Informations générales (source: ClinicalTrials.gov)
Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients
Interventional
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2023
octobre 2026
02 décembre 2025
Allograft vascular thrombosis is a devastating complication in kidney transplantation in
adults and older children. Though uncommon, it is often irreversible and represents the
main cause of graft loss within after kidney transplantation in adults and in the first
post-operative year in children. Since allograft thrombosis is usually observed in the
first 48h post-operatively, the need to promptly achieve appropriate anticoagulation in
at-risk patients is of utmost importance.
However, no consensus exists regarding the optimal prophylaxis in the peri-transplant
period and the following dose-adjustment, and practices are highly heterogeneous among
centers. Moreover, the therapeutic target is very narrow and antithrombotic agents may
conversely increase the risk of allograft hematoma. Enoxaparin is a low molecular weight
heparin commonly used in this context, but off-label in children. Therapeutic ranges are
based on anti-Xa levels 4 to 6 hours following injection and extrapolated from adults
although evidences suggest that such extrapolation may be inappropriate in many
circumstances. The current pediatric practice of dose adjustment to achieve and maintain
a target anti-Xa range is empirical and dependent on the physician.
The aim of the proposed clinical trial is to assess the efficacy/safety profile of this
bayesian-based dose optimization in the clinical setting, as compared to the current
practices of empirical adjustment. This should greatly improve the personalized
management of renal transplanted children, a subset of patients with singular renal
function and little-investigated pharmacokinetics and help standardizing and
rationalizing practices.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:22:16 | Contacter | |||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Robert Debré | |||||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | Olivia BOYER, Pr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Félix Guyon - La Réunion 6619528 - France | Etienne DARRIEUX, MD | Contact (sur clinicalTrials) | |||
| Hôpital de Hautepierre - Strasbourg 2973783 - France | Anne Sophie GUILBERT, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Villeneuve - Montpellier 2992166 - France | Julien BALEINE, MD | Contact (sur clinicalTrials) | |||
| Hôpital des Enfants - Toulouse 2972315 - France | Sophie BREINIG, MD | Contact (sur clinicalTrials) | |||
| Hôpital Mère Enfant - Lyon 2996944 - France | Fleur COUR-ANDLAUER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Pellegrin - 33000 - Bordeaux 3031582 - France | Julie GUICHOUX, MD | Contact (sur clinicalTrials) | |||
| Hôpital Robert Debré - 75019 - Paris 2988507 - France | Jérôme NAUDIN, MD | Contact (sur clinicalTrials) | |||
| Hôtel Dieu - Nantes 2990969 - France | Alexis CHENOUARD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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