Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
Condition: Renal Transplant
Intervention: Generic Tacrolimus; Branded Tacrolimus
Intervention description: Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths.; Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal transplant; kidney transplant; immunosuppressive therapy; anti-rejection medication; pharmacokinetics; tacrolimus

Summary:

      The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to
      branded tacrolimus (Prograf) in stable renal transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to participate and willing to give written informed consent and to comply with
             the study visits and restrictions.

          -  Patient who has received a primary or secondary kidney transplant

          -  Patient who is at least 6 months post transplant and on a stable dose of tacrolimus as
             defined by physician, one tacrolimus trough level within the physician defined target
             range within past 6 months and one additional trough level during the screening period
             within 30% of the physician defined target range.

          -  Body mass index (BMI) greater than or equal to 19 but less than or equal to 35

          -  Patients who are taking tacrolimus (generic, Sandoz) or Prograf

        Exclusion Criteria:

          -  Evidence of any acute rejection

          -  Patients who require dialysis within 6 months prior to study entry

          -  Recipients of antibodies blood group (ABO) incompatible allograft or positive
             crossmatch

          -  Recipients of multiple organ transplants

          -  Patients who have tested positive for hepatitis B surface antigen (HBsAG) or human
             immunodeficiency virus (HIV), or who are recipients of organ from donors who are known
             to be HBsAG or HIV positive. Virology screening at the time of transplant was
             acceptable unless more recent tests were available.

          -  History of malignancy, treated or untreated, within the past 2 years with the
             exception of carcinoma in situ or excised basal cell carcinoma

          -  Glomerular filtration rate ≤35 ml/min measured by modification of diet in renal
             disease (MDRD4)

          -  No anticipated change in the immunosuppressive regimen during patient participation
             other than that required by the protocol

          -  Initiation of any medications that could interfere with tacrolimus blood levels,
             including over the counter medications, herbal supplements, grapefruit or grapefruit
             juice.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, UNLESS they are

               -  women whose career, lifestyle, or sexual orientation precludes intercourse with a
                  male partner

               -  women whose partners have been sterilized by vasectomy or other means

               -  using a highly effective method of birth control (i.e. one that results in a less
                  than 1% per year failure rate when used consistently and correctly, such as
                  implants, injectables, combined oral contraceptives, and some intrauterine
                  devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal,
                  post-ovulation methods) is not acceptable.

          -  Patients who are taking a generic tacrolimus product other than tacrolimus (generic,
             Sandoz).