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Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes (RAPTIVA)

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00672204
First received: May 2, 2008
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
Results First Received: February 20, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Type 1 Diabetes Mellitus
Hypoglycemia
Interventions: Biological: Allogeneic islets of Langerhans transplant
Drug: Raptiva
Drug: Sirolimus
Drug: anti-thymocyte globulin

  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
Recruited from 2008 - 2009 at the University of Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Raptiva was removed from market.

Reporting Groups
  Description
Allogeneic Islets of Langerhans

Allogeneic islets of Langerhans

anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV

Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;

Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated

Participant Flow:   Overall Study
    Allogeneic Islets of Langerhans  
STARTED     23  
COMPLETED     3  
NOT COMPLETED     20  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Allogeneic Islets of Langerhans

Allogeneic islets of Langerhans

anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV

Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;

Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated

Baseline Measures
    Allogeneic Islets of Langerhans  
Number of Participants  
[units: participants]
 		  23  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  43.1  ± 9.4  
Gender  
[units: participants]
 		 
Female     15  
Male     8  
Region of Enrollment  
[units: participants]
 		 
United States     23  



  Outcome Measures

1.  Primary:   The Proportion of Insulin-independent Subjects With Full Islet Graft Function   [ Time Frame: 1 year following the first islet transplant ]
  Show Outcome Measure 1

2.  Secondary:   Insulin Independence and Islet Graft Function by Monitoring Insulin Requirements, HbA1c, Mixed-meal Tolerance Test, β-score, Frequently-sampled IV Glucose Tolerance, Glucose Variability and Hypoglycemia Duration   [ Time Frame: 75 days and 1 year following first and subsequent islet transplants ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   The Proportion of Subjects With an HbA1c <7.0% AND Free of Severe Hypoglycemic Events From Day 28 to Day 365 Inclusive.   [ Time Frame: 1 year post first islet transplant ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Proportion of Subjects With an HbA1c <7.0% AND Free of Severe Hypoglycemic Events From Day 28 to Day 1095 Inclusive.   [ Time Frame: 3 years post final islet transplant ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Proportion of Subjects Who Have Experienced Serious Adverse Events Likely or Definitely Related to the Islet Transplant Protocol   [ Time Frame: At 365 days following the 1st islet transplant ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Early termination due to Raptiva being withdrawn from market  


Results Point of Contact:  
Name/Title: Bernhard J. Hering, M.D.
Organization: University of Minnesota
phone: 612-626-5735
e-mail: bhering@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00672204     History of Changes
Other Study ID Numbers: 0612M98726
Study First Received: May 2, 2008
Results First Received: February 20, 2013
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration