Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations (NCT05089604)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).
Location: Vancouver General Hospital — Vancouver, British Columbia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Vancouver General Hospital — Vancouver, British Columbia
📞 Contact the Study Coordinator
Phone: (604) 328-4930
Email: trana.hussaini@vch.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Liver Transplantation
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- Mediterranean Diet Post-liver Transplantation — Rochester, Minnesota
- Molecular Assessment and Profiling of Liver Transplant Recipients — Los Angeles, California
- Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation — Cleveland, Ohio
- Restrictive Fluid Management In Liver Transplantation (REFIL) - Pilot — Vancouver, British Columbia
- Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) — Chicago, Illinois
Explore by condition: All Liver Transplantation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.