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Study on How Tacrolimus Monohydrate and Mycophenolate Mofetil Affect Gut Bacteria in Patients with Chronic Kidney Disease After Transplant

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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 used after a kidney transplant, specifically in patients with chronic kidney disease. The medications being studied are Tacrolimus and mycophenolate mofetil. These drugs are commonly used to prevent the body from rejecting a new kidney after a transplant. The purpose of the study is to understand how these medications interact with the gut microbiota, which is the community of microorganisms living in the digestive tract, and how this interaction affects the way the body processes these drugs.

Participants in the study will receive either Tacrolimus or mycophenolate mofetil, or a combination of both, as part of their regular treatment after a kidney transplant. The study will observe changes in the gut microbiota and how these changes might influence the effectiveness and processing of the medications. The study will also involve monitoring the participants over a period of time to gather data on how the medications are absorbed and metabolized in the body.

The study aims to provide insights into the variability of how different patients respond to these immunosuppressant drugs, which are crucial for the success of kidney transplants. By understanding these differences, the study hopes to improve treatment plans and outcomes for future patients undergoing kidney transplants. Participants will be monitored closely throughout the study to ensure their safety and to collect necessary data for the research.

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

    Participation begins after a diagnosis of chronic renal failure and a planned kidney transplantation from a living donor.

    Eligibility includes being between 18 and 75 years old, with a body mass index (BMI) between 18 and 35 kg/m².

  2. Step 2

    Initial treatment phase

    The treatment involves a combination of tacrolimus monohydrate and mycophenolate mofetil, both taken orally.

    These medications are part of the immunosuppressive treatment to prevent organ rejection after transplantation.

  3. Step 3

    Monitoring and data collection

    Regular monitoring of drug levels in the body is conducted to understand how the medications are processed.

    The study focuses on the variability in how these drugs are absorbed and metabolized, influenced by changes in gut bacteria after transplantation.

  4. Step 4

    Evaluation of outcomes

    The primary outcomes include understanding the pharmacokinetics of the immunosuppressive drugs, which refers to how the body absorbs, distributes, metabolizes, and excretes these medications.

    The study also examines the composition and function of gut bacteria and the pharmacokinetics of antibiotics.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 31, 2026.

    The findings aim to improve understanding of drug variability and potentially enhance treatment strategies for kidney transplant patients.

Who can join the trial?

6 criteria

  • The patient must have a diagnosis of chronic renal failure, which means their kidneys are not working as well as they should over a long period.
  • The patient should be scheduled for a kidney transplantation from a living donor, meaning they will receive a kidney from someone who is still alive.
  • The patient must be receiving care at Cliniques universitaires Saint-Luc.
  • The patient's treatment must include a combination of two specific medications: Tacrolimus (also known as Advagraft) and mycophenolate mofetil (also known as Cellcept). These are medications that help prevent the body from rejecting the new kidney.
  • The patient should be between the ages of 18 and 75 at the time they join the study.
  • The patient should have a BMI (Body Mass Index) between 18 and 35 kg/m2. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

1 criterion

  • Patients with chronic renal failure cannot participate. This means their kidneys are not working well for a long time.
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Investigated drugs

  • Tacrolimus

    is a medication used to prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system to stop it from attacking the new organ. In this trial, researchers are studying how the body's processing of Tacrolimus can vary and how it might be affected by changes in gut bacteria after a kidney transplant.

  • Mycophenolate mofetil

    is another medication used to prevent organ rejection in kidney transplant patients. It also works by weakening the immune system to help the body accept the new kidney. The trial aims to understand how the body's handling of Mycophenolate mofetil can differ among patients and how these differences might be linked to changes in gut bacteria after the transplant.

What is already known about the treatment

  • Tacrolimus

    Tacrolimus is administered orally or intravenously and is commonly used in the form of capsules or injections. It is widely recognized in medical literature as an essential immunosuppressant, particularly in the context of organ transplantation. The primary therapeutic indication for Tacrolimus is to prevent organ rejection after a kidney transplant. At the molecular level, Tacrolimus works by inhibiting calcineurin, which in turn reduces the activity of T-cells, a type of immune cell. It is classified as a calcineurin inhibitor in pharmacology.

  • Mycophenolate mofetil

    Mycophenolate mofetil is typically administered orally in the form of tablets or capsules. It is well-documented in medical literature as an immunosuppressant used to prevent organ rejection, especially after kidney transplants. The main therapeutic use of Mycophenolate mofetil is to suppress the immune system to prevent the body from rejecting a transplanted organ. Its mechanism of action involves inhibiting an enzyme called inosine monophosphate dehydrogenase, which is crucial for the proliferation of T and B lymphocytes. This medication is classified as an antimetabolite in pharmacology.

Investigated diseases

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can vary, with some people experiencing a slow decline in kidney function, while others may see a more rapid deterioration. Over time, chronic kidney disease can lead to complications such as high blood pressure, anemia, and bone disease. Regular monitoring and lifestyle adjustments are often necessary to manage the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508335-31-00Protocol codeENIGMAEstimated enrolment50 patientsSponsorUniversite Catholique de Louvain

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