Induction Related BK Viremia in Renal Transplant Patients

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT00610961

Collaborator

Novartis Pharmaceuticals (Industry)

Enrollment

Location

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disease Due to BK Polyomavirus Transplantation Infection Disorder Related to Transplantation

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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Official Title:

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

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Incidence of Acute Rejection of Transplanted Kidney [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida
Novartis Pharmaceuticals

Investigators

Principal Investigator: Herwig-Ulf Meier-Kriesche, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT00610961

Other Study ID Numbers:

20071016

First Posted:

Feb 8, 2008

Last Update Posted:

Sep 27, 2011

Last Verified:

Sep 1, 2011

Keywords provided by University of Florida

BK Polyomavirus

Transplantation, Kidney

Transplantation, Pancreas

Additional relevant MeSH terms:

Viremia

Study Results

No Results Posted as of Sep 27, 2011