Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

February 19, 2008 updated by: AZ-VUB
To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
      • Leuven, Belgium, 3000
        • Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 1 insulin-dependent diabetic patients in relatively good general condition
  • non-smoker
  • body weight < 80 kg
  • C-peptide < 0.03 nmol/l (<0.09 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
  • EBV antibody positive
  • cooperative and reliable patient giving informed consent by signature; the patient should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of intervention and of immunosuppressive therapy; the patient should also be informed that withdrawal of immunosuppressive therapy in patients with persistent plasma C-peptide positivity may result in subsequent loss of ß-cell graft function; the ß cell implant should be identified as a clinical trial

Exclusion Criteria:

  • history of thrombosis or pulmonary embolism
  • abnormal liver function
  • HLA antibodies

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinically relevant beta cell function.
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

AZ-VUB

Collaborators

Universitaire Ziekenhuizen KU Leuven
Vrije Universiteit Brussel
Universiteit Antwerpen
Erasme University Hospital

Investigators

  • Principal Investigator: Bart Keymeulen, MD, PhD, Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2000

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK-Tx-04

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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