Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen

This is a prospective, open-label, 2-arm, clinical trial to evaluate the efficacy of extended
release tacrolimus (Envarsus) once-daily in comparison to Prograf capsules twice-daily after
heart transplantation receiving the standard of care twice daily dosing with tacrolimus
(Prograf).

Secondary objectives are to compare the compliance, safety and efficacy of once a day dosing
(Envarsus) versus twice a day dosing (Prograf) and to evaluate the short term safety and
tolerability of Envarsus.

Approximately 25 adult male or female recipients of a heart transplant will be prospectively
enrolled to once-daily therapy with Envarsus tablets. Time of initiation will follow current
standard of care. In addition, 25 age/gender-matched subjects who are receiving twice daily
dosing with Prograf will be identified from the transplant center database and contacted to
be consented, after which their results will be analyzed retrospectively.

The Termination Visit will occur on Day 182 (± 2 days) for subjects who complete the study
treatment. Subjects who receive the first dose of study drug but withdraw from the study or
terminate study treatment for any reason should complete all the procedures outlined for the
Termination Visit.

The follow-up safety assessment may be conducted via telephone or at a study visit if needed
for clinical follow-up on any safety issues). The follow-up safety assessment is to take
place approximately 30 days (±5 days) after the last administration of study treatment,
whether the subject completed study treatment or withdrew or terminated treatment early.

Inclusion Criteria:

- Male or female, ≥ 18 years of age

- Able to comply with medication regimen

- Subjects must have the capacity to understand and sign the informed consent form

- Heart-only transplant recipients

Exclusion Criteria:

- Subject currently enrolled in another interventional research trial

- History of hypersensitivity/adverse reaction to tacrolimus

- Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf)

- Simultaneous multiple organ transplant recipients

- Liver transplant recipients / candidates