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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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AZ-VUB:

  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

No publications provided by AZ-VUB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sirolimus
Everolimus
Tacrolimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013