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

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ClinicalTrials.gov Identifier: NCT00672204
Recruitment Status : Terminated (Raptiva was withdrawn from the market)
First Posted : May 6, 2008
Results First Posted : March 27, 2013
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 23
Recruitment Details Recruited from 2008 - 2009 at the University of Minnesota.
Pre-assignment Details Raptiva was removed from market.
Arm/Group Title Allogeneic Islets of Langerhans
Hide Arm/Group Description

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

Period Title: Overall Study
Started 23
Completed 3
Not Completed 20
Arm/Group Title Allogeneic Islets of Langerhans
Hide Arm/Group Description

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

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
43.1  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
15
  65.2%
Male
8
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title The Proportion of Insulin-independent Subjects With Full Islet Graft Function
Hide Description

Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:

  • HbA1c < 7.0% or a ≥2.5% decrease from baseline;
  • fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);
  • 2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);
  • fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;
  • evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L).
Time Frame 1 year following the first islet transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Raptiva was removed from market after 3 subjects were transplanted
Arm/Group Title Allogeneic Islets of Langerhans
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allogeneic Islets of Langerhans
Hide Arm/Group Description

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

All-Cause Mortality
Allogeneic Islets of Langerhans
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Allogeneic Islets of Langerhans
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allogeneic Islets of Langerhans
Affected / at Risk (%)
Total   0/3 (0.00%) 
Early termination due to Raptiva being withdrawn from market
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Bernhard J. Hering, M.D.
Organization: University of Minnesota
Phone: 612-626-5735
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00672204     History of Changes
Other Study ID Numbers: 0612M98726
First Submitted: May 2, 2008
First Posted: May 6, 2008
Results First Submitted: February 20, 2013
Results First Posted: March 27, 2013
Last Update Posted: October 25, 2017