Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations

Launched by UNIVERSITY OF BRITISH COLUMBIA · Oct 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how two different forms of a medication called tacrolimus may affect liver transplant patients in terms of tremors. Tacrolimus is used to help prevent the body from rejecting a new liver after a transplant. The study compares an extended-release version of the medication, which patients take once a day, with the immediate-release version, which is taken twice a day. The main goal is to see if one version is better than the other at reducing the risk of tremors, which can be a side effect of the medication.

To participate in this trial, you need to be an adult who has just received your first liver transplant and is starting tacrolimus within a week after the surgery. You should have good kidney function and be able to provide informed consent. However, if you have had a previous organ transplant, need dialysis, or have certain medical conditions like a history of tremors, you may not be eligible. If you join the study, you will be monitored for any side effects and receive care as part of your ongoing treatment. This trial is currently recruiting participants, so if you're interested, this could be a chance to contribute to important research while receiving necessary post-transplant care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 18 years or older
• • 2. Recipients of a first-time liver transplant
• • 3. eGFR more than 30 ml/min on the day of tacrolimus initiation
• • 4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant
• • 5. Informed consent
• Exclusion Criteria:
• • 1. Recipients of prior organ transplant
• • 2. Need for hemodialysis either prior or following liver transplantation
• • 3. Recipients of living donor liver or split deceased donor liver allografts
• • 4. Recipients of combined liver/kidney transplants
• • 5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
• • 6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
• • 7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents
• • 8. Baseline TSH, T3, T4 indicating hyperthyroidism