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Islet After Kidney Transplant for Type 1 Diabetes

NCT00784966 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2014-09-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Adrian H Cotterell, M.D. · Virginia Commonwealth University Health System

  • John N Clore, M.D. · Virginia Commonwealth University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784966 on ClinicalTrials.gov