Islet After Kidney Transplant for Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00784966
• Other study ID #: VCU IRB 4196
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 4, 2008
• Last updated: September 12, 2014
• Start date: August 2011
• Est. completion date: September 2017

Study information

• Verified date: September 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• etanercept
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.
• etanercept
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Health System	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No