NCT00610961|Completed
Induction Related BK Viremia in Renal Transplant Patients
BK
The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
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BK
The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
Sponsor study identifier
observational
60
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
November 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 24, 2008
Actual (reported)February 8, 2008
Actual (reported)April 2009
Actual (reported)November 2009
Actual (reported)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
Incidence of Acute Rejection of Transplanted Kidney
One year
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.
de novo renal or renal/pancrease transplant patients
University of Florida
Gainesville, Florida, 32610, United States
Herwig-Ulf Meier-Kriesche, MD
University of Florida
60 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2008
First Posted
February 8, 2008
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
September 27, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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