Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
50
Countries
1
Sites
18
Allograft vascular thrombosis
To optimize the dose of enoxaparin in order to achieve appropriate antiXa activity in pediatric renal transplantation.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 28 Jun 2023 → 1 Sep 2025
- Decision date (initial)
- 2024-07-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513650-30-00
- EudraCT number
- 2021-000099-12
- ClinicalTrials.gov
- NCT05672550
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacokinetic, Efficacy, Prophylaxis
To optimize the dose of enoxaparin in order to achieve appropriate antiXa activity in pediatric renal transplantation.
Conditions and MedDRA coding
Allograft vascular thrombosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- pediatric renal transplant recipients
- aged ≥ 2 years and ≤20 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 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
Exclusion criteria 9
- per-transplant technical surgical problems
- pre-inclusion allograft thrombosis (before randomization and enoxaparin administration)
- peri-operative thrombosis or uncontrolled bleeding (before randomization and enoxaparin administration)
- peri-operative hemodynamic instability
- medical history of heparin-induced thrombocytopenia
- allergic reaction to enoxaparin or excipients
- pregnancy
- LMWH prophylactic before transplant
- UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Anti-Xa activity within the target range (i.e., success defined by an anti-Xa activity ≥0.3 IU/mL and ≤0.5 IU/mL) 28-30 hours after initiation of treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP13845235 · ATC
- Active substance
- Enoxaparin Sodium
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 100 IU/Kg iu/kilogram
- Max total dose
- 700 IU/Kg iu/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Olivia BOYER
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Olivia BOYER
Locations
1 EU/EEA country · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 50 | 18 |
| Rest of world | — | 0 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Réanimation Médico-Chirurgical Pédiatrique Spécialisée, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Bordeaux
Réanimation pédiatrique et Néonatale, Place Amelie Raba Leon, 33000, Bordeaux
Hospices Civils De Lyon
Réanimation pédiatrique, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De La Reunion
Réanimation et USC Pédiatrique, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Universitaire De Bordeaux
Néphrologie Pédiatrique, Place Amelie Raba Leon, 33000, Bordeaux
Les Hopitaux Universitaires De Strasbourg
Pédiatrie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Montpellier
Néphrologie Pédiatrique, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Néphrologie pédiatrique, 149 Rue De Sevres, 75015, Paris
Assistance Publique Hopitaux De Paris
Réanimation et Surveillance Continue Médico-Chirurgical, 149 Rue De Sevres, 75015, Paris
Hospices Civils De Lyon
Néphrologie Pédiatrique, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Médecine Intensive et Réanimation Pédiatrique, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire De Montpellier
Pédiatrie Néonatale et Réanimations, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nantes
Soins intensifs Pédiatriques, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Néphrologie Pédiatrique, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire De Nantes
Maladies Chroniques de l’Enfant, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De La Reunion
Néphrologie Pédiatrique, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Universitaire De Toulouse
Réanimation médico-chirurgicale pédiatrique et néonatale, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Toulouse
Néphrologie, médecine interne et hypertension pédiatrique, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-06-28 | 2025-09-01 | 2023-06-28 | 2025-08-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_List investigators_2024-513650-30-00_P | 6-0 |
| Protocol (for publication) | D1_Pregnancy-form_2024-513650-30-00_P | 1 |
| Protocol (for publication) | D1_Protocol_2024-513650-30-00_P | 6-0 |
| Protocol (for publication) | D1_SAE-form_2024-513650-30-00_P | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS 13-18 ans | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS 7-12 ans | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF mineur-devenu-majeur | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_autorite-parentale | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_majeur | 1-1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LOVENOX | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-513650-30-00_P | 6-0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-513650-30-00_P | 6-0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | France | Acceptable 2024-07-02
|
2024-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-14 | France | Acceptable 2025-05-22
|
2025-05-23 |