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Efficacy of Islet After Kidney Transplantation

NCT00468117 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-20

No results posted yet for this study

Summary

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the benefit of islet transplantation in type 1 diabetic (T1D) kidney transplant recipients.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

PROCEDURE

Islet transplantation

BIOLOGICAL

Antithymocyte Globulin

Participants will begin receiving ATG 2 days prior to the initial islet transplant and will continue to receive ATG until Day 2 post-transplant.

BIOLOGICAL

Daclizumab or Basiliximab

Daclizumab or Basiliximab will be used for subsequent transplants.

BIOLOGICAL

Etanercept

Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

BIOLOGICAL

Allogenic human purified pancreatic islets

200 ml suspension of allogenic human purified islets

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

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
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2015-07-31
Completion
2017-07-05

Countries

  • United States
  • Canada

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 NCT00468117 on ClinicalTrials.gov