Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation

Who is this study for? Patients who underwent liver transplant
What treatments are being studied? Envarsus
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant). The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- Adult individuals transplanted at the University of Alberta

Locations
Other Locations
Canada
Univerity of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Rahima A Bhanji, MD
rbhanji@ualberta.ca
780-492-2235
Backup
Nadia Shular, RN
nadiashular@ualberta.ca
587-588-7231
Time Frame
Start Date: 2022-05-15
Estimated Completion Date: 2034-02-15
Participants
Target number of participants: 94
Treatments
Active_comparator: Envarsus
Envarsus tablet Dose 0.11 - 0.13 mg/Kg/day Frequency: once per day
Other: Prograf (SOC)
Prograf tablet Dose 0.10 - 0.15mg/Kg daily Frequency: 2 doses per day (dose above split in half for each dose)
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov