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Smart dosing of blood thinner could save kidneys in children

NCT ID NCT05672550

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tested a personalized way to dose the blood thinner enoxaparin in 50 children after kidney transplant. The goal was to prevent dangerous blood clots in the new kidney while avoiding excessive bleeding. Doctors used a computer model (Bayesian approach) to adjust doses based on each child's needs, aiming for a precise anti-Xa target. The trial compared this smart dosing to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enoxaparin (a blood thinner)
What this could lead to
If successful, this could lead to safer, more effective blood clot prevention in children after kidney transplant, reducing graft loss.
What could go wrong
This is a small, completed Phase 4 study with only 50 participants. The approach may not work for all children or may still carry bleeding risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

50 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pediatric renal transplant recipients 2. Aged ≥ 2 years and ≤18 years 3. With an indication for enoxaparin treatment in the first post-transplant week according to the local transplant team such as inherited or acquired thrombotic disorders (eg. but not exclusive protein C, protein S, and antithrombin III deficiency; factor V Leiden mutation (FV506Q), prothrombin mutation (G20210A), mutation in the MTHFR (methyl Tetra hydro folate reductase) gene (C677T), and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulants), history of thrombosis, donor age \< 2 years, recipient age \< 5 years, cold ischemia time \>24h, multiple renal vessels. 4. Informed consent form signed by the legal guardian(s) 5. Affiliated to a health insurance system, including AME Exclusion Criteria 1. Per-transplant technical surgical problems 2. Pre-inclusion allograft thrombosis (before randomization and enoxaparin administration) 3. Peri-operative thrombosis or uncontrolled bleeding (before randomization and enoxaparin administration) 4. Peri-operative hemodynamic instability 5. Medical history of heparin-induced thrombocytopenia 6. Allergic reaction to enoxaparin or excipients 7. Pregnancy 8. LMWH (Low molecular weight heparins) prophylactic before transplant 9. UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric kidney transplant recipients

Contacts and locations

Locations

  • CHU Félix Guyon

    La Réunion, France

  • Hôpital Mère Enfant

    Lyon, France

  • Hôpital Necker - Enfants malades

    Paris, Île-de-France Region, 75015, France

  • Hôpital Necker Enfants Malades

    Paris, 75015, France

  • Hôpital Pellegrin

    Bordeaux, 33000, France

  • Hôpital Robert Debré

    Paris, 75019, France

  • Hôpital de Hautepierre

    Strasbourg, France

  • Hôpital de la Villeneuve

    Montpellier, France

  • Hôpital des Enfants

    Toulouse, France

  • Hôtel Dieu

    Nantes, France

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