Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2006

Conditions
Type 1 Diabetes MellitusHypoglycemia
Interventions
BIOLOGICAL

Allogeneic Islets of Langerhans

Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight.

DRUG

Everolimus

Loading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter.

DRUG

anti-thymocyte globulin

A total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2.

DRUG

Cyclosporine

Cyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter.

Trial Locations (1)

55455

University of Minnesota, Minneapolis

All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Novartis

INDUSTRY

lead

University of Minnesota

OTHER