RecruitingPHASE4INTERVENTIONAL

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

After a liver transplant, patients need special medicine called tacrolimus to stop their body from rejecting the new organ. However, this medicine can sometimes cause shaky hands, known as tremors. This study is looking at two ways to give tacrolimus: one that's taken once a day (extended-release) and another that's taken twice a day (immediate-release). Doctors want to find out if the once-a-day version causes fewer or less severe tremors. They hope this could improve the experience for people who have just had a liver transplant. By comparing these two common forms of medicine, the study aims to make treatment more comfortable and effective for patients.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of British Columbia

Enrolment target

124

Start

09 Jan 2023

Estimated completion

31 Dec 2026

Liver Transplantation Immunosuppression Neurotoxicity Tremor Tacrolimus

What is this study about?

When someone has a liver transplant, they need medicines called immunosuppressants to prevent their body from attacking and rejecting the new liver. Tacrolimus is a very important and common medicine used for this purpose. While it's great at protecting the new liver, it can sometimes cause side effects, like shaky hands, which doctors call tremors. These tremors can be uncomfortable and might make daily tasks difficult for patients early after their transplant.

This study is designed to compare two different ways of taking tacrolimus. One is an 'immediate-release' version, which means the medicine gets into your system quickly and is usually taken twice a day. The other is an 'extended-release' version, which releases the medicine slowly over time, so it only needs to be taken once a day. Doctors want to see if the extended-release, once-a-day version leads to fewer or less severe tremors compared to the immediate-release version.

The main goal is to find a way to give effective anti-rejection medicine that also has fewer side effects. This could make a big difference in how comfortable and easy a patient's recovery is after a liver transplant, helping them feel better sooner. The study will carefully check for tremors using special sensors and ask patients about their experiences, hoping to improve future care for liver transplant patients.

Key takeaways

Compares two forms of a key anti-rejection medicine after liver transplant.
Aims to find out if one medicine causes fewer shaky hands (tremors).
Uses special sensors to measure tremors accurately.
Could help make recovery from liver transplant more comfortable.
Participation lasts for about 8 weeks after your transplant.

Who may be eligible?

To join this study, you must be an adult aged 18 or older who has just received your first ever liver transplant. Your kidneys should be working well, and you must be able to start the tacrolimus medicine within seven days of your transplant. You'll also need to understand and agree to take part by giving your informed consent.

You cannot join if you've had an organ transplant before, or if you need kidney dialysis (either before or after your liver transplant). If you received a liver from a living donor, a split deceased donor, or a combined liver/kidney transplant, you also won't be able to take part. Patients whose donor had Hepatitis C virus (HCV) or who had shaky hands (tremors) before their transplant (like from Parkinson's disease) won't be eligible.

Additionally, if you're taking other medicines known to cause tremors, or if blood tests show you have an overactive thyroid, you wouldn't be able to participate. These rules help make sure the study results are clear and focused on the effects of the specific tacrolimus medicines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Is this your first liver transplant?
Is your new liver from a deceased donor (not split or living donor)?
Did you not have shaky hands (tremors) before your transplant?
Do you not need kidney dialysis?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you will be randomly assigned to receive one of two types of tacrolimus medicine: either the standard immediate-release medicine (taken twice a day) or the new extended-release medicine (taken once a day). This decision is made by chance, like flipping a coin. You will also receive other standard medicines for transplant patients, such as mycophenolate and short-term steroids.

Throughout the study, which will last for about 8 weeks after your transplant, doctors will regularly monitor your health. They will pay special attention to whether you experience any shaky hands (tremors) and how severe they might be, using special wearable sensors to get accurate measurements. You'll have regular hospital visits for check-ups, blood tests, and to discuss any side effects or how you're feeling. The medical team will be there to support you and answer any questions during this time.

Potential risks and benefits

Taking part in this study might offer a potential benefit if you receive the extended-release tacrolimus and it causes fewer tremors, making your recovery more comfortable. All treatments for liver transplant carry risks, and tacrolimus itself has known side effects, including tremors. The study involves taking established medicines, but potential risks include those typically associated with tacrolimus, such as kidney problems, headaches, or other side effects, although the treatment aims to reduce one specific side effect. You can choose to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is tacrolimus for?

Tacrolimus is a medicine given after a liver transplant to stop your body from rejecting the new organ.

What are tremors?

Tremors are involuntary shaky movements, often in the hands, which can be a side effect of tacrolimus.

How will I know which medicine I'm getting?

This is an 'open label' study, meaning both you and your doctor will know which form of tacrolimus you are receiving.

How long will the study last for me?

Your participation in the study will focus on the first 8 weeks after your liver transplant.

Will my regular transplant care change?

No, your general care for your liver transplant recovery will continue as usual, with the study focusing on monitoring your tacrolimus medicine and side effects.

How to find out more

Trana Hussaini

trana.hussaini@vch.ca 6043284930 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.