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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 20
Healthy Volunteers: f
View:

• Pediatric renal transplant recipients

• Aged ≥ 2 years and ≤18 years

• 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.

• Informed consent form signed by the legal guardian(s)

• Affiliated to a health insurance system, including AME

Locations
Other Locations
France
Hôpital Pellegrin
NOT_YET_RECRUITING
Bordeaux
Hôpital Pellegrin
RECRUITING
Bordeaux
CHU Félix Guyon
NOT_YET_RECRUITING
La Réunion
CHU Félix Guyon
RECRUITING
La Réunion
Hôpital Mère Enfant
NOT_YET_RECRUITING
Lyon
Hôpital Mère Enfant
RECRUITING
Lyon
Hôpital de la Villeneuve
RECRUITING
Montpellier
Hôpital de la Villeneuve
NOT_YET_RECRUITING
Montpellier
Hôtel Dieu
RECRUITING
Nantes
Hôtel Dieu
NOT_YET_RECRUITING
Nantes
Hôpital Necker - Enfants malades
RECRUITING
Paris
Hôpital Necker Enfants Malades
NOT_YET_RECRUITING
Paris
Hôpital Robert Debré
NOT_YET_RECRUITING
Paris
Hôpital Robert Debré
RECRUITING
Paris
Hôpital de Hautepierre
RECRUITING
Strasbourg
Hôpital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
Hôpital des Enfants
NOT_YET_RECRUITING
Toulouse
Hôpital des Enfants
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Olivia BOYER, Pr
olivia.boyer@aphp.fr
+33 1 42 19 26 48
Backup
Laure CHOUPEAUX, Master
laure.choupeaux@aphp.fr
+33 1 44 38 17 11
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 50
Treatments
Experimental: Bayesian based dose adjustment
Optimization of the enoxaparin dose using a bayesian program in order to prevent patients from complications due to the renal transplantation.~A first recommended dose of enoxaparin (50 IU/kg) is administered subcutaneously during transplantation or within the first 24 hours.~Then, in the experimental group, the dose is adjusted following a bayesian program integrated in the electronic Case Report Form which is based on each patient's data as the Anti-Xa activity
Active_comparator: Treatment as usual (empirical dose adjustment)
Anti-Xa activity is measured and twice-daily enoxaparin empirical dose-adjustment is performed according to the usual practices in the investigating centers
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov