Trial record 20 of 30 for:    Open Studies | islet cell transplantation

Islet After Kidney Transplant for Type 1 Diabetes

This study is currently recruiting participants.
Verified January 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00784966
First received: November 4, 2008
Last updated: January 6, 2014
Last verified: January 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 ]

Estimated Enrollment: 10
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784966

Contacts
Contact: Donna Y Winborne, BSN 804 828-2463 dwinborne@mcvh-vcu.edu
Contact: Adrian H Cotterell, M.D. 804 828-8911 acotterell@mcvh-vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Health System Recruiting
Richmond, Virginia, United States, 23298
Contact: Winborne       dwinborne@mcvh-vcu.edu   
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: January 6, 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014