Double-Blind,Double-Dummy,Effic/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx

This is a two-armed parallel group, prospective, randomized, double-blind,
double-dummy,multicenter Phase 3 clinical study to establish the efficacy and safety of
LCP-Tacro Tablets (tacrolimus, LifeCycle Pharma A/S, Hørsholm, Denmark) once daily for the
prevention of allograft rejection in de novo adult male and female recipients of a primary
or secondary kidney transplant evaluated by a combined efficacy endpoint comprised of acute
rejection, graft loss and patient loss. The trial is designed to determine if the test drug,
LCP-Tacro, is not inferior to an unacceptable extent to the reference compound, Prograf.
Recipients of akidney transplant who sign an informed consent form and fulfill all other
inclusion and exclusion criteria will be randomly assigned to once-daily therapy with
LCP-Tacro Tablets or to twice-daily therapy with Prograf Capsules (tacrolimus, Astellas
Pharma US, Inc., Deerfield, IL), each concomitantly administered with mycophenolate mofetil
(MMF) and corticosteroids. All patients will also receive interleukin-2 (IL-2) receptor
antagonist (e.g.,Simulect®, basiliximab; Novartis Pharmaceuticals, East Hanover, NJ).
Following screening,transplantation, and randomization, study visits will be conducted over
a 12-month treatment period; with additional visits during a 12 month extension period on
treatment and a follow-up safety assessment by visit or telephone interview 30 days after
withdrawal from study drug.