An Open-Label, Comparative, Randomized, Prospective Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids
The main objective is to compare renal and pancreas graft survivals at 12 months after
simultaneous pancreas-kidney transplantation in patients receiving either a regimen
combining sirolimus (SRL) plus mycophenolate mofetil (MMF) following an antibody induction
(rATG) or a regimen combining tacrolimus (TAC) plus mycophenolate mofetil following an
antibody induction (rATG). In both regimens corticosteroids (CS) will be withdrawn three
months after transplantation.
In addition, the two treatment groups will be compared for acute rejection, renal and
pancreas functions and patient survival after transplantation at 12 months and for a total
period of 5 years of follow-up.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Kidney graft and pancreas graft survivals at month 12.
Diego CANTAROVICH, Doctor
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)