Comparing two formulations of tacrolimus for liver transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the risk of tremors in liver transplant recipients using two different formulations of tacrolimus: an extended-release version (Envarsus) and an immediate-release version. It is a randomized open-label trial involving de novo liver transplant patients who will receive either formulation in combination with mycophenolate and short-term corticosteroids. The aim is to determine if the extended-release formulation results in fewer and less severe tremors compared to the immediate-release formulation. The study will utilize wearable sensors to monitor tremor incidence and severity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 years or older
2. Recipients of a first-time liver transplant
3. eGFR more than 30 ml/min on the day of tacrolimus initiation
4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant
5. Informed consent

Exclusion Criteria:

1. Recipients of prior organ transplant
2. Need for hemodialysis either prior or following liver transplantation
3. Recipients of living donor liver or split deceased donor liver allografts
4. Recipients of combined liver/kidney transplants
5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents
8. Baseline TSH, T3, T4 indicating hyperthyroidism

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Trana Hussaini, Pharm D — University of British Columbia
• Study coordinator: Trana Hussaini
• Email: trana.hussaini@vch.ca
• Phone: 6043284930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.