Results of a Randomized Controlled Trial Evaluating the Impact of Conversion to LCP Tacrolimus on Neurologic Toxicities in Liver Transplant Recipients.

Abstract

Background/aims: Neurotoxicity is commonly seen in liver transplant (LT) patients receiving tacrolimus. We sought to determine the impact of LCP tacrolimus on neurologic toxicity in LT recipients.

Methods: This single-center, semiblinded, parallel group randomized controlled trial compared neurotoxicity burden in LT patients receiving immediate-release (IR) tacrolimus versus LCP tacrolimus. Thirty LT recipients transplanted between January 2020 and February 2022 were enrolled between 15 and 364 days posttransplant and followed for 6 months postrandomization. The primary endpoint was change from baseline to 6 months in composite Patient Global Impression of Improvement (PGI-I) score. Select secondary endpoints included change in Fahn-Tolosa-Marin (FTM) Tremor Rating Scale, IMAB-Q10, SF-12, and Medical Symptom Validity Test (MSVT) scores.

Results: No significant differences were seen in composite PGI scores, though all patients saw improvement in overall PGI scores (IR -5 [-13.5 to -0.25] vs. LCP -4 [-9.5 to -0.5], p = 0.78). Other tests examining neurotoxicities showed no difference between groups but an overall trend toward improvement in symptoms between baseline and end of study. One episode of moderate rejection (rejection activity index [RAI] score of 6) was reported in the LCP group, with no episodes in the IR group (p = 0.31). No graft loss or mortality occurred in either group.

Conclusions: Our study showed LCP tacrolimus had similar rates of neurotoxicity in LT recipients compared to IR without increasing the risk of rejection, graft loss, or mortality; these results suggest LCP tacrolimus can be a safe alternative in LT recipients.

Trial registration: ClinicalTrials.gov identifier: NCT03823768.