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OpenTrials
Completed

NCT Number: NCT00610961

Induction Related BK Viremia in Renal Transplant Patients

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.

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Key information

Conditions

Disease Due to BK Polyomavirus Disorder Related to Transplantation Transplantation Infection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)

    Time frame: One year

    BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.

Secondary outcomes

  1. Incidence of Acute Rejection of Transplanted Kidney

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Acronym: BK

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2008
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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