We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409461
First Posted: December 11, 2006
Last Update Posted: December 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Belgian Government
Information provided by:
AZ-VUB
December 8, 2006
December 11, 2006
December 11, 2006
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
  • Islet Transplantation
  • Type 1 Diabetes
Drug: ATG-Sirolimus-Tacrolimus
Not Provided
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. doi: 10.1097/TP.0b013e31815e8926.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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
Not Provided
18 Years to 65 Years   (Adult)
Not Provided
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
Not Provided
Not Provided
Not Provided
Not Provided
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