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

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.
 
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

Tracking Information
First Submitted Date February 10, 2009
First Posted Date February 12, 2009
Last Update Posted Date June 29, 2011
Study Start Date September 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2009)
The primary outcome is to look for expansion of regulatory T cells at one year. [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
Official Title Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population renal transplant recipients and living donors if available
Condition Renal Transplantation
Intervention Not Provided
Study Groups/Cohorts
  • 1
    patients receiving IL-2 receptor antagonist (Simulect) as induction treatment
  • 2
    patients receiving Thymoglobulin as induction treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 11, 2009)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all patients considered for transplantation

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00842699
Other Study ID Numbers 2008p000774
Genzyme
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nader Najafian, MD, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators Genzyme, a Sanofi Company
Investigators
Principal Investigator: Nader Najafian, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date June 2011