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

AZ-VUB

Status: Terminated

Conditions: Islet Transplantation; Type 1 Diabetes

Treatments: Drug: ATG-Sirolimus-Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00409461

G.0084.02

4-2001-434

GOA/2004/10

G.0375.00

Details and patient eligibility

About

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

Sex

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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