Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients

Phase 1

Conditions: Allograft vascular thrombosis
MedDRA version: 20.0Level: PTClassification code 10072226Term: Renal vascular thrombosisSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Not possible to specify

Registration Number: EUCTR2021-000099-12-FR

Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) per-transplant technical surgical problems
2) pre-inclusion allograft thrombosis (before randomization and enoxaparin administration)
3) peri-operative thrombosis or 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 prophylactic before transplant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To optimize the dose of enoxaparin in order to achieve appropriate anti-Xa activity in pediatric renal transplantation.;Secondary Objective: •To maintain target-range anti-Xa activity at all assessments during the first week of treatment<br>•To assess the safety of this approach.<br>;Primary end point(s): Anti-Xa activity within target ranges (0.3-0.5 IU/mL) 28-30 hours after initiation of treatment.;Timepoint(s) of evaluation of this end point: 28-30 hours after initiation of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Time to achieve a target anti-Xa activity (0.3-0.5 IU/mL)<br>•Anti-Xa activity within target ranges from H28-30 to D7 after initiation of treatment (same method as primary endpoint)<br>•Graft thrombosis : assessed by allograft ultrasound<br>•Enoxaparin-related side effects during the first postoperative month: bleeding (all localisations), graft hematoma (presence/absence): assessed by ultrasound<br>•Allograft bleeding: bleeding with post-operative transfusion<br>•Enoxaparin induced thrombopenia<br>;Timepoint(s) of evaluation of this end point: - H28-30 to D7 after initiation of treatment<br>- D30