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Islet After Kidney Transplant for Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00784966
Recruitment Status : Withdrawn (University decision.)
First Posted : November 5, 2008
Last Update Posted : September 16, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 4, 2008
November 5, 2008
September 16, 2014
August 2011
September 2015   (Final data collection date for primary outcome measure)
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy. [ Time Frame: 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. ]
Same as current
Complete list of historical versions of study NCT00784966 on ClinicalTrials.gov Archive Site
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control. [ Time Frame: Outcome measures will be assessed at protocol prescribed intervals. ]
Same as current
Not Provided
Not Provided
 
Islet After Kidney Transplant for Type 1 Diabetes
Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • 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.
    Other Name: Enbrel
  • Drug: 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.
    Other Name: Enbrel
  • Active Comparator: 1
    Two weeks etanercept post islet transplant
    Intervention: Drug: etanercept
  • Active Comparator: 2
    Two months etanercept treatment post islet transplant
    Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2017
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00784966
VCU IRB 4196
Yes
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
University of Miami
Principal Investigator: Adrian H Cotterell, M.D. Virginia Commonwealth University Health System
Principal Investigator: John N Clore, M.D. Virginia Commonwealth University Health System
Virginia Commonwealth University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP