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Study on Adjusting Enoxaparin Dose for Children with Kidney Transplants to Prevent Blood Clots

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 studying a condition known as allograft vascular thrombosis, which can occur in children who have received a kidney transplant. The study is investigating the use of a medication called enoxaparin sodium. This medication is commonly used to prevent blood clots, and in this study, it is being used to help manage clotting issues in young kidney transplant recipients.

The purpose of the study is to find the best dose of enoxaparin sodium for children who have had a kidney transplant. The study will use a special method to adjust the dose, aiming to achieve the right level of medication in the blood. This is important to ensure the medication is effective in preventing clots without causing side effects. The study will involve children aged 2 to 18 years who have been identified by their transplant team as needing this treatment.

Participants in the study will receive enoxaparin sodium through a small injection under the skin. The treatment will last for up to seven days, and the effectiveness of the dose will be checked by measuring specific activity levels in the blood. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study aims to improve the care and outcomes for children undergoing kidney transplants by optimizing their treatment with enoxaparin sodium.

The research process

The trial runs in 4 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, the patient must meet specific criteria, including being a pediatric renal transplant recipient aged between 2 and 18 years, with a need for enoxaparin treatment in the first week after the transplant.

    The legal guardian(s) must sign an informed consent form, and the patient must be affiliated with a health insurance system.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with enoxaparin, which is administered through subcutaneous injection. The dosage will be adjusted using a bayesian pharmacological approach to achieve the desired anti-Xa activity.

    The goal is to maintain anti-Xa activity within the target range of 0.3 IU/mL to 0.5 IU/mL, measured 28-30 hours after starting the treatment.

  3. Step 3

    Dose adjustment

    Throughout the study, the dose of enoxaparin may be adjusted based on the patient's response to ensure the anti-Xa activity remains within the target range.

    Regular monitoring will be conducted to assess the effectiveness and safety of the treatment.

  4. Step 4

    End of treatment

    The study is estimated to conclude by July 28, 2025. The patient's participation will end once the treatment objectives are met or the study period concludes.

    Final assessments will be conducted to evaluate the outcomes of the treatment.

Who can join the trial?

13 criteria

  • The patient must be a child who has received a kidney transplant.
  • The patient should be between the ages of 2 and 18 years old.
  • The patient needs to have a reason to use **enoxaparin** during the first week after the transplant. **Enoxaparin** is a medication that helps prevent blood clots.
  • Reasons for using enoxaparin may include certain blood clotting problems, such as:
    • Inherited or acquired conditions that affect blood clotting, like protein C, protein S, or antithrombin III deficiency.
    • Specific genetic mutations, such as **factor V Leiden mutation**, **prothrombin mutation**, or **MTHFR gene mutation**.
    • Presence of certain antibodies that can affect blood clotting, like **anticardiolipin antibodies** or **lupus anticoagulants**.
    • A history of blood clots.
    • If the kidney donor is younger than 2 years old.
    • If the kidney recipient is younger than 5 years old.
    • If the kidney was without blood supply for more than 24 hours before the transplant.
    • If the kidney has multiple blood vessels.
    • The legal guardian(s) of the patient must sign a form agreeing to participate in the study.
    • The patient must be part of a health insurance system.
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Investigated drugs

Enoxaparin is a medication used to prevent and treat blood clots. In this clinical trial, the goal is to adjust the dose of enoxaparin for children who have received a kidney transplant. The adjustment is done using a special method to ensure the medication works effectively and safely by achieving the right level of activity in the blood.

What is already known about the treatment

Enoxaparin – Enoxaparin is administered as an injection, typically under the skin, and is used to prevent blood clots. It is well-established in medical literature and is commonly used in various clinical settings, including the prevention of allograft vascular thrombosis in kidney transplant patients. The main therapeutic indication for enoxaparin is to prevent and treat blood clots, particularly in patients undergoing surgery or those with certain medical conditions that increase clotting risk. At the molecular level, enoxaparin works by enhancing the activity of antithrombin III, which in turn inhibits factor Xa, a key component in the blood clotting process. It is classified as a low molecular weight heparin, a type of anticoagulant.

Investigated diseases

Allograft vascular thrombosis – This condition occurs when a blood clot forms in the blood vessels of a transplanted organ, such as a kidney. It can lead to reduced blood flow to the transplanted organ, potentially affecting its function. The formation of the clot can be influenced by various factors, including the body's immune response to the transplanted tissue. Over time, the lack of adequate blood supply can cause damage to the organ. This condition requires careful monitoring to ensure the transplanted organ remains healthy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513650-30-00Protocol codeAPHP180617Estimated enrolment50 patientsSponsorAssistance Publique Hopitaux De Paris

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