Islet After Kidney Transplant for Type 1 Diabetes - Full Text View

Sponsors and Collaborators:	Virginia Commonwealth University University of Miami
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00784966

Purpose

The purpose of this study is to determine if prolonged administration of the anti TNF-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 I Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Islet Cell Transplantation Kidney Transplantation

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus

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:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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.
Specific criteria are listed in the table below.

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	804 628-1192	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
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

Responsible Party:	Virginia Commonwealth University Health System ( Adrian H. Cotterell, M.D., F.A.C.S. )
Study ID Numbers:	VCU IRB 4196
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00784966
Health Authority:	United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:

Islet transplantation
Type 1 Diabetes Mellitus
Kidney Transplantation

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
TNFR-Fc fusion protein
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009