Induction Related BK Viremia in Renal Transplant Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00610961

Acronym

Enrollment

Registered

2008-02-08

Start date

2007-10-31

Completion date

2009-11-30

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

BK Polyomavirus, Transplantation, Kidney, Transplantation, Pancreas

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Incidence of Acute Rejection of Transplanted Kidney	One year

Countries

United States

Outcome results