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

Tracking Information

First Received Date ^ICMJE

December 8, 2006

Last Updated Date

December 8, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Islet Transplantation
Type 1 Diabetes

Intervention ^ICMJE

Drug: ATG-Sirolimus-Tacrolimus

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Not Provided

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00409461

Other Study ID Numbers ^ICMJE

4-2001-434, G.0375.00, G.0084.02, GOA/2004/10

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AZ-VUB

Collaborators ^ICMJE

Fund for Scientific Research, Flanders, Belgium
Belgian Government

Investigators ^ICMJE

Principal Investigator:

Bart Keymeulen, MD, PhD

AZ-VUB

Information Provided By

AZ-VUB

Verification Date

December 2006

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

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