TerminatedNCT00409461Updated Dec 11, 2006

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

An interventional study of ATG-Sirolimus-Tacrolimus in Islet Transplantation and Type 1 Diabetes, sponsored by AZ-VUB. Terminated at 2 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-12-11.

Sponsored by AZ-VUB · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Allocation: Non-randomized
Ages: 18 Years to 65 Years

Study summary

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

Conditions studied

Islet Transplantation
Type 1 Diabetes

Browse trials for

Diabetes Mellitus, Type 1 3,522

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

AZ-VUB is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years

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

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 design

Phase: Not applicable
Allocation: Non-randomized
Intervention model: Factorial assignment
Masking: None (open label)

Interventions

DrugATG-Sirolimus-Tacrolimus

Study locations

2 sites

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

References and documents

Publications

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. PubMed 18212631 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 11, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00409461
Lead sponsor: AZ-VUB
Collaborators: Fund for Scientific Research, Flanders, Belgium, Belgian Government
First posted: Dec 11, 2006
Last update: Dec 11, 2006

Study contacts

Bart Keymeulen, MD, PhD

principal investigator · AZ-VUB

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 1→

Other studies from this sponsor

AZ-VUB

Start the discussion