Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

An 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

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after 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, living-unrelated, or living-related mismatched donor
• Patients with a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

• Planned antibody induction
• Multiple organ transplants
• History of malignancy within five years of enrollment