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Study on Tacrolimus Dosing for Stable Adult Kidney Transplant Patients in the First Year After 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 patients who have undergone a kidney transplantation. The study is investigating the use of a medication called tacrolimus, which is commonly used to help prevent the body from rejecting a transplanted kidney. Tacrolimus is being tested in different forms, including a prolonged-release capsule, a hard capsule, and a concentrate for infusion. The purpose of the study is to compare the safety and effectiveness of a personalized approach to dosing tacrolimus, guided by measuring the immune system's functionality, against the standard dosing method.

Participants in the study will be stable adult kidney transplant recipients who are considered to have a low risk of immune system complications in the first year after their transplant. The study will last for up to 36 months, during which time participants will receive either the standard tacrolimus treatment or a personalized dose based on their immune system's response. The study aims to ensure that the personalized dosing is not inferior to the standard dosing in terms of safety and effectiveness.

Throughout the study, researchers will monitor various health outcomes, including any infections that require treatment, rejection of the transplanted kidney, and overall health and quality of life. The study will also track the levels of Torque Teno virus (TTV) in the blood, which is used to guide the personalized dosing of tacrolimus. The goal is to find a dosing strategy that maintains the health of the transplanted kidney while minimizing side effects and improving the patient's quality of life.

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 trial

    Upon joining the trial, participants will be required to provide written informed consent. This ensures understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying that the participant is an adult, has received a kidney transplant, and is at least 93 days post-transplantation.

  3. Step 3

    Treatment allocation

    Participants will be randomly assigned to one of two groups: the standard treatment group or the Torque Teno virus-guided treatment group. This allocation is done to compare the safety and effectiveness of the two approaches.

  4. Step 4

    Medication administration

    Participants in both groups will receive tacrolimus, a medication used to prevent organ rejection. The standard group will receive it orally, while the guided group may receive it through oral or infusion routes, depending on the study requirements.

    The dosage and frequency of tacrolimus will be determined by the study protocol and may vary based on individual needs and responses.

  5. Step 5

    Regular monitoring

    Participants will attend regular monitoring visits. These visits will include assessments of kidney function, medication levels, and overall health to ensure safety and effectiveness of the treatment.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by May 2025. Participants will have a final assessment to evaluate the outcomes of the treatment and any long-term effects.

Who can join the trial?

6 criteria

  • Recipient of a kidney allograft (a kidney transplant from another person).
  • Adult (at least 18 years of age).
  • At least 93 days have passed since the kidney transplant.
  • Currently on TAC-based immunosuppression (a medication regimen to prevent organ rejection).
  • Standard target TAC trough level (a specific level of medication in the blood, as defined by the local medical center; some patients might be excluded if they have conditions like lung transplantation, new antibodies against the donor, or a condition called thrombotic microangiopathy).
  • Have provided written informed consent (agreement to participate after understanding the study).

Who cannot join the trial?

4 criteria

  • Patients who have not had a **kidney transplant**.
  • Patients who are not considered **stable** after their kidney transplant.
  • Patients who are at **high immunological risk**. This means their immune system might react strongly against the transplanted kidney.
  • Patients who are not in the **first year** after their kidney transplant.
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Investigated drugs

  • TAC

    is a medication used to help prevent the body from rejecting a transplanted kidney. It works by suppressing the immune system, which is the body's defense system that can sometimes attack the new organ. In this trial, TAC is used as a standard treatment to help keep the transplanted kidney healthy and functioning properly.

  • TTV-guided immunosuppression

    is a new approach being tested in this trial. It involves adjusting the amount of immunosuppressive medication based on the levels of a virus called Torque Teno virus (TTV) in the body. The idea is that by monitoring TTV levels, doctors can better tailor the treatment to each patient, potentially improving safety and effectiveness while reducing side effects. This method is being compared to the standard TAC treatment to see if it is just as safe and effective for patients who have received a kidney transplant.

What is already known about the treatment

Tacrolimus – Tacrolimus is administered orally in the form of capsules or as an injection. It is currently used in medicine to help prevent organ rejection in patients who have received a kidney transplant. The main therapeutic indication for Tacrolimus is to suppress the immune system to prevent it from attacking the transplanted organ. At the molecular level, Tacrolimus works by inhibiting a protein called calcineurin, which is crucial for activating T-cells, a type of immune cell. This medication is classified as an immunosuppressant.

Investigated diseases

Post Kidney Transplantation – This condition occurs after a person receives a kidney transplant, which is a surgical procedure to place a healthy kidney from a donor into someone whose kidneys no longer function properly. After the transplant, the body may recognize the new kidney as foreign and attempt to reject it, which can lead to complications. The immune system plays a crucial role in this process, and immunosuppressive medications are often required to prevent rejection. Over time, the transplanted kidney may experience changes in function, which can be monitored through various tests. Patients may also be at risk for infections due to the immunosuppressive therapy. Regular follow-up and monitoring are essential to ensure the health and function of the transplanted kidney.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500024-30-00Protocol codeTTV GUIDE ITEstimated enrolment260 patientsSponsorMedical University Of Vienna

sourced from the EU Clinical Trials Register and site verification

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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).