Extended-Release Tacrolimus Following Liver Transplantation
Recruiting
Phase 4
Interventional Study
Liver Transplant; Complications
Renal Insufficiency
Immunosuppressant Adverse Reaction
Metabolic Syndrome
Cardiovascular Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 94 (estimated)
- Sponsor
- University of Alberta · Other
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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
\- Adult individuals transplanted at the University of Alberta
Exclusion Criteria:
* Individuals with congenital long QT syndrome
* Patients with elevated bilirubin \> 100 umol/L post-LT (at day 3)
* Patients with chronic kidney disease (eGFR \< 45 ml per minute per 1.73 m2)
*…
Contacts