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
Who is this study for? Liver transplant recipients with tacrolimus associated tremors
What treatments are being studied? Tacrolimus
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Trana Hussaini
trana.hussaini@vch.ca
6043284930
Backup
Eric Yoshida, MD
eric.yoshida@vch.ca
604-872-9858
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 124
Treatments
Experimental: LCPT
Active_comparator: IR-TAC
Related Therapeutic Areas
Sponsors
Collaborators: Paladin Labs Inc.
Leads: University of British Columbia