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:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00842699
First received: February 10, 2009
Last updated: June 27, 2011
Last verified: June 2011

February 10, 2009
June 27, 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 ] [ Designated as safety issue: No ]
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
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  • 1
    patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
  • 2
    patients receiving Thymoglobulin as induction treatment
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*   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:

  • none
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842699
2008p000774, Genzyme
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP