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Study on the Effects of Tacrolimus on Blood Sugar Levels in Patients Undergoing Dialysis Before Kidney 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 the medication tacrolimus on patients undergoing hemodialysis, which is a treatment for kidney failure that helps filter waste and water from the blood. The purpose of the study is to evaluate how tacrolimus affects the way the body processes carbohydrates, which are sugars and starches that the body uses for energy, in patients who are on dialysis and awaiting a kidney transplant.

Participants in the study will receive tacrolimus orally, which means they will take it by mouth. The study will last for a period of 14 days. During this time, researchers will monitor changes in the participants' glycemic profile, which refers to the levels of sugar in the blood. The goal is to determine if there is a significant change in blood sugar levels from the start of the treatment to the end of the 14-day period.

This study is important for understanding how tacrolimus might affect blood sugar levels in patients who are on dialysis and preparing for a kidney transplant. The findings could help improve the management of these patients' conditions and provide insights into the safe use of tacrolimus in this specific group of patients.

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, eligibility is confirmed based on criteria such as being 18 years or older, being a hemodialysis patient eligible for a kidney transplant, and having the ability to understand the protocol and provide informed consent.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish a baseline glycemic profile. This involves measuring blood sugar levels before starting the treatment with tacrolimus.

  3. Step 3

    Treatment with tacrolimus

    The treatment involves taking tacrolimus orally. The specific dosage and frequency are determined by the study protocol and are administered under medical supervision.

    The treatment duration is 14 days, during which the effect of tacrolimus on carbohydrate metabolism is monitored.

  4. Step 4

    Follow-up assessment

    After 14 days of treatment, a follow-up assessment is conducted to evaluate any changes in the glycemic profile. This involves measuring blood sugar levels again to determine the impact of tacrolimus.

  5. Step 5

    Completion of study participation

    Upon completion of the follow-up assessment, participation in the study concludes. The results contribute to understanding the effect of tacrolimus on carbohydrate metabolism in hemodialysis patients.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Eligible for a **kidney transplant** at Nantes University Hospital.
  • Currently undergoing **hemodialysis** at one of the participating centers. Hemodialysis is a treatment that helps clean your blood when your kidneys are not working well.
  • Able to understand the proposed study plan and have given **free and informed consent**. This means you agree to participate after being fully informed about the study.
  • Must have **social security coverage**.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing hemodialysis. Hemodialysis is a treatment that helps clean the blood when the kidneys are not working properly.
  • Patients who are not within the specified age range for the study. The study is looking for participants in certain age groups.
  • Patients who are not part of the specified clinical trial groups. The study is targeting specific groups of patients.
  • Patients who are considered part of a vulnerable population. This means people who might need extra protection or care.
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Investigated drugs

Tacrolimus is a medication used in this clinical trial to evaluate its effect on carbohydrate metabolism in patients undergoing dialysis before a kidney transplant. The main goal is to determine how many patients experience changes in their blood sugar levels while taking Tacrolimus. This medication is commonly used to prevent organ rejection in transplant patients by suppressing the immune system.

What is already known about the treatment

Tacrolimus – Tacrolimus is typically administered orally in the form of capsules or as an injection. It is currently well-established in medical literature as an immunosuppressive medication, primarily used to prevent organ rejection in transplant patients. In this clinical trial, it is being evaluated for its effects on carbohydrate metabolism in patients undergoing hemodialysis. Tacrolimus works by inhibiting calcineurin, a protein involved in activating T-cells of the immune system, thereby reducing immune responses. It is classified as a calcineurin inhibitor.

Investigated diseases

Chronic Kidney Disease – Chronic Kidney Disease (CKD) is a long-term condition where the kidneys do not work as well as they should. It often progresses slowly over time, leading to a gradual loss of kidney function. As the disease advances, waste products and excess fluids can build up in the body, causing symptoms like swelling, fatigue, and high blood pressure. In severe cases, CKD can lead to kidney failure, requiring dialysis or a kidney transplant. The progression of CKD can vary greatly among individuals, influenced by factors such as underlying health conditions and lifestyle choices. Regular monitoring and management are essential to slow the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514072-40-00Protocol codeCHD045-17Estimated enrolment20 patientsSponsorCentre Hospitalier Departemental Vendee

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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).