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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 < 0.05]) resulted post‐conversion. Change in  QUEST  was significantly (p = 0.006) correlated ( R  = 0.44) with change in  FTM ; 78.9% of patients reported an improvement after switching to  LCPT  (p < 0.0005). To our knowledge this is the first trial in  KTR  that utilizes a sophisticated and reproducible measurement of tremor. Results suggest  LCPT  is associated with clinically meaningful improvement of hand tremor and may be an alternative management approach in lieu of further dose reduction of immediate‐release tacrolimus for patients experiencing tremor.

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