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

Status:

TERMINATED

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

Lead Sponsor:

AZ-VUB

Collaborating Sponsors:

Fund for Scientific Research, Flanders, Belgium

Belgian Government

Conditions:

Islet Transplantation

Type 1 Diabetes

Eligibility:

18-65 years

Phase:

Brief Summary

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

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00409461

Last Update

December 11 2006

Active Locations (2)

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Page 1 of 1 (2 locations)

Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, Belgium, 1090