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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:
Collaborator:
Genzyme
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
History of Changes
  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:

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

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842699

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Genzyme
Investigators
Principal Investigator: Nader Najafian, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Nader Najafian, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00842699     History of Changes
Other Study ID Numbers: 2008p000774, Genzyme
Study First Received: February 10, 2009
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013