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Induction Related BK Viremia in Renal Transplant Patients

NCT ID: NCT00610961

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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

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Disease Due to BK Polyomavirus Transplantation Infection Disorder Related to Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herwig-Ulf Meier-Kriesche, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20071016

Identifier Type: -

Identifier Source: org_study_id