NCT00610961

Induction Related BK Viremia in Renal Transplant Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-04-01
• Completion: 2009-11-01
• First posted: 2008-02-08
• Last updated: 2011-09-27

Locations

1 site across 1 country: United States