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

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

This study has been terminated.

Sponsors and Collaborators:	AZ-VUB Fund for Scientific Research, Flanders, Belgium Belgian Government
Information provided by:	AZ-VUB
ClinicalTrials.gov Identifier:	NCT00409461

Purpose

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

Condition	Intervention
Islet Transplantation Type 1 Diabetes	Drug: ATG-Sirolimus-Tacrolimus

MedlinePlus related topics:

Diabetes Diabetes Type 1 Islet Cell Transplantation

Drug Information available for:

Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Factorial Assignment

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

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409461

Locations


Belgium
	Academisch Ziekenhuis and Diabetes Research Center – Brussels Free University-VUB
	Brussels, Belgium, 1090
	Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven –KUL
	Leuven, Belgium, 3000

Sponsors and Collaborators

AZ-VUB

Fund for Scientific Research, Flanders, Belgium

Belgian Government

Investigators


Principal Investigator:	Bart Keymeulen, MD, PhD	AZ-VUB

More Information

Publications indexed to this study:

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.

Study ID Numbers:	4-2001-434, G.0375.00, G.0084.02, GOA/2004/10
First Received:	December 8, 2006
Last Updated:	December 8, 2006
ClinicalTrials.gov Identifier:	NCT00409461
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Sirolimus

Metabolic Diseases

Autoimmune Diseases

Clotrimazole

Miconazole

Diabetes Mellitus

Tioconazole

Endocrine System Diseases

Tacrolimus

Diabetes Mellitus, Type 1

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Additional relevant MeSH terms:

Anti-Bacterial Agents

Anti-Infective Agents

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Antifungal Agents

Therapeutic Uses

Physiological Effects of Drugs

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008