Islet After Kidney Transplant for Type 1 Diabetes

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: etanercept

Study type: Interventional

Funder types: Other

Identifiers

NCT00784966

VCU IRB 4196

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Active Comparator group

Description:

Two weeks etanercept post islet transplant

Treatment:

Drug: etanercept

Drug: etanercept

2

Active Comparator group

Description:

Two months etanercept treatment post islet transplant

Treatment:

Drug: etanercept

Drug: etanercept