A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

INTERVENTION: Product Name: LCP‐Tacro 0.75 mg Tablet Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: TACROLIMUS CAS Number: 104987‐11‐3 Other descriptive name: Fujimycin; L 679934; MLD 987; Tsukubaenolide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.75‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: LCP‐Tacro 1.0 mg Tablet Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: TACROLIMUS CAS Number: 104987‐11‐3 Other descriptive name: Fujimycin; L 679934; MLD 987;Tsukubaenolide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: LCP‐Tacro 4.0 mg Tablet Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: TACROLIMUS CAS Number: 104987‐11‐3 Other descriptive name: Fujimycin; L 679934; MLD 987; Tsukubaenolide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4.0‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Prograf 0.5mg Hard Capsules Product Name: Prograf 0.5 mg Capsule Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987‐11‐3 Other descriptive name: Fujimycin; L 679934; MLD 987; Tsukubaenolide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Prograf 1 mg hard capsules Product Name: Prograf 1.0 mg Capsule Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987‐11‐3 Other descriptive name: Fujimycin; L 679934; MLD 987; Tsukubaenolide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ Pharmaceutical form of the placebo: Capsule* Route of ad CONDITION: Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients ; MedDRA version: 12.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of LCP‐Tacro (tacrolimus) Tablets administered once daily compared to Prograf (tacrolimus) Capsules twice daily as immunosuppression for the prevention of acute allograft rejection in de novo adult kidney transplant recipients treated for a 12 month treatment period followed by a 12 month, blinded extension period.; ; To show that LCP‐Tacro Tablets are not clinically inferior to Prograf Capsules in the; prevention of acute allograft rejection in de novo adult kidney transplant recipients. Primary end point(s): The primary efficacy endpoint for the study is the proportion of treatment failures within 12 months after randomization to study drug. Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade =1A) or lost to follow‐up.; ; The primary safety endpoints at Month 12 (Day 360) will include ; 1. Incidence of adverse events, serious adverse events, and discontinuations due to adverse events ; 2. incidence of the following predefined potentially clinically significant laboratory values:; ‐ FPG level = 126 mg/dL ; ‐ platelets < 100 x 10^9 cells/L ; ‐ WBC < 2.0 x 10^9 cells/L ; ‐ transaminases = 100 U/L ; ‐ total cholesterol = 240 mg/dL ; ‐ LDL cholesterol = 190 mg/dL ; ‐ triglycerides = 200 mg/dL ; Secondary Objective: INCLUSION CRITERIA: 1. Signed informed consent. 2. Between the ages of 18 and 70 years, inclusive. 3. Patients must be receiving primary or secondary renal allograft from a deceased donor or non‐ human leukocyte antigen (HLA) identical living donor. 4. Patients must have no known contraindications to the administration of IL‐2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus. 5. Women of childbearing potential (WOCBP) should have a negative pregnancy test (serum or urine pregnancy test with a sensitivity of a least 25 mIU/mL) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices as detailed in the Contraception Guidelines (Section 8.2.4). 6. Negative cross match test, and compatible (A, B, AB or O) blood type. 7. Able to swallow tablets and capsules. 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