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

NCT01346085 - Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation | Biotech Hunter | Biotech Hunter