Islet After Kidney Transplant for Type 1 Diabetes

NCT00784966 | Withdrawn Phase 1 DMC

• 1 other identifier: VCU IRB 4196
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Islet transplantation; Type 1 Diabetes Mellitus; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

Two weeks etanercept post islet transplant

Drug: etanercept

2

ACTIVE COMPARATOR

Two months etanercept treatment post islet transplant

Drug: etanercept

Interventions

etanercept DRUG

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.

Also known as: Enbrel

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Miami: collaborator

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Adrian H Cotterell, M.D.

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

• John N Clore, M.D.

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: August 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2017
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (1)