NCT00610961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

1.5 years

First QC Date

January 24, 2008

Last Update Submit

September 26, 2011

Conditions

Disease Due to BK PolyomavirusTransplantation InfectionDisorder Related to Transplantation

Keywords

BK PolyomavirusTransplantation, KidneyTransplantation, Pancreas

Outcome Measures

Primary Outcomes (1)

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

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

    One year

Secondary Outcomes (1)

  • Incidence of Acute Rejection of Transplanted Kidney

    One year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

de novo renal or renal/pancrease transplant patients

You may qualify if:

  • De novo transplant
  • Aged 18-75

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

  • Herwig-Ulf Meier-Kriesche, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 8, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

November 1, 2009

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(1)