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Compares treatment options for Liver Transplantation
Official title Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations
ClinicalTrials.gov ID: NCT05089604
What this study is testing
What is Tacrolimus, Immediate Release, Oral?
Tacrolimus, Immediate Release, Oral is an investigational medicine, given as an once-daily, being studied as a potential treatment for liver transplantation.
Also referred to as Tacrolimus, Sandoz, Prograf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Informed consent
You likely can't join if
- 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
- Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
- Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
See the full eligibility criteria
- 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
- Informed consent
- 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
- Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)
- Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes
- Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents
- Baseline TSH, T3, T4 indicating hyperthyroidism
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.