Actively Recruiting
Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
Led by University of British Columbia · Updated on 2024-01-02
124
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
P
Paladin Labs Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Eligible to start tacrolimus within 7 days post-liver transplant
- Provided informed consent
You will not qualify if you...
- Prior organ transplant recipients
- Need for hemodialysis before or after liver transplant
- Recipients of living donor or split deceased donor liver grafts
- Recipients of combined liver/kidney transplants
- Recipients of liver grafts from donors with active HCV infection
- History of tremors, Parkinson's disease, or Parkinsonian syndromes before transplant
- Taking medications known to cause tremors such as dopamine blockers
- Abnormal thyroid function tests indicating hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
T
Trana Hussaini
CONTACT
E
Eric Yoshida, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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