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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842699
First Posted: February 12, 2009
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Brigham and Women's Hospital
February 10, 2009
February 12, 2009
June 29, 2011
September 2008
September 2010   (Final data collection date for primary outcome measure)
The primary outcome is to look for expansion of regulatory T cells at one year. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00842699 on ClinicalTrials.gov Archive Site
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Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
renal transplant recipients and living donors if available
Renal Transplantation
Not Provided
  • 1
    patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
  • 2
    patients receiving Thymoglobulin as induction treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2011
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients considered for transplantation

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00842699
2008p000774
Genzyme
No
Not Provided
Not Provided
Nader Najafian, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Principal Investigator: Nader Najafian, MD Brigham and Women's Hospital
Brigham and Women's Hospital
June 2011