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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Urhiasrzqeavzofgozgqu Egstt Avx Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.12.2020

Trial locations

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.

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 ID:
2024-513963-22-00
Protocol code:
CoFu-01
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Human Albumin Treatment to Prevent Kidney Dysfunction in Adult Patients After Liver Transplantation

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  • Safety Study of Regulatory T Cells (Treg02) and Tacrolimus Discontinuation in Adult Liver Transplant Recipients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Germany