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

This study has been terminated.
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Belgian Government
Information provided by:
AZ-VUB
ClinicalTrials.gov Identifier:
NCT00409461
First received: December 8, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 8, 2006
December 8, 2006
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No Changes Posted
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Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients

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Interventional
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Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
  • Islet Transplantation
  • Type 1 Diabetes
Drug: ATG-Sirolimus-Tacrolimus
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Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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
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18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00409461
4-2001-434, G.0375.00, G.0084.02, GOA/2004/10
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AZ-VUB
  • Fund for Scientific Research, Flanders, Belgium
  • Belgian Government
Principal Investigator: Bart Keymeulen, MD, PhD AZ-VUB
AZ-VUB
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP