FindTrial
Sign In

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409461
Enrollment
Unknown
Registered
2006-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2006-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Islet Transplantation, Type 1 Diabetes

Brief 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

Interventions

DRUGATG-Sirolimus-Tacrolimus

Sponsors

Fund for Scientific Research, Flanders, Belgium
CollaboratorOTHER
Belgian Government
CollaboratorOTHER_GOV
AZ-VUB
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE

Eligibility

Age
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

* 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026