Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: LCP-Tacro; Tacrolimus -IR
Intervention description: once-daily extended release tablet; twice daily capsules
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Open label, prospective, single-center, randomized, two sequence, three period crossover
      study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus
      capsules administered twice daily in stable African-American renal transplant patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age ≥18-80 old, male or female

          -  African Americans

          -  Willing to give written informed consent and to comply with study visits and
             restrictions, including being able to speak, write and understand English

          -  Pt who have received a primary or secondary transplant

          -  Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus

          -  BMI ≥19

          -  Pt who are sero-positive for Hepatitis B or C positive may also be enrolled

          -  Pt maintained on concurrent immunosuppression with stable doses during screening

          -  Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion
             of the study.

          -  During PK phase Only: Pt taking any medication that could interfere with tacrolimus
             blood levels, including prescription and over-the-counter medications, herbal or food
             supplements (including grapefruit, and pomegranate products), or medications must
             continue the same dose and are willing to continue the same dose/routine

          -  During PK phase Only: the patient is not scheduled to begin any new medication that
             could interfere with tacrolimus blood levels, including prescription and
             over-the-counter medications, herbal or food

        Exclusion Criteria:

          -  Evidence of acute rejection episode within the past three months

          -  Pt not Africa-American

          -  Recipients of organ transplants other than kidney

          -  Known to be HIV positive at transplant

          -  Pt with recurrent focal segmental glomerulosclerosis (FSGS)

          -  Pt with any severe medical condition (including infection) requiring acute or chronic
             treatment

          -  Pt with a positive DSA

          -  Pt with a positive BK virus results

          -  GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days

          -  Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver
             disease

          -  Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl

          -  Pt with mental or physical conditions or known non-adherence

          -  Presence of intractable immunosuppressant complications of side effects resulting in
             dose adjustment of tacrolimus

          -  Exposed to investigational therapy within 30 days prior to enrollment

          -  No anticipated changes in the immunosuppressive regimen, other than those specified by
             the study protocol

          -  Pt with severe diabetic gastroparesis or other severe GI disturbances

          -  Pt who have underwent gastric banding or gastric bypass at any time pre or
             post-transplant

          -  Pregnant or nursing (lactating) women, or planning to become pregnant

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant who are unwilling to use a defined SOC of method