Woman and Man
- | Country : -
- | organs : -
- | Specialty : -
Extract
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.
Inclusion criteria
- 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