Comparing two formulations of tacrolimus for liver transplant patients
Tacrolimus Associated Tremors in Liver Transplant Recipients: a Randomized Open Label Trial Comparing De Novo Extended-release Once Daily (LCP-TAC) and Twice Daily Immediate-release (IR-TAC) Tacrolimus Formulations
This study is testing whether a new extended-release version of tacrolimus causes fewer and less severe tremors in liver transplant patients compared to the standard immediate-release version.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05089604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving their first liver transplant and are eligible to start tacrolimus within 7 days post-transplant.
Not a fit: Patients with a history of tremors or those receiving combined organ transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of tremors in liver transplant patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown that extended-release formulations can improve tolerability in other transplant populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.