A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 30, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Anakinra can be more effective than the standard treatment with intravenous immunoglobulin (IVIG) for children with Kawasaki disease (KD) who did not respond to the initial IVIG treatment. Kawasaki disease is a serious condition that affects blood vessels in young children and can lead to heart problems if not treated properly. The trial aims to see if Anakinra can help reduce inflammation quickly and improve long-term health outcomes for these patients.

To be eligible for the trial, children aged 3 months to under 18 years who weigh at least 5 kg and have been diagnosed with Kawasaki disease can participate. It's important that these children have not improved after receiving standard IVIG treatment, meaning they still have a fever after 48 hours. Participants will receive either Anakinra or continued IVIG treatment and will be monitored for safety and effectiveness. This trial is an opportunity to explore new treatment options for Kawasaki disease, and parents or guardians will need to give their consent for their child to be involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children, male and female, from 3 months to \<18 years old
• • Patient ≥ 5 kg
• • Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with American Heart Association criteria since the third days of fever) and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral \> 1.5 cm in diameter.
• • Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg of IV Ig. Patients may be screened 24h after the end of the first infusion if they remain febrile 24h after the end of the first infusion.
• • Patient, parents or legal guardian's written informed consent is required
• • Patient with health insurance (SS or CMU).
• • Efficient contraception for the duration of participation in the research for childbearing aged women
• Exclusion Criteria:
• • Preterm and neonates, pregnancy, pregnancy and breast feeding
• • Suspicion of another diagnosis
• • Patient with overt concomitant bacterial, viral or fungal infection
• • Patient previously treated with steroids and/or another biotherapy
• • Patient with increased risk of tuberculosis infection
• • Recent tuberculosis infection or with active tuberculosis
• • Patient with any type of immunodeficiency or cancer
• • Patients with severe renal impairment (CLcr \< 30 ml/minute)
• • Patients with hepatic insufficiency
• • Patients with neutropenia (ANC\<1.5 x109/l)
• • Patients included in another interventional protocol
• * Patient under the following treatments:
• • Preventive Antipyretics (paracetamol, NSAIDs other than aspirin 30-50mg/kg given for purpose of KD inflammation), as long as the patient receives the study medication
• • Immunosuppressive medications given in a period less than twice of their half-life prior the patient receives the study medication (systemic steroids, cyclosporine, tacrolimus, azathioprine, cyclophosphamide, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF (Tumor Necrosis Factor)), plasmapheresis)
• • Hypersensitivity to anakinra or excipients (citric acid, sodium chloride, disodium EDTA (Ethylene Diamine Tetra Acetic), polysorbate 80, sodium hydroxide, in water for injection)
• • Hypersensitivity to IV Ig, or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies (IgA: Immunoglobulin A)
• • Patients with type I or II hyperprolinemia
• • Live vaccines within 1 month prior to enrollment
• • Hypersensitivity to anakinra or to immunoglobulins or to excipients of Kineret® or Privigen® or to E.coli proteins
• • Contraindication for administration of anakinra or IVIG listed in the Summary of Products Characteristics (SmPC) of Kineret® and Privigen®
• • Ongoing or recent use of any other medication Known inhibitors/inducers of cytochrome P450 as listed on the link below: http://medicine.iupui.edu/clinpharm/ddis/main-table