Induction Related BK Viremia in Renal Transplant Patients

Transplantation Infection Clinical Trial

— BK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610961
• Other study ID #: 20071016
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: September 26, 2011
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Disease Due to BK Polyomavirus
• Disorder Related to Transplantation
• Transplantation Infection

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of Acute Rejection of Transplanted Kidney		One year	No