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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00610961
Other study ID # 20071016
Secondary ID
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


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
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