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Study on Reducing Tacrolimus Dose in Kidney Transplant Patients Using LCPT Compared to Tacrolimus-ER

Verified siteRegistered drugNo placebo
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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 patients who have undergone a kidney transplant due to kidney failure. The study is examining the use of a medication called tacrolimus, which is commonly used to help prevent the body from rejecting a transplanted kidney. The trial involves two different forms of tacrolimus: Advagraf and Envarsus, both of which are prolonged-release medications. These medications are designed to release the active ingredient slowly over time, which can help maintain stable levels in the body.

The purpose of the study is to determine if the dose of Envarsus can be reduced compared to Advagraf while still maintaining effective levels of tacrolimus in the body. Participants in the study will take one of these medications orally, and their tacrolimus levels will be monitored to ensure they remain within a therapeutic range. The study will also look at whether switching to Envarsus results in fewer pills to take, fewer side effects, and more consistent medication levels in the body.

Throughout the study, researchers will also explore if certain genetic factors, like the presence of the CYP3A5*1 allele, should be considered when prescribing these medications. The trial aims to provide insights into the best dosing strategies for patients who require higher doses of tacrolimus to prevent organ rejection. The study is expected to continue until early 2026.

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 specific criteria. Participants must be between 18 and 70 years old, have stable kidney function, and be at least six months to five years post-transplantation. Participants must not be immunized and must have stable tacrolimus levels.

    Participants must provide written consent and agree to use effective contraception if applicable.

  2. Step 2

    Initial medication phase

    Participants will begin taking one of the following medications: Advagraf or Envarsus. These are prolonged-release forms of tacrolimus, taken orally.

    The specific dosage will be determined by the study team, based on individual needs and current tacrolimus levels.

  3. Step 3

    Monitoring and adjustment

    Regular monitoring of tacrolimus levels will occur to ensure they remain within the therapeutic range. Adjustments to the dosage may be made to maintain these levels.

    The study aims to evaluate if the dose of LCPT (a form of tacrolimus) can be reduced while maintaining effective levels.

  4. Step 4

    Evaluation of outcomes

    The study will assess if the switch to LCPT results in a lower pill burden and fewer side effects.

    Additional evaluations will include the variability in tacrolimus levels and the impact of genetic factors on medication effectiveness.

  5. Step 5

    Completion of study

    The study is expected to conclude by January 11, 2026. Participants will be informed of the outcomes and any further steps if necessary.

Who can join the trial?

9 criteria

  • Patients must be between the ages of 18 and 70.
  • Patients should have a stable renal function, meaning their kidney function is not changing rapidly.
  • Patients must be at least 6 months to 5 years after their first kidney transplant.
  • Patients should not be immunized with a PRA (Panel Reactive Antibody) level of less than 5%. This means their immune system is not highly reactive to foreign tissues.
  • Patients must have therapeutic tacrolimus concentrations between 4-9 ng/L. Tacrolimus is a medication used to prevent organ rejection.
  • Patients should be on a stable dose of tacrolimus, meaning they have been taking the same amount of the extended-release form of the medication for the last month.
  • Patients must have a C/D ratio of less than 1.05 ng/mL×1/mg. This is a measure of how the body processes the medication.
  • Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.
  • Patients who can have children must agree to use highly effective methods of contraception during the study to prevent pregnancy.

Who cannot join the trial?

1 criterion

  • Patients who have **kidney failure** and need a **kidney transplant** cannot participate. **Kidney failure** means the kidneys are not working well enough to keep you healthy.
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Verified sites

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  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • LCPT

    is a form of tacrolimus that is being studied to see if its dose can be reduced while still maintaining effective levels in the body. Tacrolimus is a medication used to prevent organ rejection in transplant patients by suppressing the immune system.

  • Tacrolimus-ER

    is an extended-release version of tacrolimus. It is designed to be taken less frequently than regular tacrolimus, providing a more convenient dosing schedule for patients while still helping to prevent organ rejection.

What is already known about the treatment

Tacrolimus – Tacrolimus is typically administered orally in the form of capsules or as an extended-release tablet. It is currently well-established in medical practice and literature, primarily used to prevent organ rejection in patients who have undergone a kidney transplant. The medication works by suppressing the immune system, specifically by inhibiting the activity of T-lymphocytes, which are cells that can attack the transplanted organ. Tacrolimus is classified as an immunosuppressant.

Investigated diseases

Kidney Failure – Kidney failure occurs when the kidneys lose their ability to filter waste and excess fluids from the blood effectively. This condition can develop suddenly or progress over time, often due to chronic diseases like diabetes or high blood pressure. As kidney function declines, waste products and fluids can build up in the body, leading to symptoms such as swelling, fatigue, and difficulty concentrating. In advanced stages, kidney failure may require dialysis or a kidney transplant to manage the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515542-16-03Protocol codeNL73399.018.20Estimated enrolment25 patientsSponsorAmsterdam UMC Stichting

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