This large, multi-continent, Phase 3, double-blind, randomized, active comparator non-inferiority trial will compare efficacy and safety of a once-daily controlled agglomeration formulation of tacrolimus with MeltDose technology (LCP-Tacro) to conventional twice-daily tacrolimus (Prograf). Enrollment has been completed and preliminary data on the study sample are reported here. De novo, adult kidney transplant recipients were randomly assigned to once-daily LCP-Tacro Tablets or to twice-daily Prograf Capsules; recipients also received mycophenolate mofetil (MMF), steroids, and basiliximab. Study visits are conducted over a 12-month treatment period; with additional visits during a 12 month extension period on treatment and a follow-up safety assessment 30 days after withdrawal from study drug. The primary efficacy endpoint is treatment failures (the first event of any of the following: death, graft failure, BPAR [Banff grade ≥1A, by central reader] or lost to follow-up). Safety parameters include adverse events (AEs), serious AEs (SAEs), vital sign measurements, clinical laboratory results, physical examinations, ECGs and study drug dose. A total of 543 patients have been enrolled from 13 countries (from Europe, n=261; North America, n=137; Latin America, n=116; and Asia-Pacific, n=29). Baseline demographics and characteristics are currently available. Patients’ mean (SD) age is 45.8 (0.59) years and there are n=188 (34.6%) females and n=355 (65.4%) males. The majority of patients are White (76.2%); 28.2% are Hispanic or Latino. Slightly greater than half (51%) received kidneys from deceased donors. Most had not received any prior transplants (96%). Sixty-seven percent of patients are CMV IgG positive; 91% have PRA% of < 5%; 81% had 1 to 2 HLA-A mismatches. This is the first randomized, double blind, clinical outcomes trial utilizing LCP-Tacro in the de novo kidney transplant population as well as the first one-year double-blind study using a titratable oral medication in transplant.

Rostaing, L.: Grant/Research Support, Veloxis Pharmaceuticals. Budde, K.: Grant/Research Support, Veloxis Pharmaceuticals. Bunnapradist, S.: Grant/Research Support, Veloxis Pharmaceuticals.

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