Kidney Transplantation Clinical Trial
Official title:
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
Experience with tacrolimus in pancreas transplantation has become a standard for
immunosuppression in almost all pancreas centers over the world. Several centers have shown
very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving
antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin
inhibitor and mycophenolate mofetil with or without corticosteroids.
The use of sirolimus in SPK transplant patients has for the moment only been studied, with
good results, in association with tacrolimus or cyclospsorine (CsA). In renal
transplantation, there is also evidence that sirolimus (Rapamune) is a potent
immunosuppressant that significantly reduces the incidence of acute rejection when given
with CsA, effective as base therapy in the post-induction period. Because of Rapamune's
effectiveness and different safety profile, it might be advantageous in terms of reduced
nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of
acute rejection.
To explore this further, the following study is designed to assess the use of SRL versus
TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de
novo simultaneous pancreas-kidney transplant recipients.
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 In both regimens corticosteroids (CS) will be withdrawn three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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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