Active not recruitingPHASE4INTERVENTIONAL

Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients

This study is for people who have recently had a liver transplant. It compares two different forms of a medicine called tacrolimus, which helps stop your body from rejecting the new liver. These medicines are called Envarsus and Advagraf. Half of the participants will receive Envarsus and the other half will receive Advagraf. Doctors will regularly check the levels of the medicine in your blood to see how well it's absorbed and if it's easier to keep the levels stable with one medicine over the other. The study aims to find out if Envarsus is better absorbed by the body, which could lead to better results after your transplant. They'll also look at how safe and effective each medicine is over three years.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Edward Geissler

Enrolment target

268

Start

23 Dec 2020

Estimated completion

01 Oct 2026

Prophylaxis Against Liver Transplant Rejection

What is this study about?

When you have a liver transplant, your body might see the new organ as something foreign and try to fight it off. This is called rejection. To prevent this, you'll need to take special medicines called immunosuppressants. Tacrolimus is one of the most common and important medicines used for this purpose.

This study specifically looks at two different versions of tacrolimus: Envarsus and Advagraf. Both are designed to be taken once a day, but they are made in slightly different ways. The researchers believe that Envarsus might be absorbed into your bloodstream more effectively than Advagraf. If a medicine is absorbed better, it might mean you need a lower dose, or it could be easier to keep the right amount of medicine in your body.

The main goal is to compare how well your body absorbs Envarsus versus Advagraf. They'll also be watching to see if one medicine makes it easier for doctors to control the levels in your blood, and if this difference in absorption leads to better health outcomes and fewer problems for you over three years. Understanding this could help doctors make better choices about which tacrolimus medicine to prescribe for future liver transplant patients.

Key takeaways

Compares two forms of tacrolimus (Envarsus vs. Advagraf) for liver transplant patients.
Aims to see if Envarsus is absorbed better and easier to manage.
Participation involves being randomly assigned to one of the two medicines.
You'll have regular blood tests and check-ups over three years.
The study helps improve future care for liver transplant patients.

Who may be eligible?

This study is open to adults aged 18 or over who have recently received a liver transplant. You must have received a full liver from a deceased donor, or a part of a liver from either a deceased or living donor. Your blood group must also match that of your organ donor, and you need to be able to swallow tablets or capsules.

There are several reasons why you might not be able to join. For example, if you've had other organ transplants in the past, or if you received more than one organ (like a liver and a kidney) during your recent surgery, you won't be eligible. Also, if you currently have a serious infection, or if there are any current signs that your body is rejecting the new liver, you can't participate.

Other reasons for not being able to join include having certain types of cancer that haven't been cured, or if you've had blood clots or blockages in the main blood vessels around your liver after your transplant. You also can't participate if you have an allergy to tacrolimus or similar medicines, or if you are pregnant or breastfeeding. Women who could become pregnant must be using effective contraception.

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?
Have you recently had a liver transplant (not a multi-organ transplant)?
Are you able to swallow tablets or capsules?
Are you *not* currently pregnant or breastfeeding?
Do you *not* have any active, serious infections or ongoing rejection?
Do you *not* have a known allergy to tacrolimus or similar medicines?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to receive either Envarsus or Advagraf. This means you have an equal chance of receiving either medicine, like flipping a coin. You would start your assigned medicine within two weeks of your liver transplant surgery.

Throughout the study, which lasts for three years, you'll have ten visits to the clinic. During these visits, doctors and nurses will take blood samples to measure the levels of your tacrolimus medicine and check your general health. They will carefully adjust your medication doses to make sure you have the right amount in your system. They will also look for any side effects or problems you might experience while on the medication.

It’s important to know that you'll continue to receive the usual care you would get as a liver transplant patient, with either Envarsus or Advagraf being part of your standard medication plan. The researchers will be closely monitoring how your body responds to the specific tacrolimus medicine you are taking.

Potential risks and benefits

Participating in this study might offer you careful and close monitoring of your health and medication levels, which is always beneficial after a major surgery like a liver transplant. While there's a chance you might receive a medication that proves to be better absorbed (Envarsus), it's also possible you could receive Advagraf, which is already a standard and effective treatment. Potential risks are generally those associated with any tacrolimus treatment, such as side effects, but you will be closely monitored for these. There's also the normal discomfort of blood tests during your visits. Remember, joining a clinical study is completely voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (15)

University Hospital Aachen
Verified postcode
Aachen, Germany
Charite - University Medicine Berlin
Verified postcode
Berlin, Germany
University Hospital Essen
Verified postcode
Essen, Germany
University Hospital Frankfurt
Verified postcode
Frankfurt, Germany
University Hospital Hamburg Eppendorf
Verified postcode
Hamburg, Germany
Hannover Medical School
Verified postcode
Hanover, Germany
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany
University Hospital Jena
Verified postcode
Jena, Germany
University Hospital Schleswig-Holstein - Campus Kiel
Verified postcode
Kiel, Germany
University Hospital Leipzig
Verified postcode
Leipzig, Germany
University Hospital Magdeburg
Verified postcode
Magdeburg, Germany
University Hospital Mainz
Verified postcode
Mainz, Germany

Common questions

What is tacrolimus and why is it important?

Tacrolimus is a medicine that helps prevent your body from rejecting a transplanted organ, like a new liver.

What's the main difference between Envarsus and Advagraf?

They are both forms of tacrolimus, but they are made differently, and researchers believe Envarsus might be absorbed better by your body.

How will I know which medicine I'm on?

You will be randomly assigned to one of the two medicines, so you won't be able to choose directly. Your doctor will know which you are receiving.

How long will I be in this study?

The study will involve regular check-ups and monitoring over a period of three years after your transplant.

Will my regular medical care be affected by joining?

No, your regular medical care as a liver transplant patient will continue, and the study medicines will be a part of that standard care.