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Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

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ClinicalTrials.gov Identifier: NCT00859131
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition End Stage Renal Disease
Interventions Drug: Rabbit Antithymocyte globulin
Drug: Daclizumab
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Thymoglobulin Zenapax
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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

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

Period Title: Overall Study
Started 102 98
Completed 102 98
Not Completed 0 0
Arm/Group Title Thymoglobulin Zenapax Total
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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

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 of all reporting groups
Overall Number of Baseline Participants 102 98 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 98 participants 200 participants
52  (13) 49  (14) 50.2  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 98 participants 200 participants
Female
43
  42.2%
36
  36.7%
79
  39.5%
Male
59
  57.8%
62
  63.3%
121
  60.5%
1.Primary Outcome
Title Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
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[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
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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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
6 10
2.Secondary Outcome
Title Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: Patients
3 8
3.Secondary Outcome
Title Graft Survival at One Year Post-transplant
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
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[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
101 95
4.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
52 58
5.Secondary Outcome
Title Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
3 0
6.Secondary Outcome
Title Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
21 4
7.Secondary Outcome
Title Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 102 98
Measure Type: Number
Unit of Measure: participants
43 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thymoglobulin Zenapax
Hide Arm/Group Description

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

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

All-Cause Mortality
Thymoglobulin Zenapax
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thymoglobulin Zenapax
Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   0/98 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thymoglobulin Zenapax
Affected / at Risk (%) Affected / at Risk (%)
Total   37/102 (36.27%)   44/98 (44.90%) 
Blood and lymphatic system disorders     
BK Viremia  13/102 (12.75%)  19/98 (19.39%) 
Immune system disorders     
CMV  29/102 (28.43%)  18/98 (18.37%) 
Infections and infestations     
Bacterial Infection  10/102 (9.80%)  21/98 (21.43%) 
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
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00859131     History of Changes
Other Study ID Numbers: thymo vs IL2
First Submitted: March 6, 2009
First Posted: March 10, 2009
Results First Submitted: May 14, 2015
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016