A Phase 2 Double-Blind, Double-dummy, Multicenter, Prospective, Randomized Study of the Pharmacokinetics of LCP-Tacro Tablets, Once-Daily, Compared to Prograf Capsules, Twice-daily, for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

Inclusion Criteria:

• Subjects must be able to give written consent.
• Male and female subjects between the ages of 18 and 70 years, inclusive.
• Subjects must be receiving primary or secondary renal allograft from a deceased donor or non-HLA identical living donor.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine pregnancy test with a sensitivity of a least 25 mIU/ml) within 1 week prior to randomization or in accordance with local regulations, whichever is of shorter duration. All subjects must agree to follow the contraceptive guidelines as detained in section 8.2.4.
• Subjects must have negative cross-match test and be ABO-compatible.
• Subjects must be able to swallow tablets and capsules

Exclusion Criteria:

• Subjects who are recipients of any previous non-renal concurrent transplant (solid organ or bone marrow)
• Subjects who have panel reactive antibody > 50%
• Subjects with any condition that may affect study drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy, inflammatory bowel disease, or gastric bypass)
• Subjects with body mass index (BMI) , 18 kg/m2 or > 45 kg/m2, calculated using the formula of BMI = mass/(height2)
• Subjects with history of alcohol abuse with less than 6 months of sobriety
• Subjects with history of recreational drug abuse with less than 6 months of documented abstinence
• Subjects with screening 12-lead ECG demonstrating clinically significant abnormalities (including QTc prolongation)
• Subjects who are WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
• Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method of contraception and follow the contraception guidelines in 8.2.4
• Subjects with an oral temperature (prior to study drug dosing) of 38C (100.4F) or higher
• Subjects with clinically significant active infections (eg, those requiring hospitalization, or as judged by the Investigator)
• Subjects with known hereditary immunodeficiency
• Subjects with malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carinoma in situ
• Subjects who expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
• Subjects with any psychiatric or medical condition (cardiac, pulmonary, central nervous system, gastrointestinal, endocrine/metabolic, etc) that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Subjects with clinically symptomatic congestive heart failure or documented rejection fraction of less than 45%
• Subjects with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension
• Subjects currently enrolled in another investigational drug or device study, who are less than 30 days since discontinuing another investigational drug or device study, or who are currently receiving other investigational treatment
• Subjects with laboratory variables that are abnormal (outside laboratory reference range) and clinically significant as judged by the Investigator
• Subjects with positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab). Negative results for these serological tests much be documented within 12 months prior to randomization
• Subjects who have had primary focal segmental glomerulosclerosis
• Donor parameters must not include any of the following known conditions:

Positive serological test result for HIV-1, HBV or HCV History of malignant disease (current or historical) Cold ischemia time > 30 hours Non-heart-beating donor