Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

Exclusion Criteria

• •Recipients of any transplanted organ other than a kidney
• •White blood cell count \< 2.8 x 10\^9 /L
• •Patients who are receiving a total dose of Prograf for 24 hours \< 3mg
• •Patients unable or unwilling to provide informed consent
• •Pregnant or nursing women
• •Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
• •Administration of other investigational agent in the three months prior to enrollment
• •Patient receiving any drug interfering with tacrolimus metabolism
• •Patients who have taken sirolimus within the past three months prior to screening
• •Patient with an episode of acute cellular requiring antibody therapy within the 6 months prior to enrollment
• •Patient treated for acute cellular rejection within the 30 days prior to enrollment
• •Patient who is HCV negative and has received an HCV positive (HCV RNA by PCR or HCV antibody) donor kidney
• •Patient has a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
• •Patient has uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
• •Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
• •Patient will require therapy with any immunosuppressive agent other than those prescribed in the study
• •Patient has a known hypersensitivity to corticosteroids, mycophenolate mofetil, mycophenolic acid or tacrolimus
• •Patient has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator