Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2012

Conditions
Type 1 Diabetes
Interventions
DRUG

CNI free immunosuppression

Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).

Trial Locations (2)

1211

Universitè de Geneve, Geneva

20132

IRCCS San Raffaele Scientific Institute, Milan

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Ospedale San Raffaele

OTHER