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

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ClinicalTrials.gov Identifier: NCT00842699
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : June 29, 2011
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Brigham and Women's Hospital

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
Renal Transplantation

Study Type : Observational
Estimated 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 : September 2008
Primary Completion Date : September 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

Group/Cohort
1
patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
2
patients receiving Thymoglobulin as induction treatment



Primary Outcome Measures :
  1. The primary outcome is to look for expansion of regulatory T cells at one year. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
renal transplant recipients and living donors if available
Criteria

Inclusion Criteria:

  • all patients considered for transplantation

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842699


Locations
United States, Massachusetts
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

Responsible Party: Nader Najafian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00842699     History of Changes
Other Study ID Numbers: 2008p000774
Genzyme
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Thymoglobulin
Basiliximab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents