Extended-Release Tacrolimus Following Liver Transplantation
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.
Timeline
- Start
- 2022-05-15
- Primary completion
- 2026-12-15
- Completion
- 2034-02-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.11 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.13 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.15 mg/kg | Oral |