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Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations

Study acronym: LCP-TAC
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 2, 2024 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 2024 to Jan 1, 2026
    • Start date changed from estimate of Dec 2021 to Jan 9, 2023
    • Study sites: 0 to 1
    • Study completion date: Dec 2024 to Dec 31, 2026
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.
Trial Details
NCT Number NCT05089604
Lead Sponsor University of British Columbia
Collaborators: Paladin Labs Inc.
Conditions
(from sponsor)		 Liver Transplantation, Immunosuppression, Neurotoxicity, Tremor, Tacrolimus
Related terms Neurotoxicity Syndromes, Tremor
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov