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A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus versus Cyclosporine when Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000973-69

A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus versus Cyclosporine when Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

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Extrait

Efficacy: to demonstrate superiority of the sirolimus regimen versus Cyclosporine by intent-to-treat (ITT) analysis of renal function at 52 weeks, measured by mean calculated glomerular filtration rate (GFR). Safety: to demonstrate non-inferiority at 52 weeks in the composite endpoint of the incidence of the first occurrence of graft loss or death.

Critère d'inclusion

  • The rationale for the present study is to assess whether a CNI-free regimen including antibody induction, sirolimus, and mycophenolate mofetil (MMF) results in improved long-term renal function without having a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of sirolimus to reduce the severity and/or progression of Chronic allograft nephropathy (CAN), which could represent a major advance in the field of transplantation

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