Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05089604

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

Led by University of British Columbia · Updated on 2024-01-02

124

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

P

Paladin Labs Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Recipients of a first-time liver transplant
  • eGFR more than 30 ml/min on the day of tacrolimus initiation
  • Eligible to start tacrolimus within 7 days post-liver transplant
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Prior organ transplant recipients
  • Need for hemodialysis before or after liver transplant
  • Recipients of living donor or split deceased donor liver grafts
  • Recipients of combined liver/kidney transplants
  • Recipients of liver grafts from donors with active HCV infection
  • History of tremors, Parkinson's disease, or Parkinsonian syndromes before transplant
  • Taking medications known to cause tremors such as dopamine blockers
  • Abnormal thyroid function tests indicating hyperthyroidism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

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Research Team

T

Trana Hussaini

CONTACT

E

Eric Yoshida, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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