Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
NCT ID: NCT00409461
Last Updated: 2006-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATG-Sirolimus-Tacrolimus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fund for Scientific Research, Flanders, Belgium
OTHER
Belgian Government
OTHER_GOV
AZ-VUB
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bart Keymeulen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AZ-VUB
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, , Belgium
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked 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. doi: 10.1097/TP.0b013e31815e8926.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G.0375.00
Identifier Type: -
Identifier Source: secondary_id
G.0084.02
Identifier Type: -
Identifier Source: secondary_id
GOA/2004/10
Identifier Type: -
Identifier Source: secondary_id
4-2001-434
Identifier Type: -
Identifier Source: org_study_id