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

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What is this study about?

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.

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 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 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 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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hblbypyu Ujymmyjhbfckzn Srjzkxgeng &tepoji Hmxnzrc dd Hyzaaxrumho	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.06.2023

Trial locations

Investigated drugs:

Enoxaparin Sodium

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.

Investigated diseases:

Renal transplant

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 ID:

2024-513650-30-00

Protocol code:

APHP180617

NCT ID:

NCT05672550

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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