Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
Condition: Kidney Failure; Renal Failure
MeSH terms: Renal Insufficiency
Intervention: Tacrolimus (Tacro™); Prograf
Intervention description: The initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
Other Names:
Tacrolimus modified-release; Prograf® capsules, twice daily: Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
Other name: tacrolimus
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; Transplantation; Immunosuppression; Tacrolimus; Prograf

Summary:

      The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of
      medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf®
      capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a
      transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus)
      that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an
      extended period so that it only has to be taken once daily. LCP-Tacro is an investigational
      drug.

      This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a
      kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take
      either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In
      addition, patients will remain on study drug for 360 days in order to evaluate the relative
      safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women at least 18 years of age who are recipients of a kidney transplant
             from a deceased donor or a live donor and who receive their first oral dose of
             randomized study drug within 48 hours of the transplant surgery (graft reperfusion)

        Exclusion Criteria:

          -  Recipient of any transplanted organ other than a kidney

          -  Recipients of a kidney from a non-heart beating donor

          -  Recipients of a kidney from an ABO incompatible donor

          -  Recipients of a kidney with a cold ischemia time of ≥ 36 hours

          -  Recipients of a bone marrow or stem cell transplant

          -  Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil
             count (ANC) is > 1.0 x 109/L

          -  Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
             enzyme levels > 3 times the upper limit of normal during the 30 days prior to the
             transplant procedure

          -  Patients who fail a drugs of abuse screen

          -  Patients unable to swallow study medication

          -  Patients incapable of understanding the purposes and risks of the study, who cannot
             give written informed consent, or who are unwilling to comply with the study protocol

          -  Pregnant or nursing women (women of childbearing potential must have a negative serum
             pregnancy test within seven days prior to receiving study medication)

          -  Patients with reproductive potential who are unwilling/unable to use a double barrier
             method of contraception throughout the duration of the study

          -  Patients who were treated with any other investigational agent in the 30 days prior to
             enrollment

          -  Patients who are hepatitis C virus (HCV) negative who have received a HCV positive
             (HCV RNA by polymerase chain reaction (PCR) or HCV antibody) donor kidney

          -  Patients seropositive for human immunodeficiency virus (HIV)

          -  Patients with 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

          -  Patients with uncontrolled concomitant infection, a systemic infection requiring
             treatment, or any other unstable medical condition that could interfere with the study
             objectives

          -  Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal
             disorder that may affect the absorption of tacrolimus

          -  Patients with a known hypersensitivity to tacrolimus

          -  Patients with any form of current substance abuse, psychiatric disorder or a condition
             that, in the opinion of the Investigator, may invalidate communication with the
             investigator