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Study Comparing Tacrolimus Formulations for Preventing Liver Transplant Rejection in New Adult Recipients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of two medications, Envarsus and Advagraf, in patients who have recently received a liver transplant. The main goal is to see how well these medications work in preventing the body from rejecting the new liver. Both medications contain the active ingredient tacrolimus, which is used to suppress the immune system and help the body accept the transplanted organ. The study will compare the two medications to determine which one is more effective in maintaining the right levels of the drug in the body over time.

Participants in the study will be randomly assigned to receive either Envarsus or Advagraf after their liver transplant. The study will last for up to three years, with regular check-ups to monitor the levels of the medication in the blood and assess the health of the liver. The study will also track any side effects or complications that may arise during the treatment period. The aim is to find out which medication provides better control of drug levels, which can help improve the overall success of the liver transplant.

Throughout the study, participants will take their assigned medication once daily in the form of a prolonged-release tablet or capsule. This means the medication is designed to release slowly into the body over time, helping to maintain a steady level of the drug. The study will also look at how practical and easy it is for patients to take these medications as part of their daily routine. By comparing the two medications, researchers hope to provide valuable information that can help improve treatment options for liver transplant patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide signed and dated written informed consent.
The patient must be an adult, 18 years or older, and have received a liver transplant from a compatible donor.
The patient must be able to swallow oral formulations of the medication.
Step 2
Medication administration
The patient will be randomly assigned to receive either Envarsus or Advagraf, both of which are forms of the medication tacrolimus.
Envarsus is available in 0.75 mg, 1 mg, and 4 mg prolonged-release tablets, while Advagraf is available in 0.5 mg, 1 mg, 3 mg, and 5 mg prolonged-release capsules.
The medication is taken orally once daily.
Step 3
Monitoring and adjustments
The patient's medication dosage may be adjusted based on the concentration of the drug in the blood, known as the C/D ratio (concentration/dose ratio).
This ratio is measured at 12 weeks and may also be assessed at 1, 2, and 3 years.
The number of dose adjustments and the time to reach the target drug level will be recorded.
Step 4
Follow-up assessments
The patient will undergo regular assessments to monitor liver function, metabolic profile, and renal function at 12 weeks and at 1, 2, and 3 years.
The incidence of any adverse events, such as infections or new health conditions, will be documented.
The study will also track the occurrence of any rejection episodes, graft failure, or other complications.
Step 5
Study completion
The study is expected to conclude by December 31, 2026.
The patient's participation will be evaluated based on the continuation rate and any reasons for withdrawal from the study.

Who can join the trial?

5 criteria

Must provide a signed and dated written informed consent, which means you agree to participate in the study after being informed about it.
Must be an adult, which means you are 18 years old or older.
Must have received a whole liver transplant from a deceased donor or a split liver transplant from either a deceased or living donor.
Must have an ABO blood type that is compatible with the organ donor. This means your blood type must match with the donor's blood type.
Must be able to swallow tacrolimus, which is a medication, in the form of a tablet or capsule.

Who cannot join the trial?

4 criteria

Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
Patients who have not received a liver transplant are excluded. The study is for those who have had a liver transplant.
Patients who are not taking tacrolimus, a medication used to prevent organ rejection, are excluded. The study involves comparing two forms of this medication.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Goethe University Frankfurt
Frankfurt, Germany

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Investigated drugs

Envarsus
is a medication used to help prevent the body from rejecting a new liver after a transplant. It is a once-daily formulation of tacrolimus, which is an immunosuppressant. This means it helps to lower the body's immune response to prevent it from attacking the new liver.
Advagraf
is another once-daily formulation of tacrolimus, similar to Envarsus. It is also used to prevent organ rejection in liver transplant patients by suppressing the immune system. The study aims to compare the effectiveness and practicality of Envarsus and Advagraf in new liver transplant recipients.

Tacrolimus

What is already known about the treatment

Envarsus
Envarsus is administered orally in the form of extended-release tablets. It is currently being studied in clinical trials to assess its bioavailability and effectiveness compared to other formulations. The main therapeutic use of Envarsus is to prevent organ rejection in adult patients who have received a liver transplant. At the molecular level, it works by inhibiting calcineurin, which reduces the activity of T-cells, a type of immune cell, thereby preventing the immune system from attacking the transplanted organ. Envarsus belongs to the pharmacological class of immunosuppressants.
Advagraf
Advagraf is also administered orally as extended-release capsules. It is widely used in clinical practice and literature for preventing organ rejection in liver transplant recipients. Its primary therapeutic indication is similar to Envarsus, focusing on the prevention of transplant rejection. The mechanism of action involves the inhibition of calcineurin, leading to decreased T-cell activity and reduced immune response against the transplanted organ. Advagraf is classified as an immunosuppressant.

Investigated diseases

Transplant Rejection – Transplant rejection occurs when the recipient's immune system identifies the transplanted organ as foreign and attacks it. This immune response can lead to inflammation and damage to the transplanted organ. Rejection can be acute, happening shortly after the transplant, or chronic, developing over a longer period. Symptoms may include fever, pain at the transplant site, and changes in organ function. The severity and progression of rejection can vary, potentially affecting the long-term success of the transplant. Monitoring and managing the immune response is crucial to prevent or minimize rejection.