A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
This study evaluated renal graft function based on calculated creatinine clearance at 6
months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose
tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of
biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated
at 6 months post transplantation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
Medical Monitor, MD
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Germany: Ethics Commission