Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients

A prospective, randomized, open-label, multicenter, parallel, observational study to assess
safety and efficacy of 200 kidney transplant recipients comparing brand tacrolimus to generic
tacrolimus over a one year follow up period. All subjects will receive other
immunosuppressive medications including induction therapy (thymoglobulin, basiliximab, or no
induction) and maintenance including mycophenolate mofetil and corticosteroid therapy as
directed by standard-of-care at each center. Their medication information will be recorded in
their study files.

The study population includes recipients of kidney allografts in the first 14 days after
transplantation.

The totals of 7 visits over 12 months period are planned as follows. The blood samples
specified below are for the translational research study labs. Subjects will continue to
receive routine labs as part of their standard of care from their treating physician. These
safety labs are done as part of their stand of care from their treating physician.

If the subject needs more study drug medication before his or her next study visit the
subject will come in to the clinic to get a new supply.

First (Baseline) Visit (up to 14 days after transplant but before the study subject is
discharged from the hospital):

- Subject reviews and signs consent form

- Review of subject's medical history

- Review of subject's current medications

- Review of subject's physical exam including vital signs (blood pressure, temperature,
pulse and respiration rate), height and weight

- Review of any changes in subject's health and any reactions to the study medication will
be recorded

- About 16 cc blood sample (about 3.2 teaspoons of blood) will be collected from the
subject for translational research study laboratory tests

- Randomization of subject

- Subject will receive study drug.

Month 1 Visit:

- Review of subject's current medications

- Review of subject's physical exam including vital signs (blood pressure, temperature,
pulse and respiration rate), height and weight

- Review of any changes in subject's health and any reactions to the study medication will
be recorded

- Subject returns completed dosing diary and receives new dosing diary

- Subject will receive study drug.

Month 2/3 Visit:

- Review of subject's current medications

- Review of subject's physical exam including vital signs (blood pressure, temperature,
pulse and respiration rate), height and weight

- Review of any changes in subject's health and any reactions to the study medication will
be recorded

- Subject returns completed dosing diary and receives unfilled dosing diary

- Subject will receive study drug.

Month 6/9/12 Visit:

- Review of subject's current medications

- Review of subject's physical exam including vital signs (blood pressure, temperature,
pulse and respiration rate), height and weight

- Review of any changes in subject's health and any reactions to the study medication will
be recorded

- Subject returns completed dosing diary and receives unfilled dosing diary

- Subject will receive study drug if applicable.

Adherence will be measured with daily medication diaries and with the coefficient of
variation of tacrolimus in subjects' blood.

Inclusion Criteria

1. Signed informed consent and or/assent

2. Between the ages of 18 and 70 years, inclusive

3. Current or future kidney transplant recipients, no more than 14 days after transplant
and prior to hospital discharge. Inclusion of future kidney transplant recipients
cannot exceed 30-days pre-transplant.

4. Able to swallow tablets and capsules at the time of randomization

5. Subjects must be receiving a primary or secondary kidney allograft from a deceased
donor or from a non- HLA identical living donor

6. Negative cross match test, and compatible (A, B, AB or O) blood type

7. Subjects must have no known contraindications to tacrolimus

8. Women of childbearing potential (WOCBP) must have a negative pregnancy test and be
willing to use 2 methods of contraception during the study and for 6 weeks after
stopping the study drug.

WOCBP includes any female who has experienced menarche and who has not undergone successful
surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on
hormone replacement therapy with documented serum follicle stimulating hormone level > 35
mIU/cc). Women who are using oral, implanted, or injectable contraceptive hormones
(intrauterine device), mechanical products or barrier methods (diaphragm, condoms,
spermicides), are practicing abstinence, or have a sterile partner (e.g., vasectomy), will
be considered of child bearing potential.

In addition, WOCBP who are taking MMF must use methods of birth control as stipulated in
the package insert, namely:

Either intrauterine device, or partner with vasectomy, or one hormone (oral contraceptive
pill, transdermal patch, vaginal ring, or progesterone injection or implant) and one
barrier method (diaphragm or cervical cap with spermicide, contraceptive sponge, or male or
female condom), or two barrier methods as described above.

WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent
units of human chorionic gonadotropin [HCG]) at the time of transplant.

Exclusion Criteria

1. Those who receive simultaneous combined organ transplants

2. Subjects with clinically significant active infections (for example, those requiring
hospitalization, or as judged by the Investigator) or malignancies

3. Recipients who are concurrently receiving belatacept or anticipate to receive
belatacept as part of their immunosuppressive regimen

4. Subjects currently enrolled in another investigational device or drug study

5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for 6 weeks after stopping the study drug

6. Women who are breast-feeding or pregnant with a positive pregnancy test on enrollment
or prior to study drug administration

7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.

8. Any psychiatric or medical condition that, in the investigator's opinion, may put the
subject at significant risk, may confound the study results, or may interfere
significantly with the subject's participation in the study.