Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00859131
First received: March 6, 2009
Last updated: March 23, 2016
Last verified: February 2014
Results First Received: May 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: End Stage Renal Disease
Interventions: Drug: Rabbit Antithymocyte globulin
Drug: Daclizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Thymoglobulin

Subjects receiving Thymoglobulin as induction agent in renal transplantation

Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4

Zenapax

subject who will receive daclizumab or basiliximab as induction agent in renal transplantation

Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7


Participant Flow:   Overall Study
    Thymoglobulin     Zenapax  
STARTED     102     98  
COMPLETED     102     98  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Thymoglobulin

Subjects receiving Thymoglobulin as induction agent in renal transplantation

Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4

Zenapax

subject who will receive daclizumab or basiliximab as induction agent in renal transplantation

Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Total Total of all reporting groups

Baseline Measures
    Thymoglobulin     Zenapax     Total  
Number of Participants  
[units: participants]
  102     98     200  
Age  
[units: years]
Mean (Standard Deviation)
  52  (13)     49  (14)     50.2  (13.5)  
Gender  
[units: participants]
     
Female     43     36     79  
Male     59     62     121  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.   [ Time Frame: One year ]

2.  Secondary:   Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.   [ Time Frame: One year ]

3.  Secondary:   Graft Survival at One Year Post-transplant   [ Time Frame: One year ]

4.  Secondary:   Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis   [ Time Frame: one year ]

5.  Secondary:   Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.   [ Time Frame: One year ]

6.  Secondary:   Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3   [ Time Frame: One year ]

7.  Secondary:   Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenneth Chavin, MD, PhD
Organization: Medical University of South Carolina
phone: 843-792-3368
e-mail: chavinkd@musc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00859131     History of Changes
Other Study ID Numbers: thymo vs IL2
Study First Received: March 6, 2009
Results First Received: May 14, 2015
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board