Islet After Kidney Transplant for Type 1 Diabetes

• Status: Withdrawn
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: University of Miami
• Treatments: Etanercept

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