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Islet After Kidney Transplant for Type 1 Diabetes

This study has been withdrawn prior to enrollment.
(University decision.)
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00784966
First received: November 4, 2008
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: etanercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Two weeks etanercept post islet transplant
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
Active Comparator: 2
Two months etanercept treatment post islet transplant
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784966

Locations
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
University of Miami
Investigators
Principal Investigator: Adrian H Cotterell, M.D. Virginia Commonwealth University Health System
Principal Investigator: John N Clore, M.D. Virginia Commonwealth University Health System
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00784966     History of Changes
Other Study ID Numbers: VCU IRB 4196
Study First Received: November 4, 2008
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
Islet transplantation
Type 1 Diabetes Mellitus
Kidney Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Immunoglobulin G
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014