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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Tacrolimus
Sirolimus
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014