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MGA031, Sirolimus and Tacrolimus in Islet Transplantation

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00265473
First received: December 12, 2005
Last updated: August 16, 2011
Last verified: August 2011
Results First Received: April 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Type 1 Diabetes Mellitus
Hypoglycemia
Interventions: Biological: Islets of Langerhans
Drug: MGA031
Drug: Sirolimus
Drug: Tacrolimus

  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
Experimental Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.

Participant Flow:   Overall Study
    Experimental  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     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
Experimental Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.

Baseline Measures
    Experimental  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.4  ± 9.5  
Gender  
[units: participants]
 
Female     3  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   Proportion of Subjects With Full Islet Function.   [ Time Frame: At one year after initial transplant. ]

2.  Primary:   Occurrence of Serious Adverse Events Related to Immunosuppressive Therapy.   [ Time Frame: Day 0 - Day 365 ]

3.  Secondary:   Proportion of Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;   [ Time Frame: At one year after initial transplant ]

4.  Secondary:   Proportion of Insulin Independent Single-donor Subjects. Participant Received a Single Islet Transplant.   [ Time Frame: At 75 days after transplant ]

5.  Secondary:   Proportion of Insulin Independent Multiple-donor Subjects. Participant Received More Than One Islet Transplant.   [ Time Frame: At one year after final transplant ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Melena D. Bellin, MD
Organization: Schulze Diabetes Institute, University of Minnesota
phone: 612-625-4686
e-mail: bell0130@umn.edu


No publications provided


Responsible Party: Bernhard J. Hering, M.D., University of Minnesota
ClinicalTrials.gov Identifier: NCT00265473     History of Changes
Other Study ID Numbers: 0407M62505
Study First Received: December 12, 2005
Results First Received: April 1, 2011
Last Updated: August 16, 2011
Health Authority: United States: Food and Drug Administration