Islet After Kidney Transplant for Type 1 Diabetes

September 12, 2014 updated by: Virginia Commonwealth University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Enbrel
Active Comparator: 2
Two months etanercept treatment 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 Names:
  • 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 Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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.
Outcome measures will be assessed at protocol prescribed intervals.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCU IRB 4196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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