Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

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.

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.

Inclusion criteria

• At least 18 years of age
• End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
• Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

• Planned antibody induction
• Multiple organ transplants
• Patients at high risk of acute rejection