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Study on Cognitive Function in Liver Transplant Patients Comparing Once-Daily and Twice-Daily Tacrolimus Formulations

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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 individuals who have undergone a liver transplant. The study is examining the effects of different formulations of a medication called Tacrolimus, which is commonly used to prevent the body from rejecting a transplanted organ. The trial compares two types of Tacrolimus: a once-daily version known as Envarsus and a twice-daily version known as Prograf. The main goal is to see if the once-daily formulation can improve patients' perception of their attention and memory.

Participants in the study will be taking either Envarsus or Prograf for a period of up to 12 months. During this time, their cognitive function, which includes attention and memory, will be assessed through various tests. These tests are designed to measure how well participants can focus, remember, and process information. Additionally, the study will look at the overall quality of life of the participants, which includes their physical and mental well-being.

The trial will also monitor any side effects or changes in liver and kidney function that may occur during the study. This information will help determine the safety and effectiveness of the once-daily Tacrolimus formulation compared to the twice-daily version. The study aims to provide valuable insights into how these medications can impact cognitive function and quality of life in liver transplant patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your current health status will be assessed, and you will complete a self-report questionnaire on attention and memory, known as the FEDA.

    Your quality of life will be measured using a questionnaire called SF36. Additionally, a close relative, partner, or care provider will assess your everyday executive function using the BAFQ.

  2. Step 2

    Medication administration

    You will be assigned to take one of two formulations of the medication tacrolimus. This medication is used to help prevent organ rejection after a liver transplant.

    If you are assigned to the twice-daily formulation, you will take Prograf capsules, which come in doses of 0.5 mg, 1 mg, or 5 mg. If you are assigned to the once-daily formulation, you will take Envarsus prolonged-release tablets, which come in doses of 0.75 mg, 1 mg, or 4 mg.

  3. Step 3

    Follow-up visits

    You will have follow-up visits at 6 months and 12 months after the initial visit. During these visits, your cognitive function will be assessed using several tests, including the Trail Making Test, Adaptive Digit Ordering Test, Digit Symbol Test, Regensburg Stream of Speech Test, and Victoria Stroop Test.

    Your quality of life will be reassessed using the SF36 questionnaire, and your everyday executive function will be reassessed using the BAFQ.

  4. Step 4

    Monitoring and documentation

    Throughout the trial, any significant changes in your health, including adverse events and laboratory results, will be documented at each visit.

    Your liver and kidney function will be monitored to ensure your safety while taking the medication.

Who can join the trial?

6 criteria

  • Provide written informed consent, which means you agree to participate after understanding the study details.
  • Be between the ages of 20 and 75 years old.
  • Have had a liver transplant at least 12 months ago.
  • Currently taking a twice-daily formulation of Tacrolimus, a medication used to prevent organ rejection.
  • Have been using the same twice-daily Tacrolimus medication for at least 3 months.
  • Have at least mild cognitive impairment, which means experiencing some difficulties with memory or thinking skills.

Who cannot join the trial?

1 criterion

  • Patients who have had a liver transplant cannot participate. A liver transplant is a surgery to replace a diseased liver with a healthy one from another person.
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Investigated drugs

Tacrolimus (Envarsus ®) is a medication used to help prevent the body from rejecting a transplanted liver. It works by suppressing the immune system, which is the body's defense system that can sometimes attack the new liver as if it were a harmful invader. In this clinical trial, the focus is on a once-daily formulation of Tacrolimus, which means patients take it just once a day. The study aims to see if this once-daily version can improve how patients feel about their attention and memory compared to taking Tacrolimus twice a day.

What is already known about the treatment

Envarsus – Envarsus is a medication taken orally, usually in the form of a tablet, and is used once daily. It is currently being studied in clinical trials to assess its effects on cognitive function in patients who have undergone a liver transplant. The main therapeutic use of Envarsus is to prevent the body from rejecting a transplanted liver. It works by suppressing the immune system at the molecular level, specifically by inhibiting a protein called calcineurin, which is crucial for activating immune cells. Envarsus belongs to a class of drugs known as immunosuppressants.

Investigated diseases

Liver Transplant Status – Liver transplant status refers to the condition of a person who has undergone a liver transplant surgery. This status involves the ongoing process of the body adapting to the new liver, which is a complex and gradual process. The transplanted liver must integrate with the recipient's body systems, and the immune system must be managed to prevent rejection. Over time, the body may show signs of acceptance or rejection of the new liver, which can affect overall health and function. The condition requires continuous monitoring to ensure the transplanted liver is functioning properly and to manage any complications that may arise. The progression of this condition is unique to each individual, depending on various factors such as the underlying cause of liver failure and the body's response to the transplant.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513963-22-00Protocol codeCoFu-01Estimated enrolment150 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).