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NCT00842699 Clinical Trial

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

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00842699
Other study ID # 2008p000774
Secondary ID Genzyme
Status Completed
Phase N/A
First received February 10, 2009
Last updated June 27, 2011
Start date September 2008
Est. completion date March 2011

Study information
Verified date June 2011
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all patients considered for transplantation

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Brigham and Women's Hospital Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome is to look for expansion of regulatory T cells at one year. 12 months No
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