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Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00842699
Collaborator
Genzyme, a Sanofi Company (Industry)
40
Enrollment
1
Location
29.9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to find out the effects of two different drugs used at the beginning of organ transplantation on different populations of immune cells in the body of patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
    Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2010
    Actual Study Completion Date :
    Mar 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
    2

    patients receiving Thymoglobulin as induction treatment

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome is to look for expansion of regulatory T cells at one year. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients considered for transplantation
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • Genzyme, a Sanofi Company

    Investigators

    • Principal Investigator: Nader Najafian, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00842699
    Other Study ID Numbers:
    • 2008p000774
    • Genzyme
    First Posted:
    Feb 12, 2009
    Last Update Posted:
    Jun 29, 2011
    Last Verified:
    Jun 1, 2011

    Study Results

    No Results Posted as of Jun 29, 2011