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NCT00409461 Clinical Trial

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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00409461
Other study ID # 4-2001-434
Secondary ID G.0375.00G.0084.
Status Terminated
Phase N/A
First received December 8, 2006
Last updated December 8, 2006

Study information
Verified date December 2006
Source AZ-VUB
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• ATG-Sirolimus-Tacrolimus

Locations
Country Name City State
Belgium Academisch Ziekenhuis and Diabetes Research Center – Brussels Free University-VUB Brussels
Belgium Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven –KUL Leuven

Sponsors (3)
Lead Sponsor Collaborator
AZ-VUB Belgian Government, Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

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