Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
Condition: Renal Failure; Tremors
MeSH terms: Tremor
Intervention: Prograf; LCP-Tacro
Intervention description: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.; LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate and measure symptomatic hand tremor in stable kidney transplant
      subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion)
      and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro
      compared with Prograf or generic tacrolimus
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be able to give written consent

          2. Men and women between 18 and 65 years of age who are recipients of a kidney transplant
             between 1 month and 5 years prior to the screening date

          3. Subjects with at least one complaint of tremor and existence of postural tremor or
             action tremor on finger to nose as demonstrated by a score of at least 2 of any of the
             4 upper extremity (UE) postural or action and intention assessments on the FTM
             clinical rating scale

          4. Subjects experiencing symptomatic drug-induced hand tremor associated with use of
             Prograf or generic tacrolimus as demonstrated by responding "no" to each of the
             following question: "Did you have a tremor that you noticed prior to starting Prograf
             or generic tacrolimus for your kidney transplant?", or "Are you aware of a tremor that
             runs in your family?"

          5. Subjects taking a stable dose of oral Prograf or generic tacrolimus capsules for at
             least 7 days with trough levels of tacrolimus between 3 to 12 ng/mL. Subjects must
             maintain tacrolimus trough levels in this range during the 7 day Prograf or generic
             tacrolimus treatment phase (note that 1 dose adjustment at Study Day 3 [a.m.dose] is
             allowed for those subjects whose Day0/1 trough level is out of range.

          6. Women of childbearing potential must have a negative serum pregnancy test within 7
             days before study start.

        Exclusion Criteria:

          1. Recipients of any transplants including organ other than kidney and bone marrow

          2. Subjects with an estimated glomerular filtration rate (eGFR) (MDRD7) <30mL/min at
             Screening

          3. Subjects incapable of understanding the purposed and risks of the study, who cannot
             give written informed consent and who are unwilling or unable to comply with study
             protocol requirements

          4. Pregnant or nursing women

          5. Subjects with reproductive potential who are unwilling/unable to use a double barrier
             method of contraception

          6. Subjects who were treated with any other investigational agent within 3 months prior
             to screening

          7. Subjects who are taking drugs that are likely to affect the PK levels of tacrolimus
             and are not on a stable dose of those medications (see Appendix 1)

          8. Subjects who have essential tremor, Parkinsonism, or tremor from any cause other than
             tacrolimus-induced tremor;

          9. Subjects who are taking or had been taking any drug within the past 30 days that is
             well known to promote tremors, including: amiodarone, beta-agonist inhalers (such as
             albuterol), cyclosporine, lithium, metoclopramide, theophylline, or valproate,or
             taking within the past 6 months the dopamine blocking agents (antipsychotics) (note,
             other such medication may be considered on a case-by-case basis at the discretion of
             the investigator);

         10. Subjects who taking drugs that reduce tremor, and are not on stable doses of the
             treatment (ie, had not been taking the medication for a minimum of 30 days),
             including: gabapentin (note, other such medications may be considered on a
             case-by-case basis at the discretion of the investigator);

         11. Subjects on concurrent immunosuppression with MMD (CellCept) of MPS delayed-release
             tables (Myfortic), or generic versions of these medication, who have not been on
             stable doses at least 7 days prior to screening

         12. Subjects receiving prednisone or equivalent at a dose >10 mg per day

         13. Either subjects with an episode of acute rejection requiring treatment or subjects
             with an episode of biopsy-proven or suspected acute rejections that requires treatment
             within 3 months of screening

         14. Subjects who are being actively treated for cancer (with the exception of non-invasive
             basal cell or squamous cell) or human immunodeficiency virus (HIV)

         15. Subjects with any form of current drug or alcohol abuse