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 you are discharged from the hospital):

• Review and sign this consent form
• Review of your medical history
• Review of your current medications
• Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
• Review of clinical labs
• You will receive your study drug if you are in Part 1 of the study.

If you are a woman of child bearing potential, a pregnancy test will be completed prior to the start of the study. If you are pregnant, you cannot participate in this research study. You also cannot participate in this study if you are currently breastfeeding. You must use a medically acceptable method of birth control during the 1-year study period and for 6 weeks after the last dose of study medication.

It is possible that after the study doctor reviews your medical history and test results, he or she may tell you that you do not qualify to be in the study. If you do not qualify for the study, the doctor will tell you the reason(s) why. If you cannot be in this research study, you will not lose any medical benefits, you can still participate in other studies, and you can still receive the standard treatment prescribed by your physician.

After the Baseline Visit, you will have 6 additional study visits. These will be scheduled for 1, 2, 3, 6, 9, and 12 months after your transplant surgery. The following will occur at each visit:

Month 1, 2, 3, 6, and 9 Visits:

• Review of your current medications
• Review of your physical exam including vital signs (blood pressure, temperature, pulse and respiration rate), height and weight
• Review of any changes in your health and any reactions to the study medication will be recorded
• Review of your routine standard of care lab results
• Return completed dosing diary and receive new dosing diary
• You will receive your study drug if you are in Part 1 of the study

Month 12 Visit (End of Study Visit):

• Review of your current medications
• Review of any changes in your health and any reactions to the study medication will be recorded
• Review of your routine standard of care lab result
• Return your final completed dosing diary
• Return any study drug remaining in your possession to the study team if you are in Part 1 of the study

If you are Part 1 and require more study medication before your next study visit, you will come in to the clinic to get a new supply. If you are participating in Part 2, you will obtain more study drug from your local pharmacy.

You will continue having your routine blood and urine collections to monitor your kidney function as part of your standard of care treatment at UCLA, UCSD, UCI, and UCD. The schedule for these routine blood and urine collections will depend on your condition and will be at your treating physician's discretion.

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