Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: LCP Tacro (tacrolimus); Prograf
Intervention description: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.; Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Tacrolimus; Pharmacokinetics; Kidney Transplantation

Summary:

      A three sequence, open-label, multi-center, prospective, study in stable kidney transplant
      patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of
      LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18-65 years of age who are recipients of a renal transplant at least 6
             months prior to enrollment

          -  Patients on oral Prograf therapy as part of their maintenance immunosuppression
             therapy, with stable doses and trough levels of tacrolimus of 7-12 ng/mL for at least
             two weeks prior to enrollment.

          -  Patients maintained on concurrent immunosuppression with mycophenolate mofetil (MMF,
             CellCept) or mycophenolic acid delayed-release tablets (Myfortic), with stable doses
             for at least two weeks prior to enrollment

          -  Patients with serum creatinine < 2.0mg/dL prior to enrollment

          -  Able to swallow study medication

          -  Patients capable of understanding the purposes and risks of the study, who can give
             written informed consent and who are willing to participate in and comply with the
             study

          -  Women of childbearing potential must have a negative serum pregnancy test within seven
             days prior to receiving study medication

          -  Patients who successfully pass a drug screen

        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