Brief Communication Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial

†See the Appendix Phase III noninferiority trial examining efficacy and safety of converting stable renal transplant recipi-ents from twice-daily tacrolimus to a novel extended-release once-daily tacrolimus formulation (LCPT) with a controlled agglomeration technology. Controlsmain-tained tacrolimus twice daily. The primary efficacy end-point was proportion of patients with efficacy fail-ures (death, graft failure, locally read biopsy-proven acute rejection [BPAR], or loss to follow-up) within 12 months. Starting LCPT dose was 30 % lower (15% for blacks) than preconversion tacrolimus dose; tar-get trough levels were 4–15 ng/mL. A total of 326 pa-tients were randomized; the mITT population (n = 162 each group) was similar demographically in the two groups. Mean daily dose of LCPTwas significantly (p< 0.0001) lower than preconversion tacrolimus dose at each visit; mean trough levels between groups were similar. There were four efficacy failures in each group; safety outcomes were similar between groups. Fre-quency of premature study drug discontinuation was LCPT: 12 % versus tacrolimus twice daily: 5 % (p = 0.028). LCPT demonstrated noninferiority to tacrolimus twice daily in efficacy failure rates. LCPT may offer a safe and effective alternative for converting patients to a once-daily formulation. Compared to currently available tacrolimus formulation, LCPT requires lower doses to achieve target trough levels