Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Induction Related BK Viremia in Renal Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00610961
First received: January 24, 2008
Last updated: September 26, 2011
Last verified: September 2011

January 24, 2008
September 26, 2011
October 2007
April 2009   (final data collection date for primary outcome measure)
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.
Overall Incidence of Positive BK virus PCR [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00610961 on ClinicalTrials.gov Archive Site
Incidence of Acute Rejection of Transplanted Kidney [ Time Frame: One year ] [ Designated as safety issue: No ]
Incidence of Positive BK viremia over time [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Induction Related BK Viremia in Renal Transplant Patients
The Induction Agent Effect on BK Viremia in Renal and Pancreas 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.

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.

Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample

de novo renal or renal/pancrease transplant patients

  • Disease Due to BK Polyomavirus
  • Transplantation Infection
  • Disorder Related to Transplantation
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610961
20071016
No
University of Florida
University of Florida
Novartis Pharmaceuticals
Principal Investigator: Herwig-Ulf Meier-Kriesche, MD University of Florida
University of Florida
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP