Islet After Kidney Transplant for Type 1 Diabetes

Phase 1

Withdrawn

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: etanercept

• Registration Number: NCT00784966
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2011-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	etanercept	Two weeks etanercept post islet transplant
2	etanercept	Two months etanercept treatment post islet transplant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States