Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)

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 transplantbetween 1 month and 5 years prior to the screening date

3. Subjects with at least one complaint of tremor and existence of postural tremor oraction 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 FTMclinical rating scale

4. Subjects experiencing symptomatic drug-induced hand tremor associated with use ofPrograf or generic tacrolimus as demonstrated by responding "no" to each of thefollowing question: "Did you have a tremor that you noticed prior to starting Prografor generic tacrolimus for your kidney transplant?", or "Are you aware of a tremor thatruns in your family?"

5. Subjects taking a stable dose of oral Prograf or generic tacrolimus capsules for atleast 7 days with trough levels of tacrolimus between 3 to 12 ng/mL. Subjects mustmaintain tacrolimus trough levels in this range during the 7 day Prograf or generictacrolimus treatment phase (note that 1 dose adjustment at Study Day 3 [a.m.dose] isallowed 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 7days 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 atScreening

3. Subjects incapable of understanding the purposed and risks of the study, who cannotgive written informed consent and who are unwilling or unable to comply with studyprotocol requirements

4. Pregnant or nursing women

5. Subjects with reproductive potential who are unwilling/unable to use a double barriermethod of contraception

6. Subjects who were treated with any other investigational agent within 3 months priorto screening

7. Subjects who are taking drugs that are likely to affect the PK levels of tacrolimusand 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 thantacrolimus-induced tremor;

9. Subjects who are taking or had been taking any drug within the past 30 days that iswell known to promote tremors, including: amiodarone, beta-agonist inhalers (such asalbuterol), cyclosporine, lithium, metoclopramide, theophylline, or valproate,ortaking 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 ofthe investigator);

10. Subjects who taking drugs that reduce tremor, and are not on stable doses of thetreatment (ie, had not been taking the medication for a minimum of 30 days),including: gabapentin (note, other such medications may be considered on acase-by-case basis at the discretion of the investigator);

11. Subjects on concurrent immunosuppression with MMD (CellCept) of MPS delayed-releasetables (Myfortic), or generic versions of these medication, who have not been onstable 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 subjectswith an episode of biopsy-proven or suspected acute rejections that requires treatmentwithin 3 months of screening

14. Subjects who are being actively treated for cancer (with the exception of non-invasivebasal cell or squamous cell) or human immunodeficiency virus (HIV)

15. Subjects with any form of current drug or alcohol abuse