Induction Related BK Viremia in Renal Transplant Patients - Full Text View

Induction Related BK Viremia in Renal Transplant Patients

This study is currently recruiting participants.
Verified by University of Florida, February 2008

Sponsors and Collaborators:	University of Florida Novartis
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00610961

Purpose

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

Polyoma Virus
Organ Transplants

MedlinePlus related topics:

Kidney Transplantation Pancreas Transplantation

ChemIDplus related topics:

Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	The Induction Agent Effect on BK Viremia in Renal and Pancrease Transplant Patients

Further study details as provided by University of Florida:

Primary Outcome Measures:

Overall Incidence of Positive BK virus PCR [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of Positive BK viremia over time [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Groups/Cohorts

Study

Single observation group consisting of current standard of care treatment

Detailed Description:

Our standard of care has been changed to Simulect and we are now enrolling patients in this observational trial to gather data on their outcomes related to BK viremia and rejection rates.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

de novo renal or renal/pancrease transplant patients

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610961

Contacts


Contact: Aaron E Eagan, RN	352-846-2571	aaron.eagan@medicine.ufl.edu

Locations


United States, Florida
	University of Florida	Recruiting
	Gainesville, Florida, United States, 32610
	Sub-Investigator: Aaron E Eagan, RN

Sponsors and Collaborators

University of Florida

Novartis

Investigators


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

More Information

Responsible Party:	University of Florida ( Aaron Eagan, Director of Clinical Transplant Nephrology Research Program )
Study ID Numbers:	20071016
First Received:	January 24, 2008
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00610961
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

BK virus

Renal transplant

Pancrease transplant

Study placed in the following topic categories:

Virus Diseases

Viremia

Pancrelipase

ClinicalTrials.gov processed this record on October 15, 2008