A Randomized Open Label Study to compare the Safety and Efficacy of Two Different

INTERVENTION: Trade Name: Rapamune Tablets 1mg Product Name: Rapamune Pharmaceutical Form: Coated tablet INN or Proposed INN: Sirolimus CAS Number: 53123‐88‐9 Other descriptive name: Rapamycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: Rapamune Tablets 2mg Product Name: Rapamune Pharmaceutical Form: Coated tablet INN or Proposed INN: Sirolimus CAS Number: 53123‐88‐9 Other descriptive name: Rapamycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Trade Name: Rapamune Oral Solution 1mg/mL Product Name: Rapamune Pharmaceutical Form: Oral solution INN or Proposed INN: Sirolimus CAS Number: 53123‐88‐9 Other descriptive name: Rapamycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Zenapax Product Name: Zenapax Product Code: N/A Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Daclizumab CAS Number: unknown Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: Tacrolimus CAS Number: unknown Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: Tacrolimus CAS Number: unknown Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: Tacrolimus CAS Number: unknown Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: mycophenolate mofetil CAS Number: unknown Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: mycophenolate mofetil CAS Number: unknown Concentration unit: mg mil CONDITION: de novo Renal Allograft Recipients PRIMARY OUTCOME: Main Objective: To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) ; and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at 12 months. Primary end point(s): Calculated creatinine clearance (Nankivell method) at 12 months after transplant. Secondary Objective: To evaluate the safety of all three regimens. INCLUSION CRITERIA: Age >= 18 years End stage renal disease with subjects scheduled to reciev a primary or secondary renal allograft from a cadaveric, living unrelated, or a living related donor. A minimum of 1 HLA match is required. Negative pregnancy test and women of childbearing potential must agree to use a medically accepted method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Signed and dated informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range