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Two-Year Safety Results from the Phase 3b Switching Study of Kidney Transplant Patients with Tremor to LCP-Tacro (STRATO) Study.

S. Steinberg,1 R. Gedaly,2 L. Chan,3 A. Langone.4

1California Institute of Renal Research, San Diego
2University of Kentucky Medical Center, Lexington
3University of Colorado, Aurora
4Vanderbilt University Medical Center, Nashville.

Meeting: 2016 American Transplant Congress

Abstract number: D143

Keywords: FK506, Immunosuppression, Kidney transplantation

Session Information

Date: Tuesday, June 14, 2016

Session Name: Poster Session D: Kidney Immunosuppression: Novel Agents

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Halls C&D

Related Abstracts
  • LCP-Tacro Improves TAC-Induced Tremors: Preliminary Analysis of Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): An Exploratory Study
  • Efficacy, Safety and Pharmacokinetics of Once-Daily, MeltDose® Tacrolimus (Envarsus® XR) Versus Twice-Daily Tacrolimus (Prograf®) in De Novo Kidney Transplant Recipient Sub-Groups: A 2 Year Phase 3 Randomized, Double-Blind, Double-Dummy, Trial

Tremor is a common side effect of tacrolimus (tac) correlated with peak-dose drug concentration. Envarsus XR®, a novel, once-daily, extended-release formulation of tac, has a reduced Cmax with comparable AUC exposure, requiring a ~30% dose reduction vs. immediate-release tac. In this Phase 3b study, kidney transplant recipients (KTR) on a stable dose of tac, at targeted exposure levels and with a reported clinically significant tremor were offered a switch to Envarsus XR as an alternative management approach in lieu of further dose reduction with immediate-release tac. Tremor pre- and 7 days post-conversion was evaluated by independent, blinded movement disorder neurologists using the Fahn-Tolosa-Marin (FTM) scale and by an accelerometry device; patients completed the QUEST (quality of life [QoL] in essential tremor) and the Patient Global Impression of Change. Previously reported results showed a statistically and clinically significant improvement in tremor, and improvement in QoL for 80% of patients switched from traditional twice-daily tac capsule to Envarsus XR. Here we report safety, trough levels, and dose adjustments from the two years' follow-up of the study among the 40 Envarsus XR-treated patients who entered the extended-use phase. Mean duration of treatment was 21.3±6.7 months; at least one dose adjustment (DA) was made in n=35 (87.5%) patients, mainly based on trough results; 32.5% had 1-2 DA, and 55% had ≥3 DAs. Mean trough levels were similar across the two years (range: 5.5-6.6 ng/mL at months 3, 6, 9, 12, 15, 18, 24). Most patients (95%) experienced ≥1 adverse event (AE); 83% were mild or moderate and only 2 patients discontinued Envarsus XR due to an AE; of the 13 serious AEs, none were considered study drug-related. These results show that Envarsus XR is not associated with any unexpected safety concerns. Once-daily Envarsus XR showed consistent trough levels across the extended follow-up.

CITATION INFORMATION: Steinberg S, Gedaly R, Chan L, Langone A. Two-Year Safety Results from the Phase 3b Switching Study of Kidney Transplant Patients with Tremor to LCP-Tacro (STRATO) Study. Am J Transplant. 2016;16 (suppl 3).

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To cite this abstract in AMA style:

Steinberg S, Gedaly R, Chan L, Langone A. Two-Year Safety Results from the Phase 3b Switching Study of Kidney Transplant Patients with Tremor to LCP-Tacro (STRATO) Study. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/two-year-safety-results-from-the-phase-3b-switching-study-of-kidney-transplant-patients-with-tremor-to-lcp-tacro-strato-study/. Accessed February 24, 2021.

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