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MGA031, Sirolimus and Tacrolimus in Islet Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00265473
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : September 21, 2011
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 1 Diabetes Mellitus
Hypoglycemia
Intervention Biological: Allogeneic Islets of Langerhans
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental
Hide Arm/Group Description Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Experimental
Hide Arm/Group Description Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
43.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Subjects With Full Islet Function.
Hide Description Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.
Time Frame At one year after initial transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was based on the participants that were actually transplanted.
Arm/Group Title Experimental
Hide Arm/Group Description:
Islet infusion
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
3
2.Primary Outcome
Title Serious Adverse Events Related to Immunosuppressive Therapy.
Hide Description Number of serious adverse events related to immunosuppressive therapy.
Time Frame Day 0 - Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:
Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Serious Adverse Events
0
3.Secondary Outcome
Title Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;
Hide Description Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.
Time Frame At one year after initial transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:
Islet infusion
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Insulin Independent Single-donor Subjects.
Hide Description Proportion of insulin independent single-donor subjects at day 75 after transplant
Time Frame At 75 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:
Islet infusion
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
1
5.Secondary Outcome
Title Insulin Independent Multiple-donor Subjects.
Hide Description Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.
Time Frame At one year after final transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:
Islet infusion
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental
Hide Arm/Group Description Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
All-Cause Mortality
Experimental
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Experimental
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melena D. Bellin, MD
Organization: Schulze Diabetes Institute, University of Minnesota
Phone: 612-625-4686
EMail: bell0130@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00265473    
Other Study ID Numbers: 0407M62505
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: April 1, 2011
Results First Posted: September 21, 2011
Last Update Posted: March 9, 2017