- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409461
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
December 8, 2006 updated by: AZ-VUB
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1090
- Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
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Leuven, Belgium, 3000
- Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bart Keymeulen, MD, PhD, AZ-VUB
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 8, 2006
First Submitted That Met QC Criteria
December 8, 2006
First Posted (Estimate)
December 11, 2006
Study Record Updates
Last Update Posted (Estimate)
December 11, 2006
Last Update Submitted That Met QC Criteria
December 8, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Calcineurin Inhibitors
- Tacrolimus
- Sirolimus
Other Study ID Numbers
- 4-2001-434
- G.0375.00
- G.0084.02
- GOA/2004/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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