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

NCT05089604 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-01-02

No results posted yet for this study

Summary

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.

Conditions

  • Liver Transplantation
  • Immunosuppression
  • Neurotoxicity
  • Tremor
  • Tacrolimus

Interventions

DRUG

Tacrolimus, Immediate Release, Oral

Twice Daily Tacrolimus

DRUG

Tacrolimus Extended Release Oral Tablet

Once Daily Tacrolimus

Sponsors & Collaborators

  • Paladin Labs Inc.

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Trana Hussaini, Pharm D · University of British Columbia

  • Jo-Ann Ford, RN · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2026-01-01
Completion
2026-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089604 on ClinicalTrials.gov