Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)

This study has been completed.
Sponsor:
Collaborators:
Sanofi
University of Arizona
Wake Forest University
University of Nebraska
The Methodist Hospital System
Information provided by (Responsible Party):
R. Brian Stevens, MD, PhD, FACS, FAST, Wright State University
ClinicalTrials.gov Identifier:
NCT00906204
First received: May 19, 2009
Last updated: November 2, 2015
Last verified: November 2015
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: End-Stage Renal Disease
Kidney Failure
Interventions: Biological: Single-dose rabbit Anti-thymocyte Globulin induction
Biological: Divided-dose rabbit Anti-thymocyte Globulin induction

  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
Trial enrollment occurred between 3/30/2010 and 3/25/2014. Patients scheduled to undergo kidney transplantation were evaluated for trial suitability/enrollment in the transplant hospital or clinic just before transplantation, typically from a few hours to ~24 hours before transplantation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Occasionally patients were evaluated and thought to be suitable trial candidates until transplantation was imminent, when they were ruled out by last-minute observation of medical problems or donor shortcomings.

Reporting Groups
  Description
Single-dose Thymoglobulin

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Divided-dose Thymoglobulin

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.


Participant Flow for 2 periods

Period 1:   Primary Endpoint (Early Safety)
    Single-dose Thymoglobulin     Divided-dose Thymoglobulin  
STARTED     45     52  
COMPLETED     43     51  
NOT COMPLETED     2     1  
Physician Decision                 1                 0  
Untransplantable donor kidney                 0                 1  
Withdrawal by Subject                 1                 0  

Period 2:   Secondary Endpoints (Long-term Safety)
    Single-dose Thymoglobulin     Divided-dose Thymoglobulin  
STARTED     43     51  
COMPLETED     41     48  
NOT COMPLETED     2     3  
Adverse Event                 2                 2  
Death                 0                 1  



  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.
Patients who received a kidney transplant along with the study intervention, either single-dose or divided-dose rabbit anti-thymocyte globulin.

Reporting Groups
  Description
Single-dose Thymoglobulin

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Divided-dose Thymoglobulin

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Total Total of all reporting groups

Baseline Measures
    Single-dose Thymoglobulin     Divided-dose Thymoglobulin     Total  
Number of Participants  
[units: participants]
  44     51     95  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     48     90  
>=65 years     2     3     5  
Age  
[units: years]
Mean (Standard Deviation)
  48.0  (11.8)     49.0  (12.4)     48.5  (12.1)  
Gender  
[units: participants]
     
Female     15     13     28  
Male     29     38     67  
Region of Enrollment  
[units: participants]
     
United States     44     51     95  
Type of kidney donor  
[units: participants]
     
Living donor     26     29     55  
Deceased donor     18     22     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function   [ Time Frame: During first 7 days after kidney transplantation ]

2.  Secondary:   Patient Survival   [ Time Frame: 12 months post-transplantation ]

3.  Secondary:   Graft Survival   [ Time Frame: 12 months post-transplantation ]

4.  Secondary:   Acute Kidney Rejection   [ Time Frame: 12 months post-transplantation ]

5.  Secondary:   Incomplete Thymoglobulin Infusion   [ Time Frame: First 7 days post-transplantation ]

6.  Secondary:   Kidney Function   [ Time Frame: 12 months post-transplantation ]


  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
After an interim analysis at the trial mid-point, the trial was terminated because a futility trend analysis showed a >1.72% chance of the primary endpoint rates between the two groups achieving a significant difference with further enrollment.


  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. R. Brian Stevens, MD, PhD, FACS
Organization: Wright State University Boonshoft School of Medicine, Dayton, Ohio, USA
phone: 937-545-4817
e-mail: rbstevens1@icloud.com


Publications:

Responsible Party: R. Brian Stevens, MD, PhD, FACS, FAST, Wright State University
ClinicalTrials.gov Identifier: NCT00906204     History of Changes
Other Study ID Numbers: 183-09-FB
Study First Received: May 19, 2009
Results First Received: September 11, 2015
Last Updated: November 2, 2015
Health Authority: United States: Institutional Review Board