Envarsus Neurotoxicity Burden in Liver Transplant Patients

Phase 4 Completed 30 enrolled Medical University of South Carolina Veloxis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.

Timeline

Start: 2020-01-31
Primary completion: 2023-04-30
Completion: 2024-01-30

Outcome

Missed primary endpoint

paper No significant differences were seen in composite PGI scores PMID 41089174 ↗

paper IR -5 [-13.5 to -0.25] vs. LCP -4 [-9.5 to -0.5], p = 0.78 PMID 41089174 ↗

Publications

Coffman KS, Revuelta GJ, DeTurk N, Palmer C, Culpepper H, Overstreet M, Fleming J, Terry K, Patel N, McGillicuddy J, Nagaraju S, Rice TC, Taber DJ. Results of a Randomized Controlled Trial Evaluating the Impact of Conversion to LCP Tacrolimus on Neurologic Toxicities in Liver Transplant Recipients. Int J Hepatol. 2025 Oct 6;2025:4374144. doi: 10.1155/ijh/4374144. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	—