Islet After Kidney Transplant for Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: etanercept
* Drug: etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Two weeks etanercept post islet transplant | Drug: etanercept<br>* 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.<br>* Other names: Enbrel;|
| Active Comparator: 2<br>Two months etanercept treatment post islet transplant | Drug: etanercept<br>* 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.<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy. |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control. |  | Outcome measures will be assessed at protocol prescribed intervals. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation