Switching ST udy of Kidney TRansplant PA tients with Tremor to LCP ‐TacrO ( STRATO ): an open‐label, multicenter, prospective phase 3b study

• Published in: Clinical transplantation 2015-09, Vol.29 (9), p.796-805
• Main Authors: Langone, Anthony, Steinberg, Steven M., Gedaly, Roberto, Chan, Laurence K., Shah, Tariq, Sethi, Kapil D., Nigro, Vincenza, Morgan, John C.
• Format: Article
• Language: English
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/ctr.12581

Tremor is a common side effect of tacrolimus correlated with peak‐dose drug concentration. LCPT , a novel, once‐daily, extended‐release formulation of tacrolimus, has a reduced C max with comparable AUC exposure, requiring a ~30% dose reduction vs. immediate‐release tacrolimus. In this p hase 3b study, kidney transplant recipients ( KTR ) on a stable dose of tacrolimus and with a reported clinically significant tremor were offered a switch to LCPT . Tremor pre‐ and seven d post‐conversion was evaluated by independent, blinded movement disorder neurologists using the F ahn– T olosa– M arin ( FTM ) scale and by an accelerometry device; patients completed the QUEST (quality of life in essential tremor) and the P atient G lobal I mpression of C hange. There were 38 patients in the m ITT population. A statistically and clinically significant improvement in tremor ( FTM score, amplitude as measured by the accelerometry device and QOL [p‐values