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Switching ST udy of Kidney TRansplant PA tients with Tremor to LCP ‐TacrO ( STRATO ): an open‐label, multicenter, prospective phase 3b study
Author(s) -
Langone Anthony,
Steinberg Steven M.,
Gedaly Roberto,
Chan Laurence K.,
Shah Tariq,
Sethi Kapil D.,
Nigro Vincenza,
Morgan John C.
Publication year - 2015
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12581
Subject(s) - medicine , tacrolimus , open label , prospective cohort study , urology , adverse effect , pharmacology , gastroenterology , transplantation
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.