Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
Recruiting now · Phase 4
Conditions studied: Liver Transplantation, Immunosuppression, Neurotoxicity, Tremor, Tacrolimus
In brief
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.
Key facts
- Study ID
- NCT05089604
- Run by
- University of British Columbia
- People needed
- 124
- Starts
- 2023-01-09
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-01-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant
- Informed consent
You may not qualify if…
- Recipients of prior organ transplant
- Need for hemodialysis either prior or following liver transplantation
- Recipients of living donor liver or split deceased donor liver allografts
- Recipients of combined liver/kidney transplants
- Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
- Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
- Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents
- Baseline TSH, T3, T4 indicating hyperthyroidism
Where it is running
- Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
Full record on ClinicalTrials.gov
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