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

Not Applicable

Terminated

• Conditions: Islet Transplantation; Type 1 Diabetes

• Registration Number: NCT00409461
• Lead Sponsor: AZ-VUB

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-12
• Study First Submitted: 2006-12-08
• Study First Submitted QC: 2006-12-08
• Last Update Submitted: 2006-12-08
• Study First Posted: 2006-12-11
• Last Update Posted: 2006-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (2)

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