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Induction Related BK Viremia in Renal Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00610961
First received: January 24, 2008
Last updated: September 26, 2011
Last verified: September 2011
  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 Phase
Disease Due to BK Polyomavirus
Transplantation Infection
Disorder Related to Transplantation
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.


Secondary Outcome Measures:
  • Incidence of Acute Rejection of Transplanted Kidney [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Novartis Pharmaceuticals
Investigators
Principal Investigator: Herwig-Ulf Meier-Kriesche, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00610961     History of Changes
Other Study ID Numbers: 20071016
Study First Received: January 24, 2008
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
BK Polyomavirus
Transplantation, Kidney
Transplantation, Pancreas

ClinicalTrials.gov processed this record on November 25, 2014