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

This is a 2-arm , parallel group, prospective, double-blind, double-dummy,
multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily
in comparison to Prograf capsules twice-daily after kidney transplantation.

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