Adjusting Enoxaparin Doses for Children After Kidney Transplant

Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients

This study is testing a new way to adjust blood thinner doses for kids who have had a kidney transplant to see if it works better than the usual method.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 18 sites (Paris, Ile-de-France and 17 other locations)
• Trial ID: NCT05672550 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a Bayesian pharmacological approach for adjusting enoxaparin doses in pediatric kidney transplant recipients. The study will compare this method to traditional dosing based on physician experience, focusing on achieving optimal anti-Xa activity levels within a critical time frame post-transplant. Conducted as an open-label randomized trial across nine specialized nephrology centers, the primary endpoint is to determine the efficacy of the Bayesian dosing strategy in maintaining therapeutic anticoagulation. The trial seeks to address the lack of consensus on prophylactic anticoagulation in pediatric kidney transplantation.

Who should consider this trial

Good fit: Ideal candidates include pediatric patients aged 2 to 17 years who are undergoing kidney transplantation and require enoxaparin treatment.

Not a fit: Patients with pre-existing allograft thrombosis or those experiencing peri-operative complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of allograft thrombosis and improve outcomes for pediatric kidney transplant recipients.

How similar studies have performed: While the use of Bayesian approaches in pharmacology is gaining traction, this specific application in pediatric kidney transplantation is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Paris, Ile-de-France and 17 other locations

• Hôpital Necker - Enfants malades — Paris, Ile-de-France, France (RECRUITING)
• Hôpital Pellegrin — Bordeaux, France (RECRUITING)
• Hôpital Pellegrin — Bordeaux, France (NOT_YET_RECRUITING)
• CHU Félix Guyon — La Réunion, France (RECRUITING)
• CHU Félix Guyon — La Réunion, France (NOT_YET_RECRUITING)
• Hôpital Mère Enfant — Lyon, France (RECRUITING)
• Hôpital Mère Enfant — Lyon, France (NOT_YET_RECRUITING)
• Hôpital la Timone — Marseille, France (NOT_YET_RECRUITING)
• Hôpital la Timone — Marseille, France (NOT_YET_RECRUITING)
• Hôpital de la Villeneuve — Montpellier, France (RECRUITING)
• Hôpital de la Villeneuve — Montpellier, France (NOT_YET_RECRUITING)
• Hôtel Dieu — Nantes, France (RECRUITING)
• Hôtel Dieu — Nantes, France (NOT_YET_RECRUITING)
• Hôpital Necker Enfants Malades — Paris, France (NOT_YET_RECRUITING)
• Hôpital Robert Debré — Paris, France (RECRUITING)
• Hôpital Robert Debré — Paris, France (NOT_YET_RECRUITING)
• Hôpital de Hautepierre — Strasbourg, France (RECRUITING)
• Hôpital de Hautepierre — Strasbourg, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Olivia BOYER, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Olivia BOYER, Pr

Conditions: Pediatric Kidney Transplant Recipients, Kidney transplantation, Children, Enoxaparin, Bayesian based dose, Anti-Xa activity, allograft thrombosis