Induction Related BK Viremia in Renal Transplant Patients

University of Florida

Status: Completed

Conditions: Disease Due to BK Polyomavirus; Transplantation Infection; Disorder Related to Transplantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00610961

20071016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

60 participants in 2 patient groups

Basiliximab (Simulect) Induction

Description:

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

Description:

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.