Induction Related BK Viremia in Renal Transplant Patients

Completed

• Conditions: Disease Due to BK Polyomavirus; Transplantation Infection; Disorder Related to Transplantation

• Registration Number: NCT00610961
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2009-04
• Study Completion: 2009-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)	One year	BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.

Secondary Outcome Measures

Name	Time	Method
Incidence of Acute Rejection of Transplanted Kidney	One year

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States