NCT05089604 Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
| NCT ID | NCT05089604 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of British Columbia |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 124 participants in total. It began in 2023-01-09 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Trana Hussaini, Pharm D
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05089604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05089604 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05089604 currently recruiting?
Yes, NCT05089604 is actively recruiting participants. Contact the research team at trana.hussaini@vch.ca for enrollment information.
Where is the NCT05089604 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05089604 clinical trial?
NCT05089604 is sponsored by University of British Columbia. The principal investigator is Trana Hussaini, Pharm D at University of British Columbia. The trial plans to enroll 124 participants.