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Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

NCT00888628 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-11-29

Study results available
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Summary

The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.

The primary objectives of the study are:

\- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works

The Secondary objective of the study is:

* To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes

Conditions

  • Diabetes Mellitus, Type I

Interventions

BIOLOGICAL

Purified Pancreatic Islets

Islet after kidney transplant in patients with type I diabetes.

DRUG

Etanercept

Given as induction for islet cell transplant

Sponsors & Collaborators

  • Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • James F Markmann, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2014-08-31
Completion
2016-08-31

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 NCT00888628 on ClinicalTrials.gov