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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
  Purpose
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
Renal Transplantation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

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

Estimated Enrollment: 40
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
2
patients receiving Thymoglobulin as induction treatment

  Eligibility

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:

  Contacts and Locations
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
  More Information

Responsible Party: Nader Najafian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00842699     History of Changes
Other Study ID Numbers: 2008p000774
Genzyme
First Submitted: February 10, 2009
First Posted: February 12, 2009
Last Update Posted: June 29, 2011
Last Verified: June 2011

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