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Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant

NCT00790439 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-06-12

No results posted yet for this study

Summary

Type 1 diabetes mellitus (T1D) 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 safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on post-transplant islet function in people with T1D who have responded to intensive insulin therapy and have received kidney transplants. This study is taking place in Uppsala and Stockholm, Sweden, and Oslo, Norway.

Conditions

  • Diabetes Mellitus, Type I

Interventions

DRUG

Low Molecular Weight Sulfated Dextran

Inhibitor of instant blood-mediated inflammatory reaction

DRUG

Heparin

Anticoagulant

DRUG

Mycophenolate Mofetil

Cell proliferation inhibitor, Transplantation (immunosuppressive)

DRUG

Sirolimus

Cell proliferation inhibitor, immunologic (immunosuppressive)

DRUG

Tacrolimus

Calcineurin inhibitor

DRUG

Cyclosporine

Calcineurin inhibitor, immunosuppressant

DRUG

Daclizumab

Monoclonal IL-2 receptor blocker

DRUG

Basiliximab

Monoclonal IL-2 receptor blocker

BIOLOGICAL

Allogeneic Pancreatic Islet Cells

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

  • Olle Korsgren, MD · Department of Oncology, Radiology, and Clinical Immunology, Rudbeck Laboratory, Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Drugs

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 NCT00790439 on ClinicalTrials.gov