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Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00771745
First received: October 10, 2008
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Renal Transplant Rejection
Transplants and Implants
Intervention: Drug: Thymoglobulin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Preloading Induction With Thymoglobulin

Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

Preloading Induction With Thymoglobulin® X 3 Doses

Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF


Participant Flow:   Overall Study
    Preloading Induction With Thymoglobulin   Preloading Induction With Thymoglobulin® X 3 Doses
STARTED   6   5 
COMPLETED   6   5 
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.
No text entered.

Reporting Groups
  Description
Preloading Induction With Thymoglobulin

Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

Preloading Induction With Thymoglobulin® X 3 Doses

Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

Total Total of all reporting groups

Baseline Measures
   Preloading Induction With Thymoglobulin   Preloading Induction With Thymoglobulin® X 3 Doses   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   11 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   5   11 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (17.1)   36.1  (12.5)   43.1  (17.1) 
Gender 
[Units: Participants]
     
Female   1   2   3 
Male   5   3   8 
Region of Enrollment 
[Units: Participants]
     
United States   6   5   11 


  Outcome Measures

1.  Primary:   Composite End Point of Acute Rejection, Graft Loss or Patient Death   [ Time Frame: 6 months ]

2.  Secondary:   Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.   [ Time Frame: Ongoing ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Incidence of Infections   [ Time Frame: Not defined ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection   [ Time Frame: Not defined ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Severity of Biopsy-proven Rejection Using Banff 97 Criteria   [ Time Frame: Not defined ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Serum Creatinine   [ Time Frame: Post-operative days 1-7, 30, 90 and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Malignancy   [ Time Frame: Undefined ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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: Dr. Rita Alloway
Organization: University of Cincinnati
phone: 513-558-1568
e-mail: Rita.Alloway@uc.edu



Responsible Party: E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00771745     History of Changes
Other Study ID Numbers: Pre-Tx Thymo
Study First Received: October 10, 2008
Results First Received: January 18, 2013
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board