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Study to Evaluate the Effectiveness of Pre-emptive Genotyping to Optimize Tacrolimus Dosage in Patients with Chronic Kidney Disease Awaiting Transplant

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 focuses on patients with chronic kidney disease who are awaiting a kidney transplant. The study aims to evaluate the effectiveness of a strategy that uses genetic testing to optimize the dosage of tacrolimus, a medication that helps prevent organ rejection after a transplant. Tacrolimus is an immunosuppressor, which means it helps to suppress the immune system to prevent it from attacking the new kidney.

Participants in the study will receive one of several forms of tacrolimus, including Conferoport, Tacrolimus STADA, Advagraf, Modigraf, Adoport, Envarsus, or Prograf. These medications are administered orally, either as capsules, tablets, or granules. Some participants may receive a placebo. The study will last for a maximum of 26 weeks, during which the effectiveness of the genetic testing strategy in achieving the desired levels of tacrolimus in the blood will be assessed.

The purpose of the study is to determine if using genetic information before the transplant can help in adjusting the tacrolimus dose more effectively, potentially improving outcomes for patients. The trial will also look at the cost-effectiveness of this approach, as well as monitor for any side effects or adverse events related to the treatment. The ultimate goal is to enhance the safety and effectiveness of tacrolimus therapy in kidney transplant patients.

The research process

The trial runs in 6 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, participants must provide written informed consent. This is a document that confirms understanding and agreement to participate in the study.

    Participants must be on the waiting list for a kidney transplant and have not undergone any genotyping tests for the CYP3A5 gene.

  2. Step 2

    Medication administration

    Participants will receive tacrolimus, a medication used to help prevent organ rejection after a kidney transplant.

    The medication is administered orally in various forms, including prolonged-release capsules, hard capsules, oral suspension, and prolonged-release tablets.

    The specific product and dosage will be determined based on individual needs and the study protocol.

  3. Step 3

    Monitoring and adjustments

    Tacrolimus blood levels will be monitored to ensure they are within the therapeutic range of 7-10 ng/ml by day 4, with a margin of one day.

    Adjustments to the dosage may be made based on these levels to optimize effectiveness and minimize side effects.

  4. Step 4

    Evaluation of effectiveness

    The study aims to evaluate the effectiveness of a pre-emptive genotyping strategy in achieving target tacrolimus levels.

    Effectiveness will be assessed by the number and percentage of participants reaching the target plasma concentrations.

  5. Step 5

    Monitoring for adverse events

    Participants will be monitored for any adverse events related to the treatment.

    The rate of adverse events and any necessary treatment modifications will be recorded.

  6. Step 6

    Completion of the study

    The study is estimated to end by March 3, 2027.

    Participants will be followed up for the majority of the study duration to ensure comprehensive data collection and analysis.

Who can join the trial?

5 criteria

  • Participants must be willing and able to provide written informed consent before starting any study procedures. This means they agree to join the study and understand what it involves.
  • The participant or their legally authorized representative must have voluntarily signed the informed consent document. This is a form that shows they agree to participate.
  • The participant must be on the waiting list for a kidney transplant. This means they are waiting to receive a new kidney.
  • The participant must be able and willing to take part in the study for most of its duration and follow the procedures outlined in the study plan.
  • Participants must not have had any genotyping test for the gene CYP3A5. Genotyping is a test that looks at specific genes to understand how they might affect a person's response to certain medications.

Who cannot join the trial?

1 criterion

  • Individuals who have had a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into someone whose kidneys no longer function properly.
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Investigated drugs

Tacrolimus is a medication used to help prevent organ rejection in people who have received a kidney transplant. It works by suppressing the immune system to stop it from attacking the transplanted organ. In this trial, the focus is on optimizing the dosage of tacrolimus for patients with chronic kidney disease before they receive a transplant, using a genetic testing strategy to help determine the best dose for each individual.

What is already known about the treatment

Tacrolimus – Tacrolimus is administered orally or intravenously and is primarily used to prevent organ rejection in kidney transplant patients. It is currently well-established in medical practice and literature as an immunosuppressant. The main therapeutic indication for tacrolimus is to reduce the risk of organ rejection following a kidney transplant. At the molecular level, tacrolimus works by inhibiting calcineurin, a protein phosphatase, which in turn reduces the activity of T-cells, a type of white blood cell involved in immune responses. It is classified pharmacologically as a calcineurin inhibitor.

Investigated diseases

Kidney Transplant – A kidney transplant is a surgical procedure in which a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. This condition arises when the kidneys lose their ability to filter waste and excess fluids from the blood, leading to a buildup of harmful substances in the body. The transplanted kidney takes over the function of filtering the blood, helping to restore normal balance and function. Over time, the body may recognize the new kidney as foreign, potentially leading to transplant rejection. Rejection can occur when the immune system attacks the transplanted organ, which may require medical intervention to manage. Regular monitoring and medication are often necessary to ensure the transplanted kidney continues to function effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516596-32-00Protocol codeTRANSPGxEstimated enrolment114 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

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