
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.
- BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR) [ Time Frame: One year ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610961
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Herwig-Ulf Meier-Kriesche, MD||University of Florida|