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Study on the Effects of Tacrolimus and Mycophenolate Mofetil in Patients After Liver Transplantation

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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 effects of certain medications in patients who have undergone a liver transplantation. The medications being tested are Envarsus, Advagraf, and CellCept. These drugs are known as immunosuppressants, which help prevent the body from rejecting the new liver. The study aims to evaluate the benefits of taking these medications as a single daily dose over the first year after the transplant.

The trial will compare two different forms of the drug tacrolimus, which are Envarsus and Advagraf, to see if they are equally effective in preventing treatment failure. Treatment failure is defined as any of the following events: patient death, loss of the transplanted liver, or acute rejection of the liver, which is confirmed by a biopsy. The study will also compare the effects of taking CellCept once a day versus twice a day.

Participants in the study will be monitored for up to 18 months after their liver transplant. The study will look at various outcomes, including the proportion of deaths, loss of the transplanted liver, and cases of acute rejection. It will also assess the quality of life and any side effects experienced by the participants. The goal is to determine the most effective and safe way to administer these immunosuppressive drugs to liver transplant recipients.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be enrolled as a liver transplant recipient. The study focuses on evaluating the benefits of administering immunosuppressive drugs as single daily doses over the first year after transplantation.

  2. Step 2

    Initial medication administration

    The patient will begin taking Envarsus and Advagraf, which are forms of tacrolimus, a medication used to prevent organ rejection. These are prolonged-release tablets and capsules taken orally once daily.

    The patient will also take CellCept, which contains mycophenolate mofetil, another medication to prevent rejection. This is available in film-coated tablets and capsules, also taken orally.

  3. Step 3

    Medication dosage and frequency

    The specific dosage of Envarsus and Advagraf will vary, with available strengths including 0.5 mg, 0.75 mg, 1 mg, 3 mg, and 5 mg for Advagraf, and 0.75 mg, 1 mg, and 4 mg for Envarsus.

    For CellCept, the available strengths are 250 mg and 500 mg. The frequency of administration is once daily for all medications.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the patient will be monitored for treatment effectiveness and any potential side effects. The primary focus is on preventing treatment failure, which includes patient death, graft loss, or acute rejection.

    The study will compare the effectiveness of different dosing strategies, including once daily (QD) versus twice daily (BID) administration of mycophenolate mofetil.

  5. Step 5

    Study duration

    The study will last for 18 months post-transplantation, with evaluations at 6 months and 18 months to assess the outcomes of the treatment strategies.

Who can join the trial?

6 criteria

  • Male and female patients, aged 18 and older.
  • Recipients of a first liver **allograft** from a deceased donor. An allograft is a transplanted organ or tissue from a donor.
  • Transplanted for less than four weeks at enrollment.
  • Without any current progressive life-threatening or graft-threatening disease. This means the patient should not have any serious illness that could endanger their life or the transplanted organ.
  • Having signed a written informed consent for their participation in the study. This means the patient agrees to join the study after understanding all the details.
  • Affiliated to, or beneficiary of, a social security regimen. This means the patient should be part of a social security system or have similar benefits.

Who cannot join the trial?

4 criteria

  • Patients who have not received a liver transplant.
  • Patients who are younger than 18 years old.
  • Patients who are older than 65 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • ENVARSUS®

    is a medication used in liver transplant patients to help prevent the body from rejecting the new liver. It is an immunosuppressive drug, which means it works by suppressing the immune system to prevent it from attacking the transplanted organ. In this trial, it is being evaluated to see if it can be effectively administered once daily.

  • MMF

    (Mycophenolate Mofetil) is another immunosuppressive medication used to prevent organ rejection in liver transplant patients. It is being studied to determine if taking it once daily is as effective as taking it twice daily in preventing treatment failure.

  • ADVAGRAF®

    is an extended-release form of tacrolimus, another immunosuppressive drug used in liver transplant patients. This trial is comparing its effectiveness when taken once daily to that of ENVARSUS® to see if they are equivalent in preventing treatment failure.

What is already known about the treatment

  • Envarsus

    This medication is administered orally in the form of extended-release tablets. It is currently used in the medical field for patients who have undergone liver transplantation, with ongoing research to optimize its dosing schedule. The main therapeutic indication for Envarsus is to prevent organ rejection in transplant recipients. At the molecular level, it works by inhibiting calcineurin, which reduces the activity of T-cells, a type of immune cell, thereby suppressing the immune response. Envarsus is classified as an immunosuppressant.

  • Advagraf

    This medication is also administered orally as extended-release capsules. It is used in the medical community for liver transplant patients, with studies evaluating its effectiveness compared to other dosing regimens. The primary therapeutic use of Advagraf is to prevent organ rejection following transplantation. Its mechanism of action involves inhibiting calcineurin, leading to decreased T-cell activity and a suppressed immune response. Advagraf is categorized as an immunosuppressant.

Investigated diseases

Liver Transplantation – Liver transplantation is a surgical procedure that involves replacing a diseased liver with a healthy liver from a donor. This procedure is typically considered when the liver no longer functions properly due to conditions such as cirrhosis, liver cancer, or acute liver failure. After the transplant, the recipient's body may recognize the new liver as foreign and attempt to reject it, which is why immunosuppressive medications are necessary to prevent rejection. Over time, the body may adapt to the new liver, but ongoing monitoring and medication adjustments are often required. The success of the transplant can be influenced by factors such as the recipient's overall health, the condition of the donor liver, and adherence to medical advice.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506601-19-00Protocol code87RI23_0031Estimated enrolment200 patientsSponsorCentre Hospitalier Et Universitaire De Limoges

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