Status:
WITHDRAWN
Islet After Kidney Transplant for Type 1 Diabetes
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
University of Miami
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00784966
Start Date
August 1 2011
End Date
September 1 2017
Last Update
September 16 2014
Active Locations (1)
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1
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298