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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A

Details

• Lead Sponsor: AZ-VUB
• Collaborators: Belgian Government; Fund for Scientific Research, Flanders, Belgium
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

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