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Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

This study has been terminated.
Fund for Scientific Research, Flanders, Belgium
Belgian Government
Information provided by:
AZ-VUB Identifier:
First received: December 8, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients

Condition Intervention
Islet Transplantation
Type 1 Diabetes
Drug: ATG-Sirolimus-Tacrolimus

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Resource links provided by NLM:

Further study details as provided by AZ-VUB:


Ages Eligible for Study:   18 Years to 65 Years   (Adult)

Inclusion Criteria:

  • Type 1 insulin-dependent diabetic patients
  • C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
  • diabetic nephropathy
  • hypoglycaemic unawareness

Exclusion Criteria:

  • smoker before transplantation
  • plasma creatinine > 2 mg/dl
  • albuminuria >1000 mg/24 hrs
  • abnormal liver function
  • history of thrombosis or pulmonary embolism
  • history of malignancy, tuberculosis or chronic viral hepatitis
  • history of any other serious illness which could be relevant for the protocol
  • HLA antibodies
  • EBV antibody negative
  • HIV 1 & 2 antibody positive
  Contacts and Locations
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Please refer to this study by its identifier: NCT00409461

Academisch Ziekenhuis and Diabetes Research Center – Brussels Free University-VUB
Brussels, Belgium, 1090
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven –KUL
Leuven, Belgium, 3000
Sponsors and Collaborators
Fund for Scientific Research, Flanders, Belgium
Belgian Government
Principal Investigator: Bart Keymeulen, MD, PhD AZ-VUB
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00409461     History of Changes
Other Study ID Numbers: 4-2001-434
Study First Received: December 8, 2006
Last Updated: December 8, 2006

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents processed this record on May 25, 2017