Back to resultsIslet After Kidney Transplant for Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
etanercept
etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation
Eligibility Criteria
Inclusion Criteria:
- Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.
Exclusion Criteria:
- Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
- Active infections (clinically or by laboratory testing)
- History of current malignancy or suspicion of malignancy until properly investigated and excluded
- Liver or biliary abnormalities
- Unstable cardiovascular disease
- Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception
Sites / Locations
- Virginia Commonwealth University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Two weeks etanercept post islet transplant
Two months etanercept treatment post islet transplant
Outcomes
Primary Outcome Measures
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
Secondary Outcome Measures
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.
Full Information
NCT ID
NCT00784966
First Posted
November 4, 2008
Last Updated
September 12, 2014
Sponsor
Virginia Commonwealth University
Collaborators
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT00784966
Brief Title
Islet After Kidney Transplant for Type 1 Diabetes
Official Title
Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
University decision.
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Two weeks etanercept post islet transplant
Arm Title
2
Arm Type
Active Comparator
Arm Description
Two months etanercept treatment post islet transplant
Intervention Type
Drug
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.
Intervention Type
Drug
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Etanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months.
Primary Outcome Measure Information:
Title
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
Time Frame
Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.
Secondary Outcome Measure Information:
Title
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.
Time Frame
Outcome measures will be assessed at protocol prescribed intervals.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.
Exclusion Criteria:
Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
Active infections (clinically or by laboratory testing)
History of current malignancy or suspicion of malignancy until properly investigated and excluded
Liver or biliary abnormalities
Unstable cardiovascular disease
Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian H Cotterell, M.D.
Organizational Affiliation
Virginia Commonwealth University Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John N Clore, M.D.
Organizational Affiliation
Virginia Commonwealth University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Islet After Kidney Transplant for Type 1 Diabetes
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