Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tacrolimus, Immediate Release, Oral
- Tacrolimus Extended Release Oral Tablet
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of British Columbia
Lead sponsor
Paladin Labs Inc.
Collaborator
Source ClinicalTrials.gov